xml: <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/NCT05976243</url>
    </required_header>
    <id_info>
      <org_study_id>CLOU064M12301</org_study_id>
      <nct_id>NCT05976243</nct_id>
    </id_info>
    <brief_title>A Study to Investigate Efficacy, Safety, and Tolerability of Remibrutinib Compared With Placebo in Adults With CINDU Inadequately Controlled by H1-antihistamines</brief_title>
    <official_title>A 52-week Multi-center, Randomized, Double-blind, Placebo Controlled, Basket Study With an Open-label Extension to Investigate the Efficacy, Safety, and Tolerability of Remibrutinib (LOU064) in Chronic Inducible Urticaria (CINDU) in Adults Inadequately Controlled by H1-antihistamines</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Novartis Pharmaceuticals</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Novartis</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a Phase 3, parallel group, placebo-controlled, double-blind, confirmatory study in&#xD;
        patients with CINDU, with an optional Open-label Extension (OLE).&#xD;
  &#xD;
        The purpose of the core period (52 weeks of treatment) of this study is to evaluate the&#xD;
        efficacy, safety, and tolerability of remibrutinib (LOU064) vs. placebo in adults suffering&#xD;
        from CINDU inadequately controlled by H1-antihistamines (H1-AHs).&#xD;
  &#xD;
        The purpose of the OLE period is to collect long-term efficacy, safety, and tolerability data&#xD;
        on remibrutinib in participants after having completed the Core period&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study consists of a core and extension periods.&#xD;
  &#xD;
        The Core period (6 arms) has a total duration of up to 60 weeks including a double-blind&#xD;
        placebo-controlled treatment period until Week 24 followed by open-label treatment with&#xD;
        remibrutinib up to Week 52. The primary endpoint for all CINDU subtypes is assessed at Week&#xD;
        12.&#xD;
  &#xD;
        The Core period consists of:&#xD;
  &#xD;
          -  Screening period (up to 4 weeks): During the screening period, participants who have&#xD;
             provided informed consent will be assessed for study eligibility.&#xD;
  &#xD;
          -  Double-blind, placebo-controlled treatment period (24 weeks): 24 weeks of double-blind&#xD;
             treatment with remibrutinib or placebo.&#xD;
  &#xD;
          -  Open-label treatment period (28 weeks): 28 weeks of open-label treatment with&#xD;
             remibrutinib.&#xD;
  &#xD;
          -  Follow-up period: 4 weeks of treatment free follow-up. The open-label extension period&#xD;
             consists of observation and treatment period. At the end of the core period of the&#xD;
             study, if participants continue to experience symptoms, they will transition to the&#xD;
             treatment period in OLE. If they do not experience symtpoms they will transition to the&#xD;
             observation period in the OLE.&#xD;
  &#xD;
        The duration of the Open-label Extension period will be approximately 3 years where&#xD;
        participants can switch from observation to treatment depending on if they start developing&#xD;
        symptoms. Only those participants participating in the Open-label Extension Treatment period&#xD;
        will receive remibrutinib. The participants in the Open-label Extension Observation period&#xD;
        will not receive remibrutinib&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 19, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2028</completion_date>
    <primary_completion_date type="Anticipated">July 8, 2026</primary_completion_date>
    <phase>Phase 3</phase>
    <study_type>Interventional</study_type>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
      <masking_description>This masking applies to the core period. There is no masking in the open-label extension (OLE).</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Proportion of participants with complete response in Total Fric Score; symptomatic dermographism</measure>
      <time_frame>Week 12</time_frame>
      <description>Total Fric score (a scale from 0-4 where a positive response with all of the four pins is TFS = 4, while a positive response with only one pin - the largest pin is TFS = 1)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Proportion of participants with complete response in critical temperature threshold; cold urticaria</measure>
      <time_frame>Week 12</time_frame>
      <description>The Temptest is used to induce itch and hives in participants with cold urticaria. Critical temperature threshold (CTT), as measured by the Temptest, determines the highest temperature that induces symptoms.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Proportion of participants with itch numerical rating scale =0; cholinergic urticaria</measure>
      <time_frame>Week 12</time_frame>
      <description>Itch numerical rating scale, a scale from 0 to 10&#xD;
  Patients are asked to rate itching severity based on the worst level of itching in the past 24 h using an 11-point scale from 0 (&quot;no itch&quot;) to 10 (&quot;worst itch imaginable&quot;)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in Total Fric score; symptomatic dermographism</measure>
