<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03762265</url>
  </required_header>
  <id_info>
    <org_study_id>EFC17092</org_study_id>
    <secondary_id>PRN1008-012</secondary_id>
    <secondary_id>2018-002261-19</secondary_id>
    <nct_id>NCT03762265</nct_id>
  </id_info>
  <brief_title>A Study of PRN1008 in Patients With Pemphigus</brief_title>
  <official_title>A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Oral BTK Inhibitor Rilzabrutinib (PRN1008) in Moderate to Severe Pemphigus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Principia Biopharma, a Sanofi Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sanofi</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This was a Phase 3 randomized, parallel-group, double-blind, placebo-controlled trial&#xD;
      (blinded treatment [BT] period) followed by an open-label extension [OLE] period intended to&#xD;
      evaluate the efficacy and safety of oral PRN1008 in moderate to severe pemphigus. After&#xD;
      completing the open-label extension period, eligible participants might continue in a long&#xD;
      term extension (LTE) Period of 48 weeks.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A total of 131 male or female participants with newly diagnosed or relapsing moderate to&#xD;
      severe pemphigus (pemphigus vulgaris [PV] or pemphigus foliaceus [PF]) were enrolled in the&#xD;
      trial worldwide.&#xD;
&#xD;
      The trial would last 68 weeks (approximately 17 months) for each participant. For&#xD;
      participants eligible to enroll in the LTE, the trial might last up to 116 weeks.&#xD;
&#xD;
      Participants were randomized at Day 1, using a 1:1 ratio to receive PRN1008 or placebo twice&#xD;
      per day, by relapsing/newly diagnosed disease history (newly diagnosed defined as within 6&#xD;
      months of screening).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Sponsor decision based on lack of efficacy&#xD;
  </why_stopped>
  <start_date type="Actual">January 8, 2019</start_date>
  <completion_date type="Actual">December 17, 2021</completion_date>
  <primary_completion_date type="Actual">July 30, 2021</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants Who Achieved Complete Remission (CR) With a Corticosteroids Dose of Less Than or Equal to (&lt;=) 10 mg/Day From Week 29 to Week 37: Pemphigus Vulgaris Participants in Modified Intent-to-Treat (PV mITT) Population</measure>
    <time_frame>From Week 29 to Week 37</time_frame>
    <description>Complete remission was defined as absence of new and established lesions and was intended to mean &quot;no disease activity&quot; for 2 consecutive weeks, with Pemphigus Disease Area Index (PDAI) activity score =0 and CS dose &lt;=10 mg. PDAI score weighted for number and size of lesions with score of 0 (absent) to 10 given for skin (12 body locations), scalp and mucous membrane showing disease activity (erosions/blisters or new erythema). PDAI total score ranged from 0 to 250 points representing disease activity (120 points for skin activity; 10 points for scalp activity; 120 points for mucosal activity). Higher score indicated more disease activity. In this outcome measure (OM), percentage of participants who achieved CR while on a daily corticosteroids dose of &lt;=10 mg/day were reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Who Achieved Complete Remission With a Corticosteroids Dose of &lt;=10 mg/Day From Week 29 to Week 37: Modified Intent-to-Treat (mITT) Population</measure>
    <time_frame>From Week 29 to Week 37</time_frame>
    <description>Complete remission was defined as absence of new and established lesions and was intended to mean &quot;no disease activity&quot; for 2 consecutive weeks, with PDAI activity score =0 and CS dose &lt;=10 mg. PDAI score weighted for number and size of lesions with score of 0 (absent) to 10 given for skin (12 body locations), scalp and mucous membrane showing disease activity (erosions/blisters or new erythema). PDAI total score ranged from 0 to 250 points representing disease activity (120 points for skin activity; 10 points for scalp activity; 120 points for mucosal activity). Higher score indicated more disease activity. In this OM, percentage of participants who achieved CR while on a daily corticosteroids dose of &lt;=10 mg/day were reported.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cumulative Oral Corticosteroid Dose From Baseline to Week 37: PV mITT Population</measure>
    <time_frame>Baseline to Week 37</time_frame>
    <description>The cumulative dose (in milligrams) of sponsor-provided oral CS (prednisone or prednisolone) received by the participants during the BT period was calculated from Baseline to Week 37 and is reported in this OM.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative Oral Corticosteroid Dose From Baseline to Week 37: mITT Population</measure>
    <time_frame>Baseline to Week 37</time_frame>
    <description>The cumulative dose (in milligrams) of sponsor-provided oral CS (prednisone or prednisolone) received by the participants during the BT period was calculated from Baseline to Week 37 and is reported in this OM.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative Duration of Complete Remission With a Corticosteroids Dose &lt;=10 mg/Day From Baseline to Week 37: PV mITT Population</measure>
    <time_frame>Baseline to Week 37</time_frame>
    <description>Cumulative duration (in days) of CR post first CS dose of &lt;= 10 mg/day from Baseline to Week 37 was analyzed with a zero-inflated negative binomial model with terms of treatment group and disease history, and an offset based on the number of days on blinded treatment period and were reported in this OM. Complete remission was defined as the absence of new and established lesions and was intended to mean &quot;no disease activity&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative Duration of Complete Remission With a Corticosteroids Dose &lt;=10 mg/Day From Baseline to Week 37: mITT Population</measure>
    <time_frame>Baseline to Week 37</time_frame>
    <description>Cumulative duration (in days) of CR post first CS dose of &lt;= 10 mg/day from Baseline to Week 37 was analyzed with a zero-inflated negative binomial model with terms of treatment group and disease history, and an offset based on the number of days on blinded treatment period and were reported in this OM. Complete remission was defined as the absence of new and established lesions and was intended to mean &quot;no disease activity&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to First Complete Remission With a Corticosteroids Dose &lt;=10 mg/Day From Baseline to Week 37: PV mITT Population</measure>
    <time_frame>Baseline to Week 37</time_frame>
    <description>Time to first CR was the time (in days) to achieve CR while on CS dose of &lt;=10 mg/day. Complete remission was defined as the absence of new and established lesions to the &quot;no disease activity&quot;. Kaplan-Meier method was used for the analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to First Complete Remission With a Corticosteroids Dose &lt;=10 mg/Day From Baseline to Week 37: mITT Population</measure>
    <time_frame>Baseline to Week 37</time_frame>
    <description>Time to first CR was the time (in days) to achieve CR while on CS dose of &lt;=10 mg/day. Complete remission was defined as the absence of new and established lesions to the &quot;no disease activity&quot;. Kaplan-Meier method was used for the analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved Complete Remission With a Corticosteroids Dose of &lt;=5 mg/Day From Week 29 to Week 37: PV mITT Population</measure>
    <time_frame>From Week 29 to Week 37</time_frame>
    <description>Complete remission was defined as the absence of new and established lesions and was intended to mean &quot;no disease activity&quot;. In this OM, percentage of participants who achieved CR while on a daily corticosteroids dose of &lt;=5 mg/day were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved Complete Remission With a Corticosteroids Dose of &lt;=5 mg/Day From Week 29 to Week 37: mITT Population</measure>
    <time_frame>From Week 29 to Week 37</time_frame>
    <description>Complete remission was defined as the absence of new and established lesions and was intended to mean &quot;no disease activity&quot;. In this OM, percentage of participants who achieved CR while on a daily corticosteroids dose of &lt;=5 mg/day were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Had Pemphigus Disease Area Index (PDAI) Score &lt;3 With a Corticosteroids Dose &lt;=10 mg/Day From Week 29 to Week 37: PV mITT Population</measure>
    <time_frame>From Week 29 to Week 37</time_frame>
    <description>PDAI is specific cutaneous and mucosal disease activity assessment performed by investigator based on evaluation of lesions in well-defined anatomical locations. The score weighted for the number and size of lesions with score of 0 (absent) to 10 given for skin (12 body locations), scalp and mucous membrane showing disease activity (erosions/blisters or new erythema). Thus, PDAI total activity score ranged from 0 to 250 points representing disease activity (120 points for skin activity; 10 points for scalp activity; 120 points for mucosal activity). Higher score indicated more disease activity. In this OM, participants with PDAI score &lt;3 while on a CS dose of &lt;=10 mg/day were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Had Pemphigus Disease Area Index Score &lt;3 With a Corticosteroids Dose &lt;=10 mg/Day From Week 29 to Week 37: mITT Population</measure>
    <time_frame>From Week 29 to Week 37</time_frame>
    <description>PDAI is specific cutaneous and mucosal disease activity assessment performed by investigator based on evaluation of lesions in well-defined anatomical locations. The score weighted for the number and size of lesions with score of 0 (absent) to 10 given for skin (12 body locations), scalp and mucous membrane showing disease activity (erosions/blisters or new erythema). Thus, PDAI total activity score ranged from 0 to 250 points representing disease activity (120 points for skin activity; 10 points for scalp activity; 120 points for mucosal activity). Higher score indicated more disease activity. In this OM, participants with PDAI score &lt;3 while on a CS dose of &lt;=10 mg/day were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative Duration of Complete Remission With a Corticosteroids Dose &lt;=10 mg/Day From Baseline to Weeks 61 and 109: PV mITT Population</measure>
    <time_frame>Baseline to Week 61 and Baseline to Week 109</time_frame>
    <description>Cumulative duration (in days) of CR post all doses of CS &lt;=10 mg/day during Baseline to Week 61 and Baseline to Week 109 were reported in this OM. Complete remission was defined as the absence of new and established lesions to the &quot;no disease activity&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative Duration of Complete Remission With a Corticosteroids Dose &lt;=10 mg/Day From Baseline to Weeks 61 and 109: mITT Population</measure>
    <time_frame>Baseline to Weeks 61 and Baseline to Week 109</time_frame>
    <description>Cumulative duration (in days) of CR post all doses of CS &lt;=10 mg/day during Baseline to Week 61 and Baseline to Week 109 were reported in this OM. Complete remission was defined as the absence of new and established lesions to the &quot;no disease activity&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative Duration of Complete Remission With a Corticosteroids Dose = 0 mg/Day From Baseline to Weeks 61 and 109: PV mITT Population</measure>
    <time_frame>Baseline to Week 61 and Baseline to Week 109</time_frame>
    <description>Cumulative duration (in days) of CR post all doses of CS =0 mg/day during Baseline to Week 61 and Baseline to Week 109 were reported in this OM. Complete remission was defined as the absence of new and established lesions to the &quot;no disease activity&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative Duration of Complete Remission With a Corticosteroids Dose = 0 mg/Day From Baseline to Weeks 61 and 109: mITT Population</measure>
    <time_frame>Baseline to Week 61 and Baseline to Week 109</time_frame>
    <description>Cumulative duration (in days) of CR post all doses of CS dose = 0 mg/day during Baseline to Week 61 and Baseline to Week 109 were reported in this OM. Complete remission was defined as the absence of new and established lesions to the &quot;no disease activity&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucocorticoid Toxicity Index (GTI) - Cumulative Worsening Score (CWS) and Aggregate Improvement Score (AIS) at Week 37: PV mITT Population</measure>
    <time_frame>At Week 37</time_frame>
    <description>GTI assessed glucocorticoid (GC) related morbidity and GC-sparing ability of other therapies; composed of 2 components: Composite GTI and specific list. Composite GTI had 9 domains and specific list had 23 items (11 domains), used as complementary tool to C-GTI. Composite GTI score:sum of 9 domain-specific scores at each visit and cumulative GTI score:sum of composite GTI scores across each visit. 2 cumulative GTI scores: CWS and AIS at Week 37 reported in this OM. CWS assessed cumulative GC toxicity regardless of whether toxicity had lasting effects/was transient. AIS assessed new therapy effectiveness in decreasing any Baseline GC toxicity over time. CWS composite score range: 0 to 439 and AIS composite score range: -346 to 439. In CWS and AIS, minimum score=least toxicity and maximum score=most toxicity. Least square (LS) mean and standard error (SE) from analysis of covariance model using treatment, disease history as fixed effects and Baseline GTI score and CS dose as covariates.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucocorticoid Toxicity Index - Cumulative Worsening Score and Aggregate Improvement Score at Week 37: mITT Population</measure>
    <time_frame>At Week 37</time_frame>
    <description>GTI assessed GC related morbidity and GC-sparing ability of other therapies; composed of 2 components: Composite GTI and specific list. Composite GTI contained 9 domains and specific list contained of 23 items (11 domains), used as complementary tool to C-GTI. Composite GTI score: sum of 9 domain-specific scores at each visit and cumulative GTI score: sum of composite GTI scores across each visit. Two cumulative GTI scores: CWS and AIS at Week 37 were reported in this OM. CWS assessed cumulative GC toxicity regardless of whether toxicity had lasting effects/was transient. AIS assessed new therapy effectiveness in decreasing any Baseline GC toxicity over time. CWS composite score ranged from 0 to 439 and AIS composite score ranged from -346 to 439. For CWS and AIS, minimum score = least toxicity and maximum score = most toxicity. LS mean and SE from analysis of covariance model using treatment, disease history as fixed effects and Baseline GTI score and CS dose as covariates.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Pemphigus Disease Area Index Score at Weeks 5, 13, 25, 37, 61, and 109: PV mITT Population</measure>
    <time_frame>Baseline, Weeks 5, 13, 25, 37, 61, and 109</time_frame>
    <description>PDAI is specific cutaneous and mucosal disease activity assessment performed by investigator based on evaluation of lesions in well-defined anatomical locations. The score weighted for the number and size of lesions with score of 0 (absent) to 10 given for skin (12 body locations), scalp and mucous membrane showing disease activity (erosions/blisters or new erythema). Thus, PDAI total activity score ranged from 0 to 250 points representing disease activity (120 points for skin activity; 10 points for scalp activity; 120 points for mucosal activity). Higher score indicated more disease activity. PDAI activity score was measured independently of the CS dose administered in the participants.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Pemphigus Disease Area Index Score at Weeks 5, 13, 25, 37, 61, and 109: mITT Population</measure>
    <time_frame>Baseline, Weeks 5, 13, 25, 37, 61, and 109</time_frame>
    <description>PDAI is specific cutaneous and mucosal disease activity assessment performed by investigator based on evaluation of lesions in well-defined anatomical locations. The score weighted for the number and size of lesions with score of 0 (absent) to 10 given for skin (12 body locations), scalp and mucous membrane showing disease activity (erosions/blisters or new erythema). Thus, PDAI total activity score ranged from 0 to 250 points representing disease activity (120 points for skin activity; 10 points for scalp activity; 120 points for mucosal activity). Higher score indicated more disease activity. PDAI activity score was measured independently of the CS dose administered in the participants.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Autoimmune Bullous Disease Quality of Life (ABQOL) Score at Weeks 5, 13, 25, 37, 61, and 109: PV mITT Population</measure>
    <time_frame>Baseline, Weeks 5, 13, 25, 37, 61, and 109</time_frame>
    <description>ABQOL, a 17-item questionnaire is a valid and reliable tool to assess quality of life in participants with autoimmune blistering diseases. Each question score ranged from 0 to 3 points, 0 = never, 1 = occasionally, 2 = sometimes and 3 = all the time, where higher score = poor QOL. The total ABQoL score was calculated by summing the score of each question and it ranged from 0 to 51, where higher score = more QOL impairment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Autoimmune Bullous Disease Quality of Life Score at Weeks 5, 13, 25, 37, 61, and 109: mITT Population</measure>
    <time_frame>Baseline, Weeks 5, 13, 25, 37, 61, and 109</time_frame>
    <description>ABQOL, a 17-item questionnaire is a valid and reliable tool to assess quality of life in participants with autoimmune blistering diseases. Each question score ranged from 0 to 3 points, 0 = never, 1 = occasionally, 2 = sometimes and 3 = all the time, where higher score = poor QOL. The total ABQoL score was calculated by summing the score of each question and it ranged from 0 to 51, where higher score = more QOL impairment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Autoimmune Bullous Disease Quality of Life Score of Zero at Weeks 5, 13, 25, 37, 61, and 109: PV mITT Population</measure>
    <time_frame>At Weeks 5, 13, 25, 37, 61, and 109</time_frame>
    <description>ABQOL, a 17-item questionnaire is a valid and reliable tool to assess quality of life in participants with autoimmune blistering diseases. Each question score ranged from 0 to 3 points, 0 = never, 1 = occasionally, 2 = sometimes and 3 = all the time, where higher score = poor QOL. The total ABQoL score was calculated by summing the score of each question and it ranged from 0 to 51, where higher score = more QOL impairment. Percentage of participants with ABQOL score of '0' were reported in this outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Autoimmune Bullous Disease Quality of Life Score of Zero at Weeks 5, 13, 25, 37, 61, and 109: mITT Population</measure>
    <time_frame>At Weeks 5, 13, 25, 37, 61, and 109</time_frame>
    <description>ABQOL, a 17-item questionnaire is a valid and reliable tool to assess quality of life in participants with autoimmune blistering diseases. Each question score ranged from 0 to 3 points, 0 = never, 1 = occasionally, 2 = sometimes and 3 = all the time, where higher score = poor QOL. The total ABQoL score was calculated by summing the score of each question and it ranged from 0 to 51, where higher score = more QOL impairment. Percentage of participants with ABQOL score of '0' were reported in this outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Score: Visual Analogue Scale (VAS) Scores at Weeks 5, 13, 25, 37, 61, and 109</measure>
    <time_frame>Baseline, Weeks 5, 13, 25, 37, 61, and 109</time_frame>
    <description>EQ-5D-5L: standardized measure of health status that provides general assessment of health and wellbeing. EQ-5D VAS was used to record a participant's rating for his/her current health-related quality of life state and captured on a vertical VAS scale ranging from 0 to 100, where 0=worst imaginable health state and 100=best imaginable health state, where higher states indicated better outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels Score: Individual Dimension at Weeks 5, 13, 25, 37, 61, and 109</measure>
    <time_frame>Baseline, Weeks 5, 13, 25, 37, 61, and 109</time_frame>
    <description>EQ-5D-5L: standardized measure of health status that provides general assessment of health and wellbeing. The EQ-5D descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has a 5-level response: no problems, slight problems, moderate problems, severe problems, and extreme problems. Response options are measured with a 5-point Likert scale (for the 5L version). The 5D-5L systems are converted into a single index utility score between 0 to 1, where higher score indicates a better health state and lower score indicate worse health state.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to First Complete Remission With a Corticosteroids Dose &lt;=10 mg/Day From Baseline to Weeks 61 and 109</measure>
    <time_frame>Baseline to Week 61 and Baseline to Week 109</time_frame>
    <description>Time to first CR was the time (in days) to achieve CR while on a CS dose of &lt;=10 mg/day from Baseline to Week 61 and from Baseline to Week 109. Complete remission was defined as absence of new and established lesions to the &quot;no disease activity&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Number of Disease Relapses/Flares From Initial Control of Disease Activity (CDA) to Week 37: PV mITT Population</measure>
    <time_frame>From initial CDA up to Week 37 (i.e., during any time from Baseline up to Week 37)</time_frame>
    <description>Total Number of Disease Relapses/Flares which occurred from initial CDA to Week 37 were reported. CDA was defined as disappearance of new lesions cease to form and established lesions begin to heal. Relapse/flare was defined by the appearance of 3 or more new lesions after CDA and within a month that do not heal spontaneously within 1 week, or by the extension of established lesions, in a participant who had achieved CDA.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Number of Disease Relapses/Flares From Initial Control of Disease Activity to Week 37: mITT Population</measure>
    <time_frame>From initial CDA up to Week 37 (i.e., during any time from Baseline up to Week 37)</time_frame>
    <description>Total Number of Disease Relapses/Flares which occurred from initial CDA to Week 37 were reported. CDA was defined as disappearance of new lesions cease to form and established lesions begin to heal. Relapse/flare was defined by the appearance of 3 or more new lesions after CDA and within a month that do not heal spontaneously within 1 week, or by the extension of established lesions, in a participant who had achieved CDA.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Initial Relapse/Flare From Initial Control of Disease Activity to Week 37: PV mITT Population</measure>
    <time_frame>From initial CDA up to Week 37 (i.e., during any time from Baseline up to Week 37)</time_frame>
    <description>Time duration (in days) from the time of initial relapse/flare which occurred from initial CDA up to Week 37 were reported in this OM. CDA was defined as the visit at which new lesions cease to form and established lesions begin to heal. Relapse/flare was defined by the appearance of 3 or more new lesions after CDA and within a month that do not heal spontaneously within 1 week, or by the extension of established lesions, in a participant who had achieved CDA. Kaplan-Meier method was used for the analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Initial Relapse/Flare From Initial Control of Disease Activity to Week 37: mITT Population</measure>
    <time_frame>From initial CDA up to Week 37 (i.e., during any time from Baseline up to Week 37)</time_frame>
    <description>Time duration (in days) from the time of initial relapse/flare which occurred from initial CDA up to Week 37 were reported in this OM. CDA was defined as the visit at which new lesions cease to form and established lesions begin to heal. Relapse/flare was defined by the appearance of 3 or more new lesions after CDA and within a month that do not heal spontaneously within 1 week, or by the extension of established lesions, in a participant who had achieved CDA. Kaplan-Meier method was used for the analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With 3 or More New Lesions Within 1 Month That do Not Heal Spontaneously Within 1 Week, or With Extension of Established Lesions at Week 37: PV mITT Population</measure>
    <time_frame>At Week 37</time_frame>
    <description>Percentage of Participants With 3 or More New Lesions Within past 1 month that do not heal spontaneously within past 1 week, or with extension of established lesions, were assessed at Week 37 and reported in this OM.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With 3 or More New Lesions Within 1 Month That do Not Heal Spontaneously Within 1 Week, or With Extension of Established Lesions at Week 37: mITT Population</measure>
    <time_frame>At Week 37</time_frame>
    <description>Percentage of participants with 3 or more new lesions within past 1 month that do not heal spontaneously within past 1 week, or with extension of established lesions, were assessed at Week 37 and reported in this OM.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With at Least One Disease Relapse/Flare From Initial Control of Disease Activity to Week 37: PV mITT Population</measure>
    <time_frame>From initial CDA up to Week 37 (i.e., during any time from Baseline up to Week 37)</time_frame>
