<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/NCT03816891</url>
  </required_header>
  <id_info>
    <org_study_id>KPL-716-C201</org_study_id>
    <nct_id>NCT03816891</nct_id>
  </id_info>
  <brief_title>Study to Assess the Efficacy, Safety, and Tolerability of Vixarelimab in Reducing Pruritus in Prurigo Nodularis</brief_title>
  <official_title>A Phase 2a/b, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy, Safety, Tolerability and Pharmacokinetics of KPL-716 in Reducing Pruritus in Subjects With Prurigo Nodularis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kiniksa Pharmaceuticals, Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kiniksa Pharmaceuticals, Ltd.</source>
  <oversight_info>
    <has_dmc>No</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>
      Study of the efficacy, safety, tolerability, pharmacokinetics (PK), and immunogenicity of&#xD;
      Vixarelimab (KPL-716) in subjects with prurigo nodularis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Phase 2a/b randomized, double-blind, placebo-controlled study to investigate the&#xD;
      efficacy, safety, tolerability, PK and immunogenicity of Vixarelimab administered&#xD;
      subcutaneously (SC) in subjects with prurigo nodularis experiencing pruritus.&#xD;
&#xD;
      Phase 2a portion (completed):&#xD;
&#xD;
      Forty-nine subjects with moderate to severe PN experiencing moderate to severe pruritus were&#xD;
      treated in the Phase 2a portion of the study. At Baseline, subjects were randomized 1:1 to&#xD;
      receive double-blind Vixarelimab or placebo: Vixarelimab 720 mg loading dose followed by 360&#xD;
      mg every week; Placebo loading dose followed by placebo every week. The treatment Period was&#xD;
      8 weeks or 16 weeks (treatment duration was reduced from 16 weeks to 8 weeks in a protocol&#xD;
      amendment [Protocol Version 3]).&#xD;
&#xD;
      Phase 2b portion (enrolling):&#xD;
&#xD;
      The Phase 2b study (Figure 1) will consist of a 4-week Screening Period and a 16-week&#xD;
      Double-Blind Period, followed by a 36-week Open-Label-Extension (OLE) Period. Approximately&#xD;
      180 subjects with PN, experiencing severe pruritus, will be randomized (at 1:1:1:1 ratio)&#xD;
      into one of 4 arms (3 active arms and one placebo arm). A total of 4 doses of study drug will&#xD;
      be administered during the Double-Blind Period to measure the efficacy, safety, and PK of&#xD;
      Vixarelimab. After the Double-Blind Period, all subjects will have the option to receive&#xD;
      Vixarelimab during the OLE Period to evaluate the long-term safety and PK.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">March 11, 2019</start_date>
  <completion_date type="Anticipated">August 2023</completion_date>
  <primary_completion_date type="Actual">December 28, 2022</primary_completion_date>
  <phase>Phase 2</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>
    <intervention_model_description>Phase 2a (completed): 2 arms; Phase 2b (enrolling): 5 arms (4 arms during Double Blind Period and 1 arm during Open Label Extension)</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Phase 2a &amp; 2b: Percent change from baseline in Worst Itch Numeric Rating Scale (WI-NRS)</measure>
    <time_frame>at Week 8 (Phase 2a); at Week 16 (Phase 2b)</time_frame>
    <description>Subjects rate pruritus daily on Worst Itch [pruritis] Numerical Rating Scale (0=no pruritus; 10=worst imaginable pruritus)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>*Phase 2a: Proportion of subjects achieving at least a 4-point reduction from baseline in weekly average WI-NRS</measure>
    <time_frame>at Week 8</time_frame>
    <description>Subjects rate pruritus daily on Worst Itch [pruritis] Numerical Rating Scale (0=no pruritus; 10=worst imaginable pruritus)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2a: Percent change from baseline in pruritus visual analog scale (VAS)</measure>
    <time_frame>at Week 8</time_frame>
    <description>At every visit, subjects rate intensity of their average pruritus over previous 3 days on 0-10 line scale (0=no pruritis, 10=worst imaginable pruritis)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2a: Change from baseline in weekly average of WI-NRS (Worst Itch [pruritis] - Numerical Rating Scale; 0=no pruritis, 10=worst imaginable pruritis) over time</measure>
    <time_frame>to end of treatment, assessed up to 24 weeks</time_frame>
    <description>Subjects rate pruritus daily on Worst Itch [pruritis] Numerical Rating Scale (0=no pruritus; 10=worst imaginable pruritus)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2a: Percent change from baseline in weekly average of WI-NRS (Worst Itch [pruritis] - Numerical Rating Scale; 0=no pruritis, 10=worst imaginable pruritis) over time</measure>
    <time_frame>to end of treatment, assessed up to 24 weeks</time_frame>
    <description>Subjects rate pruritus daily on Worst Itch [pruritis] Numerical Rating Scale (0=no pruritus; 10=worst imaginable pruritus)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2a: Change from baseline in pruritis visual analog scale (VAS) over time</measure>
    <time_frame>to end of treatment, assessed up to 24 weeks</time_frame>
    <description>At every visit, subjects rate intensity of their average pruritus over previous 3 days on 0-10 line scale (0=no pruritis, 10=worst imaginable pruritis)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2a: Percent change from baseline in pruritis visual analog scale (VAS) over time</measure>
    <time_frame>to end of treatment, assessed up to 24 weeks</time_frame>
    <description>At every visit, subjects rate intensity of their average pruritus over previous 3 days on 0-10 line scale (0=no pruritis, 10=worst imaginable pruritis)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2a: Change from baseline in 5-D Pruritus total score over time</measure>
    <time_frame>to end of treatment, assessed up to 24 weeks</time_frame>
    <description>Administered every 2 visits, the 5-D Pruritus Scale evaluates pruritus in five domains: duration, degree, direction, disability and distribution. The scores from each domain are added together to obtain a total 5-D score ranging from 5 (no pruritus) and 25 (most severe pruritus)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2a: Percent change from baseline in 5-D Pruritus total score over time</measure>
    <time_frame>to end of treatment, assessed up to 24 weeks</time_frame>
    <description>Administered every 2 visits, the 5-D Pruritus Scale evaluates pruritus in five domains: duration, degree, direction, disability and distribution. The scores from each domain are added together to obtain a total 5-D score ranging from 5 (no pruritus) and 25 (most severe pruritus)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2a: Proportion of subjects achieving at least a 4-point reduction from baseline in weekly average WI-NRS (Worst Itch [pruritis] - Numerical Rating Scale; 0=no pruritis, 10=worst imaginable pruritis) over time</measure>
    <time_frame>to end of treatment, assessed up to 24 weeks</time_frame>