      <time_frame>Week 12</time_frame>
      <description>Total Fric score, a scale from 0-4 where a positive response with all four pins is TFS=4, while a positive only 1 pin - the largest pin is TFS=1</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in criticial temperature threshold following Temptest; cold urticaria</measure>
      <time_frame>Week 12</time_frame>
      <description>Critical temperature threshold, as measured by the Temptest, determines the highest temperature that induces symptoms</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in itch numerical rating scale; cholinergic urticaria</measure>
      <time_frame>Week 12</time_frame>
      <description>Itch numerical rating scale (NRS), scale from 0 to 10. 0 (&quot;no itch&quot;) to 10 (&quot;worst imaginable itch&quot;).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>proportion of participants with Physician Global Assessment (PGA) severity of hives =0; cholinergic urticaria</measure>
      <time_frame>Week 12</time_frame>
      <description>Physician global assessment of severity of hives. This assessment is scored 0 to 4 with 0=no hives, 1=mild hives, 2=moderate hives, 3=severe hives and 4=very severe hives</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of participants with complete response in TFS; symptomatic dermographism</measure>
      <time_frame>Week 24</time_frame>
      <description>Total Fric score (a scale from 0-4 where a positive response with all of the four pins is TFS = 4, while a positive response with only one pin - the largest pin is TFS = 1)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of participants with complete response in Critical Temperature threshold; cold urticaria</measure>
      <time_frame>Week 24</time_frame>
      <description>Critical Temperature Threshold, as measured by the Temptest, is the highest temperature that induces symptoms</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of participants with complete response in itch numerical rating scale; cholinergic urticaria</measure>
      <time_frame>Week 24</time_frame>
      <description>Itch numerical rating scale (NRS), scale from 0 to 10. 0 (&quot;no itch&quot;) to 10 (&quot;worst imaginable itch&quot;).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in itch numerical rating scale in participants with symptomatic dermographism</measure>
      <time_frame>Week 12</time_frame>
      <description>Itch numerical rating scale (NRS), scale from 0 to 10. 0 (&quot;no itch&quot;) to 10 (&quot;worst imaginable itch&quot;).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in itch numerical rating scale in participants with cold urticaria</measure>
      <time_frame>Week 12</time_frame>
      <description>Itch numerical rating scale (NRS), scale from 0 to 10. 0 (&quot;no itch&quot;) to 10 (&quot;worst imaginable itch&quot;).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of participants with complete response in Total Fric score; symptomatic dermographism</measure>
      <time_frame>Week 2</time_frame>
      <description>Total Fric score (a scale from 0-4 where a positive response with all of the four pins is TFS = 4, while a positive response with only one pin - the largest pin is TFS = 1)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of participants with complete response in Critical Temperature Threshold; cold urticaria</measure>
      <time_frame>Week 2</time_frame>
      <description>Critical temperature threshold (CTT), as measured by the Temptest, determines the highest temperature that induces symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of participants with itch NRS=0; cholinergic urticaria</measure>
      <time_frame>Week 2</time_frame>
      <description>Itch numerical rating scale (NRS), scale from 0 to 10. 0 (&quot;no itch&quot;) to 10 (&quot;worst imaginable itch&quot;).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in TFS in participants with symptomatic dermographism</measure>
      <time_frame>Week 2</time_frame>
      <description>Total Fric score (a scale from 0-4 where a positive response with all of the four pins is TFS = 4, while a positive response with only one pin - the largest pin is TFS = 1)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in Critical Temperature Threshold in participants with cold urticaria</measure>
      <time_frame>Week 2</time_frame>
      <description>Critical temperature threshold (CTT), as measured by the Temptest, determines the highest temperature that induces symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in itch NRS in participants with cholinergic urticaria</measure>
      <time_frame>Week 2</time_frame>
      <description>Itch numerical rating scale (NRS), scale from 0 to 10. 0 (&quot;no itch&quot;) to 10 (&quot;worst imaginable itch&quot;).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in itch NRS in participants with symptomatic dermographism</measure>
      <time_frame>Week 2</time_frame>
      <description>Total Fric score (a scale from 0-4 where a positive response with all of the four pins is TFS = 4, while a positive response with only one pin - the largest pin is TFS = 1)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in itch NRS in participants with cold urticaria</measure>