    <description>CDA was defined as the visit at which new lesions cease to form and established lesions begin to heal. Disease relapse/flare was defined by the appearance of 3 or more new lesions after CDA and within a month that do not heal spontaneously within 1 week, or by the extension of established lesions, in a participant who had achieved CDA. Percentages were calculated based on number of participants assessed (i.e. participants achieved CDA) in each treatment group. Percentage of participants with at least one disease relapse/flare from Initial CDA to Week 37 were reported in this OM.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With at Least One Disease Relapse/Flare From Initial Control of Disease Activity to Week 37: mITT Population</measure>
    <time_frame>From initial CDA up to Week 37 (i.e., during any time from Baseline up to Week 37)</time_frame>
    <description>CDA was defined as the visit at which new lesions cease to form and established lesions begin to heal. Disease relapse/flare was defined by the appearance of 3 or more new lesions after CDA and within a month that do not heal spontaneously within 1 week, or by the extension of established lesions, in a participant who had achieved CDA. Percentages were calculated based on number of participants assessed (i.e. participants achieved CDA) in each treatment group. Percentage of participants with at least one disease relapse/flare from Initial CDA to Week 37 were reported in this OM.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative Duration of Complete Remission With a Corticosteroids Dose &lt;=10 mg/Day From Week 37 to Week 61: PV mITT Population</measure>
    <time_frame>From Week 37 to Week 61</time_frame>
    <description>Cumulative duration (in days) of CR post first dose of CS &lt;=10 mg/day from Week 37 to Week 61 were reported in this OM. Complete remission was defined as the absence of new and established lesions and was intended to mean &quot;no disease activity&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative Duration of Complete Remission With a Corticosteroids Dose &lt;=10 mg/Day From Week 37 to Week 61: mITT Population</measure>
    <time_frame>From Week 37 to Week 61</time_frame>
    <description>Cumulative duration (in days) of CR post first dose of CS &lt;=10 mg/day from Week 37 to Week 61 were reported in this OM. Complete remission was defined as the absence of new and established lesions and was intended to mean &quot;no disease activity&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative Duration of Complete Remission With a Corticosteroids Dose = 0 mg/Day From Week 37 to Week 61: PV mITT Population</measure>
    <time_frame>From Week 37 to Week 61</time_frame>
    <description>Cumulative duration (in days) of CR post first dose of CS = 0 mg/day from Week 37 to Week 61 were reported in this OM. Complete remission was defined as the absence of new and established lesions and was intended to mean &quot;no disease activity&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative Duration of Complete Remission With a Corticosteroids Dose = 0 mg/Day From Week 37 to Week 61: mITT Population</measure>
    <time_frame>From Week 37 to Week 61</time_frame>
    <description>Cumulative duration (in days) of CR post first dose of CS = 0 mg/day from Week 37 to Week 61 were reported in this OM. Complete remission was defined as the absence of new and established lesions and was intended to mean &quot;no disease activity&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)</measure>
    <time_frame>BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)</time_frame>
    <description>An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug and does not necessarily had to have a causal relationship with the treatment. Serious AEs (SAEs) were any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. TEAEs were the AEs that developed or worsened or became serious after the administration of first dose of study drug in each period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics (PK): Plasma Concentration of Rilzabrutinib</measure>
    <time_frame>Pre-dose and 2 hours post-dose on Day 1</time_frame>
    <description>Data for this OM was not planned to be collected and analyzed for placebo arm of the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacodynamics (PD): Change From Baseline in Antibody Levels - Anti-desmoglein 1 (Anti-dsg 1) and Anti-desmoglein 3 (Anti-dsg 3) at Weeks 13, 25, 37, 49, 61, 73, 85, 97, and 109: PV mITT Population</measure>
    <time_frame>Baseline, Weeks 13, 25, 37, 49, 61, 73, 85, 97, and 109</time_frame>
    <description>Anti-dsg1 and anti-dsg3 autoantibody levels was assessed by enzyme-linked immunosorbent assay (ELISA) method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacodynamics: Change From Baseline in Antibody Levels - Anti-desmoglein 1 (Anti-dsg 1) and Anti-desmoglein 3 (Anti-dsg 3) at Weeks 13, 25, 37, 49, 61, 73, 85, 97 and 109: mITT Population</measure>
    <time_frame>Baseline, Weeks 13, 25, 37, 49, 61, 73, 85, 97, and 109</time_frame>
    <description>Anti-dsg1 and anti-dsg3 autoantibody levels was assessed by ELISA method.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">131</enrollment>
  <condition>Pemphigus</condition>
  <arm_group>
    <arm_group_label>Placebo Then Rilzabrutinib</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>In BT period, participants received placebo orally twice daily (BID) up to 37 weeks along with sponsor-provided corticosteroids (CS). After at least two weeks of control of disease activity (CDA; no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 milligrams (mg) prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Rilzabrutinib Then Rilzabrutinib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rilzabrutinib</intervention_name>
    <description>Pharmaceutical form: Tablet Route of administration: Oral</description>
    <arm_group_label>Placebo Then Rilzabrutinib</arm_group_label>
    <arm_group_label>Rilzabrutinib Then Rilzabrutinib</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Pharmaceutical form: Tablet Route of administration: Oral</description>
    <arm_group_label>Placebo Then Rilzabrutinib</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female participants, aged 18 to 80 years old with moderate to severe, newly&#xD;
             diagnosed or relapsing PV or PF, with a clinical presentation and histopathology&#xD;
             consistent with PV or PF.&#xD;
&#xD;
          -  Positive circulating anti-desmoglein 1 (anti-dsg1) or 3 autoantibody titer.&#xD;
&#xD;
          -  At screening, pemphigus disease area index score of at least 9 points for relapsing&#xD;
             participants or at least 15 points for newly diagnosed participants.&#xD;
&#xD;
          -  Adequate hematologic, hepatic, and renal function.&#xD;
&#xD;
          -  Effective means of contraception.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Suspected paraneoplastic pemphigus and other forms of pemphigus that were not PV or&#xD;
             PF.&#xD;
&#xD;
          -  Previous use of a Bruton tyrosine kinase inhibitor.&#xD;
&#xD;
          -  Pregnant or lactating women.&#xD;
&#xD;
          -  Electrocardiogram clinically significant abnormalities.&#xD;
&#xD;
          -  A history of malignancy of any type within 5 years before Day 1, other than surgically&#xD;
             excised non-melanoma skin cancers or in situ cervical cancer.&#xD;
&#xD;
          -  Use of immunologic response modifiers as concomitant medication and with the washout&#xD;
             period.&#xD;
&#xD;
          -  Use of proton pump inhibitor drugs such as omeprazole and esomeprazole within 3 days&#xD;
             of Day 1.&#xD;
&#xD;
          -  Concomitant use of known strong-to-moderate inducers or inhibitors of cytochrome P450&#xD;
             3A (CYP3A) within 3 days or 5 half-lives (whichever is longer) of Day 1&#xD;
&#xD;
          -  Use of CYP3A-sensitive substrate drugs.&#xD;
&#xD;
          -  Had received any investigational drug within the 30 days before Day 1.&#xD;
&#xD;
          -  History of drug abuse within the previous 12 months.&#xD;
&#xD;
          -  Alcoholism or excessive alcohol use.&#xD;
&#xD;
          -  Any other clinically significant disease, condition or medical history that, in the&#xD;
             opinion of the Investigator, would interfere with participant safety, trial&#xD;
             evaluations, and/or trial procedures.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33433</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Coral Gables</city>
        <state>Florida</state>
        <zip>33134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10028</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Murray</city>
        <state>Utah</state>
        <zip>84107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Buenos Aires</city>
        <zip>B1663GJR</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Buenos Aires</city>
        <zip>C1199ABD</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>San Nicolás</city>
        <zip>B2900DPA</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Fremantle</city>
        <state>Western Australia</state>
        <zip>6160</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Melbourne</city>
        <zip>3050</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Sydney</city>
        <zip>2217</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Campinas</city>
        <zip>87131-001</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Campo Grande</city>
        <zip>79080-190</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Ribeirão Preto</city>
        <zip>14051-140</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Pleven</city>
        <zip>5800</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Plovdiv</city>
        <zip>4002</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Sofia</city>
        <zip>01431</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <zip>R3M 3Z4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Osijek</city>
        <zip>31000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Zagreb</city>
        <zip>10000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Bobigny</city>
        <zip>93009</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Bordeaux</city>
        <zip>33000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Lille</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Pierre-Bénite</city>
        <zip>69495</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Rouen</city>
        <zip>76031</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Toulouse</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Dresden</city>
        <zip>01307</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Düsseldorf</city>
        <zip>40225</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Erlangen</city>
        <zip>91054</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Heidelberg</city>
        <zip>69120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Kiel</city>
        <zip>24105</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Lübeck</city>
        <zip>23538</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Münster</city>
        <zip>48151</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Athens</city>
        <zip>16121</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Ioánnina</city>
        <zip>54643</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Larisa</city>
        <zip>41110</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Thessaloníki</city>
        <zip>54643</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Thessaloníki</city>
        <zip>56403</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Be'er Sheva</city>
        <zip>8457108</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Haifa</city>
        <zip>3109601</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Ramat Gan</city>
        <zip>5262100</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Tel Aviv</city>
        <zip>64239</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Brescia</city>
        <zip>25123</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Catania</city>
        <zip>95123</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Florence</city>
        <zip>50121</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Milan</city>
        <zip>20122</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Padova</city>
        <zip>35128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Parma</city>
        <zip>43100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Rome</city>
        <zip>00167</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Torino</city>
        <zip>43100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Gdańsk</city>
        <zip>80-214</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Kraków</city>
        <zip>31-066</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Lublin</city>
        <zip>20-081</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Warsaw</city>
        <zip>02-005</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Wroclaw</city>
        <zip>51-124</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Wrocław</city>
        <zip>50-367</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Belgrade</city>
        <zip>11000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Novi Sad</city>
        <zip>21000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Barcelona</city>
        <zip>08003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Barcelona</city>
        <zip>08916</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Córdoba</city>
        <zip>14004</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Madrid</city>
        <zip>28007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Pamplona</city>
        <zip>31008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Dalin</city>
        <zip>62247</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Kaohsiung</city>
        <zip>83301</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Taipei</city>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Fatih</city>
        <zip>34093</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Istanbul</city>
        <zip>34662</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Istanbul</city>
        <zip>34722</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Konyaaltı</city>
        <zip>07070</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Merkez</city>
        <zip>61080</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Dnipro</city>
        <zip>49000</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Dnipro</city>
        <zip>49074</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Kyiv</city>
        <zip>04209</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Lviv</city>
        <zip>79013</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>Zaporizhzhya</city>
        <zip>69063</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Recruiting (Principia Biopharma)</name>
      <address>
        <city>London</city>
        <zip>E1 1BB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Australia</country>
    <country>Brazil</country>
    <country>Bulgaria</country>
    <country>Canada</country>
    <country>Croatia</country>
    <country>France</country>
    <country>Germany</country>
    <country>Greece</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Poland</country>
    <country>Serbia</country>
    <country>Spain</country>
    <country>Taiwan</country>
    <country>Turkey</country>
    <country>Ukraine</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>November 29, 2018</study_first_submitted>
  <study_first_submitted_qc>November 30, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <results_first_submitted>July 13, 2022</results_first_submitted>
  <results_first_submitted_qc>August 26, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">September 21, 2022</results_first_posted>
  <last_update_submitted>July 21, 2023</last_update_submitted>
  <last_update_submitted_qc>July 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pemphigus Vulgaris (PV)</keyword>
  <keyword>Pemphigus Foliaceus (PF)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pemphigus</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 30, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/65/NCT03762265/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 29, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/65/NCT03762265/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Study was conducted at 88 active sites in 19 countries. A total of 210 participants were screened from 08 January 2019 to 23 October 2020, of whom 79 participants were screen failures, mainly due to not meeting inclusion criteria. A total of 131 participants were enrolled and randomized in the study, consisted of 3 parts: blinded treatment (BT) period (Baseline to Week 37), open-label extension (OLE) period (Week 37 to Week 61) and long term extension (LTE) Period (Week 61 to Week 109).</recruitment_details>
      <pre_assignment_details>Participants with moderate to severe pemphigus (pemphigus vulgaris [PV] and pemphigus foliaceus [PF]) were randomized (1:1 ratio) to receive either rilzabrutinib or placebo in BT period.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo Then Rilzabrutinib</title>
          <description>In BT period, participants received placebo orally twice daily (BID) up to 37 weeks along with sponsor-provided corticosteroids (CS). After at least two weeks of control of disease activity (CDA; no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 milligrams (mg) prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.</description>
        </group>
        <group group_id="P2">
          <title>Rilzabrutinib Then Rilzabrutinib</title>
          <description>In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>BT Period: Weeks 1 to 37</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="66"/>
                <participants group_id="P2" count="65"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="51"/>
                <participants group_id="P2" count="62"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Required prohibited medication</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>OLE Period: Weeks 37 to 61</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="51"/>
                <participants group_id="P2" count="61">One participant did not enter OLE Period.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="35"/>
                <participants group_id="P2" count="45"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="16"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Non-compliance with study drug</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Study terminated by sponsor</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>LTE Period: Weeks 61 to 109</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="35"/>
                <participants group_id="P2" count="34">11 participants did not enter LTE Period.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
                <participants group_id="P2" count="28"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Study terminated by sponsor</title>
              <participants_list>
                <participants group_id="P1" count="28"/>
                <participants group_id="P2" count="25"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Analysis was performed on randomized population.</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo Then Rilzabrutinib</title>
          <description>In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.</description>
        </group>
        <group group_id="B2">
          <title>Rilzabrutinib Then Rilzabrutinib</title>
          <description>In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="66"/>
            <count group_id="B2" value="65"/>
            <count group_id="B3" value="131"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="52.9" spread="14.00"/>
                    <measurement group_id="B2" value="50.5" spread="14.11"/>
                    <measurement group_id="B3" value="51.7" spread="14.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="70"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="52"/>
                    <measurement group_id="B2" value="58"/>
                    <measurement group_id="B3" value="110"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Achieved Complete Remission (CR) With a Corticosteroids Dose of Less Than or Equal to (&lt;=) 10 mg/Day From Week 29 to Week 37: Pemphigus Vulgaris Participants in Modified Intent-to-Treat (PV mITT) Population</title>
        <description>Complete remission was defined as absence of new and established lesions and was intended to mean &quot;no disease activity&quot; for 2 consecutive weeks, with Pemphigus Disease Area Index (PDAI) activity score =0 and CS dose &lt;=10 mg. PDAI score weighted for number and size of lesions with score of 0 (absent) to 10 given for skin (12 body locations), scalp and mucous membrane showing disease activity (erosions/blisters or new erythema). PDAI total score ranged from 0 to 250 points representing disease activity (120 points for skin activity; 10 points for scalp activity; 120 points for mucosal activity). Higher score indicated more disease activity. In this outcome measure (OM), percentage of participants who achieved CR while on a daily corticosteroids dose of &lt;=10 mg/day were reported.</description>
        <time_frame>From Week 29 to Week 37</time_frame>
        <population>Analysis was performed on PV mITT which included randomized PV participants who had received at least one dose of study medication and were analyzed according to the treatment they were allocated to at randomization.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Then Rilzabrutinib</title>
            <description>In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.</description>
          </group>
          <group group_id="O2">
            <title>Rilzabrutinib Then Rilzabrutinib</title>
            <description>In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved Complete Remission (CR) With a Corticosteroids Dose of Less Than or Equal to (&lt;=) 10 mg/Day From Week 29 to Week 37: Pemphigus Vulgaris Participants in Modified Intent-to-Treat (PV mITT) Population</title>
          <description>Complete remission was defined as absence of new and established lesions and was intended to mean &quot;no disease activity&quot; for 2 consecutive weeks, with Pemphigus Disease Area Index (PDAI) activity score =0 and CS dose &lt;=10 mg. PDAI score weighted for number and size of lesions with score of 0 (absent) to 10 given for skin (12 body locations), scalp and mucous membrane showing disease activity (erosions/blisters or new erythema). PDAI total score ranged from 0 to 250 points representing disease activity (120 points for skin activity; 10 points for scalp activity; 120 points for mucosal activity). Higher score indicated more disease activity. In this outcome measure (OM), percentage of participants who achieved CR while on a daily corticosteroids dose of &lt;=10 mg/day were reported.</description>
          <population>Analysis was performed on PV mITT which included randomized PV participants who had received at least one dose of study medication and were analyzed according to the treatment they were allocated to at randomization.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.2"/>
                    <measurement group_id="O2" value="24.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-value and 95% confidence interval (CI) were based on Cochran-Mantel-Haenszel general association test stratified by disease type (PV or PF) and disease history (newly diagnosed [&lt;=6 months prior to screening] or relapsing [diagnosed greater than [&gt;] 6 months prior to screening]).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4469</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Difference in percentage</param_type>
            <param_value>5.73</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>7.535</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-9.037</ci_lower_limit>
            <ci_upper_limit>20.500</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Achieved Complete Remission With a Corticosteroids Dose of &lt;=10 mg/Day From Week 29 to Week 37: Modified Intent-to-Treat (mITT) Population</title>
        <description>Complete remission was defined as absence of new and established lesions and was intended to mean &quot;no disease activity&quot; for 2 consecutive weeks, with PDAI activity score =0 and CS dose &lt;=10 mg. PDAI score weighted for number and size of lesions with score of 0 (absent) to 10 given for skin (12 body locations), scalp and mucous membrane showing disease activity (erosions/blisters or new erythema). PDAI total score ranged from 0 to 250 points representing disease activity (120 points for skin activity; 10 points for scalp activity; 120 points for mucosal activity). Higher score indicated more disease activity. In this OM, percentage of participants who achieved CR while on a daily corticosteroids dose of &lt;=10 mg/day were reported.</description>
        <time_frame>From Week 29 to Week 37</time_frame>
        <population>Analysis was performed on mITT population which included all randomized participants (i.e. PV + PF participants) who had received at least one dose of study medication and were analyzed according to the treatment they were allocated to at randomization.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Then Rilzabrutinib</title>
            <description>In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.</description>
          </group>
          <group group_id="O2">
            <title>Rilzabrutinib Then Rilzabrutinib</title>
            <description>In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved Complete Remission With a Corticosteroids Dose of &lt;=10 mg/Day From Week 29 to Week 37: Modified Intent-to-Treat (mITT) Population</title>