    <description>Subjects rate pruritus daily on Worst Itch [pruritis] Numerical Rating Scale (0=no pruritus; 10=worst imaginable pruritus)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2a: Change from baseline in Sleep Loss VAS over time</measure>
    <time_frame>to end of treatment, assessed up to 24 weeks</time_frame>
    <description>At every visit, subjects rate intensity of their average sleeplessness over previous 3 days on 0-10 line scale (0=no sleeplessness, 10=worst imaginable sleeplessness)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2a: Percent change from baseline in Sleep Loss VAS over time</measure>
    <time_frame>to end of treatment, assessed up to 24 weeks</time_frame>
    <description>At every visit, subjects rate intensity of their average sleeplessness over previous 3 days on 0-10 line scale (0=no sleeplessness, 10=worst imaginable sleeplessness)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2a: Change from baseline in weekly average of difficulty falling asleep NRS over time</measure>
    <time_frame>to end of treatment, assessed up to 24 weeks</time_frame>
    <description>Subjects rate difficulty falling asleep daily on Numerical Rating Scale (0=no difficulty, 10=extremely difficult)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2a: Percent change from baseline in weekly average of difficulty falling asleep NRS over time</measure>
    <time_frame>to end of treatment, assessed up to 24 weeks</time_frame>
    <description>Subjects rate difficulty falling asleep daily on Numerical Rating Scale (0=no difficulty, 10=extremely difficult)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2a: Change from baseline in weekly average of sleep quality NRS over time</measure>
    <time_frame>to end of treatment, assessed up to 24 weeks</time_frame>
    <description>Subjects rate daily sleep quality on Numerical Rating Scale (0=best possible sleep, 10=worst possible sleep)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2a: Percent change from baseline in weekly average of sleep quality NRS over time</measure>
    <time_frame>to end of treatment, assessed up to 24 weeks</time_frame>
    <description>Subjects rate daily sleep quality on Numerical Rating Scale (0=best possible sleep, 10=worst possible sleep)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2a: Change from baseline in quality of life (QoL) measures (DLQI and Itchy QoL) over time</measure>
    <time_frame>to end of treatment, assessed up to 24 weeks</time_frame>
    <description>QoL is assessed at designated visits and includes the Dermatology QoL Index (DLQI) whereby 0=no effect on quality of life; 30= extremely large effect on QoL; and Itchy QoL, administered as designated visits, which contains 22 items focused on the impact of pruritus on daily activities and on the level of psychological stress. The frequency items are scored using a 5-point Likert scale ranging from &quot;never&quot; to &quot;all the time&quot;. The bother items are scored from 1 (not bothered) to 5 (severely bothered)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2a: Percent change from baseline in quality of life (QoL) measures (DLQI and Itchy QoL) over time</measure>
    <time_frame>to end of treatment, assessed up to 24 weeks</time_frame>
    <description>QoL is assessed at designated visits and includes the Dermatology QoL Index (DLQI) whereby 0=no effect on quality of life; 30= extremely large effect on QoL; and Itchy QoL, administered as designated visits, which contains 22 items focused on the impact of pruritus on daily activities and on the level of psychological stress. The frequency items are scored using a 5-point Likert scale ranging from &quot;never&quot; to &quot;all the time&quot;. The bother items are scored from 1 (not bothered) to 5 (severely bothered)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2a: Change from baseline in Prurigo Nodularis Nodule Assessment Tool (PN-NAT) over time</measure>
    <time_frame>to end of treatment, assessed up to 24 weeks</time_frame>
    <description>PN-NAT, assessed at designated visits, is a novel exploratory tool for the evaluation of disease severity based on estimate of the number of nodules over the whole body, estimate of hardness of nodules over the whole body, estimate of extent of excoriation over the whole body, distribution of nodules, exact number of nodules in the representative area.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2a: Proportion of subjects with improvement in Prurigo Nodularis Investigator Global Assessment (PN-IGA) by 2 categories over time</measure>
    <time_frame>to end of treatment, assessed up to 24 weeks</time_frame>
    <description>PN-IGA, assessed at designated visits, is a novel exploratory tool for the overall investigator assessment of PN disease severity based on the size of the nodules as defined by their elevation. The IGA utilizes a 5-point scale that ranges from 0 (clear) to 4 (severe disease)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2b: Proportion of subjects achieving at least a 6-point reduction from baseline in weekly average WI-NRS (Worst Itch [pruritis] - Numerical Rating Scale; 0=no pruritis, 10=worst imaginable pruritis)</measure>
    <time_frame>to end of treatment, assessed up to 52 weeks</time_frame>
    <description>Subjects rate pruritus daily on Worst Itch [pruritis] Numerical Rating Scale (0=no pruritus; 10=worst imaginable pruritus)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2b: Proportion of subjects achieving at least a 4-point reduction from baseline in weekly average WI-NRS (Worst Itch [pruritis] - Numerical Rating Scale; 0=no pruritis, 10=worst imaginable pruritis)</measure>
    <time_frame>at Week 16</time_frame>
    <description>Subjects rate pruritus daily on Worst Itch [pruritis] Numerical Rating Scale (0=no pruritus; 10=worst imaginable pruritus)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2b: Proportion of subjects achieving 0 or 1 from baseline in PN-IGA</measure>
    <time_frame>at Week 16</time_frame>
    <description>PN-IGA, assessed at designated visits, is a novel exploratory tool for the overall investigator assessment of PN disease severity based on the size of the nodules as defined by their elevation. The IGA utilizes a 5-point scale that ranges from 0 (clear) to 4 (severe disease)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2b: Change from baseline in weekly average of WI-NRS (Worst Itch [pruritis] - Numerical Rating Scale; 0=no pruritis, 10=worst imaginable pruritis) over time</measure>
    <time_frame>to end of treatment, assessed up to 52 weeks</time_frame>
    <description>Subjects rate pruritus daily on Worst Itch [pruritis] Numerical Rating Scale (0=no pruritus; 10=worst imaginable pruritus)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2b: Percent change from baseline in weekly average of WI-NRS (Worst Itch [pruritis] - Numerical Rating Scale; 0=no pruritis, 10=worst imaginable pruritis) over time</measure>
    <time_frame>to end of treatment, assessed up to 52 weeks</time_frame>