      <time_frame>Week 2</time_frame>
      <description>Itch numerical rating scale (NRS), scale from 0 to 10. 0 (&quot;no itch&quot;) to 10 (&quot;worst imaginable itch&quot;).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of participants with cholinergic urticaria with PGA=0</measure>
      <time_frame>Week 2</time_frame>
      <description>Physician global assessment of severity of hives is a 4-point scale (0 = no active disease, 1 = mild disease, 2 = moderate disease, 3 = severe disease).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in weekly most bothersome symptom NRS score on the USDD</measure>
      <time_frame>Week 12</time_frame>
      <description>Urtricara symptom daily diary (USDD). This daily diary records if the participant experiences any symptoms or avoided the triggers</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of participants with DLQI=0-1</measure>
      <time_frame>Week 12</time_frame>
      <description>The Dermatology Life Quality Index (DLQI) is a 10-item dermatology-specific quality of life (QoL) measure. Subjects rate their dermatology symptoms as well as the impact of their skin condition on various aspects of their lives thinking about the previous 7 days. An overall score is calculated and ranges from 0 to 30 (higher score meaning worse disease-related QoL). A DLQI score of 0 or 1 means that there is no impact of a skin disease on the patient's life.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Occurrence of treatment emergent adverse events and serious adverse events during the study</measure>
      <time_frame>Week 52</time_frame>
      <description>Treatment emergent adverse events and serious adverse events are those that occur at any time only after treatment has started</description>
    </secondary_outcome>
    <number_of_arms>6</number_of_arms>
    <enrollment type="Anticipated">348</enrollment>
    <condition>Chronic Inducible Urticaria</condition>
    <arm_group>
      <arm_group_label>Remibrutinib, symptomatic dermographism group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Remibrutinib oral twice daily in participants with symptomatic dermographism</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo, symptomatic dermographism group</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Placebo oral twice daily, symptomatic dermographism</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Remibrutinib, cold urticaria group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Remibrutinib oral twice daily, cold urticaria</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo, cold urticaria group</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Placebo oral twice daily, cold urticaria</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Remibrutinib, cholinergic urticaria group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Remibrutinib oral twice daily, cholinergic urticaria</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo, cholinergic urticaria</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Placebo oral twice daily, cholinergic urticaria</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Remibrutinib</intervention_name>
      <description>Remibrutinib treated groups and arms</description>
      <arm_group_label>Remibrutinib, cholinergic urticaria group</arm_group_label>
      <arm_group_label>Remibrutinib, cold urticaria group</arm_group_label>
      <arm_group_label>Remibrutinib, symptomatic dermographism group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Placebo treated groups and arms</description>
      <arm_group_label>Placebo, cholinergic urticaria</arm_group_label>
      <arm_group_label>Placebo, cold urticaria group</arm_group_label>
      <arm_group_label>Placebo, symptomatic dermographism group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria for core period:&#xD;
  &#xD;
            1. Male and female participants ≥18 years of age at the time of signing of the ICFs&#xD;
  &#xD;
            2. Confirmed CINDU diagnosis (as per guidelines) for symptomatic dermographism, cold&#xD;
               urticaria or cholinergic urticaria for ≥ 4 months (defined as onset of CINDU with&#xD;
               supporting documentation (e.g medical record, clinical history, photographs)) and&#xD;
               inadequate control with H1-AH at local label approved doses at the time of&#xD;
               randomization&#xD;
  &#xD;
            3. The following response to the provocation test for each subtype is required at the&#xD;
               randomization visit :&#xD;
  &#xD;
                 -  Symptomatic Dermographism: A Total Fric Score of ≥3 using the FricTest® 4.0 and a&#xD;
                    numerical rating scale score of ≥5 for itch after the provocation test.&#xD;
  &#xD;
                 -  Cold Urticaria: A Critical Threshold Temperature of ≥15°C using the TempTest® 4.0&#xD;
                    and a numerical rating scale score of ≥5 for itch after the provocation test.&#xD;
  &#xD;
                 -  Cholinergic Urticaria: A physician global assessment of severity of hives ≥ 2&#xD;
                    using the Pulse-controlled ergometry test and a numerical rating scale score of&#xD;
                    ≥5 for itch after the provocation test.&#xD;
  &#xD;