          <description>Complete remission was defined as absence of new and established lesions and was intended to mean &quot;no disease activity&quot; for 2 consecutive weeks, with PDAI activity score =0 and CS dose &lt;=10 mg. PDAI score weighted for number and size of lesions with score of 0 (absent) to 10 given for skin (12 body locations), scalp and mucous membrane showing disease activity (erosions/blisters or new erythema). PDAI total score ranged from 0 to 250 points representing disease activity (120 points for skin activity; 10 points for scalp activity; 120 points for mucosal activity). Higher score indicated more disease activity. In this OM, percentage of participants who achieved CR while on a daily corticosteroids dose of &lt;=10 mg/day were reported.</description>
          <population>Analysis was performed on mITT population which included all randomized participants (i.e. PV + PF participants) who had received at least one dose of study medication and were analyzed according to the treatment they were allocated to at randomization.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="66"/>
                <count group_id="O2" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.2"/>
                    <measurement group_id="O2" value="26.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-value and 95% CI were based on Cochran-Mantel-Haenszel general association test stratified by disease type (PV or PF) and disease history (newly diagnosed [&lt;=6 months prior to screening] or relapsing [diagnosed &gt;6 months prior to screening]).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2510</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Difference in percentage</param_type>
            <param_value>8.13</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>7.085</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.752</ci_lower_limit>
            <ci_upper_limit>22.019</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cumulative Oral Corticosteroid Dose From Baseline to Week 37: PV mITT Population</title>
        <description>The cumulative dose (in milligrams) of sponsor-provided oral CS (prednisone or prednisolone) received by the participants during the BT period was calculated from Baseline to Week 37 and is reported in this OM.</description>
        <time_frame>Baseline to Week 37</time_frame>
        <population>Analysis was performed on PV mITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Then Rilzabrutinib</title>
            <description>In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.</description>
          </group>
          <group group_id="O2">
            <title>Rilzabrutinib Then Rilzabrutinib</title>
            <description>In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.</description>
          </group>
        </group_list>
        <measure>
          <title>Cumulative Oral Corticosteroid Dose From Baseline to Week 37: PV mITT Population</title>
          <description>The cumulative dose (in milligrams) of sponsor-provided oral CS (prednisone or prednisolone) received by the participants during the BT period was calculated from Baseline to Week 37 and is reported in this OM.</description>
          <population>Analysis was performed on PV mITT population.</population>
          <units>milligrams</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5653.2" spread="3155.97"/>
                    <measurement group_id="O2" value="5131.4" spread="2623.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cumulative Oral Corticosteroid Dose From Baseline to Week 37: mITT Population</title>
        <description>The cumulative dose (in milligrams) of sponsor-provided oral CS (prednisone or prednisolone) received by the participants during the BT period was calculated from Baseline to Week 37 and is reported in this OM.</description>
        <time_frame>Baseline to Week 37</time_frame>
        <population>Analysis was performed on mITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Then Rilzabrutinib</title>
            <description>In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.</description>
          </group>
          <group group_id="O2">
            <title>Rilzabrutinib Then Rilzabrutinib</title>
            <description>In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.</description>
          </group>
        </group_list>
        <measure>
          <title>Cumulative Oral Corticosteroid Dose From Baseline to Week 37: mITT Population</title>
          <description>The cumulative dose (in milligrams) of sponsor-provided oral CS (prednisone or prednisolone) received by the participants during the BT period was calculated from Baseline to Week 37 and is reported in this OM.</description>
          <population>Analysis was performed on mITT population.</population>
          <units>milligrams</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="66"/>
                <count group_id="O2" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5392.2" spread="2993.02"/>
                    <measurement group_id="O2" value="4860.2" spread="2545.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cumulative Duration of Complete Remission With a Corticosteroids Dose &lt;=10 mg/Day From Baseline to Week 37: PV mITT Population</title>
        <description>Cumulative duration (in days) of CR post first CS dose of &lt;= 10 mg/day from Baseline to Week 37 was analyzed with a zero-inflated negative binomial model with terms of treatment group and disease history, and an offset based on the number of days on blinded treatment period and were reported in this OM. Complete remission was defined as the absence of new and established lesions and was intended to mean &quot;no disease activity&quot;.</description>
        <time_frame>Baseline to Week 37</time_frame>
        <population>Analysis was performed on PV mITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Then Rilzabrutinib</title>
            <description>In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.</description>
          </group>
          <group group_id="O2">
            <title>Rilzabrutinib Then Rilzabrutinib</title>
            <description>In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.</description>
          </group>
        </group_list>
        <measure>
          <title>Cumulative Duration of Complete Remission With a Corticosteroids Dose &lt;=10 mg/Day From Baseline to Week 37: PV mITT Population</title>
          <description>Cumulative duration (in days) of CR post first CS dose of &lt;= 10 mg/day from Baseline to Week 37 was analyzed with a zero-inflated negative binomial model with terms of treatment group and disease history, and an offset based on the number of days on blinded treatment period and were reported in this OM. Complete remission was defined as the absence of new and established lesions and was intended to mean &quot;no disease activity&quot;.</description>
          <population>Analysis was performed on PV mITT population.</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.1" spread="51.58"/>
                    <measurement group_id="O2" value="50.5" spread="67.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cumulative Duration of Complete Remission With a Corticosteroids Dose &lt;=10 mg/Day From Baseline to Week 37: mITT Population</title>
        <description>Cumulative duration (in days) of CR post first CS dose of &lt;= 10 mg/day from Baseline to Week 37 was analyzed with a zero-inflated negative binomial model with terms of treatment group and disease history, and an offset based on the number of days on blinded treatment period and were reported in this OM. Complete remission was defined as the absence of new and established lesions and was intended to mean &quot;no disease activity&quot;.</description>
        <time_frame>Baseline to Week 37</time_frame>
        <population>Analysis was performed on mITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Then Rilzabrutinib</title>
            <description>In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.</description>
          </group>
          <group group_id="O2">
            <title>Rilzabrutinib Then Rilzabrutinib</title>
            <description>In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.</description>
          </group>
        </group_list>
        <measure>
          <title>Cumulative Duration of Complete Remission With a Corticosteroids Dose &lt;=10 mg/Day From Baseline to Week 37: mITT Population</title>
          <description>Cumulative duration (in days) of CR post first CS dose of &lt;= 10 mg/day from Baseline to Week 37 was analyzed with a zero-inflated negative binomial model with terms of treatment group and disease history, and an offset based on the number of days on blinded treatment period and were reported in this OM. Complete remission was defined as the absence of new and established lesions and was intended to mean &quot;no disease activity&quot;.</description>
          <population>Analysis was performed on mITT population.</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="66"/>
                <count group_id="O2" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.0" spread="54.36"/>
                    <measurement group_id="O2" value="54.3" spread="68.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to First Complete Remission With a Corticosteroids Dose &lt;=10 mg/Day From Baseline to Week 37: PV mITT Population</title>
        <description>Time to first CR was the time (in days) to achieve CR while on CS dose of &lt;=10 mg/day. Complete remission was defined as the absence of new and established lesions to the &quot;no disease activity&quot;. Kaplan-Meier method was used for the analysis.</description>
        <time_frame>Baseline to Week 37</time_frame>
        <population>Analysis was performed on PV mITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Then Rilzabrutinib</title>
            <description>In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.</description>
          </group>
          <group group_id="O2">
            <title>Rilzabrutinib Then Rilzabrutinib</title>
            <description>In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to First Complete Remission With a Corticosteroids Dose &lt;=10 mg/Day From Baseline to Week 37: PV mITT Population</title>
          <description>Time to first CR was the time (in days) to achieve CR while on CS dose of &lt;=10 mg/day. Complete remission was defined as the absence of new and established lesions to the &quot;no disease activity&quot;. Kaplan-Meier method was used for the analysis.</description>
          <population>Analysis was performed on PV mITT population.</population>
          <units>days</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="252.0" lower_limit="150.00" upper_limit="NA">Upper limit of 95% CI was not estimable due to low number of participants with events.</measurement>
                    <measurement group_id="O2" value="197.0" lower_limit="156.00" upper_limit="NA">Upper limit of 95% CI was not estimable due to very low number of participants with events.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to First Complete Remission With a Corticosteroids Dose &lt;=10 mg/Day From Baseline to Week 37: mITT Population</title>
        <description>Time to first CR was the time (in days) to achieve CR while on CS dose of &lt;=10 mg/day. Complete remission was defined as the absence of new and established lesions to the &quot;no disease activity&quot;. Kaplan-Meier method was used for the analysis.</description>
        <time_frame>Baseline to Week 37</time_frame>
        <population>Analysis was performed on mITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Then Rilzabrutinib</title>
            <description>In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.</description>
          </group>
          <group group_id="O2">
            <title>Rilzabrutinib Then Rilzabrutinib</title>
            <description>In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to First Complete Remission With a Corticosteroids Dose &lt;=10 mg/Day From Baseline to Week 37: mITT Population</title>
          <description>Time to first CR was the time (in days) to achieve CR while on CS dose of &lt;=10 mg/day. Complete remission was defined as the absence of new and established lesions to the &quot;no disease activity&quot;. Kaplan-Meier method was used for the analysis.</description>
          <population>Analysis was performed on mITT population.</population>
          <units>days</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="66"/>
                <count group_id="O2" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">Median, upper and lower limit of 95% CI was not estimable due to low number of participants with events.</measurement>
                    <measurement group_id="O2" value="197.0" lower_limit="142.00" upper_limit="NA">Upper limit of 95% CI was not estimable due to low number of participants with events.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved Complete Remission With a Corticosteroids Dose of &lt;=5 mg/Day From Week 29 to Week 37: PV mITT Population</title>
        <description>Complete remission was defined as the absence of new and established lesions and was intended to mean &quot;no disease activity&quot;. In this OM, percentage of participants who achieved CR while on a daily corticosteroids dose of &lt;=5 mg/day were reported.</description>
        <time_frame>From Week 29 to Week 37</time_frame>
        <population>Analysis was performed on PV mITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Then Rilzabrutinib</title>
            <description>In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.</description>
          </group>
          <group group_id="O2">
            <title>Rilzabrutinib Then Rilzabrutinib</title>
            <description>In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved Complete Remission With a Corticosteroids Dose of &lt;=5 mg/Day From Week 29 to Week 37: PV mITT Population</title>
          <description>Complete remission was defined as the absence of new and established lesions and was intended to mean &quot;no disease activity&quot;. In this OM, percentage of participants who achieved CR while on a daily corticosteroids dose of &lt;=5 mg/day were reported.</description>
          <population>Analysis was performed on PV mITT population.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.9"/>
                    <measurement group_id="O2" value="24.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved Complete Remission With a Corticosteroids Dose of &lt;=5 mg/Day From Week 29 to Week 37: mITT Population</title>
        <description>Complete remission was defined as the absence of new and established lesions and was intended to mean &quot;no disease activity&quot;. In this OM, percentage of participants who achieved CR while on a daily corticosteroids dose of &lt;=5 mg/day were reported.</description>
        <time_frame>From Week 29 to Week 37</time_frame>
        <population>Analysis was performed on mITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Then Rilzabrutinib</title>
            <description>In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.</description>
          </group>
          <group group_id="O2">
            <title>Rilzabrutinib Then Rilzabrutinib</title>
            <description>In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved Complete Remission With a Corticosteroids Dose of &lt;=5 mg/Day From Week 29 to Week 37: mITT Population</title>
          <description>Complete remission was defined as the absence of new and established lesions and was intended to mean &quot;no disease activity&quot;. In this OM, percentage of participants who achieved CR while on a daily corticosteroids dose of &lt;=5 mg/day were reported.</description>
          <population>Analysis was performed on mITT population.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="66"/>
                <count group_id="O2" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.1"/>
                    <measurement group_id="O2" value="26.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Had Pemphigus Disease Area Index (PDAI) Score &lt;3 With a Corticosteroids Dose &lt;=10 mg/Day From Week 29 to Week 37: PV mITT Population</title>
        <description>PDAI is specific cutaneous and mucosal disease activity assessment performed by investigator based on evaluation of lesions in well-defined anatomical locations. The score weighted for the number and size of lesions with score of 0 (absent) to 10 given for skin (12 body locations), scalp and mucous membrane showing disease activity (erosions/blisters or new erythema). Thus, PDAI total activity score ranged from 0 to 250 points representing disease activity (120 points for skin activity; 10 points for scalp activity; 120 points for mucosal activity). Higher score indicated more disease activity. In this OM, participants with PDAI score &lt;3 while on a CS dose of &lt;=10 mg/day were reported.</description>
        <time_frame>From Week 29 to Week 37</time_frame>
        <population>Analysis was performed on PV mITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Then Rilzabrutinib</title>
            <description>In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.</description>
          </group>
          <group group_id="O2">
            <title>Rilzabrutinib Then Rilzabrutinib</title>
            <description>In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Had Pemphigus Disease Area Index (PDAI) Score &lt;3 With a Corticosteroids Dose &lt;=10 mg/Day From Week 29 to Week 37: PV mITT Population</title>
          <description>PDAI is specific cutaneous and mucosal disease activity assessment performed by investigator based on evaluation of lesions in well-defined anatomical locations. The score weighted for the number and size of lesions with score of 0 (absent) to 10 given for skin (12 body locations), scalp and mucous membrane showing disease activity (erosions/blisters or new erythema). Thus, PDAI total activity score ranged from 0 to 250 points representing disease activity (120 points for skin activity; 10 points for scalp activity; 120 points for mucosal activity). Higher score indicated more disease activity. In this OM, participants with PDAI score &lt;3 while on a CS dose of &lt;=10 mg/day were reported.</description>
          <population>Analysis was performed on PV mITT population.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.1"/>
                    <measurement group_id="O2" value="35.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Had Pemphigus Disease Area Index Score &lt;3 With a Corticosteroids Dose &lt;=10 mg/Day From Week 29 to Week 37: mITT Population</title>
        <description>PDAI is specific cutaneous and mucosal disease activity assessment performed by investigator based on evaluation of lesions in well-defined anatomical locations. The score weighted for the number and size of lesions with score of 0 (absent) to 10 given for skin (12 body locations), scalp and mucous membrane showing disease activity (erosions/blisters or new erythema). Thus, PDAI total activity score ranged from 0 to 250 points representing disease activity (120 points for skin activity; 10 points for scalp activity; 120 points for mucosal activity). Higher score indicated more disease activity. In this OM, participants with PDAI score &lt;3 while on a CS dose of &lt;=10 mg/day were reported.</description>
        <time_frame>From Week 29 to Week 37</time_frame>
        <population>Analysis was performed on mITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Then Rilzabrutinib</title>
            <description>In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.</description>
          </group>
          <group group_id="O2">
            <title>Rilzabrutinib Then Rilzabrutinib</title>
            <description>In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Had Pemphigus Disease Area Index Score &lt;3 With a Corticosteroids Dose &lt;=10 mg/Day From Week 29 to Week 37: mITT Population</title>
          <description>PDAI is specific cutaneous and mucosal disease activity assessment performed by investigator based on evaluation of lesions in well-defined anatomical locations. The score weighted for the number and size of lesions with score of 0 (absent) to 10 given for skin (12 body locations), scalp and mucous membrane showing disease activity (erosions/blisters or new erythema). Thus, PDAI total activity score ranged from 0 to 250 points representing disease activity (120 points for skin activity; 10 points for scalp activity; 120 points for mucosal activity). Higher score indicated more disease activity. In this OM, participants with PDAI score &lt;3 while on a CS dose of &lt;=10 mg/day were reported.</description>
          <population>Analysis was performed on mITT population.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="66"/>
                <count group_id="O2" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.3"/>
                    <measurement group_id="O2" value="38.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cumulative Duration of Complete Remission With a Corticosteroids Dose &lt;=10 mg/Day From Baseline to Weeks 61 and 109: PV mITT Population</title>
        <description>Cumulative duration (in days) of CR post all doses of CS &lt;=10 mg/day during Baseline to Week 61 and Baseline to Week 109 were reported in this OM. Complete remission was defined as the absence of new and established lesions to the &quot;no disease activity&quot;.</description>
        <time_frame>Baseline to Week 61 and Baseline to Week 109</time_frame>
        <population>Analysis was performed on PV mITT population, based on data collected up to database lock for the blinded treatment period.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Then Rilzabrutinib</title>
            <description>In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.</description>
          </group>
          <group group_id="O2">
            <title>Rilzabrutinib Then Rilzabrutinib</title>
            <description>In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.</description>
          </group>
        </group_list>
        <measure>
          <title>Cumulative Duration of Complete Remission With a Corticosteroids Dose &lt;=10 mg/Day From Baseline to Weeks 61 and 109: PV mITT Population</title>
          <description>Cumulative duration (in days) of CR post all doses of CS &lt;=10 mg/day during Baseline to Week 61 and Baseline to Week 109 were reported in this OM. Complete remission was defined as the absence of new and established lesions to the &quot;no disease activity&quot;.</description>
          <population>Analysis was performed on PV mITT population, based on data collected up to database lock for the blinded treatment period.</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline to Week 61</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.8" spread="95.35"/>
                    <measurement group_id="O2" value="112.2" spread="120.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline to Week 109</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="102.2" spread="133.22"/>
                    <measurement group_id="O2" value="157.0" spread="179.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cumulative Duration of Complete Remission With a Corticosteroids Dose &lt;=10 mg/Day From Baseline to Weeks 61 and 109: mITT Population</title>
        <description>Cumulative duration (in days) of CR post all doses of CS &lt;=10 mg/day during Baseline to Week 61 and Baseline to Week 109 were reported in this OM. Complete remission was defined as the absence of new and established lesions to the &quot;no disease activity&quot;.</description>
        <time_frame>Baseline to Weeks 61 and Baseline to Week 109</time_frame>
        <population>Analysis was performed on mITT population, based on data collected up to database lock for the blinded treatment period.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Then Rilzabrutinib</title>
            <description>In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.</description>
          </group>
          <group group_id="O2">
            <title>Rilzabrutinib Then Rilzabrutinib</title>
            <description>In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.</description>
          </group>
        </group_list>
        <measure>
          <title>Cumulative Duration of Complete Remission With a Corticosteroids Dose &lt;=10 mg/Day From Baseline to Weeks 61 and 109: mITT Population</title>
          <description>Cumulative duration (in days) of CR post all doses of CS &lt;=10 mg/day during Baseline to Week 61 and Baseline to Week 109 were reported in this OM. Complete remission was defined as the absence of new and established lesions to the &quot;no disease activity&quot;.</description>
          <population>Analysis was performed on mITT population, based on data collected up to database lock for the blinded treatment period.</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="66"/>
                <count group_id="O2" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline to Week 61</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78.1" spread="98.68"/>
                    <measurement group_id="O2" value="120.4" spread="124.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline to Week 109</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="124.6" spread="153.76"/>
                    <measurement group_id="O2" value="171.6" spread="186.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cumulative Duration of Complete Remission With a Corticosteroids Dose = 0 mg/Day From Baseline to Weeks 61 and 109: PV mITT Population</title>
