<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/NCT04501679</url>
  </required_header>
  <id_info>
    <org_study_id>RD.06.SPR.203065</org_study_id>
    <secondary_id>2019-004789-17</secondary_id>
    <nct_id>NCT04501679</nct_id>
  </id_info>
  <brief_title>A Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)</brief_title>
  <official_title>A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Subjects With Prurigo Nodularis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Galderma R&amp;D</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Galderma R&amp;D</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>
      The primary objective is to assess the efficacy of nemolizumab (CD14152) compared to placebo&#xD;
      in participants greater than or equal to (&gt;=) 18 years of age with prurigo nodularis (PN)&#xD;
      after a 16-week treatment period.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 11, 2020</start_date>
  <completion_date type="Actual">March 31, 2022</completion_date>
  <primary_completion_date type="Actual">March 30, 2022</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of Participants with an Improvement of Greater than or Equal to (&gt;=) 4 from Baseline in Peak Pruritus Numeric Rating Scale (PP NRS) at Week 16</measure>
    <time_frame>Week 16</time_frame>
    <description>PP NRS is an 11-point scale (0 to10) where 0 is &quot;no itch&quot; and 10 is the &quot;worst itch imaginable&quot;.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of Participants with an Investigator Global Assessment (IGA) Success (Defined as an IGA of 0 [Clear] or 1 [Almost clear] and a &gt;= 2-Point Improvement from Baseline) at Week 16</measure>
    <time_frame>Week 16</time_frame>
    <description>IGA is a 5-point scale used by the investigator or trained designee to evaluate the global severity of PN. The Investigator will review the participant's skin and give a score of 0 (Clear), 1 (Almost clear), 2 (Mild), 3 (Moderate), or 4 (Severe).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Adverse Events, Treatment Emergent Adverse Events (TEAEs), Adverse Events of Special Interest (AESIs), and Serious Adverse Events (SAEs)</measure>
    <time_frame>Up to Week 24</time_frame>
    <description>An AE is defined as any untoward medical occurrence in a clinical study participant administered a medicinal product which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not it is related to the medicinal (investigational) product.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Participants with an Improvement of &gt;= 4 from Baseline in PP NRS at Week 4</measure>
    <time_frame>Week 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Participants with Less than (&lt;) 2 PP NRS at Week 16</measure>
    <time_frame>Week 16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Participants with an Improvement of &gt;= 4 from Baseline in Sleep Disturbance (SD) Numeric Rating Scale (NRS) at Week 16</measure>
    <time_frame>Week 16</time_frame>
    <description>SD NRS is an 11-point scale (0 to10) where 0 is &quot;no sleep loss&quot; and 10 is &quot;I did not sleep at all&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Participants with an Improvement of &gt;= 4 from Baseline in SD NRS at Week 4</measure>
    <time_frame>Week 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Participants with &lt; 2 PP NRS at Week 4</measure>
    <time_frame>Week 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IGA Success Rate at Each Visit Through Week 16</measure>
    <time_frame>At each visit through Week 16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Pruriginous Lesions with Excoriations/Crusts (Prurigo Activity Score [PAS] item 5a) at Each Visit Through Week 16</measure>
    <time_frame>At each visit through Week 16</time_frame>
    <description>PAS will include a count of the number of lesions in a representative area and a calculated staging (stage 0 to stage 4) based on the percentage of lesions with excoriations/crusts and healed lesions compared to all lesions. PAS item 5a reflects the current itch/scratch activity. It is used to estimate what percentage of the pruriginous legions show excoriations/crusts. 100 percent (%) = All pruriginous lesions have excoriations/crusts.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Healed Prurigo Lesions (PAS Item 5b) at Each Visit Through Week 16</measure>
    <time_frame>At each visit through Week 16</time_frame>
    <description>PAS item 5b item reflects the stage of the prurigo. It is used to estimate what percentage of the pruriginous lesions have healed.100% = all pruriginous lesions have healed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Number of Lesions in Representative Area (PAS Item 4) at Each Visit Through Week 16</measure>
    <time_frame>Baseline, at each visit through Week 16</time_frame>
    <description>PAS Item 4 is measure of number of lesions in representative area.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Participants with an Improvement of &gt;=4 from Baseline in PP NRS Through Week 16</measure>
    <time_frame>Through Week 16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Participants with PP NRS &lt; 2 from Baseline Through Week 16</measure>