            4. Cold Urticaria: Positive ice-cube test resulting in hives at the provocation site for&#xD;
               participants at Screening.&#xD;
  &#xD;
            5. Cholinergic urticaria: Participants must show sweating in performing the&#xD;
               pulse-controlled ergometry test on day of randomization. Participants with anhidrosis&#xD;
               must not be included.&#xD;
  &#xD;
          Inclusion criteria for the OLE:&#xD;
  &#xD;
            1. Participants who have completed the Core period up to Week 52 and are willing to enter&#xD;
               the OLE period&#xD;
  &#xD;
               Exclusion Criteria for core period:&#xD;
  &#xD;
                 -  1. Previous use of remibrutinib or other BTK inhibitors.&#xD;
  &#xD;
            2. Participants who have concomitant CSU at screening. Participants with resolved CSU at&#xD;
               the time of screening can be included in the study.&#xD;
  &#xD;
            3. Participants who have a familial form (e.g familial cold autoinflammatory syndrome,&#xD;
               familial cold urticaria) of the target CINDU that is being considered for the&#xD;
               participant's inclusion in this study.&#xD;
  &#xD;
            4. Participants having a more defined other form of inducible urticaria than the target&#xD;
               CINDU that is being considered for the participant's inclusion in this study.&#xD;
  &#xD;
            5. Diseases, other than chronic inducible urticaria, with urticaria or angioedema&#xD;
               symptoms including but not limited to urticarial vasculitis, erythema multiforme,&#xD;
               cutaneous mastocytosis (urticaria pigmentosa) and hereditary or acquired angioedema&#xD;
  &#xD;
            6. Any other skin disease associated with chronic itching that might influence, in the&#xD;
               investigator's opinion, the study evaluations and results (e.g., atopic dermatitis,&#xD;
               bullous pemphigoid, dermatitis herpetiformis, senile pruritus, etc.) or skin diseases&#xD;
               associated with only wheals and no itch e.g asymptomatic dermographism&#xD;
  &#xD;
          There are no exclusion criteria for OLE&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Novartis Pharmaceuticals</last_name>
      <role>Study Director</role>
      <affiliation>Novartis Pharmaceuticals</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Novartis Pharmaceuticals</last_name>
      <phone>1-888-669-6682</phone>
      <email>novartis.email@novartis.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Novartis Pharmaceuticals</last_name>
      <phone>+41613241111</phone>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>CINDU</keyword>
    <keyword>Chronic inducible urticaria</keyword>
    <keyword>BTK</keyword>
    <keyword>remibrutinib</keyword>
    <keyword>symptomatic dermographsim</keyword>
    <keyword>cold urticaria</keyword>
    <keyword>cholinergic urticaria</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Urticaria</mesh_term>
      <mesh_term>Chronic Inducible Urticaria</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Remibrutinib</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.&#xD;
  This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05976243
  org study id: CLOU064M12301
  nct id: NCT05976243
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  This is a Phase 3, parallel group, placebo-controlled, double-blind, confirmatory study in
        patients with CINDU, with an optional Open-label Extension (OLE).
  
        The purpose of the core period (52 weeks of treatment) of this study is to evaluate the
        efficacy, safety, and tolerability of remibrutinib (LOU064) vs. placebo in adults suffering
        from CINDU inadequately controlled by H1-antihistamines (H1-AHs).
  
        The purpose of the OLE period is to collect long-term efficacy, safety, and tolerability data
        on remibrutinib in participants after having completed the Core period
  This study consists of a core and extension periods.
  
        The Core period (6 arms) has a total duration of up to 60 weeks including a double-blind
        placebo-controlled treatment period until Week 24 followed by open-label treatment with
        remibrutinib up to Week 52. The primary endpoint for all CINDU subtypes is assessed at Week
        12.
  
        The Core period consists of:
  
          -  Screening period (up to 4 weeks): During the screening period, participants who have
             provided informed consent will be assessed for study eligibility.
  
          -  Double-blind, placebo-controlled treatment period (24 weeks): 24 weeks of double-blind
             treatment with remibrutinib or placebo.
  
          -  Open-label treatment period (28 weeks): 28 weeks of open-label treatment with
             remibrutinib.
  
          -  Follow-up period: 4 weeks of treatment free follow-up. The open-label extension period
             consists of observation and treatment period. At the end of the core period of the
             study, if participants continue to experience symptoms, they will transition to the
             treatment period in OLE. If they do not experience symtpoms they will transition to the
             observation period in the OLE.