        <description>Cumulative duration (in days) of CR post all doses of CS =0 mg/day during Baseline to Week 61 and Baseline to Week 109 were reported in this OM. Complete remission was defined as the absence of new and established lesions to the &quot;no disease activity&quot;.</description>
        <time_frame>Baseline to Week 61 and Baseline to Week 109</time_frame>
        <population>Analysis was performed on PV mITT population, based on data collected up to database lock for the blinded treatment period.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Then Rilzabrutinib</title>
            <description>In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.</description>
          </group>
          <group group_id="O2">
            <title>Rilzabrutinib Then Rilzabrutinib</title>
            <description>In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.</description>
          </group>
        </group_list>
        <measure>
          <title>Cumulative Duration of Complete Remission With a Corticosteroids Dose = 0 mg/Day From Baseline to Weeks 61 and 109: PV mITT Population</title>
          <description>Cumulative duration (in days) of CR post all doses of CS =0 mg/day during Baseline to Week 61 and Baseline to Week 109 were reported in this OM. Complete remission was defined as the absence of new and established lesions to the &quot;no disease activity&quot;.</description>
          <population>Analysis was performed on PV mITT population, based on data collected up to database lock for the blinded treatment period.</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline to Week 61</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.5" spread="35.33"/>
                    <measurement group_id="O2" value="28.6" spread="52.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline to Week 109</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.4" spread="77.54"/>
                    <measurement group_id="O2" value="60.7" spread="118.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cumulative Duration of Complete Remission With a Corticosteroids Dose = 0 mg/Day From Baseline to Weeks 61 and 109: mITT Population</title>
        <description>Cumulative duration (in days) of CR post all doses of CS dose = 0 mg/day during Baseline to Week 61 and Baseline to Week 109 were reported in this OM. Complete remission was defined as the absence of new and established lesions to the &quot;no disease activity&quot;.</description>
        <time_frame>Baseline to Week 61 and Baseline to Week 109</time_frame>
        <population>Analysis was performed on mITT population, based on data collected up to database lock for the blinded treatment period.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Then Rilzabrutinib</title>
            <description>In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.</description>
          </group>
          <group group_id="O2">
            <title>Rilzabrutinib Then Rilzabrutinib</title>
            <description>In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.</description>
          </group>
        </group_list>
        <measure>
          <title>Cumulative Duration of Complete Remission With a Corticosteroids Dose = 0 mg/Day From Baseline to Weeks 61 and 109: mITT Population</title>
          <description>Cumulative duration (in days) of CR post all doses of CS dose = 0 mg/day during Baseline to Week 61 and Baseline to Week 109 were reported in this OM. Complete remission was defined as the absence of new and established lesions to the &quot;no disease activity&quot;.</description>
          <population>Analysis was performed on mITT population, based on data collected up to database lock for the blinded treatment period.</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="66"/>
                <count group_id="O2" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline to Week 61</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.6" spread="38.56"/>
                    <measurement group_id="O2" value="33.5" spread="55.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline to Week 109</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.5" spread="106.14"/>
                    <measurement group_id="O2" value="72.5" spread="125.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Glucocorticoid Toxicity Index (GTI) - Cumulative Worsening Score (CWS) and Aggregate Improvement Score (AIS) at Week 37: PV mITT Population</title>
        <description>GTI assessed glucocorticoid (GC) related morbidity and GC-sparing ability of other therapies; composed of 2 components: Composite GTI and specific list. Composite GTI had 9 domains and specific list had 23 items (11 domains), used as complementary tool to C-GTI. Composite GTI score:sum of 9 domain-specific scores at each visit and cumulative GTI score:sum of composite GTI scores across each visit. 2 cumulative GTI scores: CWS and AIS at Week 37 reported in this OM. CWS assessed cumulative GC toxicity regardless of whether toxicity had lasting effects/was transient. AIS assessed new therapy effectiveness in decreasing any Baseline GC toxicity over time. CWS composite score range: 0 to 439 and AIS composite score range: -346 to 439. In CWS and AIS, minimum score=least toxicity and maximum score=most toxicity. Least square (LS) mean and standard error (SE) from analysis of covariance model using treatment, disease history as fixed effects and Baseline GTI score and CS dose as covariates.</description>
        <time_frame>At Week 37</time_frame>
        <population>Analysis was performed on PV mITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Then Rilzabrutinib</title>
            <description>In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.</description>
          </group>
          <group group_id="O2">
            <title>Rilzabrutinib Then Rilzabrutinib</title>
            <description>In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.</description>
          </group>
        </group_list>
        <measure>
          <title>Glucocorticoid Toxicity Index (GTI) - Cumulative Worsening Score (CWS) and Aggregate Improvement Score (AIS) at Week 37: PV mITT Population</title>
          <description>GTI assessed glucocorticoid (GC) related morbidity and GC-sparing ability of other therapies; composed of 2 components: Composite GTI and specific list. Composite GTI had 9 domains and specific list had 23 items (11 domains), used as complementary tool to C-GTI. Composite GTI score:sum of 9 domain-specific scores at each visit and cumulative GTI score:sum of composite GTI scores across each visit. 2 cumulative GTI scores: CWS and AIS at Week 37 reported in this OM. CWS assessed cumulative GC toxicity regardless of whether toxicity had lasting effects/was transient. AIS assessed new therapy effectiveness in decreasing any Baseline GC toxicity over time. CWS composite score range: 0 to 439 and AIS composite score range: -346 to 439. In CWS and AIS, minimum score=least toxicity and maximum score=most toxicity. Least square (LS) mean and standard error (SE) from analysis of covariance model using treatment, disease history as fixed effects and Baseline GTI score and CS dose as covariates.</description>
          <population>Analysis was performed on PV mITT population.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>CWS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54.46" spread="8.136"/>
                    <measurement group_id="O2" value="73.60" spread="7.397"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AIS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.42" spread="6.516"/>
                    <measurement group_id="O2" value="19.95" spread="5.924"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Glucocorticoid Toxicity Index - Cumulative Worsening Score and Aggregate Improvement Score at Week 37: mITT Population</title>
        <description>GTI assessed GC related morbidity and GC-sparing ability of other therapies; composed of 2 components: Composite GTI and specific list. Composite GTI contained 9 domains and specific list contained of 23 items (11 domains), used as complementary tool to C-GTI. Composite GTI score: sum of 9 domain-specific scores at each visit and cumulative GTI score: sum of composite GTI scores across each visit. Two cumulative GTI scores: CWS and AIS at Week 37 were reported in this OM. CWS assessed cumulative GC toxicity regardless of whether toxicity had lasting effects/was transient. AIS assessed new therapy effectiveness in decreasing any Baseline GC toxicity over time. CWS composite score ranged from 0 to 439 and AIS composite score ranged from -346 to 439. For CWS and AIS, minimum score = least toxicity and maximum score = most toxicity. LS mean and SE from analysis of covariance model using treatment, disease history as fixed effects and Baseline GTI score and CS dose as covariates.</description>
        <time_frame>At Week 37</time_frame>
        <population>Analysis was performed on mITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Then Rilzabrutinib</title>
            <description>In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.</description>
          </group>
          <group group_id="O2">
            <title>Rilzabrutinib Then Rilzabrutinib</title>
            <description>In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.</description>
          </group>
        </group_list>
        <measure>
          <title>Glucocorticoid Toxicity Index - Cumulative Worsening Score and Aggregate Improvement Score at Week 37: mITT Population</title>
          <description>GTI assessed GC related morbidity and GC-sparing ability of other therapies; composed of 2 components: Composite GTI and specific list. Composite GTI contained 9 domains and specific list contained of 23 items (11 domains), used as complementary tool to C-GTI. Composite GTI score: sum of 9 domain-specific scores at each visit and cumulative GTI score: sum of composite GTI scores across each visit. Two cumulative GTI scores: CWS and AIS at Week 37 were reported in this OM. CWS assessed cumulative GC toxicity regardless of whether toxicity had lasting effects/was transient. AIS assessed new therapy effectiveness in decreasing any Baseline GC toxicity over time. CWS composite score ranged from 0 to 439 and AIS composite score ranged from -346 to 439. For CWS and AIS, minimum score = least toxicity and maximum score = most toxicity. LS mean and SE from analysis of covariance model using treatment, disease history as fixed effects and Baseline GTI score and CS dose as covariates.</description>
          <population>Analysis was performed on mITT population.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="66"/>
                <count group_id="O2" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>CWS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.68" spread="7.368"/>
                    <measurement group_id="O2" value="68.15" spread="6.732"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AIS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.63" spread="5.730"/>
                    <measurement group_id="O2" value="18.23" spread="5.236"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Pemphigus Disease Area Index Score at Weeks 5, 13, 25, 37, 61, and 109: PV mITT Population</title>
        <description>PDAI is specific cutaneous and mucosal disease activity assessment performed by investigator based on evaluation of lesions in well-defined anatomical locations. The score weighted for the number and size of lesions with score of 0 (absent) to 10 given for skin (12 body locations), scalp and mucous membrane showing disease activity (erosions/blisters or new erythema). Thus, PDAI total activity score ranged from 0 to 250 points representing disease activity (120 points for skin activity; 10 points for scalp activity; 120 points for mucosal activity). Higher score indicated more disease activity. PDAI activity score was measured independently of the CS dose administered in the participants.</description>
        <time_frame>Baseline, Weeks 5, 13, 25, 37, 61, and 109</time_frame>
        <population>Analysis was performed on PV mITT population, based on data collected up to database lock for the blinded treatment period. Here, 'number analyzed' = participants with available data for each specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Then Rilzabrutinib</title>
            <description>In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.</description>
          </group>
          <group group_id="O2">
            <title>Rilzabrutinib Then Rilzabrutinib</title>
            <description>In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Pemphigus Disease Area Index Score at Weeks 5, 13, 25, 37, 61, and 109: PV mITT Population</title>
          <description>PDAI is specific cutaneous and mucosal disease activity assessment performed by investigator based on evaluation of lesions in well-defined anatomical locations. The score weighted for the number and size of lesions with score of 0 (absent) to 10 given for skin (12 body locations), scalp and mucous membrane showing disease activity (erosions/blisters or new erythema). Thus, PDAI total activity score ranged from 0 to 250 points representing disease activity (120 points for skin activity; 10 points for scalp activity; 120 points for mucosal activity). Higher score indicated more disease activity. PDAI activity score was measured independently of the CS dose administered in the participants.</description>
          <population>Analysis was performed on PV mITT population, based on data collected up to database lock for the blinded treatment period. Here, 'number analyzed' = participants with available data for each specified category.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.567" spread="12.6310"/>
                    <measurement group_id="O2" value="-7.224" spread="6.9832"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 13</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="53"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-11.076" spread="11.4549"/>
                    <measurement group_id="O2" value="-13.925" spread="10.1497"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 25</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-11.333" spread="13.8064"/>
                    <measurement group_id="O2" value="-15.292" spread="10.5552"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 37</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="41"/>
                    <count group_id="O2" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-13.000" spread="10.9202"/>
                    <measurement group_id="O2" value="-14.167" spread="9.8679"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 61</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-12.900" spread="6.6418"/>
                    <measurement group_id="O2" value="-16.475" spread="10.1585"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 109</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-21.300"/>
                    <measurement group_id="O2" value="-18.250" spread="9.8288"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Pemphigus Disease Area Index Score at Weeks 5, 13, 25, 37, 61, and 109: mITT Population</title>
        <description>PDAI is specific cutaneous and mucosal disease activity assessment performed by investigator based on evaluation of lesions in well-defined anatomical locations. The score weighted for the number and size of lesions with score of 0 (absent) to 10 given for skin (12 body locations), scalp and mucous membrane showing disease activity (erosions/blisters or new erythema). Thus, PDAI total activity score ranged from 0 to 250 points representing disease activity (120 points for skin activity; 10 points for scalp activity; 120 points for mucosal activity). Higher score indicated more disease activity. PDAI activity score was measured independently of the CS dose administered in the participants.</description>
        <time_frame>Baseline, Weeks 5, 13, 25, 37, 61, and 109</time_frame>
        <population>Analysis was performed on mITT population, based on data collected up to database lock for the blinded treatment period. Here, 'number analyzed' = participants with available data for each specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Then Rilzabrutinib</title>
            <description>In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.</description>
          </group>
          <group group_id="O2">
            <title>Rilzabrutinib Then Rilzabrutinib</title>
            <description>In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Pemphigus Disease Area Index Score at Weeks 5, 13, 25, 37, 61, and 109: mITT Population</title>
          <description>PDAI is specific cutaneous and mucosal disease activity assessment performed by investigator based on evaluation of lesions in well-defined anatomical locations. The score weighted for the number and size of lesions with score of 0 (absent) to 10 given for skin (12 body locations), scalp and mucous membrane showing disease activity (erosions/blisters or new erythema). Thus, PDAI total activity score ranged from 0 to 250 points representing disease activity (120 points for skin activity; 10 points for scalp activity; 120 points for mucosal activity). Higher score indicated more disease activity. PDAI activity score was measured independently of the CS dose administered in the participants.</description>
          <population>Analysis was performed on mITT population, based on data collected up to database lock for the blinded treatment period. Here, 'number analyzed' = participants with available data for each specified category.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="66"/>
                <count group_id="O2" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="63"/>
                    <count group_id="O2" value="62"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.870" spread="12.5361"/>
                    <measurement group_id="O2" value="-7.161" spread="6.5918"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 13</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="59"/>
                    <count group_id="O2" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-11.253" spread="12.1328"/>
                    <measurement group_id="O2" value="-13.139" spread="10.3317"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 25</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="61"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-11.722" spread="13.2580"/>
                    <measurement group_id="O2" value="-14.174" spread="11.1997"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 37</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="62"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-12.918" spread="11.0260"/>
                    <measurement group_id="O2" value="-13.442" spread="10.2669"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 61</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                    <count group_id="O2" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-13.793" spread="8.9794"/>
                    <measurement group_id="O2" value="-14.649" spread="11.4991"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 109</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-23.967" spread="16.4628"/>
                    <measurement group_id="O2" value="-18.250" spread="9.8288"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Autoimmune Bullous Disease Quality of Life (ABQOL) Score at Weeks 5, 13, 25, 37, 61, and 109: PV mITT Population</title>
        <description>ABQOL, a 17-item questionnaire is a valid and reliable tool to assess quality of life in participants with autoimmune blistering diseases. Each question score ranged from 0 to 3 points, 0 = never, 1 = occasionally, 2 = sometimes and 3 = all the time, where higher score = poor QOL. The total ABQoL score was calculated by summing the score of each question and it ranged from 0 to 51, where higher score = more QOL impairment.</description>
        <time_frame>Baseline, Weeks 5, 13, 25, 37, 61, and 109</time_frame>
        <population>Analysis was performed on PV mITT population, based on data collected up to database lock for the blinded treatment period. Here, 'overall number of participants analyzed'=participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Then Rilzabrutinib</title>
            <description>In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.</description>
          </group>
          <group group_id="O2">
            <title>Rilzabrutinib Then Rilzabrutinib</title>
            <description>In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Autoimmune Bullous Disease Quality of Life (ABQOL) Score at Weeks 5, 13, 25, 37, 61, and 109: PV mITT Population</title>
          <description>ABQOL, a 17-item questionnaire is a valid and reliable tool to assess quality of life in participants with autoimmune blistering diseases. Each question score ranged from 0 to 3 points, 0 = never, 1 = occasionally, 2 = sometimes and 3 = all the time, where higher score = poor QOL. The total ABQoL score was calculated by summing the score of each question and it ranged from 0 to 51, where higher score = more QOL impairment.</description>
          <population>Analysis was performed on PV mITT population, based on data collected up to database lock for the blinded treatment period. Here, 'overall number of participants analyzed'=participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="49"/>
                    <count group_id="O2" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.20" spread="6.856"/>
                    <measurement group_id="O2" value="-4.47" spread="7.668"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 13</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                    <count group_id="O2" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.04" spread="6.831"/>
                    <measurement group_id="O2" value="-6.22" spread="7.218"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 25</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.88" spread="7.443"/>
                    <measurement group_id="O2" value="-8.32" spread="7.647"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 37</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="38"/>
                    <count group_id="O2" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.53" spread="7.518"/>
                    <measurement group_id="O2" value="-7.19" spread="8.187"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 61</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.76" spread="6.389"/>
                    <measurement group_id="O2" value="-8.64" spread="10.140"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 109</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-19.00"/>
                    <measurement group_id="O2" value="-19.50" spread="6.364"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Autoimmune Bullous Disease Quality of Life Score at Weeks 5, 13, 25, 37, 61, and 109: mITT Population</title>
        <description>ABQOL, a 17-item questionnaire is a valid and reliable tool to assess quality of life in participants with autoimmune blistering diseases. Each question score ranged from 0 to 3 points, 0 = never, 1 = occasionally, 2 = sometimes and 3 = all the time, where higher score = poor QOL. The total ABQoL score was calculated by summing the score of each question and it ranged from 0 to 51, where higher score = more QOL impairment.</description>
        <time_frame>Baseline, Weeks 5, 13, 25, 37, 61, and 109</time_frame>
        <population>Analysis was performed on mITT population, based on data collected up to database lock for the blinded treatment period. Here, 'overall number of participants analyzed'=participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Then Rilzabrutinib</title>
            <description>In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.</description>
          </group>
          <group group_id="O2">
            <title>Rilzabrutinib Then Rilzabrutinib</title>
            <description>In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Autoimmune Bullous Disease Quality of Life Score at Weeks 5, 13, 25, 37, 61, and 109: mITT Population</title>
          <description>ABQOL, a 17-item questionnaire is a valid and reliable tool to assess quality of life in participants with autoimmune blistering diseases. Each question score ranged from 0 to 3 points, 0 = never, 1 = occasionally, 2 = sometimes and 3 = all the time, where higher score = poor QOL. The total ABQoL score was calculated by summing the score of each question and it ranged from 0 to 51, where higher score = more QOL impairment.</description>
          <population>Analysis was performed on mITT population, based on data collected up to database lock for the blinded treatment period. Here, 'overall number of participants analyzed'=participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="59"/>
                    <count group_id="O2" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.02" spread="6.474"/>
                    <measurement group_id="O2" value="-4.50" spread="7.324"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 13</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="56"/>
                    <count group_id="O2" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.18" spread="7.262"/>
                    <measurement group_id="O2" value="-5.93" spread="7.168"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 25</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="58"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.23" spread="7.259"/>
                    <measurement group_id="O2" value="-7.57" spread="7.667"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 37</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                    <count group_id="O2" value="58"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.43" spread="7.150"/>