    <time_frame>Through Week 16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Participants with PP NRS &lt; 3 from Baseline Through Week 16</measure>
    <time_frame>Through Week 16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute Change from Baseline in PP NRS Through Week 16</measure>
    <time_frame>Baseline, through Week 16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change from Baseline in PP NRS Through Week 16</measure>
    <time_frame>Baseline, through Week 16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Participants with an Improvement of &gt;= 4 from Baseline in Average Pruritus (AP) Numeric Rating Scale (NRS) Through Week 16</measure>
    <time_frame>Through Week 16</time_frame>
    <description>AP NRS is an 11-point scale (0 to10) where 0 is &quot;no itch&quot; and 10 is the &quot;worst itch imaginable&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Participants with AP NRS &lt; 2 from Baseline Through Week 16</measure>
    <time_frame>Through Week 16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute Change from Baseline in AP NRS Through Week 16</measure>
    <time_frame>Baseline, through Week 16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change from Baseline in AP NRS Through Week 16</measure>
    <time_frame>Baseline, through Week 16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Participants with an Improvement of &gt;= 4 from Baseline in Sleep Disturbance (SD) Numeric Rating Scale (NRS) Through Week 16</measure>
    <time_frame>Through Week 16</time_frame>
    <description>SD NRS is an 11-point scale (0 to10) where 0 is &quot;no sleep loss&quot; and 10 is &quot;I did not sleep at all&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute Change from Baseline in SD NRS Through Week 16</measure>
    <time_frame>Baseline, through Week 16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change from Baseline in SD NRS Through Week 16</measure>
    <time_frame>Baseline, through Week 16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Sleep Onset Latency Through Week 16</measure>
    <time_frame>Baseline, through Week 16</time_frame>
    <description>Change from baseline in sleep onset latency based on recordings from participant's sleep diary.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Wakefulness After Sleep Onset (WASO) Through Week 16</measure>
    <time_frame>Baseline, through Week 16</time_frame>
    <description>Change from baseline in WASO, defined as the duration of wakefulness from the onset of persistent sleep. WASO is assessed with 3 questions: 1) How many times did you wake up due to the symptoms of prurigo nodularis (for example itching, burning), not counting the final time you woke up for the day? 2) In total, how long did the awakenings related to the symptoms of prurigo nodularis (for example itching, burning) last and 3) In total, how long did these awakenings related to other things last (for example to drink water, to go to the bathroom).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Total Awake Time and Sleep Time Through Week 16</measure>
    <time_frame>Baseline, through Week 16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Sleep Efficiency Through Week 16</measure>
    <time_frame>Baseline, through Week 16</time_frame>
    <description>The Sleep Efficiency Index is the ratio of total sleep time to time in bed. This shall be assessed by responses from the following questions from participant's sleep diary: 1) What time did you get into bed? 2) What time did you try to go to sleep? 3) How long did it take you to fall asleep? 4) What time did you wake up for the day? 5) What time did you get out of bed for the day?</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in WASO related to PN Through Week 16</measure>
    <time_frame>Baseline, through Week 16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Number of WASO related to PN Through Week 16</measure>
    <time_frame>Baseline, through Week 16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in PN-associated Pain Frequency Through Week 16</measure>
    <time_frame>Baseline, through Week 16</time_frame>
    <description>The pain frequency will be assessed on a 6 point scale of 0 to 5 where 0 = never, 1 = less than once a week, 2 = 1-2 days a week, 3 = 3-4 days a week, and 4 = 5-6 days a week, 5 = every day.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in PN-associated Pain Intensity Through Week 16</measure>
    <time_frame>Baseline, through Week 16</time_frame>
    <description>The pain intensity will be assessed on a scale of 0 to 10, with 0 being &quot;no pain&quot; and 10 being &quot;the worst unbearable pain&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Participants Reporting low Disease Activity (Clear, Almost clear, or Mild) Based on Patient Global Assessment of Disease (PGAD) at Week 16</measure>
    <time_frame>Week 16</time_frame>
    <description>For the PGAD, participants will be asked to rate their overall impression of their skin disease (prurigo nodularis) severity using a 5-point scale from &quot;0=clear&quot; to &quot;5=severe&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Participants Satisfied with Study Treatment (Good, Very good, or Excellent) Based on Patient Global Assessment of Treatment (PGAT) at Week 16</measure>
    <time_frame>Week 16</time_frame>