    <description>Subjects rate pruritus daily on Worst Itch [pruritis] Numerical Rating Scale (0=no pruritus; 10=worst imaginable pruritus)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2b: Proportion of subjects achieving at least a 6-point reduction from baseline in weekly average WI-NRS (Worst Itch [pruritis] - Numerical Rating Scale; 0=no pruritis, 10=worst imaginable pruritis) over time</measure>
    <time_frame>to end of treatment, assessed up to 52 weeks</time_frame>
    <description>Subjects rate pruritus daily on Worst Itch [pruritis] Numerical Rating Scale (0=no pruritus; 10=worst imaginable pruritus)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2b: Proportion of subjects achieving at least a 4-point reduction from baseline in weekly average WI-NRS (Worst Itch [pruritis] - Numerical Rating Scale; 0=no pruritis, 10=worst imaginable pruritis) over time</measure>
    <time_frame>to end of treatment, assessed up to 52 weeks</time_frame>
    <description>Subjects rate pruritus daily on Worst Itch [pruritis] Numerical Rating Scale (0=no pruritus; 10=worst imaginable pruritus)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2b: Proportion of subjects achieving 0 or 1 in PN-IGA over time</measure>
    <time_frame>to end of treatment, assessed up to 52 weeks</time_frame>
    <description>PN-IGA is a novel exploratory tool for the overall investigator assessment of PN disease severity based on the size of the nodules as defined by their elevation. The IGA utilizes a 5-point scale that ranges from 0 (clear) to 4 (severe disease)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2b: Proportion of subjects with at least 2-point improvement from baseline in PN-IGA over time</measure>
    <time_frame>to end of treatment, assessed up to 52 weeks</time_frame>
    <description>PN-IGA, assessed at designated visits, is a novel exploratory tool for the overall investigator assessment of PN disease severity based on the size of the nodules as defined by their elevation. The IGA utilizes a 5-point scale that ranges from 0 (clear) to 4 (severe disease)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2b: Proportion of subjects achieving 0 or 1 in Investigator's Global Assessment for Prurigo Nodularis-Stage (IGA-CNPG-S) over time</measure>
    <time_frame>to end of treatment, assessed up to 52 weeks</time_frame>
    <description>IGA-CNPG-S, administered at designated visits, is a novel tool for the investigator assessment of PN disease severity based on the number of palpable nodules and utilizes a 5-point scale that ranges from 0 (clear) to 4 (severe). A score is assigned based on the appearance of the disease at the time of the evaluation without referring to the baseline state.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2b: Proportion of subjects with at least 2-point improvement from baseline in IGA-CNPG-S over time</measure>
    <time_frame>to end of treatment, assessed up to 52 weeks</time_frame>
    <description>IGA-CNPG-S, administered at designated visits, is a novel tool for the investigator assessment of PN disease severity based on the number of palpable nodules and utilizes a 5-point scale that ranges from 0 (clear) to 4 (severe). A score is assigned based on the appearance of the disease at the time of the evaluation without referring to the baseline state.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2b: Change from baseline in weekly average of Sleep Loss VAS over time</measure>
    <time_frame>to end of treatment, assessed up to 52 weeks</time_frame>
    <description>At every visit, subjects rate intensity of their average sleeplessness over previous 3 days on 0-10 line scale (0=no sleeplessness, 10=worst imaginable sleeplessness)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2b: Percent change from baseline in weekly average of Sleep Loss VAS over time</measure>
    <time_frame>to end of treatment, assessed up to 52 weeks</time_frame>
    <description>At every visit, subjects rate intensity of their average sleeplessness over previous 3 days on 0-10 line scale (0=no sleeplessness, 10=worst imaginable sleeplessness)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2b: Change from baseline in ItchyQoL over time</measure>
    <time_frame>to end of treatment, assessed up to 52 weeks</time_frame>
    <description>Itchy QoL, administered as designated visits, contains 22 items focused on the impact of pruritus on daily activities and on the level of psychological stress. The frequency items are scored using a 5-point Likert scale ranging from &quot;never&quot; to &quot;all the time&quot;. The bother items are scored from 1 (not bothered) to 5 (severely bothered)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2b: Percent change from baseline in ItchyQoL over time</measure>
    <time_frame>to end of treatment, assessed up to 52 weeks</time_frame>
    <description>Itchy QoL, administered as designated visits, contains 22 items focused on the impact of pruritus on daily activities and on the level of psychological stress. The frequency items are scored using a 5-point Likert scale ranging from &quot;never&quot; to &quot;all the time&quot;. The bother items are scored from 1 (not bothered) to 5 (severely bothered)</description>
  </secondary_outcome>
  <number_of_arms>7</number_of_arms>
  <enrollment type="Actual">190</enrollment>
  <condition>Prurigo Nodularis</condition>
  <condition>Pruritis</condition>
  <arm_group>
    <arm_group_label>Phase 2a - Vixarelimab 360 mg SC QW</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Vixarelimab 720 mg loading dose followed by 360 mg weekly for 8 weeks (Protocol Version 3) or 16 weeks (Protocol Version 2)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase 2a - Placebo SC QW</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo loading dose followed by placebo weekly for 8 weeks (Protocol Version 3) or 16 weeks (Protocol Version 2)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase 2b - Vixarelimab 540 mg SC Q4W (DBL)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Vixarelimab 540 mg SC, every 4 weeks for 16 weeks during Double Blind Period</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Vixarelimab 360 mg SC, every 4 weeks for 16 weeks during Double Blind Period</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase 2b - Vixarelimab 120 mg SC, Q4W (DBL)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Vixarelimab 120 mg SC, every 4 weeks for 16 weeks during Double Blind Period</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase 2b - Placebo SC, Q4W (DBL)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo SC, every 4 weeks for 16 weeks during Double Blind Period</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase 2b - Vixarelimab 360 mg SC, Q2W (OLE)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Vixarelimab 360 mg SC, every 2 weeks for 36 weeks during Open Label Extension</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>vixarelimab</intervention_name>
    <description>solution for injection</description>
    <arm_group_label>Phase 2a - Vixarelimab 360 mg SC QW</arm_group_label>