                    <measurement group_id="O2" value="-7.00" spread="7.843"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 61</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.40" spread="7.416"/>
                    <measurement group_id="O2" value="-7.47" spread="9.263"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 109</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-13.00" spread="6.000"/>
                    <measurement group_id="O2" value="-19.50" spread="6.364"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Autoimmune Bullous Disease Quality of Life Score of Zero at Weeks 5, 13, 25, 37, 61, and 109: PV mITT Population</title>
        <description>ABQOL, a 17-item questionnaire is a valid and reliable tool to assess quality of life in participants with autoimmune blistering diseases. Each question score ranged from 0 to 3 points, 0 = never, 1 = occasionally, 2 = sometimes and 3 = all the time, where higher score = poor QOL. The total ABQoL score was calculated by summing the score of each question and it ranged from 0 to 51, where higher score = more QOL impairment. Percentage of participants with ABQOL score of '0' were reported in this outcome measure.</description>
        <time_frame>At Weeks 5, 13, 25, 37, 61, and 109</time_frame>
        <population>Analysis was performed on PV mITT population, based on data collected up to database lock for the blinded treatment period. Here, 'number analyzed' = participants with available data for each specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Then Rilzabrutinib</title>
            <description>In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.</description>
          </group>
          <group group_id="O2">
            <title>Rilzabrutinib Then Rilzabrutinib</title>
            <description>In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Autoimmune Bullous Disease Quality of Life Score of Zero at Weeks 5, 13, 25, 37, 61, and 109: PV mITT Population</title>
          <description>ABQOL, a 17-item questionnaire is a valid and reliable tool to assess quality of life in participants with autoimmune blistering diseases. Each question score ranged from 0 to 3 points, 0 = never, 1 = occasionally, 2 = sometimes and 3 = all the time, where higher score = poor QOL. The total ABQoL score was calculated by summing the score of each question and it ranged from 0 to 51, where higher score = more QOL impairment. Percentage of participants with ABQOL score of '0' were reported in this outcome measure.</description>
          <population>Analysis was performed on PV mITT population, based on data collected up to database lock for the blinded treatment period. Here, 'number analyzed' = participants with available data for each specified category.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 13</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                    <count group_id="O2" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.1"/>
                    <measurement group_id="O2" value="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 25</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.4"/>
                    <measurement group_id="O2" value="4.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 37</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="38"/>
                    <count group_id="O2" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.9"/>
                    <measurement group_id="O2" value="4.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 61</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.8"/>
                    <measurement group_id="O2" value="12.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 109</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="50.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Autoimmune Bullous Disease Quality of Life Score of Zero at Weeks 5, 13, 25, 37, 61, and 109: mITT Population</title>
        <description>ABQOL, a 17-item questionnaire is a valid and reliable tool to assess quality of life in participants with autoimmune blistering diseases. Each question score ranged from 0 to 3 points, 0 = never, 1 = occasionally, 2 = sometimes and 3 = all the time, where higher score = poor QOL. The total ABQoL score was calculated by summing the score of each question and it ranged from 0 to 51, where higher score = more QOL impairment. Percentage of participants with ABQOL score of '0' were reported in this outcome measure.</description>
        <time_frame>At Weeks 5, 13, 25, 37, 61, and 109</time_frame>
        <population>Analysis was performed on mITT population, based on data collected up to database lock for the blinded treatment period. Here, 'number analyzed' = participants with available data for each specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Then Rilzabrutinib</title>
            <description>In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.</description>
          </group>
          <group group_id="O2">
            <title>Rilzabrutinib Then Rilzabrutinib</title>
            <description>along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.&#xD;
In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Autoimmune Bullous Disease Quality of Life Score of Zero at Weeks 5, 13, 25, 37, 61, and 109: mITT Population</title>
          <description>ABQOL, a 17-item questionnaire is a valid and reliable tool to assess quality of life in participants with autoimmune blistering diseases. Each question score ranged from 0 to 3 points, 0 = never, 1 = occasionally, 2 = sometimes and 3 = all the time, where higher score = poor QOL. The total ABQoL score was calculated by summing the score of each question and it ranged from 0 to 51, where higher score = more QOL impairment. Percentage of participants with ABQOL score of '0' were reported in this outcome measure.</description>
          <population>Analysis was performed on mITT population, based on data collected up to database lock for the blinded treatment period. Here, 'number analyzed' = participants with available data for each specified category.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="66"/>
                <count group_id="O2" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="61"/>
                    <count group_id="O2" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 13</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="57"/>
                    <count group_id="O2" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8"/>
                    <measurement group_id="O2" value="5.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 25</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="59"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.7"/>
                    <measurement group_id="O2" value="6.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 37</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                    <count group_id="O2" value="59"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.4"/>
                    <measurement group_id="O2" value="5.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 61</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.0"/>
                    <measurement group_id="O2" value="8.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 109</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.3"/>
                    <measurement group_id="O2" value="50.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Score: Visual Analogue Scale (VAS) Scores at Weeks 5, 13, 25, 37, 61, and 109</title>
        <description>EQ-5D-5L: standardized measure of health status that provides general assessment of health and wellbeing. EQ-5D VAS was used to record a participant's rating for his/her current health-related quality of life state and captured on a vertical VAS scale ranging from 0 to 100, where 0=worst imaginable health state and 100=best imaginable health state, where higher states indicated better outcomes.</description>
        <time_frame>Baseline, Weeks 5, 13, 25, 37, 61, and 109</time_frame>
        <population>For this OM, the planned data collection and analysis was not performed because of early termination of the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Then Rilzabrutinib</title>
            <description>In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.</description>
          </group>
          <group group_id="O2">
            <title>Rilzabrutinib Then Rilzabrutinib</title>
            <description>In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Score: Visual Analogue Scale (VAS) Scores at Weeks 5, 13, 25, 37, 61, and 109</title>
          <description>EQ-5D-5L: standardized measure of health status that provides general assessment of health and wellbeing. EQ-5D VAS was used to record a participant's rating for his/her current health-related quality of life state and captured on a vertical VAS scale ranging from 0 to 100, where 0=worst imaginable health state and 100=best imaginable health state, where higher states indicated better outcomes.</description>
          <population>For this OM, the planned data collection and analysis was not performed because of early termination of the study.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels Score: Individual Dimension at Weeks 5, 13, 25, 37, 61, and 109</title>
        <description>EQ-5D-5L: standardized measure of health status that provides general assessment of health and wellbeing. The EQ-5D descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has a 5-level response: no problems, slight problems, moderate problems, severe problems, and extreme problems. Response options are measured with a 5-point Likert scale (for the 5L version). The 5D-5L systems are converted into a single index utility score between 0 to 1, where higher score indicates a better health state and lower score indicate worse health state.</description>
        <time_frame>Baseline, Weeks 5, 13, 25, 37, 61, and 109</time_frame>
        <population>For this OM, the planned data collection and analysis was not performed because of early termination of the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Then Rilzabrutinib</title>
            <description>In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.</description>
          </group>
          <group group_id="O2">
            <title>Rilzabrutinib Then Rilzabrutinib</title>
            <description>In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels Score: Individual Dimension at Weeks 5, 13, 25, 37, 61, and 109</title>
          <description>EQ-5D-5L: standardized measure of health status that provides general assessment of health and wellbeing. The EQ-5D descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has a 5-level response: no problems, slight problems, moderate problems, severe problems, and extreme problems. Response options are measured with a 5-point Likert scale (for the 5L version). The 5D-5L systems are converted into a single index utility score between 0 to 1, where higher score indicates a better health state and lower score indicate worse health state.</description>
          <population>For this OM, the planned data collection and analysis was not performed because of early termination of the study.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to First Complete Remission With a Corticosteroids Dose &lt;=10 mg/Day From Baseline to Weeks 61 and 109</title>
        <description>Time to first CR was the time (in days) to achieve CR while on a CS dose of &lt;=10 mg/day from Baseline to Week 61 and from Baseline to Week 109. Complete remission was defined as absence of new and established lesions to the &quot;no disease activity&quot;.</description>
        <time_frame>Baseline to Week 61 and Baseline to Week 109</time_frame>
        <population>For this OM, the planned data collection and analysis was not performed because of early termination of the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Then Rilzabrutinib</title>
            <description>In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.</description>
          </group>
          <group group_id="O2">
            <title>Rilzabrutinib Then Rilzabrutinib</title>
            <description>In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to First Complete Remission With a Corticosteroids Dose &lt;=10 mg/Day From Baseline to Weeks 61 and 109</title>
          <description>Time to first CR was the time (in days) to achieve CR while on a CS dose of &lt;=10 mg/day from Baseline to Week 61 and from Baseline to Week 109. Complete remission was defined as absence of new and established lesions to the &quot;no disease activity&quot;.</description>
          <population>For this OM, the planned data collection and analysis was not performed because of early termination of the study.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Number of Disease Relapses/Flares From Initial Control of Disease Activity (CDA) to Week 37: PV mITT Population</title>
        <description>Total Number of Disease Relapses/Flares which occurred from initial CDA to Week 37 were reported. CDA was defined as disappearance of new lesions cease to form and established lesions begin to heal. Relapse/flare was defined by the appearance of 3 or more new lesions after CDA and within a month that do not heal spontaneously within 1 week, or by the extension of established lesions, in a participant who had achieved CDA.</description>
        <time_frame>From initial CDA up to Week 37 (i.e., during any time from Baseline up to Week 37)</time_frame>
        <population>Analysis was performed on PV mITT population. Here, overall number of participants analyzed = participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Then Rilzabrutinib</title>
            <description>In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.</description>
          </group>
          <group group_id="O2">
            <title>Rilzabrutinib Then Rilzabrutinib</title>
            <description>In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Number of Disease Relapses/Flares From Initial Control of Disease Activity (CDA) to Week 37: PV mITT Population</title>
          <description>Total Number of Disease Relapses/Flares which occurred from initial CDA to Week 37 were reported. CDA was defined as disappearance of new lesions cease to form and established lesions begin to heal. Relapse/flare was defined by the appearance of 3 or more new lesions after CDA and within a month that do not heal spontaneously within 1 week, or by the extension of established lesions, in a participant who had achieved CDA.</description>
          <population>Analysis was performed on PV mITT population. Here, overall number of participants analyzed = participants evaluable for this outcome measure.</population>
          <units>relapses</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6" spread="0.96"/>
                    <measurement group_id="O2" value="0.3" spread="0.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Number of Disease Relapses/Flares From Initial Control of Disease Activity to Week 37: mITT Population</title>
        <description>Total Number of Disease Relapses/Flares which occurred from initial CDA to Week 37 were reported. CDA was defined as disappearance of new lesions cease to form and established lesions begin to heal. Relapse/flare was defined by the appearance of 3 or more new lesions after CDA and within a month that do not heal spontaneously within 1 week, or by the extension of established lesions, in a participant who had achieved CDA.</description>
        <time_frame>From initial CDA up to Week 37 (i.e., during any time from Baseline up to Week 37)</time_frame>
        <population>Analysis was performed on mITT population. Here, overall number of participants analyzed = participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Then Rilzabrutinib</title>
            <description>In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.</description>
          </group>
          <group group_id="O2">
            <title>Rilzabrutinib Then Rilzabrutinib</title>
            <description>In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Number of Disease Relapses/Flares From Initial Control of Disease Activity to Week 37: mITT Population</title>
          <description>Total Number of Disease Relapses/Flares which occurred from initial CDA to Week 37 were reported. CDA was defined as disappearance of new lesions cease to form and established lesions begin to heal. Relapse/flare was defined by the appearance of 3 or more new lesions after CDA and within a month that do not heal spontaneously within 1 week, or by the extension of established lesions, in a participant who had achieved CDA.</description>
          <population>Analysis was performed on mITT population. Here, overall number of participants analyzed = participants evaluable for this outcome measure.</population>
          <units>relapses</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
                <count group_id="O2" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6" spread="0.94"/>
                    <measurement group_id="O2" value="0.3" spread="0.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Initial Relapse/Flare From Initial Control of Disease Activity to Week 37: PV mITT Population</title>
        <description>Time duration (in days) from the time of initial relapse/flare which occurred from initial CDA up to Week 37 were reported in this OM. CDA was defined as the visit at which new lesions cease to form and established lesions begin to heal. Relapse/flare was defined by the appearance of 3 or more new lesions after CDA and within a month that do not heal spontaneously within 1 week, or by the extension of established lesions, in a participant who had achieved CDA. Kaplan-Meier method was used for the analysis.</description>
        <time_frame>From initial CDA up to Week 37 (i.e., during any time from Baseline up to Week 37)</time_frame>
        <population>Analysis was performed on PV mITT population. Here, overall number of participants analyzed = participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Then Rilzabrutinib</title>
            <description>In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.</description>
          </group>
          <group group_id="O2">
            <title>Rilzabrutinib Then Rilzabrutinib</title>
            <description>In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Initial Relapse/Flare From Initial Control of Disease Activity to Week 37: PV mITT Population</title>
          <description>Time duration (in days) from the time of initial relapse/flare which occurred from initial CDA up to Week 37 were reported in this OM. CDA was defined as the visit at which new lesions cease to form and established lesions begin to heal. Relapse/flare was defined by the appearance of 3 or more new lesions after CDA and within a month that do not heal spontaneously within 1 week, or by the extension of established lesions, in a participant who had achieved CDA. Kaplan-Meier method was used for the analysis.</description>
          <population>Analysis was performed on PV mITT population. Here, overall number of participants analyzed = participants evaluable for this outcome measure.</population>
          <units>days</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="243.0" lower_limit="144.00" upper_limit="NA">Upper limit of 95% CI was not estimable due to low number of participants with the events.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">Median, upper and lower limit of 95% CI were not estimable due to low number of participants with the events.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Initial Relapse/Flare From Initial Control of Disease Activity to Week 37: mITT Population</title>
        <description>Time duration (in days) from the time of initial relapse/flare which occurred from initial CDA up to Week 37 were reported in this OM. CDA was defined as the visit at which new lesions cease to form and established lesions begin to heal. Relapse/flare was defined by the appearance of 3 or more new lesions after CDA and within a month that do not heal spontaneously within 1 week, or by the extension of established lesions, in a participant who had achieved CDA. Kaplan-Meier method was used for the analysis.</description>
        <time_frame>From initial CDA up to Week 37 (i.e., during any time from Baseline up to Week 37)</time_frame>
        <population>Analysis was performed on mITT population. Here, overall number of participants analyzed = participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Then Rilzabrutinib</title>
            <description>In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.</description>
          </group>
          <group group_id="O2">
            <title>Rilzabrutinib Then Rilzabrutinib</title>
            <description>In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Initial Relapse/Flare From Initial Control of Disease Activity to Week 37: mITT Population</title>
          <description>Time duration (in days) from the time of initial relapse/flare which occurred from initial CDA up to Week 37 were reported in this OM. CDA was defined as the visit at which new lesions cease to form and established lesions begin to heal. Relapse/flare was defined by the appearance of 3 or more new lesions after CDA and within a month that do not heal spontaneously within 1 week, or by the extension of established lesions, in a participant who had achieved CDA. Kaplan-Meier method was used for the analysis.</description>
          <population>Analysis was performed on mITT population. Here, overall number of participants analyzed = participants evaluable for this outcome measure.</population>
          <units>days</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
                <count group_id="O2" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="243.0" lower_limit="148.00" upper_limit="NA">Upper limit of 95% CI was not estimable due to low number of participants with the events.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">Median, upper and lower limit of 95% CI were not estimable due to low number of participants with the events.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With 3 or More New Lesions Within 1 Month That do Not Heal Spontaneously Within 1 Week, or With Extension of Established Lesions at Week 37: PV mITT Population</title>
        <description>Percentage of Participants With 3 or More New Lesions Within past 1 month that do not heal spontaneously within past 1 week, or with extension of established lesions, were assessed at Week 37 and reported in this OM.</description>
        <time_frame>At Week 37</time_frame>
        <population>Analysis was performed on PV mITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Then Rilzabrutinib</title>
            <description>In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.</description>
          </group>
          <group group_id="O2">
            <title>Rilzabrutinib Then Rilzabrutinib</title>
            <description>In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With 3 or More New Lesions Within 1 Month That do Not Heal Spontaneously Within 1 Week, or With Extension of Established Lesions at Week 37: PV mITT Population</title>
          <description>Percentage of Participants With 3 or More New Lesions Within past 1 month that do not heal spontaneously within past 1 week, or with extension of established lesions, were assessed at Week 37 and reported in this OM.</description>
          <population>Analysis was performed on PV mITT population.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.2"/>
                    <measurement group_id="O2" value="35.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With 3 or More New Lesions Within 1 Month That do Not Heal Spontaneously Within 1 Week, or With Extension of Established Lesions at Week 37: mITT Population</title>
        <description>Percentage of participants with 3 or more new lesions within past 1 month that do not heal spontaneously within past 1 week, or with extension of established lesions, were assessed at Week 37 and reported in this OM.</description>
        <time_frame>At Week 37</time_frame>
        <population>Analysis was performed on mITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Then Rilzabrutinib</title>
            <description>In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.</description>
          </group>
          <group group_id="O2">
            <title>Rilzabrutinib Then Rilzabrutinib</title>
            <description>In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With 3 or More New Lesions Within 1 Month That do Not Heal Spontaneously Within 1 Week, or With Extension of Established Lesions at Week 37: mITT Population</title>
          <description>Percentage of participants with 3 or more new lesions within past 1 month that do not heal spontaneously within past 1 week, or with extension of established lesions, were assessed at Week 37 and reported in this OM.</description>
          <population>Analysis was performed on mITT population.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="66"/>
                <count group_id="O2" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.1"/>
                    <measurement group_id="O2" value="36.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With at Least One Disease Relapse/Flare From Initial Control of Disease Activity to Week 37: PV mITT Population</title>
        <description>CDA was defined as the visit at which new lesions cease to form and established lesions begin to heal. Disease relapse/flare was defined by the appearance of 3 or more new lesions after CDA and within a month that do not heal spontaneously within 1 week, or by the extension of established lesions, in a participant who had achieved CDA. Percentages were calculated based on number of participants assessed (i.e. participants achieved CDA) in each treatment group. Percentage of participants with at least one disease relapse/flare from Initial CDA to Week 37 were reported in this OM.</description>