  
        The duration of the Open-label Extension period will be approximately 3 years where
        participants can switch from observation to treatment depending on if they start developing
        symptoms. Only those participants participating in the Open-label Extension Treatment period
        will receive remibrutinib. The participants in the Open-label Extension Observation period
        will not receive remibrutinib
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  masking description: This masking applies to the core period. There is no masking in the open-label extension (OLE).
  measure: Proportion of participants with complete response in Total Fric Score; symptomatic dermographism
  time frame: Week 12
  description: Total Fric score (a scale from 0-4 where a positive response with all of the four pins is TFS = 4, while a positive response with only one pin - the largest pin is TFS = 1)
  measure: Proportion of participants with complete response in critical temperature threshold; cold urticaria
  time frame: Week 12
  description: The Temptest is used to induce itch and hives in participants with cold urticaria. Critical temperature threshold (CTT), as measured by the Temptest, determines the highest temperature that induces symptoms.
  measure: Proportion of participants with itch numerical rating scale =0; cholinergic urticaria
  time frame: Week 12
  description: Itch numerical rating scale, a scale from 0 to 10
  Patients are asked to rate itching severity based on the worst level of itching in the past 24 h using an 11-point scale from 0 ("no itch") to 10 ("worst itch imaginable")
  measure: Change from baseline in Total Fric score; symptomatic dermographism
  time frame: Week 12
  description: Total Fric score, a scale from 0-4 where a positive response with all four pins is TFS=4, while a positive only 1 pin - the largest pin is TFS=1
  measure: Change from baseline in criticial temperature threshold following Temptest; cold urticaria
  time frame: Week 12
  description: Critical temperature threshold, as measured by the Temptest, determines the highest temperature that induces symptoms
  measure: Change from baseline in itch numerical rating scale; cholinergic urticaria
  time frame: Week 12
  description: Itch numerical rating scale (NRS), scale from 0 to 10. 0 ("no itch") to 10 ("worst imaginable itch").
  measure: proportion of participants with Physician Global Assessment (PGA) severity of hives =0; cholinergic urticaria
  time frame: Week 12
  description: Physician global assessment of severity of hives. This assessment is scored 0 to 4 with 0=no hives, 1=mild hives, 2=moderate hives, 3=severe hives and 4=very severe hives
  measure: Proportion of participants with complete response in TFS; symptomatic dermographism
  time frame: Week 24
  description: Total Fric score (a scale from 0-4 where a positive response with all of the four pins is TFS = 4, while a positive response with only one pin - the largest pin is TFS = 1)
  measure: Proportion of participants with complete response in Critical Temperature threshold; cold urticaria
  time frame: Week 24
  description: Critical Temperature Threshold, as measured by the Temptest, is the highest temperature that induces symptoms
  measure: Proportion of participants with complete response in itch numerical rating scale; cholinergic urticaria
  time frame: Week 24
  description: Itch numerical rating scale (NRS), scale from 0 to 10. 0 ("no itch") to 10 ("worst imaginable itch").
  measure: Change from baseline in itch numerical rating scale in participants with symptomatic dermographism
  time frame: Week 12
  description: Itch numerical rating scale (NRS), scale from 0 to 10. 0 ("no itch") to 10 ("worst imaginable itch").
  measure: Change from baseline in itch numerical rating scale in participants with cold urticaria
  time frame: Week 12
  description: Itch numerical rating scale (NRS), scale from 0 to 10. 0 ("no itch") to 10 ("worst imaginable itch").
  measure: Proportion of participants with complete response in Total Fric score; symptomatic dermographism
  time frame: Week 2
  description: Total Fric score (a scale from 0-4 where a positive response with all of the four pins is TFS = 4, while a positive response with only one pin - the largest pin is TFS = 1)
  measure: Proportion of participants with complete response in Critical Temperature Threshold; cold urticaria
  time frame: Week 2
  description: Critical temperature threshold (CTT), as measured by the Temptest, determines the highest temperature that induces symptoms.
  measure: Proportion of participants with itch NRS=0; cholinergic urticaria
  time frame: Week 2
  description: Itch numerical rating scale (NRS), scale from 0 to 10. 0 ("no itch") to 10 ("worst imaginable itch").