    <arm_group_label>Phase 2b - Vixarelimab 120 mg SC, Q4W (DBL)</arm_group_label>
    <arm_group_label>Phase 2b - Vixarelimab 360 mg SC, Q2W (OLE)</arm_group_label>
    <arm_group_label>Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL)</arm_group_label>
    <arm_group_label>Phase 2b - Vixarelimab 540 mg SC Q4W (DBL)</arm_group_label>
    <other_name>KPL-716</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>solution for injection</description>
    <arm_group_label>Phase 2a - Placebo SC QW</arm_group_label>
    <arm_group_label>Phase 2b - Placebo SC, Q4W (DBL)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria (apply to both Phase 2a and Phase 2b unless otherwise specified):&#xD;
&#xD;
          1. Male or female aged 18 to 75 years (Phase 2a), 18 to 80 years (Phase 2b)&#xD;
&#xD;
          2. Have clinical diagnosis of prurigo nodularis for at least 6 months&#xD;
&#xD;
          3. Have at least 10 nodules (Phase 2a), 20 nodules (Phase 2b) at the Screening Visit and&#xD;
             Day 1&#xD;
&#xD;
          4. Moderate to severe pruritus (Phase 2a); severe pruritus (Phase 2b)&#xD;
&#xD;
          5. Female subjects of childbearing potential must have a negative pregnancy test, be&#xD;
             nonlactating, and having agreed to use a highly effective method of contraception, as&#xD;
             specified in the protocol, from the Screening Visit until 16 weeks after final study&#xD;
             drug administration&#xD;
&#xD;
          6. Able to comprehend and willing to sign an Informed Consent Form and able to abide by&#xD;
             the study restrictions and comply with all study procedures for the duration of the&#xD;
             study&#xD;
&#xD;
        Exclusion Criteria (apply to both Phase 2a and Phase 2b unless otherwise specified):&#xD;
&#xD;
          1. Use of prohibited medications within the indicated timeframe from Day 1&#xD;
&#xD;
          2. Is currently using medication known to cause pruritus&#xD;
&#xD;
          3. Presence of any inflammatory, pruritic, and/or fibrotic skin condition other than&#xD;
             moderate to severe prurigo nodularis or atopic dermatitis unless approved by the&#xD;
             Sponsor&#xD;
&#xD;
          4. Laboratory abnormalities that fall outside the windows specified in the protocol at&#xD;
             the Screening Visit&#xD;
&#xD;
          5. Has an active infection, including skin infection&#xD;
&#xD;
          6. Any medical or psychiatric condition which, in the opinion of the Investigator or the&#xD;
             Sponsor, may place the subject at increased risk as a result of study participation,&#xD;
             interfere with study participation or study assessments, affect compliance with study&#xD;
             requirements, or complicate interpretation of study results&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John Paolini, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>Kiniksa Pharmaceuticals, Ltd.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Site 104</name>
      <address>
        <city>Anniston</city>
        <state>Alabama</state>
        <zip>36207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 125</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85053</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1127</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85255</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1132</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 137</name>
      <address>
        <city>Colton</city>
        <state>California</state>
        <zip>92324</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1116</name>
      <address>
        <city>Fountain Valley</city>
        <state>California</state>
        <zip>92708</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1154</name>
      <address>
        <city>Fremont</city>
        <state>California</state>
        <zip>94538</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1102</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1167</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90056</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1165</name>
      <address>
        <city>North Hollywood</city>
        <state>California</state>
        <zip>91606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 122</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1139</name>
      <address>
        <city>Centennial</city>
        <state>Colorado</state>
        <zip>80111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1151</name>
      <address>
        <city>Fort Lauderdale</city>
        <state>Florida</state>
        <zip>33316</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1107</name>
      <address>
        <city>Largo</city>
        <state>Florida</state>
        <zip>33770</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1135</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 111</name>
      <address>
        <city>Pembroke Pines</city>
        <state>Florida</state>
        <zip>33028</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1163</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 117</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33614</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1166</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33615</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 114</name>
      <address>
        <city>Sandy Springs</city>
        <state>Georgia</state>
        <zip>30328</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 105</name>
      <address>
        <city>Boise</city>
        <state>Idaho</state>
        <zip>83712</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 123</name>
      <address>
        <city>New Albany</city>
        <state>Indiana</state>
        <zip>47150</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1155</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40241</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1110</name>
      <address>
        <city>Beverly</city>
        <state>Massachusetts</state>
        <zip>01915</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1159</name>
      <address>
        <city>Clinton Township</city>
        <state>Michigan</state>
        <zip>48038</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1113</name>
      <address>
        <city>Fort Gratiot</city>
        <state>Michigan</state>
        <zip>48059</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1118</name>
      <address>
        <city>Troy</city>
        <state>Michigan</state>
        <zip>48084</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 130</name>
      <address>
        <city>Warren</city>
        <state>Michigan</state>
        <zip>08088</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 108</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1150</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1158</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14620</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1121</name>
      <address>
        <city>Fairborn</city>
        <state>Ohio</state>