    <description>The PGAT utilizes a 5-point scale with ratings: poor, fair, good, very good, or excellent, for participants to rate the way they feel their skin disease (prurigo nodularis) is responding to the study treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Participants with an Improvement of &gt;= 4 in Dermatology Life Quality Index (DLQI) Through Week 16</measure>
    <time_frame>Through Week 16</time_frame>
    <description>The DLQI is a validated 10-item questionnaire covering domains including symptoms/feelings, daily activities, leisure, work/school, personal relationships, and treatment. The participant will rate each question ranging from 0 (not at all) to 3 (very much). A higher total score indicates a poorer quality of life (QoL).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Dermatology Life Quality Index (DLQI) Through Week 16</measure>
    <time_frame>Baseline, through Week 16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Hospital Anxiety and Depression Scale (HADS) for each Subscale (Depression and Anxiety) at Week 16</measure>
    <time_frame>Baseline, Week 16</time_frame>
    <description>Hospital Anxiety and Depression Scale (HADS) is a 14-question validated questionnaire completed by the participant for each subscale (i.e. depression and anxiety). Each question has a multiple choice answer which is scored between 0 and 3. Questions are identified as relating to anxiety (A) or depression (D) and a summation for each area is performed leading to a total score of 0 to 21 for each area. Scores of 0 to 7 are considered normal, 8 to 10 are borderline, and &gt;= 11 indicates clinical effects.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in EuroQoL 5-Dimension (EQ-5D) at Week 16</measure>
    <time_frame>Baseline, Week 16</time_frame>
    <description>The EQ-5D instrument is a validated questionnaire, completed by the participant that consists of 2 parts. The first part consists of 5 multiple choice QoL questions and the second is a 100 point visual analogue scale (VAS) with 0 being &quot;Worst imaginable health state&quot; and 100 being &quot;Best imaginable health state&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Observed Ctrough of Nemolizumab in Serum</measure>
    <time_frame>Pre-infusion, Post infusion on Day 8, 29, 57, 85, 113, 169</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Positive Anti-drug antibody (ADA) for Nemolizumab</measure>
    <time_frame>Baseline, Day 57, Day 113/ Early Termination (ET)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects with PP NRS improvement ≥ 4 from baseline and IGA success</measure>
    <time_frame>Week 16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nemolizumab (CD14152) serum concentrations</measure>
    <time_frame>Week 4, 8, 12, 16, 24, ET</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">274</enrollment>
  <condition>Prurigo Nodularis</condition>
  <arm_group>
    <arm_group_label>Nemolizumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants weighing less than (&lt;) 90 kilogram (kg) will receive two subcutaneous (SC) injections of 30 milligrams (mg) nemolizumab (60 mg loading dose) at baseline then one SC injection once for every 4 weeks (Q4W). Participants weighing greater than or equal to (&gt;=) 90 kg will receive two SC injections of 60 mg nemolizumab at baseline (no loading dose) and two SC injections Q4W throughout the treatment period of 16 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants weighing &lt; 90 kg will receive two SC injections of matching placebo at baseline, then one SC injection Q4W. Participants weighing &gt;= 90 kg will receive two SC injections of matching placebo at baseline, then two SC injections Q4W throughout the treatment period of 16 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nemolizumab</intervention_name>
    <description>Participants will receive either 30 mg or 60 mg dose of nemolizumab as SC injection.</description>
    <arm_group_label>Nemolizumab</arm_group_label>
    <other_name>CD14152</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Participants will receive matching placebo as SC injection.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of PN for at least 6 months with: Pruriginous nodular lesions on&#xD;
             upper limbs, trunk, and/or lower limbs, at least 20 nodules on the entire body with a&#xD;
             bilateral distribution and Investigator Global Assessment (IGA) score &gt;= 3 (based on&#xD;
             the IGA scale ranging from 0 to 4, in which 3 is moderate and 4 is severe) at both the&#xD;
             screening and baseline visits&#xD;
&#xD;
          -  Severe pruritus defined as follows on the PP NRS:&#xD;
&#xD;
               1. At the screening visit (Visit 1): PP NRS score is &gt;= 7.0 for the 24-hour period&#xD;
                  immediately preceding the screening visit.&#xD;
&#xD;
               2. At the baseline visit (Visit 2): Mean of the daily intensity of the PP NRS score&#xD;
                  is &gt;= 7.0 over the previous week&#xD;
&#xD;
          -  Female participants of childbearing potential (that is [i.e,], fertile, following&#xD;
             menarche and until becoming post-menopausal unless permanently sterile) must agree to&#xD;