  measure: Change from baseline in TFS in participants with symptomatic dermographism
  time frame: Week 2
  description: Total Fric score (a scale from 0-4 where a positive response with all of the four pins is TFS = 4, while a positive response with only one pin - the largest pin is TFS = 1)
  measure: Change from baseline in Critical Temperature Threshold in participants with cold urticaria
  time frame: Week 2
  description: Critical temperature threshold (CTT), as measured by the Temptest, determines the highest temperature that induces symptoms.
  measure: Change from baseline in itch NRS in participants with cholinergic urticaria
  time frame: Week 2
  description: Itch numerical rating scale (NRS), scale from 0 to 10. 0 ("no itch") to 10 ("worst imaginable itch").
  measure: Change from baseline in itch NRS in participants with symptomatic dermographism
  time frame: Week 2
  description: Total Fric score (a scale from 0-4 where a positive response with all of the four pins is TFS = 4, while a positive response with only one pin - the largest pin is TFS = 1)
  measure: Change from baseline in itch NRS in participants with cold urticaria
  time frame: Week 2
  description: Itch numerical rating scale (NRS), scale from 0 to 10. 0 ("no itch") to 10 ("worst imaginable itch").
  measure: Proportion of participants with cholinergic urticaria with PGA=0
  time frame: Week 2
  description: Physician global assessment of severity of hives is a 4-point scale (0 = no active disease, 1 = mild disease, 2 = moderate disease, 3 = severe disease).
  measure: Change from baseline in weekly most bothersome symptom NRS score on the USDD
  time frame: Week 12
  description: Urtricara symptom daily diary (USDD). This daily diary records if the participant experiences any symptoms or avoided the triggers
  measure: Proportion of participants with DLQI=0-1
  time frame: Week 12
  description: The Dermatology Life Quality Index (DLQI) is a 10-item dermatology-specific quality of life (QoL) measure. Subjects rate their dermatology symptoms as well as the impact of their skin condition on various aspects of their lives thinking about the previous 7 days. An overall score is calculated and ranges from 0 to 30 (higher score meaning worse disease-related QoL). A DLQI score of 0 or 1 means that there is no impact of a skin disease on the patient's life.
  measure: Occurrence of treatment emergent adverse events and serious adverse events during the study
  time frame: Week 52
  description: Treatment emergent adverse events and serious adverse events are those that occur at any time only after treatment has started
  arm group label: Remibrutinib, symptomatic dermographism group
  arm group type: Experimental
  description: Remibrutinib oral twice daily in participants with symptomatic dermographism
  arm group label: Placebo, symptomatic dermographism group
  arm group type: Placebo Comparator
  description: Placebo oral twice daily, symptomatic dermographism
  arm group label: Remibrutinib, cold urticaria group
  arm group type: Experimental
  description: Remibrutinib oral twice daily, cold urticaria
  arm group label: Placebo, cold urticaria group
  arm group type: Placebo Comparator
  description: Placebo oral twice daily, cold urticaria
  arm group label: Remibrutinib, cholinergic urticaria group
  arm group type: Experimental
  description: Remibrutinib oral twice daily, cholinergic urticaria
  arm group label: Placebo, cholinergic urticaria
  arm group type: Placebo Comparator
  description: Placebo oral twice daily, cholinergic urticaria
  intervention type: Drug
  intervention name: Remibrutinib
  description: Remibrutinib treated groups and arms
  arm group label: Remibrutinib, cholinergic urticaria group
  arm group label: Remibrutinib, cold urticaria group
  arm group label: Remibrutinib, symptomatic dermographism group
  intervention type: Other
  intervention name: Placebo
  description: Placebo treated groups and arms
  arm group label: Placebo, cholinergic urticaria
  arm group label: Placebo, cold urticaria group
  arm group label: Placebo, symptomatic dermographism group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Novartis Pharmaceuticals
  role: Study Director
  affiliation: Novartis Pharmaceuticals
  last name: Novartis Pharmaceuticals
  phone: 1-888-669-6682
  email: novartis.email@novartis.com
  last name: Novartis Pharmaceuticals
  phone: +41613241111
  responsible party type: Sponsor
  mesh term: Urticaria
  mesh term: Chronic Inducible Urticaria
  mesh term: Remibrutinib
  sharing ipd: Yes
  ipd description: Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
  This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com