        <zip>45324</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1133</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 101</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 106</name>
      <address>
        <city>Pflugerville</city>
        <state>Texas</state>
        <zip>78660</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 128</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1115</name>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 4106</name>
      <address>
        <city>Kogarah</city>
        <state>New South Wales</state>
        <zip>2217</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 4105</name>
      <address>
        <city>Woolloongabba</city>
        <state>Queensland</state>
        <zip>4102</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 4104</name>
      <address>
        <city>Parkville</city>
        <state>Victoria</state>
        <zip>3050</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 2102</name>
      <address>
        <city>Graz</city>
        <zip>8036</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 2101</name>
      <address>
        <city>Wien</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 2702</name>
      <address>
        <city>Brussels</city>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 2701</name>
      <address>
        <city>Liège</city>
        <zip>4000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1302</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T5K 1X3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1308</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 1C3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1301</name>
      <address>
        <city>Red Deer</city>
        <state>Alberta</state>
        <zip>T4N6V7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1306</name>
      <address>
        <city>Fredericton</city>
        <state>New Brunswick</state>
        <zip>E3B 1G9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1307</name>
      <address>
        <city>Barrie</city>
        <state>Ontario</state>
        <zip>L4M 7G1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1305</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6H 5L5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1309</name>
      <address>
        <city>Markham</city>
        <state>Ontario</state>
        <zip>L3P 1X2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 303</name>
      <address>
        <city>Saint-Jérôme</city>
        <state>Quebec</state>
        <zip>J7Z 7E2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 2301</name>
      <address>
        <city>Pardubice</city>
        <zip>53 002</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 2302</name>
      <address>
        <city>Praha 10</city>
        <zip>10000</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 2503</name>
      <address>
        <city>Bordeaux</city>
        <zip>33075</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 2502</name>
      <address>
        <city>Brest</city>
        <zip>29609</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 2504</name>
      <address>
        <city>Nantes</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 2001</name>
      <address>
        <city>Bad Bentheim</city>
        <state>Niedersachsen</state>
        <zip>48455</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 2003</name>
      <address>
        <city>Bielefeld</city>
        <state>NRW</state>
        <zip>33647</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 2011</name>
      <address>
        <city>Dresden</city>
        <zip>01307</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 2008</name>
      <address>
        <city>Göttingen</city>
        <zip>37075</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 2002</name>
      <address>
        <city>Münster</city>
        <zip>48149</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 2005</name>
      <address>
        <city>Witten</city>
        <zip>58453</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 2604</name>
      <address>
        <city>Catania</city>
        <state>Sicily</state>
        <zip>95123</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 2603</name>
      <address>
        <city>Brescia</city>
        <zip>25123</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 4304</name>
      <address>
        <city>Incheon</city>
        <zip>21431</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 4303</name>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 4302</name>
      <address>
        <city>Seoul</city>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 2207</name>
      <address>
        <city>Kraków</city>
        <zip>30-033</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 2204</name>
      <address>
        <city>Rzeszów</city>
        <zip>35-055</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 2201</name>
      <address>
        <city>Wrocław</city>
        <zip>50-367</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 4203</name>
      <address>
        <city>New Taipei City</city>
        <zip>23561</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 4207</name>
      <address>
        <city>Taipei</city>
        <zip>10002</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 4201</name>
      <address>
        <city>Taipei</city>
        <zip>11217</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 4204</name>
      <address>
        <city>Taoyuan City</city>
        <zip>333</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 2901</name>
      <address>
        <city>Leytonstone</city>
        <zip>E11 1NR</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 2903</name>
      <address>
        <city>Liverpool</city>
        <zip>L14 3AB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Austria</country>
    <country>Belgium</country>
    <country>Canada</country>
    <country>Czechia</country>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Korea, Republic of</country>
    <country>Poland</country>
    <country>Taiwan</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>January 23, 2019</study_first_submitted>
  <study_first_submitted_qc>January 23, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>August 14, 2023</last_update_submitted>
  <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 16, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pruritus</mesh_term>
    <mesh_term>Prurigo</mesh_term>
    <mesh_term>Neurodermatitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03816891
org study id: KPL-716-C201
nct id: NCT03816891
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
Study of the efficacy, safety, tolerability, pharmacokinetics (PK), and immunogenicity of
      Vixarelimab (KPL-716) in subjects with prurigo nodularis.
This is a Phase 2a/b randomized, double-blind, placebo-controlled study to investigate the
      efficacy, safety, tolerability, PK and immunogenicity of Vixarelimab administered
      subcutaneously (SC) in subjects with prurigo nodularis experiencing pruritus.