             use at least 1 adequate and approved method of contraception throughout the study and&#xD;
             for 12 weeks after the last study drug injection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Body weight less than (&lt;) 30 kg&#xD;
&#xD;
          -  Chronic pruritus resulting from another active condition other than PN, such as but&#xD;
             not limited to scabies, lichen simplex chronicus, psoriasis, atopic dermatitis,&#xD;
             contact dermatitis, acne, folliculitis, lichen planus, habitual picking/excoriation&#xD;
             disorder, sporotrichosis, bullous autoimmune disease, end-stage renal disease, or&#xD;
             cholestatic liver disease (example [eg] primary biliary cirrhosis) or diabetes&#xD;
             mellitus or thyroid disease that is not adequately treated, as per standard of care&#xD;
&#xD;
          -  Unilateral lesions of prurigo (eg, only one arm affected)&#xD;
&#xD;
          -  History of or current confounding skin condition (eg, Netherton syndrome, cutaneous&#xD;
             T-cell lymphoma [mycosis fungoides or Sezary syndrome], chronic actinic dermatitis,&#xD;
             dermatitis herpetiformis)&#xD;
&#xD;
          -  Participants with a current medical history of chronic obstructive pulmonary disease&#xD;
             and/or chronic bronchitis&#xD;
&#xD;
          -  Neuropathic and psychogenic pruritus such as but not limited to notalgia paresthetica,&#xD;
             brachioradial pruritus, small fiber neuropathy, skin picking syndrome, or delusional&#xD;
             parasitosis&#xD;
&#xD;
          -  Requiring rescue therapy for PN during the screening period or expected to require&#xD;
             rescue therapy within 4 weeks following the baseline visit&#xD;
&#xD;
          -  Positive serology results (hepatitis B surface antigen [HBsAg] or hepatitis B core&#xD;
             antibody [HBcAb], hepatitis C (HCV) antibody with positive confirmatory test for HCV&#xD;
             (eg, polymerase chain reaction [PCR]), or human immunodeficiency virus antibody) at&#xD;
             the screening visit&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Fountain Valley</city>
        <state>California</state>
        <zip>92708</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Aventura</city>
        <state>Florida</state>
        <zip>33180</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>North Miami Beach</city>
        <state>Florida</state>
        <zip>33162-4708</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Ormond Beach</city>
        <state>Florida</state>
        <zip>32174</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60602</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46250</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40241</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Saint Joseph</city>
        <state>Michigan</state>
        <zip>49085</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45627</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Dublin</city>
        <state>Ohio</state>
        <zip>43016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Anderson</city>
        <state>South Carolina</state>
        <zip>29621</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Murfreesboro</city>
        <state>Tennessee</state>
        <zip>37130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Dripping Springs</city>
        <state>Texas</state>
        <zip>78620</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Pflugerville</city>
        <state>Texas</state>
        <zip>78660</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Webster</city>
        <state>Texas</state>
        <zip>77004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <zip>26505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Brussel</city>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Ghent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Jette</city>
        <zip>1090</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Liège</city>
        <zip>4000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>North York</city>
        <state>Ontario</state>
        <zip>M2M 4J5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Bathurst</city>
        <zip>M3H 5Y8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Calgary</city>
        <zip>T2G 1B1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>London</city>
        <zip>N6H 5L5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Markham</city>
        <zip>L3P 1X2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Bordeaux</city>
        <zip>33000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Brest</city>
        <zip>29200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Lille</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Nantes</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Nice</city>
        <zip>06202</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Paris</city>
        <zip>75020</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Paris</city>
        <zip>75475</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Pierre-Bénite</city>
        <zip>69495</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Rouen</city>
        <zip>76000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Saint-Étienne</city>