        <time_frame>From initial CDA up to Week 37 (i.e., during any time from Baseline up to Week 37)</time_frame>
        <population>Analysis was performed on PV mITT population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Then Rilzabrutinib</title>
            <description>In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.</description>
          </group>
          <group group_id="O2">
            <title>Rilzabrutinib Then Rilzabrutinib</title>
            <description>In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With at Least One Disease Relapse/Flare From Initial Control of Disease Activity to Week 37: PV mITT Population</title>
          <description>CDA was defined as the visit at which new lesions cease to form and established lesions begin to heal. Disease relapse/flare was defined by the appearance of 3 or more new lesions after CDA and within a month that do not heal spontaneously within 1 week, or by the extension of established lesions, in a participant who had achieved CDA. Percentages were calculated based on number of participants assessed (i.e. participants achieved CDA) in each treatment group. Percentage of participants with at least one disease relapse/flare from Initial CDA to Week 37 were reported in this OM.</description>
          <population>Analysis was performed on PV mITT population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.1"/>
                    <measurement group_id="O2" value="28.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With at Least One Disease Relapse/Flare From Initial Control of Disease Activity to Week 37: mITT Population</title>
        <description>CDA was defined as the visit at which new lesions cease to form and established lesions begin to heal. Disease relapse/flare was defined by the appearance of 3 or more new lesions after CDA and within a month that do not heal spontaneously within 1 week, or by the extension of established lesions, in a participant who had achieved CDA. Percentages were calculated based on number of participants assessed (i.e. participants achieved CDA) in each treatment group. Percentage of participants with at least one disease relapse/flare from Initial CDA to Week 37 were reported in this OM.</description>
        <time_frame>From initial CDA up to Week 37 (i.e., during any time from Baseline up to Week 37)</time_frame>
        <population>Analysis was performed on mITT population. Here, overall number of participants analyzed = participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Then Rilzabrutinib</title>
            <description>In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.</description>
          </group>
          <group group_id="O2">
            <title>Rilzabrutinib Then Rilzabrutinib</title>
            <description>In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With at Least One Disease Relapse/Flare From Initial Control of Disease Activity to Week 37: mITT Population</title>
          <description>CDA was defined as the visit at which new lesions cease to form and established lesions begin to heal. Disease relapse/flare was defined by the appearance of 3 or more new lesions after CDA and within a month that do not heal spontaneously within 1 week, or by the extension of established lesions, in a participant who had achieved CDA. Percentages were calculated based on number of participants assessed (i.e. participants achieved CDA) in each treatment group. Percentage of participants with at least one disease relapse/flare from Initial CDA to Week 37 were reported in this OM.</description>
          <population>Analysis was performed on mITT population. Here, overall number of participants analyzed = participants evaluable for this outcome measure.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
                <count group_id="O2" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.5"/>
                    <measurement group_id="O2" value="29.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cumulative Duration of Complete Remission With a Corticosteroids Dose &lt;=10 mg/Day From Week 37 to Week 61: PV mITT Population</title>
        <description>Cumulative duration (in days) of CR post first dose of CS &lt;=10 mg/day from Week 37 to Week 61 were reported in this OM. Complete remission was defined as the absence of new and established lesions and was intended to mean &quot;no disease activity&quot;.</description>
        <time_frame>From Week 37 to Week 61</time_frame>
        <population>Analysis was performed on PV mITT population, based on data collected up to database lock for the blinded treatment period. Here, overall number of participants analyzed = participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Then Rilzabrutinib</title>
            <description>In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.</description>
          </group>
          <group group_id="O2">
            <title>Rilzabrutinib Then Rilzabrutinib</title>
            <description>In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.</description>
          </group>
        </group_list>
        <measure>
          <title>Cumulative Duration of Complete Remission With a Corticosteroids Dose &lt;=10 mg/Day From Week 37 to Week 61: PV mITT Population</title>
          <description>Cumulative duration (in days) of CR post first dose of CS &lt;=10 mg/day from Week 37 to Week 61 were reported in this OM. Complete remission was defined as the absence of new and established lesions and was intended to mean &quot;no disease activity&quot;.</description>
          <population>Analysis was performed on PV mITT population, based on data collected up to database lock for the blinded treatment period. Here, overall number of participants analyzed = participants evaluable for this outcome measure.</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.0" spread="59.01"/>
                    <measurement group_id="O2" value="62.5" spread="67.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cumulative Duration of Complete Remission With a Corticosteroids Dose &lt;=10 mg/Day From Week 37 to Week 61: mITT Population</title>
        <description>Cumulative duration (in days) of CR post first dose of CS &lt;=10 mg/day from Week 37 to Week 61 were reported in this OM. Complete remission was defined as the absence of new and established lesions and was intended to mean &quot;no disease activity&quot;.</description>
        <time_frame>From Week 37 to Week 61</time_frame>
        <population>Analysis was performed on mITT population, based on data collected up to database lock for the blinded treatment period. Here, overall number of participants analyzed = participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Then Rilzabrutinib</title>
            <description>In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.</description>
          </group>
          <group group_id="O2">
            <title>Rilzabrutinib Then Rilzabrutinib</title>
            <description>In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.</description>
          </group>
        </group_list>
        <measure>
          <title>Cumulative Duration of Complete Remission With a Corticosteroids Dose &lt;=10 mg/Day From Week 37 to Week 61: mITT Population</title>
          <description>Cumulative duration (in days) of CR post first dose of CS &lt;=10 mg/day from Week 37 to Week 61 were reported in this OM. Complete remission was defined as the absence of new and established lesions and was intended to mean &quot;no disease activity&quot;.</description>
          <population>Analysis was performed on mITT population, based on data collected up to database lock for the blinded treatment period. Here, overall number of participants analyzed = participants evaluable for this outcome measure.</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.1" spread="59.99"/>
                    <measurement group_id="O2" value="67.1" spread="68.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cumulative Duration of Complete Remission With a Corticosteroids Dose = 0 mg/Day From Week 37 to Week 61: PV mITT Population</title>
        <description>Cumulative duration (in days) of CR post first dose of CS = 0 mg/day from Week 37 to Week 61 were reported in this OM. Complete remission was defined as the absence of new and established lesions and was intended to mean &quot;no disease activity&quot;.</description>
        <time_frame>From Week 37 to Week 61</time_frame>
        <population>Analysis was performed on PV mITT population, based on data collected up to database lock for the blinded treatment period. Here, overall number of participants analyzed = participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Then Rilzabrutinib</title>
            <description>In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.</description>
          </group>
          <group group_id="O2">
            <title>Rilzabrutinib Then Rilzabrutinib</title>
            <description>In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.</description>
          </group>
        </group_list>
        <measure>
          <title>Cumulative Duration of Complete Remission With a Corticosteroids Dose = 0 mg/Day From Week 37 to Week 61: PV mITT Population</title>
          <description>Cumulative duration (in days) of CR post first dose of CS = 0 mg/day from Week 37 to Week 61 were reported in this OM. Complete remission was defined as the absence of new and established lesions and was intended to mean &quot;no disease activity&quot;.</description>
          <population>Analysis was performed on PV mITT population, based on data collected up to database lock for the blinded treatment period. Here, overall number of participants analyzed = participants evaluable for this outcome measure.</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.7" spread="39.60"/>
                    <measurement group_id="O2" value="30.5" spread="53.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cumulative Duration of Complete Remission With a Corticosteroids Dose = 0 mg/Day From Week 37 to Week 61: mITT Population</title>
        <description>Cumulative duration (in days) of CR post first dose of CS = 0 mg/day from Week 37 to Week 61 were reported in this OM. Complete remission was defined as the absence of new and established lesions and was intended to mean &quot;no disease activity&quot;.</description>
        <time_frame>From Week 37 to Week 61</time_frame>
        <population>Analysis was performed on mITT population, based on data collected up to database lock for the blinded treatment period. Here, overall number of participants analyzed = participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Then Rilzabrutinib</title>
            <description>In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week109 in LTE period according to protocol-specified criteria.</description>
          </group>
          <group group_id="O2">
            <title>Rilzabrutinib Then Rilzabrutinib</title>
            <description>In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.</description>
          </group>
        </group_list>
        <measure>
          <title>Cumulative Duration of Complete Remission With a Corticosteroids Dose = 0 mg/Day From Week 37 to Week 61: mITT Population</title>
          <description>Cumulative duration (in days) of CR post first dose of CS = 0 mg/day from Week 37 to Week 61 were reported in this OM. Complete remission was defined as the absence of new and established lesions and was intended to mean &quot;no disease activity&quot;.</description>
          <population>Analysis was performed on mITT population, based on data collected up to database lock for the blinded treatment period. Here, overall number of participants analyzed = participants evaluable for this outcome measure.</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.8" spread="42.58"/>
                    <measurement group_id="O2" value="35.3" spread="56.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)</title>
        <description>An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug and does not necessarily had to have a causal relationship with the treatment. Serious AEs (SAEs) were any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. TEAEs were the AEs that developed or worsened or became serious after the administration of first dose of study drug in each period.</description>
        <time_frame>BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)</time_frame>
        <population>Analysis was performed on safety population which included all participants who had received at least one dose of study medication and were analyzed according to the treatment they actually received.</population>
        <group_list>
          <group group_id="O1">
            <title>BT Period: Placebo</title>
            <description>Participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37.</description>
          </group>
          <group group_id="O2">
            <title>BT Period: Rilzabrutinib</title>
            <description>Participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with Sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone per day from Week 29 to Week 37.</description>
          </group>
          <group group_id="O3">
            <title>OLE Period: Placebo Then Rilzabrutinib</title>
            <description>Eligible participants post completion of BT period (after receiving placebo), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.</description>
          </group>
          <group group_id="O4">
            <title>OLE Period: Rilzabrutinib Then Rilzabrutinib</title>
            <description>Eligible participants post completion of BT period (after receiving rilzabrutinib), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.</description>
          </group>
          <group group_id="O5">
            <title>LTE Period: Placebo Then Rilzabrutinib</title>
            <description>Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.</description>
          </group>
          <group group_id="O6">
            <title>LTE Period: Rilzabrutinib Then Rilzabrutinib</title>
            <description>Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)</title>
          <description>An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug and does not necessarily had to have a causal relationship with the treatment. Serious AEs (SAEs) were any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. TEAEs were the AEs that developed or worsened or became serious after the administration of first dose of study drug in each period.</description>
          <population>Analysis was performed on safety population which included all participants who had received at least one dose of study medication and were analyzed according to the treatment they actually received.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="66"/>
                <count group_id="O2" value="65"/>
                <count group_id="O3" value="51"/>
                <count group_id="O4" value="61"/>
                <count group_id="O5" value="35"/>
                <count group_id="O6" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54"/>
                    <measurement group_id="O2" value="55"/>
                    <measurement group_id="O3" value="33"/>
                    <measurement group_id="O4" value="35"/>
                    <measurement group_id="O5" value="18"/>
                    <measurement group_id="O6" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TESAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetics (PK): Plasma Concentration of Rilzabrutinib</title>
        <description>Data for this OM was not planned to be collected and analyzed for placebo arm of the study.</description>
        <time_frame>Pre-dose and 2 hours post-dose on Day 1</time_frame>
        <population>Analysis was performed on PK population which included all participants who had received at least one dose of study medication and had sufficient data for PK analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Rilzabrutinib</title>
            <description>In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics (PK): Plasma Concentration of Rilzabrutinib</title>
          <description>Data for this OM was not planned to be collected and analyzed for placebo arm of the study.</description>
          <population>Analysis was performed on PK population which included all participants who had received at least one dose of study medication and had sufficient data for PK analysis.</population>
          <units>nanograms per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1: pre-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Pre-dose concentration was below limit of quantification (0.1 nanogram per milliliter) and thus mean and standard deviation data were not calculable.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1: 2-hour post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="273.13" spread="264.136"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacodynamics (PD): Change From Baseline in Antibody Levels - Anti-desmoglein 1 (Anti-dsg 1) and Anti-desmoglein 3 (Anti-dsg 3) at Weeks 13, 25, 37, 49, 61, 73, 85, 97, and 109: PV mITT Population</title>
        <description>Anti-dsg1 and anti-dsg3 autoantibody levels was assessed by enzyme-linked immunosorbent assay (ELISA) method.</description>
        <time_frame>Baseline, Weeks 13, 25, 37, 49, 61, 73, 85, 97, and 109</time_frame>
        <population>Analysis was performed on PV mITT population. Here, 'number analyzed' = participants with available data for each specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37.</description>
          </group>
          <group group_id="O2">
            <title>Rilzabrutinib</title>
            <description>In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacodynamics (PD): Change From Baseline in Antibody Levels - Anti-desmoglein 1 (Anti-dsg 1) and Anti-desmoglein 3 (Anti-dsg 3) at Weeks 13, 25, 37, 49, 61, 73, 85, 97, and 109: PV mITT Population</title>
          <description>Anti-dsg1 and anti-dsg3 autoantibody levels was assessed by enzyme-linked immunosorbent assay (ELISA) method.</description>
          <population>Analysis was performed on PV mITT population. Here, 'number analyzed' = participants with available data for each specified category.</population>
          <units>units/milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline: Anti-dsg1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="108.4" spread="288.97"/>
                    <measurement group_id="O2" value="85.9" spread="139.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline: Anti-dsg3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="392.5" spread="697.52"/>
                    <measurement group_id="O2" value="464.1" spread="668.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 13: Anti-dsg1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="48"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.6" spread="116.32"/>
                    <measurement group_id="O2" value="15.4" spread="34.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 13: Anti-dsg3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="48"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="197.1" spread="320.37"/>
                    <measurement group_id="O2" value="99.8" spread="146.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 25: Anti-dsg1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="46"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48.2" spread="93.15"/>
                    <measurement group_id="O2" value="17.5" spread="37.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 25: Anti-dsg3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="46"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="218.6" spread="314.74"/>
                    <measurement group_id="O2" value="153.7" spread="351.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 37: Anti-dsg1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="41"/>
                    <count group_id="O2" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.0" spread="95.02"/>
                    <measurement group_id="O2" value="24.1" spread="60.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 37: Anti-dsg3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="41"/>
                    <count group_id="O2" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="204.4" spread="313.26"/>
                    <measurement group_id="O2" value="213.9" spread="389.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 49: Anti-dsg1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.1" spread="18.66"/>
                    <measurement group_id="O2" value="17.1" spread="31.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 49: Anti-dsg3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="215.6" spread="327.22"/>
                    <measurement group_id="O2" value="277.1" spread="575.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 61: Anti-dsg1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.0" spread="20.61"/>
                    <measurement group_id="O2" value="12.5" spread="26.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 61: Anti-dsg3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="252.3" spread="439.45"/>
                    <measurement group_id="O2" value="223.5" spread="271.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 73: Anti-dsg1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.8" spread="23.21"/>
                    <measurement group_id="O2" value="10.5" spread="26.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 73: Anti-dsg3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="237.1" spread="412.33"/>
                    <measurement group_id="O2" value="157.6" spread="186.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 85: Anti-dsg1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.7" spread="24.31"/>
                    <measurement group_id="O2" value="14.2" spread="28.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 85: Anti-dsg3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="169.9" spread="349.29"/>
                    <measurement group_id="O2" value="132.4" spread="189.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 97: Anti-dsg1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.6" spread="5.27"/>
                    <measurement group_id="O2" value="4.7" spread="8.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 97: Anti-dsg3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="193.0" spread="330.12"/>
                    <measurement group_id="O2" value="95.4" spread="180.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 109: Anti-dsg1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0"/>
                    <measurement group_id="O2" value="2.0" spread="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 109: Anti-dsg3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="94.0" spread="115.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacodynamics: Change From Baseline in Antibody Levels - Anti-desmoglein 1 (Anti-dsg 1) and Anti-desmoglein 3 (Anti-dsg 3) at Weeks 13, 25, 37, 49, 61, 73, 85, 97 and 109: mITT Population</title>
        <description>Anti-dsg1 and anti-dsg3 autoantibody levels was assessed by ELISA method.</description>
        <time_frame>Baseline, Weeks 13, 25, 37, 49, 61, 73, 85, 97, and 109</time_frame>
        <population>Analysis was performed on mITT population. Here, 'number analyzed' = participants with available data for each specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>In BT period, participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37.</description>
          </group>
          <group group_id="O2">
            <title>Rilzabrutinib</title>
            <description>In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacodynamics: Change From Baseline in Antibody Levels - Anti-desmoglein 1 (Anti-dsg 1) and Anti-desmoglein 3 (Anti-dsg 3) at Weeks 13, 25, 37, 49, 61, 73, 85, 97 and 109: mITT Population</title>
          <description>Anti-dsg1 and anti-dsg3 autoantibody levels was assessed by ELISA method.</description>
          <population>Analysis was performed on mITT population. Here, 'number analyzed' = participants with available data for each specified category.</population>
          <units>units/milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="66"/>
                <count group_id="O2" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline: Anti-dsg1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="66"/>
                    <count group_id="O2" value="65"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="132.2" spread="275.92"/>
                    <measurement group_id="O2" value="141.7" spread="366.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline: Anti-dsg3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="66"/>
                    <count group_id="O2" value="65"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="328.8" spread="651.84"/>
                    <measurement group_id="O2" value="385.8" spread="632.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 13: Anti-dsg1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="57"/>
                    <count group_id="O2" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.7" spread="116.08"/>
                    <measurement group_id="O2" value="39.8" spread="102.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 13: Anti-dsg3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="57"/>
                    <count group_id="O2" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="166.1" spread="302.25"/>