      Phase 2a portion (completed):

      Forty-nine subjects with moderate to severe PN experiencing moderate to severe pruritus were
      treated in the Phase 2a portion of the study. At Baseline, subjects were randomized 1:1 to
      receive double-blind Vixarelimab or placebo: Vixarelimab 720 mg loading dose followed by 360
      mg every week; Placebo loading dose followed by placebo every week. The treatment Period was
      8 weeks or 16 weeks (treatment duration was reduced from 16 weeks to 8 weeks in a protocol
      amendment [Protocol Version 3]).

      Phase 2b portion (enrolling):

      The Phase 2b study (Figure 1) will consist of a 4-week Screening Period and a 16-week
      Double-Blind Period, followed by a 36-week Open-Label-Extension (OLE) Period. Approximately
      180 subjects with PN, experiencing severe pruritus, will be randomized (at 1:1:1:1 ratio)
      into one of 4 arms (3 active arms and one placebo arm). A total of 4 doses of study drug will
      be administered during the Double-Blind Period to measure the efficacy, safety, and PK of
      Vixarelimab. After the Double-Blind Period, all subjects will have the option to receive
      Vixarelimab during the OLE Period to evaluate the long-term safety and PK.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Phase 2a (completed): 2 arms; Phase 2b (enrolling): 5 arms (4 arms during Double Blind Period and 1 arm during Open Label Extension)
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Phase 2a & 2b: Percent change from baseline in Worst Itch Numeric Rating Scale (WI-NRS)
time frame: at Week 8 (Phase 2a); at Week 16 (Phase 2b)
description: Subjects rate pruritus daily on Worst Itch [pruritis] Numerical Rating Scale (0=no pruritus; 10=worst imaginable pruritus)
measure: *Phase 2a: Proportion of subjects achieving at least a 4-point reduction from baseline in weekly average WI-NRS
time frame: at Week 8
description: Subjects rate pruritus daily on Worst Itch [pruritis] Numerical Rating Scale (0=no pruritus; 10=worst imaginable pruritus)
measure: Phase 2a: Percent change from baseline in pruritus visual analog scale (VAS)
time frame: at Week 8
description: At every visit, subjects rate intensity of their average pruritus over previous 3 days on 0-10 line scale (0=no pruritis, 10=worst imaginable pruritis)
measure: Phase 2a: Change from baseline in weekly average of WI-NRS (Worst Itch [pruritis] - Numerical Rating Scale; 0=no pruritis, 10=worst imaginable pruritis) over time
time frame: to end of treatment, assessed up to 24 weeks
description: Subjects rate pruritus daily on Worst Itch [pruritis] Numerical Rating Scale (0=no pruritus; 10=worst imaginable pruritus)
measure: Phase 2a: Percent change from baseline in weekly average of WI-NRS (Worst Itch [pruritis] - Numerical Rating Scale; 0=no pruritis, 10=worst imaginable pruritis) over time
time frame: to end of treatment, assessed up to 24 weeks
description: Subjects rate pruritus daily on Worst Itch [pruritis] Numerical Rating Scale (0=no pruritus; 10=worst imaginable pruritus)
measure: Phase 2a: Change from baseline in pruritis visual analog scale (VAS) over time
time frame: to end of treatment, assessed up to 24 weeks
description: At every visit, subjects rate intensity of their average pruritus over previous 3 days on 0-10 line scale (0=no pruritis, 10=worst imaginable pruritis)
measure: Phase 2a: Percent change from baseline in pruritis visual analog scale (VAS) over time
time frame: to end of treatment, assessed up to 24 weeks
description: At every visit, subjects rate intensity of their average pruritus over previous 3 days on 0-10 line scale (0=no pruritis, 10=worst imaginable pruritis)
measure: Phase 2a: Change from baseline in 5-D Pruritus total score over time
time frame: to end of treatment, assessed up to 24 weeks
description: Administered every 2 visits, the 5-D Pruritus Scale evaluates pruritus in five domains: duration, degree, direction, disability and distribution. The scores from each domain are added together to obtain a total 5-D score ranging from 5 (no pruritus) and 25 (most severe pruritus)
measure: Phase 2a: Percent change from baseline in 5-D Pruritus total score over time
time frame: to end of treatment, assessed up to 24 weeks
description: Administered every 2 visits, the 5-D Pruritus Scale evaluates pruritus in five domains: duration, degree, direction, disability and distribution. The scores from each domain are added together to obtain a total 5-D score ranging from 5 (no pruritus) and 25 (most severe pruritus)
measure: Phase 2a: Proportion of subjects achieving at least a 4-point reduction from baseline in weekly average WI-NRS (Worst Itch [pruritis] - Numerical Rating Scale; 0=no pruritis, 10=worst imaginable pruritis) over time
time frame: to end of treatment, assessed up to 24 weeks
description: Subjects rate pruritus daily on Worst Itch [pruritis] Numerical Rating Scale (0=no pruritus; 10=worst imaginable pruritus)
measure: Phase 2a: Change from baseline in Sleep Loss VAS over time
time frame: to end of treatment, assessed up to 24 weeks
description: At every visit, subjects rate intensity of their average sleeplessness over previous 3 days on 0-10 line scale (0=no sleeplessness, 10=worst imaginable sleeplessness)
measure: Phase 2a: Percent change from baseline in Sleep Loss VAS over time
time frame: to end of treatment, assessed up to 24 weeks
description: At every visit, subjects rate intensity of their average sleeplessness over previous 3 days on 0-10 line scale (0=no sleeplessness, 10=worst imaginable sleeplessness)
measure: Phase 2a: Change from baseline in weekly average of difficulty falling asleep NRS over time
time frame: to end of treatment, assessed up to 24 weeks
description: Subjects rate difficulty falling asleep daily on Numerical Rating Scale (0=no difficulty, 10=extremely difficult)
measure: Phase 2a: Percent change from baseline in weekly average of difficulty falling asleep NRS over time
time frame: to end of treatment, assessed up to 24 weeks
description: Subjects rate difficulty falling asleep daily on Numerical Rating Scale (0=no difficulty, 10=extremely difficult)
measure: Phase 2a: Change from baseline in weekly average of sleep quality NRS over time
time frame: to end of treatment, assessed up to 24 weeks
description: Subjects rate daily sleep quality on Numerical Rating Scale (0=best possible sleep, 10=worst possible sleep)
measure: Phase 2a: Percent change from baseline in weekly average of sleep quality NRS over time
time frame: to end of treatment, assessed up to 24 weeks