                    <measurement group_id="O2" value="82.5" spread="138.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 25: Anti-dsg1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.6" spread="105.99"/>
                    <measurement group_id="O2" value="40.5" spread="106.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 25: Anti-dsg3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="182.4" spread="298.18"/>
                    <measurement group_id="O2" value="124.3" spread="320.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 37: Anti-dsg1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.5" spread="101.58"/>
                    <measurement group_id="O2" value="37.0" spread="68.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 37: Anti-dsg3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="167.8" spread="293.78"/>
                    <measurement group_id="O2" value="176.5" spread="362.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 49: Anti-dsg1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="37"/>
                    <count group_id="O2" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.9" spread="53.27"/>
                    <measurement group_id="O2" value="44.1" spread="102.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 49: Anti-dsg3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="37"/>
                    <count group_id="O2" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="163.4" spread="298.38"/>
                    <measurement group_id="O2" value="216.4" spread="520.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 61: Anti-dsg1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                    <count group_id="O2" value="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.5" spread="68.66"/>
                    <measurement group_id="O2" value="44.6" spread="88.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 61: Anti-dsg3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                    <count group_id="O2" value="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="165.3" spread="372.10"/>
                    <measurement group_id="O2" value="159.2" spread="249.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 73: Anti-dsg1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                    <count group_id="O2" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.5" spread="87.58"/>
                    <measurement group_id="O2" value="48.5" spread="139.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 73: Anti-dsg3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                    <count group_id="O2" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="165.2" spread="358.15"/>
                    <measurement group_id="O2" value="112.0" spread="171.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 85: Anti-dsg1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.3" spread="39.62"/>
                    <measurement group_id="O2" value="42.1" spread="105.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 85: Anti-dsg3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="116.9" spread="296.51"/>
                    <measurement group_id="O2" value="97.9" spread="170.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 97: Anti-dsg1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.9" spread="46.36"/>
                    <measurement group_id="O2" value="52.2" spread="141.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 97: Anti-dsg3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="107.6" spread="254.47"/>
                    <measurement group_id="O2" value="76.0" spread="161.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 109: Anti-dsg1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.7" spread="4.73"/>
                    <measurement group_id="O2" value="2.0" spread="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 109: Anti-dsg3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" spread="1.73"/>
                    <measurement group_id="O2" value="94.0" spread="115.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)</time_frame>
      <desc>Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious after the administration of first dose of study drug in each period. Analysis was performed on safety population. For the OLE and LTE period, AE data for individual arms as well as for the combined population were analyzed and reported under the respective arm.</desc>
      <group_list>
        <group group_id="E1">
          <title>BT Period: Placebo</title>
          <description>Participants received placebo orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37.</description>
        </group>
        <group group_id="E2">
          <title>BT Period: Rilzabrutinib</title>
          <description>Participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with Sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone per day from Week 29 to Week 37.</description>
        </group>
        <group group_id="E3">
          <title>OLE Period: Placebo Then Rilzabrutinib</title>
          <description>Eligible participants post completion of BT period (after receiving placebo), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.</description>
        </group>
        <group group_id="E4">
          <title>OLE Period: Rilzabrutinib Then Rilzabrutinib</title>
          <description>Eligible participants post completion of BT period (after receiving rilzabrutinib), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.</description>
        </group>
        <group group_id="E5">
          <title>OLE Period: Overall (All Participants)</title>
          <description>All eligible participants post completion of BT period (after receiving placebo/rilzabrutinib), entered OLE period and received rilzabrutinib 400 mg orally BID up to Week 61 in OLE period.</description>
        </group>
        <group group_id="E6">
          <title>LTE Period: Placebo Then Rilzabrutinib</title>
          <description>Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.</description>
        </group>
        <group group_id="E7">
          <title>LTE Period: Rilzabrutinib Then Rilzabrutinib</title>
          <description>Eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.</description>
        </group>
        <group group_id="E8">
          <title>LTE Period: Overall (All Participants)</title>
          <description>All eligible participants post completion of OLE period (after receiving rilzabrutinib), entered LTE period and continued to receive rilzabrutinib 400 mg BID until Week 109 in LTE period.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 24.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="66"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="66"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="65"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="112"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial Fibrillation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="66"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Atrial Flutter</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="66"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Cardiac Arrest</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Cardiac Failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Ventricular Extrasystoles</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Vogt-Koyanagi-Harada Disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="66"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Covid-19</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="66"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E8" events="2" subjects_affected="2" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Covid-19 Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="66"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Meningitis Bacterial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="66"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="66"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Septic Shock</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Steroid Diabetes</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="66"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Renal Neoplasm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Mania</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="66"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pulmonary Embolism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="66"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Respiratory Failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="66"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pemphigus</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="66"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Rash Maculo-Papular</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Embolism Arterial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 24.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="41" subjects_at_risk="66"/>
                <counts group_id="E2" subjects_affected="47" subjects_at_risk="65"/>
                <counts group_id="E3" subjects_affected="18" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="22" subjects_at_risk="61"/>
                <counts group_id="E5" subjects_affected="40" subjects_at_risk="112"/>
                <counts group_id="E6" subjects_affected="11" subjects_at_risk="35"/>
                <counts group_id="E7" subjects_affected="7" subjects_at_risk="34"/>
                <counts group_id="E8" subjects_affected="18" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Increased Tendency To Bruise</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="66"/>
                <counts group_id="E2" events="17" subjects_affected="16" subjects_at_risk="65"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="61"/>
                <counts group_id="E5" events="5" subjects_affected="5" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Cushingoid</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="66"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Vision Blurred</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="66"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal Distension</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="66"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="66"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="112"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E8" events="2" subjects_affected="2" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Abdominal Pain Upper</sub_title>
                <counts group_id="E1" events="7" subjects_affected="4" subjects_at_risk="66"/>
                <counts group_id="E2" events="6" subjects_affected="4" subjects_at_risk="65"/>
                <counts group_id="E3" events="5" subjects_affected="3" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E5" events="5" subjects_affected="3" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="66"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="66"/>
                <counts group_id="E2" events="9" subjects_affected="8" subjects_at_risk="65"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="51"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="61"/>
                <counts group_id="E5" events="7" subjects_affected="7" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="66"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="65"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="66"/>
                <counts group_id="E2" events="12" subjects_affected="8" subjects_at_risk="65"/>
                <counts group_id="E3" events="8" subjects_affected="8" subjects_at_risk="51"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="61"/>
                <counts group_id="E5" events="10" subjects_affected="10" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="66"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Oedema Peripheral</sub_title>
                <counts group_id="E1" events="7" subjects_affected="4" subjects_at_risk="66"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="65"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Herpes Simplex</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E7" events="4" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E8" events="4" subjects_affected="2" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Oral Herpes</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="66"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E8" events="2" subjects_affected="2" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Tinea Versicolour</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="66"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="112"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E8" events="2" subjects_affected="2" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine Aminotransferase Increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="65"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Weight Increased</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="66"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="66"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="65"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E4" events="4" subjects_affected="3" subjects_at_risk="61"/>
                <counts group_id="E5" events="6" subjects_affected="5" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Myopathy</sub_title>
                <counts group_id="E1" events="11" subjects_affected="10" subjects_at_risk="66"/>
                <counts group_id="E2" events="16" subjects_affected="15" subjects_at_risk="65"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="61"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cognitive Disorder</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="66"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="66"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="65"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="66"/>
                <counts group_id="E2" events="14" subjects_affected="9" subjects_at_risk="65"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E4" events="5" subjects_affected="3" subjects_at_risk="61"/>
                <counts group_id="E5" events="7" subjects_affected="5" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E8" events="2" subjects_affected="2" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="66"/>
                <counts group_id="E2" events="14" subjects_affected="11" subjects_at_risk="65"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="61"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="66"/>
                <counts group_id="E2" events="14" subjects_affected="12" subjects_at_risk="65"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Mania</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="66"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis Acneiform</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="66"/>
                <counts group_id="E2" events="10" subjects_affected="9" subjects_at_risk="65"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="61"/>
                <counts group_id="E5" events="4" subjects_affected="3" subjects_at_risk="112"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E8" events="2" subjects_affected="2" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Hirsutism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="66"/>
                <counts group_id="E2" events="7" subjects_affected="6" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="66"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="61"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="112"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="35"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E8" events="3" subjects_affected="3" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Skin Striae</sub_title>
                <counts group_id="E1" events="4" subjects_affected="1" subjects_at_risk="66"/>
                <counts group_id="E2" events="8" subjects_affected="6" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="61"/>
                <counts group_id="E5" events="3" subjects_affected="2" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="66"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="61"/>
                <counts group_id="E5" events="3" subjects_affected="2" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Study was terminated prematurely by the Sponsor.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Trial Transparency Team</name_or_title>
      <organization>Sanofi</organization>
      <phone>800-633-1610 ext 6#</phone>
      <email>Contact-US@Sanofi.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03762265
org study id: EFC17092
secondary id: PRN1008-012
secondary id: 2018-002261-19
nct id: NCT03762265
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
This was a Phase 3 randomized, parallel-group, double-blind, placebo-controlled trial
      (blinded treatment [BT] period) followed by an open-label extension [OLE] period intended to
      evaluate the efficacy and safety of oral PRN1008 in moderate to severe pemphigus. After
      completing the open-label extension period, eligible participants might continue in a long
      term extension (LTE) Period of 48 weeks.
A total of 131 male or female participants with newly diagnosed or relapsing moderate to
      severe pemphigus (pemphigus vulgaris [PV] or pemphigus foliaceus [PF]) were enrolled in the
      trial worldwide.

      The trial would last 68 weeks (approximately 17 months) for each participant. For
      participants eligible to enroll in the LTE, the trial might last up to 116 weeks.

      Participants were randomized at Day 1, using a 1:1 ratio to receive PRN1008 or placebo twice
      per day, by relapsing/newly diagnosed disease history (newly diagnosed defined as within 6
      months of screening).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Percentage of Participants Who Achieved Complete Remission (CR) With a Corticosteroids Dose of Less Than or Equal to (<=) 10 mg/Day From Week 29 to Week 37: Pemphigus Vulgaris Participants in Modified Intent-to-Treat (PV mITT) Population
time frame: From Week 29 to Week 37
description: Complete remission was defined as absence of new and established lesions and was intended to mean "no disease activity" for 2 consecutive weeks, with Pemphigus Disease Area Index (PDAI) activity score =0 and CS dose <=10 mg. PDAI score weighted for number and size of lesions with score of 0 (absent) to 10 given for skin (12 body locations), scalp and mucous membrane showing disease activity (erosions/blisters or new erythema). PDAI total score ranged from 0 to 250 points representing disease activity (120 points for skin activity; 10 points for scalp activity; 120 points for mucosal activity). Higher score indicated more disease activity. In this outcome measure (OM), percentage of participants who achieved CR while on a daily corticosteroids dose of <=10 mg/day were reported.
measure: Percentage of Participants Who Achieved Complete Remission With a Corticosteroids Dose of <=10 mg/Day From Week 29 to Week 37: Modified Intent-to-Treat (mITT) Population
time frame: From Week 29 to Week 37
description: Complete remission was defined as absence of new and established lesions and was intended to mean "no disease activity" for 2 consecutive weeks, with PDAI activity score =0 and CS dose <=10 mg. PDAI score weighted for number and size of lesions with score of 0 (absent) to 10 given for skin (12 body locations), scalp and mucous membrane showing disease activity (erosions/blisters or new erythema). PDAI total score ranged from 0 to 250 points representing disease activity (120 points for skin activity; 10 points for scalp activity; 120 points for mucosal activity). Higher score indicated more disease activity. In this OM, percentage of participants who achieved CR while on a daily corticosteroids dose of <=10 mg/day were reported.
measure: Cumulative Oral Corticosteroid Dose From Baseline to Week 37: PV mITT Population
time frame: Baseline to Week 37
description: The cumulative dose (in milligrams) of sponsor-provided oral CS (prednisone or prednisolone) received by the participants during the BT period was calculated from Baseline to Week 37 and is reported in this OM.
measure: Cumulative Oral Corticosteroid Dose From Baseline to Week 37: mITT Population
time frame: Baseline to Week 37
description: The cumulative dose (in milligrams) of sponsor-provided oral CS (prednisone or prednisolone) received by the participants during the BT period was calculated from Baseline to Week 37 and is reported in this OM.
measure: Cumulative Duration of Complete Remission With a Corticosteroids Dose <=10 mg/Day From Baseline to Week 37: PV mITT Population
time frame: Baseline to Week 37
description: Cumulative duration (in days) of CR post first CS dose of <= 10 mg/day from Baseline to Week 37 was analyzed with a zero-inflated negative binomial model with terms of treatment group and disease history, and an offset based on the number of days on blinded treatment period and were reported in this OM. Complete remission was defined as the absence of new and established lesions and was intended to mean "no disease activity".
measure: Cumulative Duration of Complete Remission With a Corticosteroids Dose <=10 mg/Day From Baseline to Week 37: mITT Population
time frame: Baseline to Week 37
description: Cumulative duration (in days) of CR post first CS dose of <= 10 mg/day from Baseline to Week 37 was analyzed with a zero-inflated negative binomial model with terms of treatment group and disease history, and an offset based on the number of days on blinded treatment period and were reported in this OM. Complete remission was defined as the absence of new and established lesions and was intended to mean "no disease activity".
measure: Time to First Complete Remission With a Corticosteroids Dose <=10 mg/Day From Baseline to Week 37: PV mITT Population
time frame: Baseline to Week 37
description: Time to first CR was the time (in days) to achieve CR while on CS dose of <=10 mg/day. Complete remission was defined as the absence of new and established lesions to the "no disease activity". Kaplan-Meier method was used for the analysis.
measure: Time to First Complete Remission With a Corticosteroids Dose <=10 mg/Day From Baseline to Week 37: mITT Population
time frame: Baseline to Week 37
description: Time to first CR was the time (in days) to achieve CR while on CS dose of <=10 mg/day. Complete remission was defined as the absence of new and established lesions to the "no disease activity". Kaplan-Meier method was used for the analysis.
measure: Percentage of Participants Who Achieved Complete Remission With a Corticosteroids Dose of <=5 mg/Day From Week 29 to Week 37: PV mITT Population
time frame: From Week 29 to Week 37
description: Complete remission was defined as the absence of new and established lesions and was intended to mean "no disease activity". In this OM, percentage of participants who achieved CR while on a daily corticosteroids dose of <=5 mg/day were reported.
measure: Percentage of Participants Who Achieved Complete Remission With a Corticosteroids Dose of <=5 mg/Day From Week 29 to Week 37: mITT Population
time frame: From Week 29 to Week 37
description: Complete remission was defined as the absence of new and established lesions and was intended to mean "no disease activity". In this OM, percentage of participants who achieved CR while on a daily corticosteroids dose of <=5 mg/day were reported.
measure: Percentage of Participants Who Had Pemphigus Disease Area Index (PDAI) Score <3 With a Corticosteroids Dose <=10 mg/Day From Week 29 to Week 37: PV mITT Population
time frame: From Week 29 to Week 37
description: PDAI is specific cutaneous and mucosal disease activity assessment performed by investigator based on evaluation of lesions in well-defined anatomical locations. The score weighted for the number and size of lesions with score of 0 (absent) to 10 given for skin (12 body locations), scalp and mucous membrane showing disease activity (erosions/blisters or new erythema). Thus, PDAI total activity score ranged from 0 to 250 points representing disease activity (120 points for skin activity; 10 points for scalp activity; 120 points for mucosal activity). Higher score indicated more disease activity. In this OM, participants with PDAI score <3 while on a CS dose of <=10 mg/day were reported.
measure: Percentage of Participants Who Had Pemphigus Disease Area Index Score <3 With a Corticosteroids Dose <=10 mg/Day From Week 29 to Week 37: mITT Population
time frame: From Week 29 to Week 37
description: PDAI is specific cutaneous and mucosal disease activity assessment performed by investigator based on evaluation of lesions in well-defined anatomical locations. The score weighted for the number and size of lesions with score of 0 (absent) to 10 given for skin (12 body locations), scalp and mucous membrane showing disease activity (erosions/blisters or new erythema). Thus, PDAI total activity score ranged from 0 to 250 points representing disease activity (120 points for skin activity; 10 points for scalp activity; 120 points for mucosal activity). Higher score indicated more disease activity. In this OM, participants with PDAI score <3 while on a CS dose of <=10 mg/day were reported.
measure: Cumulative Duration of Complete Remission With a Corticosteroids Dose <=10 mg/Day From Baseline to Weeks 61 and 109: PV mITT Population
time frame: Baseline to Week 61 and Baseline to Week 109
description: Cumulative duration (in days) of CR post all doses of CS <=10 mg/day during Baseline to Week 61 and Baseline to Week 109 were reported in this OM. Complete remission was defined as the absence of new and established lesions to the "no disease activity".