description: Subjects rate daily sleep quality on Numerical Rating Scale (0=best possible sleep, 10=worst possible sleep)
measure: Phase 2a: Change from baseline in quality of life (QoL) measures (DLQI and Itchy QoL) over time
time frame: to end of treatment, assessed up to 24 weeks
description: QoL is assessed at designated visits and includes the Dermatology QoL Index (DLQI) whereby 0=no effect on quality of life; 30= extremely large effect on QoL; and Itchy QoL, administered as designated visits, which contains 22 items focused on the impact of pruritus on daily activities and on the level of psychological stress. The frequency items are scored using a 5-point Likert scale ranging from "never" to "all the time". The bother items are scored from 1 (not bothered) to 5 (severely bothered)
measure: Phase 2a: Percent change from baseline in quality of life (QoL) measures (DLQI and Itchy QoL) over time
time frame: to end of treatment, assessed up to 24 weeks
description: QoL is assessed at designated visits and includes the Dermatology QoL Index (DLQI) whereby 0=no effect on quality of life; 30= extremely large effect on QoL; and Itchy QoL, administered as designated visits, which contains 22 items focused on the impact of pruritus on daily activities and on the level of psychological stress. The frequency items are scored using a 5-point Likert scale ranging from "never" to "all the time". The bother items are scored from 1 (not bothered) to 5 (severely bothered)
measure: Phase 2a: Change from baseline in Prurigo Nodularis Nodule Assessment Tool (PN-NAT) over time
time frame: to end of treatment, assessed up to 24 weeks
description: PN-NAT, assessed at designated visits, is a novel exploratory tool for the evaluation of disease severity based on estimate of the number of nodules over the whole body, estimate of hardness of nodules over the whole body, estimate of extent of excoriation over the whole body, distribution of nodules, exact number of nodules in the representative area.
measure: Phase 2a: Proportion of subjects with improvement in Prurigo Nodularis Investigator Global Assessment (PN-IGA) by 2 categories over time
time frame: to end of treatment, assessed up to 24 weeks
description: PN-IGA, assessed at designated visits, is a novel exploratory tool for the overall investigator assessment of PN disease severity based on the size of the nodules as defined by their elevation. The IGA utilizes a 5-point scale that ranges from 0 (clear) to 4 (severe disease)
measure: Phase 2b: Proportion of subjects achieving at least a 6-point reduction from baseline in weekly average WI-NRS (Worst Itch [pruritis] - Numerical Rating Scale; 0=no pruritis, 10=worst imaginable pruritis)
time frame: to end of treatment, assessed up to 52 weeks
description: Subjects rate pruritus daily on Worst Itch [pruritis] Numerical Rating Scale (0=no pruritus; 10=worst imaginable pruritus)
measure: Phase 2b: Proportion of subjects achieving at least a 4-point reduction from baseline in weekly average WI-NRS (Worst Itch [pruritis] - Numerical Rating Scale; 0=no pruritis, 10=worst imaginable pruritis)
time frame: at Week 16
description: Subjects rate pruritus daily on Worst Itch [pruritis] Numerical Rating Scale (0=no pruritus; 10=worst imaginable pruritus)
measure: Phase 2b: Proportion of subjects achieving 0 or 1 from baseline in PN-IGA
time frame: at Week 16
description: PN-IGA, assessed at designated visits, is a novel exploratory tool for the overall investigator assessment of PN disease severity based on the size of the nodules as defined by their elevation. The IGA utilizes a 5-point scale that ranges from 0 (clear) to 4 (severe disease)
measure: Phase 2b: Change from baseline in weekly average of WI-NRS (Worst Itch [pruritis] - Numerical Rating Scale; 0=no pruritis, 10=worst imaginable pruritis) over time
time frame: to end of treatment, assessed up to 52 weeks
description: Subjects rate pruritus daily on Worst Itch [pruritis] Numerical Rating Scale (0=no pruritus; 10=worst imaginable pruritus)
measure: Phase 2b: Percent change from baseline in weekly average of WI-NRS (Worst Itch [pruritis] - Numerical Rating Scale; 0=no pruritis, 10=worst imaginable pruritis) over time
time frame: to end of treatment, assessed up to 52 weeks
description: Subjects rate pruritus daily on Worst Itch [pruritis] Numerical Rating Scale (0=no pruritus; 10=worst imaginable pruritus)
measure: Phase 2b: Proportion of subjects achieving at least a 6-point reduction from baseline in weekly average WI-NRS (Worst Itch [pruritis] - Numerical Rating Scale; 0=no pruritis, 10=worst imaginable pruritis) over time
time frame: to end of treatment, assessed up to 52 weeks
description: Subjects rate pruritus daily on Worst Itch [pruritis] Numerical Rating Scale (0=no pruritus; 10=worst imaginable pruritus)
measure: Phase 2b: Proportion of subjects achieving at least a 4-point reduction from baseline in weekly average WI-NRS (Worst Itch [pruritis] - Numerical Rating Scale; 0=no pruritis, 10=worst imaginable pruritis) over time
time frame: to end of treatment, assessed up to 52 weeks
description: Subjects rate pruritus daily on Worst Itch [pruritis] Numerical Rating Scale (0=no pruritus; 10=worst imaginable pruritus)
measure: Phase 2b: Proportion of subjects achieving 0 or 1 in PN-IGA over time
time frame: to end of treatment, assessed up to 52 weeks
description: PN-IGA is a novel exploratory tool for the overall investigator assessment of PN disease severity based on the size of the nodules as defined by their elevation. The IGA utilizes a 5-point scale that ranges from 0 (clear) to 4 (severe disease)
measure: Phase 2b: Proportion of subjects with at least 2-point improvement from baseline in PN-IGA over time
time frame: to end of treatment, assessed up to 52 weeks
description: PN-IGA, assessed at designated visits, is a novel exploratory tool for the overall investigator assessment of PN disease severity based on the size of the nodules as defined by their elevation. The IGA utilizes a 5-point scale that ranges from 0 (clear) to 4 (severe disease)
measure: Phase 2b: Proportion of subjects achieving 0 or 1 in Investigator's Global Assessment for Prurigo Nodularis-Stage (IGA-CNPG-S) over time
time frame: to end of treatment, assessed up to 52 weeks
description: IGA-CNPG-S, administered at designated visits, is a novel tool for the investigator assessment of PN disease severity based on the number of palpable nodules and utilizes a 5-point scale that ranges from 0 (clear) to 4 (severe). A score is assigned based on the appearance of the disease at the time of the evaluation without referring to the baseline state.