measure: Cumulative Duration of Complete Remission With a Corticosteroids Dose <=10 mg/Day From Baseline to Weeks 61 and 109: mITT Population
time frame: Baseline to Weeks 61 and Baseline to Week 109
description: Cumulative duration (in days) of CR post all doses of CS <=10 mg/day during Baseline to Week 61 and Baseline to Week 109 were reported in this OM. Complete remission was defined as the absence of new and established lesions to the "no disease activity".
measure: Cumulative Duration of Complete Remission With a Corticosteroids Dose = 0 mg/Day From Baseline to Weeks 61 and 109: PV mITT Population
time frame: Baseline to Week 61 and Baseline to Week 109
description: Cumulative duration (in days) of CR post all doses of CS =0 mg/day during Baseline to Week 61 and Baseline to Week 109 were reported in this OM. Complete remission was defined as the absence of new and established lesions to the "no disease activity".
measure: Cumulative Duration of Complete Remission With a Corticosteroids Dose = 0 mg/Day From Baseline to Weeks 61 and 109: mITT Population
time frame: Baseline to Week 61 and Baseline to Week 109
description: Cumulative duration (in days) of CR post all doses of CS dose = 0 mg/day during Baseline to Week 61 and Baseline to Week 109 were reported in this OM. Complete remission was defined as the absence of new and established lesions to the "no disease activity".
measure: Glucocorticoid Toxicity Index (GTI) - Cumulative Worsening Score (CWS) and Aggregate Improvement Score (AIS) at Week 37: PV mITT Population
time frame: At Week 37
description: GTI assessed glucocorticoid (GC) related morbidity and GC-sparing ability of other therapies; composed of 2 components: Composite GTI and specific list. Composite GTI had 9 domains and specific list had 23 items (11 domains), used as complementary tool to C-GTI. Composite GTI score:sum of 9 domain-specific scores at each visit and cumulative GTI score:sum of composite GTI scores across each visit. 2 cumulative GTI scores: CWS and AIS at Week 37 reported in this OM. CWS assessed cumulative GC toxicity regardless of whether toxicity had lasting effects/was transient. AIS assessed new therapy effectiveness in decreasing any Baseline GC toxicity over time. CWS composite score range: 0 to 439 and AIS composite score range: -346 to 439. In CWS and AIS, minimum score=least toxicity and maximum score=most toxicity. Least square (LS) mean and standard error (SE) from analysis of covariance model using treatment, disease history as fixed effects and Baseline GTI score and CS dose as covariates.
measure: Glucocorticoid Toxicity Index - Cumulative Worsening Score and Aggregate Improvement Score at Week 37: mITT Population
time frame: At Week 37
description: GTI assessed GC related morbidity and GC-sparing ability of other therapies; composed of 2 components: Composite GTI and specific list. Composite GTI contained 9 domains and specific list contained of 23 items (11 domains), used as complementary tool to C-GTI. Composite GTI score: sum of 9 domain-specific scores at each visit and cumulative GTI score: sum of composite GTI scores across each visit. Two cumulative GTI scores: CWS and AIS at Week 37 were reported in this OM. CWS assessed cumulative GC toxicity regardless of whether toxicity had lasting effects/was transient. AIS assessed new therapy effectiveness in decreasing any Baseline GC toxicity over time. CWS composite score ranged from 0 to 439 and AIS composite score ranged from -346 to 439. For CWS and AIS, minimum score = least toxicity and maximum score = most toxicity. LS mean and SE from analysis of covariance model using treatment, disease history as fixed effects and Baseline GTI score and CS dose as covariates.
measure: Change From Baseline in Pemphigus Disease Area Index Score at Weeks 5, 13, 25, 37, 61, and 109: PV mITT Population
time frame: Baseline, Weeks 5, 13, 25, 37, 61, and 109
description: PDAI is specific cutaneous and mucosal disease activity assessment performed by investigator based on evaluation of lesions in well-defined anatomical locations. The score weighted for the number and size of lesions with score of 0 (absent) to 10 given for skin (12 body locations), scalp and mucous membrane showing disease activity (erosions/blisters or new erythema). Thus, PDAI total activity score ranged from 0 to 250 points representing disease activity (120 points for skin activity; 10 points for scalp activity; 120 points for mucosal activity). Higher score indicated more disease activity. PDAI activity score was measured independently of the CS dose administered in the participants.
measure: Change From Baseline in Pemphigus Disease Area Index Score at Weeks 5, 13, 25, 37, 61, and 109: mITT Population
time frame: Baseline, Weeks 5, 13, 25, 37, 61, and 109
description: PDAI is specific cutaneous and mucosal disease activity assessment performed by investigator based on evaluation of lesions in well-defined anatomical locations. The score weighted for the number and size of lesions with score of 0 (absent) to 10 given for skin (12 body locations), scalp and mucous membrane showing disease activity (erosions/blisters or new erythema). Thus, PDAI total activity score ranged from 0 to 250 points representing disease activity (120 points for skin activity; 10 points for scalp activity; 120 points for mucosal activity). Higher score indicated more disease activity. PDAI activity score was measured independently of the CS dose administered in the participants.
measure: Change From Baseline in Autoimmune Bullous Disease Quality of Life (ABQOL) Score at Weeks 5, 13, 25, 37, 61, and 109: PV mITT Population
time frame: Baseline, Weeks 5, 13, 25, 37, 61, and 109
description: ABQOL, a 17-item questionnaire is a valid and reliable tool to assess quality of life in participants with autoimmune blistering diseases. Each question score ranged from 0 to 3 points, 0 = never, 1 = occasionally, 2 = sometimes and 3 = all the time, where higher score = poor QOL. The total ABQoL score was calculated by summing the score of each question and it ranged from 0 to 51, where higher score = more QOL impairment.
measure: Change From Baseline in Autoimmune Bullous Disease Quality of Life Score at Weeks 5, 13, 25, 37, 61, and 109: mITT Population
time frame: Baseline, Weeks 5, 13, 25, 37, 61, and 109
description: ABQOL, a 17-item questionnaire is a valid and reliable tool to assess quality of life in participants with autoimmune blistering diseases. Each question score ranged from 0 to 3 points, 0 = never, 1 = occasionally, 2 = sometimes and 3 = all the time, where higher score = poor QOL. The total ABQoL score was calculated by summing the score of each question and it ranged from 0 to 51, where higher score = more QOL impairment.
measure: Percentage of Participants With Autoimmune Bullous Disease Quality of Life Score of Zero at Weeks 5, 13, 25, 37, 61, and 109: PV mITT Population
time frame: At Weeks 5, 13, 25, 37, 61, and 109
description: ABQOL, a 17-item questionnaire is a valid and reliable tool to assess quality of life in participants with autoimmune blistering diseases. Each question score ranged from 0 to 3 points, 0 = never, 1 = occasionally, 2 = sometimes and 3 = all the time, where higher score = poor QOL. The total ABQoL score was calculated by summing the score of each question and it ranged from 0 to 51, where higher score = more QOL impairment. Percentage of participants with ABQOL score of '0' were reported in this outcome measure.
measure: Percentage of Participants With Autoimmune Bullous Disease Quality of Life Score of Zero at Weeks 5, 13, 25, 37, 61, and 109: mITT Population
time frame: At Weeks 5, 13, 25, 37, 61, and 109
description: ABQOL, a 17-item questionnaire is a valid and reliable tool to assess quality of life in participants with autoimmune blistering diseases. Each question score ranged from 0 to 3 points, 0 = never, 1 = occasionally, 2 = sometimes and 3 = all the time, where higher score = poor QOL. The total ABQoL score was calculated by summing the score of each question and it ranged from 0 to 51, where higher score = more QOL impairment. Percentage of participants with ABQOL score of '0' were reported in this outcome measure.
measure: Change From Baseline in the European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Score: Visual Analogue Scale (VAS) Scores at Weeks 5, 13, 25, 37, 61, and 109
time frame: Baseline, Weeks 5, 13, 25, 37, 61, and 109
description: EQ-5D-5L: standardized measure of health status that provides general assessment of health and wellbeing. EQ-5D VAS was used to record a participant's rating for his/her current health-related quality of life state and captured on a vertical VAS scale ranging from 0 to 100, where 0=worst imaginable health state and 100=best imaginable health state, where higher states indicated better outcomes.
measure: Change From Baseline in the European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels Score: Individual Dimension at Weeks 5, 13, 25, 37, 61, and 109
time frame: Baseline, Weeks 5, 13, 25, 37, 61, and 109
description: EQ-5D-5L: standardized measure of health status that provides general assessment of health and wellbeing. The EQ-5D descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has a 5-level response: no problems, slight problems, moderate problems, severe problems, and extreme problems. Response options are measured with a 5-point Likert scale (for the 5L version). The 5D-5L systems are converted into a single index utility score between 0 to 1, where higher score indicates a better health state and lower score indicate worse health state.
measure: Time to First Complete Remission With a Corticosteroids Dose <=10 mg/Day From Baseline to Weeks 61 and 109
time frame: Baseline to Week 61 and Baseline to Week 109
description: Time to first CR was the time (in days) to achieve CR while on a CS dose of <=10 mg/day from Baseline to Week 61 and from Baseline to Week 109. Complete remission was defined as absence of new and established lesions to the "no disease activity".
measure: Total Number of Disease Relapses/Flares From Initial Control of Disease Activity (CDA) to Week 37: PV mITT Population
time frame: From initial CDA up to Week 37 (i.e., during any time from Baseline up to Week 37)
description: Total Number of Disease Relapses/Flares which occurred from initial CDA to Week 37 were reported. CDA was defined as disappearance of new lesions cease to form and established lesions begin to heal. Relapse/flare was defined by the appearance of 3 or more new lesions after CDA and within a month that do not heal spontaneously within 1 week, or by the extension of established lesions, in a participant who had achieved CDA.
measure: Total Number of Disease Relapses/Flares From Initial Control of Disease Activity to Week 37: mITT Population
time frame: From initial CDA up to Week 37 (i.e., during any time from Baseline up to Week 37)
description: Total Number of Disease Relapses/Flares which occurred from initial CDA to Week 37 were reported. CDA was defined as disappearance of new lesions cease to form and established lesions begin to heal. Relapse/flare was defined by the appearance of 3 or more new lesions after CDA and within a month that do not heal spontaneously within 1 week, or by the extension of established lesions, in a participant who had achieved CDA.
measure: Time to Initial Relapse/Flare From Initial Control of Disease Activity to Week 37: PV mITT Population
time frame: From initial CDA up to Week 37 (i.e., during any time from Baseline up to Week 37)
description: Time duration (in days) from the time of initial relapse/flare which occurred from initial CDA up to Week 37 were reported in this OM. CDA was defined as the visit at which new lesions cease to form and established lesions begin to heal. Relapse/flare was defined by the appearance of 3 or more new lesions after CDA and within a month that do not heal spontaneously within 1 week, or by the extension of established lesions, in a participant who had achieved CDA. Kaplan-Meier method was used for the analysis.
measure: Time to Initial Relapse/Flare From Initial Control of Disease Activity to Week 37: mITT Population
time frame: From initial CDA up to Week 37 (i.e., during any time from Baseline up to Week 37)
description: Time duration (in days) from the time of initial relapse/flare which occurred from initial CDA up to Week 37 were reported in this OM. CDA was defined as the visit at which new lesions cease to form and established lesions begin to heal. Relapse/flare was defined by the appearance of 3 or more new lesions after CDA and within a month that do not heal spontaneously within 1 week, or by the extension of established lesions, in a participant who had achieved CDA. Kaplan-Meier method was used for the analysis.
measure: Percentage of Participants With 3 or More New Lesions Within 1 Month That do Not Heal Spontaneously Within 1 Week, or With Extension of Established Lesions at Week 37: PV mITT Population
time frame: At Week 37
description: Percentage of Participants With 3 or More New Lesions Within past 1 month that do not heal spontaneously within past 1 week, or with extension of established lesions, were assessed at Week 37 and reported in this OM.
measure: Percentage of Participants With 3 or More New Lesions Within 1 Month That do Not Heal Spontaneously Within 1 Week, or With Extension of Established Lesions at Week 37: mITT Population
time frame: At Week 37
description: Percentage of participants with 3 or more new lesions within past 1 month that do not heal spontaneously within past 1 week, or with extension of established lesions, were assessed at Week 37 and reported in this OM.
measure: Percentage of Participants With at Least One Disease Relapse/Flare From Initial Control of Disease Activity to Week 37: PV mITT Population
time frame: From initial CDA up to Week 37 (i.e., during any time from Baseline up to Week 37)
description: CDA was defined as the visit at which new lesions cease to form and established lesions begin to heal. Disease relapse/flare was defined by the appearance of 3 or more new lesions after CDA and within a month that do not heal spontaneously within 1 week, or by the extension of established lesions, in a participant who had achieved CDA. Percentages were calculated based on number of participants assessed (i.e. participants achieved CDA) in each treatment group. Percentage of participants with at least one disease relapse/flare from Initial CDA to Week 37 were reported in this OM.
measure: Percentage of Participants With at Least One Disease Relapse/Flare From Initial Control of Disease Activity to Week 37: mITT Population
time frame: From initial CDA up to Week 37 (i.e., during any time from Baseline up to Week 37)
description: CDA was defined as the visit at which new lesions cease to form and established lesions begin to heal. Disease relapse/flare was defined by the appearance of 3 or more new lesions after CDA and within a month that do not heal spontaneously within 1 week, or by the extension of established lesions, in a participant who had achieved CDA. Percentages were calculated based on number of participants assessed (i.e. participants achieved CDA) in each treatment group. Percentage of participants with at least one disease relapse/flare from Initial CDA to Week 37 were reported in this OM.
measure: Cumulative Duration of Complete Remission With a Corticosteroids Dose <=10 mg/Day From Week 37 to Week 61: PV mITT Population
time frame: From Week 37 to Week 61
description: Cumulative duration (in days) of CR post first dose of CS <=10 mg/day from Week 37 to Week 61 were reported in this OM. Complete remission was defined as the absence of new and established lesions and was intended to mean "no disease activity".
measure: Cumulative Duration of Complete Remission With a Corticosteroids Dose <=10 mg/Day From Week 37 to Week 61: mITT Population
time frame: From Week 37 to Week 61
description: Cumulative duration (in days) of CR post first dose of CS <=10 mg/day from Week 37 to Week 61 were reported in this OM. Complete remission was defined as the absence of new and established lesions and was intended to mean "no disease activity".
measure: Cumulative Duration of Complete Remission With a Corticosteroids Dose = 0 mg/Day From Week 37 to Week 61: PV mITT Population
time frame: From Week 37 to Week 61
description: Cumulative duration (in days) of CR post first dose of CS = 0 mg/day from Week 37 to Week 61 were reported in this OM. Complete remission was defined as the absence of new and established lesions and was intended to mean "no disease activity".
measure: Cumulative Duration of Complete Remission With a Corticosteroids Dose = 0 mg/Day From Week 37 to Week 61: mITT Population
time frame: From Week 37 to Week 61
description: Cumulative duration (in days) of CR post first dose of CS = 0 mg/day from Week 37 to Week 61 were reported in this OM. Complete remission was defined as the absence of new and established lesions and was intended to mean "no disease activity".
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
time frame: BT Period: From Day 1 of Week 1 to Week 37, OLE Period: from Week 37 to Week 61 and LTE Period: from Week 61 up to 4 weeks after the last dose at Week 109 (i.e., up to Week 113)
description: An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug and does not necessarily had to have a causal relationship with the treatment. Serious AEs (SAEs) were any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. TEAEs were the AEs that developed or worsened or became serious after the administration of first dose of study drug in each period.
measure: Pharmacokinetics (PK): Plasma Concentration of Rilzabrutinib
time frame: Pre-dose and 2 hours post-dose on Day 1
description: Data for this OM was not planned to be collected and analyzed for placebo arm of the study.
measure: Pharmacodynamics (PD): Change From Baseline in Antibody Levels - Anti-desmoglein 1 (Anti-dsg 1) and Anti-desmoglein 3 (Anti-dsg 3) at Weeks 13, 25, 37, 49, 61, 73, 85, 97, and 109: PV mITT Population
time frame: Baseline, Weeks 13, 25, 37, 49, 61, 73, 85, 97, and 109
description: Anti-dsg1 and anti-dsg3 autoantibody levels was assessed by enzyme-linked immunosorbent assay (ELISA) method.
measure: Pharmacodynamics: Change From Baseline in Antibody Levels - Anti-desmoglein 1 (Anti-dsg 1) and Anti-desmoglein 3 (Anti-dsg 3) at Weeks 13, 25, 37, 49, 61, 73, 85, 97 and 109: mITT Population
time frame: Baseline, Weeks 13, 25, 37, 49, 61, 73, 85, 97, and 109
description: Anti-dsg1 and anti-dsg3 autoantibody levels was assessed by ELISA method.
arm group label: Placebo Then Rilzabrutinib
arm group type: Placebo Comparator
description: In BT period, participants received placebo orally twice daily (BID) up to 37 weeks along with sponsor-provided corticosteroids (CS). After at least two weeks of control of disease activity (CDA; no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 milligrams (mg) prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.
arm group label: Rilzabrutinib Then Rilzabrutinib
arm group type: Experimental
description: In BT period, participants received rilzabrutinib 400 mg orally BID up to 37 weeks along with sponsor-provided CS. After at least two weeks of CDA (no new lesions and established lesions begin to heal), based on protocol-specified clinical criteria, investigators could decrease the CS dose to a minimum of 5 mg prednisone/prednisolone per day from Week 29 to Week 37. Post completion of BT period, eligible participants received rilzabrutinib 400 mg BID up to Week 61 in OLE period and those who were eligible after OLE period completion, continued the same treatment until Week 109 in LTE period according to protocol-specified criteria.
intervention type: Drug
intervention name: Rilzabrutinib
description: Pharmaceutical form: Tablet Route of administration: Oral
arm group label: Placebo Then Rilzabrutinib
arm group label: Rilzabrutinib Then Rilzabrutinib
intervention type: Drug
intervention name: Placebo
description: Pharmaceutical form: Tablet Route of administration: Oral
arm group label: Placebo Then Rilzabrutinib
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
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country: Argentina
country: Australia
country: Brazil
country: Bulgaria
country: Canada
country: Croatia
country: France
country: Germany
country: Greece
country: Israel
country: Italy
country: Poland
country: Serbia
country: Spain
country: Taiwan
country: Turkey
country: Ukraine
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Pemphigus
sharing ipd: Yes
ipd description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
provided document: 
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outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Study was terminated prematurely by the Sponsor.
point of contact: 