measure: Phase 2b: Proportion of subjects with at least 2-point improvement from baseline in IGA-CNPG-S over time
time frame: to end of treatment, assessed up to 52 weeks
description: IGA-CNPG-S, administered at designated visits, is a novel tool for the investigator assessment of PN disease severity based on the number of palpable nodules and utilizes a 5-point scale that ranges from 0 (clear) to 4 (severe). A score is assigned based on the appearance of the disease at the time of the evaluation without referring to the baseline state.
measure: Phase 2b: Change from baseline in weekly average of Sleep Loss VAS over time
time frame: to end of treatment, assessed up to 52 weeks
description: At every visit, subjects rate intensity of their average sleeplessness over previous 3 days on 0-10 line scale (0=no sleeplessness, 10=worst imaginable sleeplessness)
measure: Phase 2b: Percent change from baseline in weekly average of Sleep Loss VAS over time
time frame: to end of treatment, assessed up to 52 weeks
description: At every visit, subjects rate intensity of their average sleeplessness over previous 3 days on 0-10 line scale (0=no sleeplessness, 10=worst imaginable sleeplessness)
measure: Phase 2b: Change from baseline in ItchyQoL over time
time frame: to end of treatment, assessed up to 52 weeks
description: Itchy QoL, administered as designated visits, contains 22 items focused on the impact of pruritus on daily activities and on the level of psychological stress. The frequency items are scored using a 5-point Likert scale ranging from "never" to "all the time". The bother items are scored from 1 (not bothered) to 5 (severely bothered)
measure: Phase 2b: Percent change from baseline in ItchyQoL over time
time frame: to end of treatment, assessed up to 52 weeks
description: Itchy QoL, administered as designated visits, contains 22 items focused on the impact of pruritus on daily activities and on the level of psychological stress. The frequency items are scored using a 5-point Likert scale ranging from "never" to "all the time". The bother items are scored from 1 (not bothered) to 5 (severely bothered)
arm group label: Phase 2a - Vixarelimab 360 mg SC QW
arm group type: Experimental
description: Vixarelimab 720 mg loading dose followed by 360 mg weekly for 8 weeks (Protocol Version 3) or 16 weeks (Protocol Version 2)
arm group label: Phase 2a - Placebo SC QW
arm group type: Placebo Comparator
description: Placebo loading dose followed by placebo weekly for 8 weeks (Protocol Version 3) or 16 weeks (Protocol Version 2)
arm group label: Phase 2b - Vixarelimab 540 mg SC Q4W (DBL)
arm group type: Experimental
description: Vixarelimab 540 mg SC, every 4 weeks for 16 weeks during Double Blind Period
arm group label: Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL)
arm group type: Experimental
description: Vixarelimab 360 mg SC, every 4 weeks for 16 weeks during Double Blind Period
arm group label: Phase 2b - Vixarelimab 120 mg SC, Q4W (DBL)
arm group type: Experimental
description: Vixarelimab 120 mg SC, every 4 weeks for 16 weeks during Double Blind Period
arm group label: Phase 2b - Placebo SC, Q4W (DBL)
arm group type: Placebo Comparator
description: Placebo SC, every 4 weeks for 16 weeks during Double Blind Period
arm group label: Phase 2b - Vixarelimab 360 mg SC, Q2W (OLE)
arm group type: Experimental
description: Vixarelimab 360 mg SC, every 2 weeks for 36 weeks during Open Label Extension
intervention type: Drug
intervention name: vixarelimab
description: solution for injection
arm group label: Phase 2a - Vixarelimab 360 mg SC QW
arm group label: Phase 2b - Vixarelimab 120 mg SC, Q4W (DBL)
arm group label: Phase 2b - Vixarelimab 360 mg SC, Q2W (OLE)
arm group label: Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL)
arm group label: Phase 2b - Vixarelimab 540 mg SC Q4W (DBL)
other name: KPL-716
intervention type: Drug
intervention name: Placebo
description: solution for injection
arm group label: Phase 2a - Placebo SC QW
arm group label: Phase 2b - Placebo SC, Q4W (DBL)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: John Paolini, M.D.
role: Study Director
affiliation: Kiniksa Pharmaceuticals, Ltd.
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country: Australia
country: Austria
country: Belgium
country: Canada
country: Czechia
country: France
country: Germany
country: Italy
country: Korea, Republic of
country: Poland
country: Taiwan
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Pruritus
mesh term: Prurigo
mesh term: Neurodermatitis
sharing ipd: Undecided