        <zip>42055</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Toulouse</city>
        <zip>31000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Valence</city>
        <zip>26953</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Gyeonggi-do</city>
        <zip>15355</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Seoul</city>
        <zip>02841</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Seoul</city>
        <zip>04763</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Seoul</city>
        <zip>07441</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Groningen</city>
        <zip>9713</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Utrecht</city>
        <zip>3508</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Bydgoszcz</city>
        <zip>85-065</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Chorzów</city>
        <zip>41-500</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Kraków</city>
        <zip>31-559</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Lublin</city>
        <zip>20-081</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Olsztyn</city>
        <zip>10-229</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Ostrowiec Świętokrzyski</city>
        <zip>27-400</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Rzeszów</city>
        <zip>35-055</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Szczecin</city>
        <zip>71-434</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Warsaw</city>
        <zip>01-518</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Warsaw</city>
        <zip>01-817</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Warsaw</city>
        <zip>02-507</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Warsaw</city>
        <zip>02-758</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Wrocław</city>
        <zip>50-566</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Wrocław</city>
        <zip>51-318</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Łódź</city>
        <zip>90-265</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Łódź</city>
        <zip>90-436</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Barcelona</city>
        <zip>08041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Las Palmas De Gran Canaria</city>
        <zip>35019</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Bern</city>
        <zip>3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Buochs</city>
        <zip>6374</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Lausanne</city>
        <zip>1011</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Saint Gallen</city>
        <zip>9007</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Weinfelden</city>
        <zip>8570</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Canada</country>
    <country>France</country>
    <country>Korea, Republic of</country>
    <country>Netherlands</country>
    <country>Poland</country>
    <country>Spain</country>
    <country>Switzerland</country>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>July 30, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <disposition_first_submitted>March 29, 2023</disposition_first_submitted>
  <disposition_first_submitted_qc>March 29, 2023</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">April 3, 2023</disposition_first_posted>
  <last_update_submitted>June 27, 2023</last_update_submitted>
  <last_update_submitted_qc>June 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 29, 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>Prurigo</mesh_term>
    <mesh_term>Neurodermatitis</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT04501679
org study id: RD.06.SPR.203065
secondary id: 2019-004789-17
nct id: NCT04501679
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The primary objective is to assess the efficacy of nemolizumab (CD14152) compared to placebo
      in participants greater than or equal to (>=) 18 years of age with prurigo nodularis (PN)
      after a 16-week treatment period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Proportion of Participants with an Improvement of Greater than or Equal to (>=) 4 from Baseline in Peak Pruritus Numeric Rating Scale (PP NRS) at Week 16
time frame: Week 16
description: PP NRS is an 11-point scale (0 to10) where 0 is "no itch" and 10 is the "worst itch imaginable".
measure: Proportion of Participants with an Investigator Global Assessment (IGA) Success (Defined as an IGA of 0 [Clear] or 1 [Almost clear] and a >= 2-Point Improvement from Baseline) at Week 16
time frame: Week 16
description: IGA is a 5-point scale used by the investigator or trained designee to evaluate the global severity of PN. The Investigator will review the participant's skin and give a score of 0 (Clear), 1 (Almost clear), 2 (Mild), 3 (Moderate), or 4 (Severe).
measure: Number of Participants with Adverse Events, Treatment Emergent Adverse Events (TEAEs), Adverse Events of Special Interest (AESIs), and Serious Adverse Events (SAEs)
time frame: Up to Week 24
description: An AE is defined as any untoward medical occurrence in a clinical study participant administered a medicinal product which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not it is related to the medicinal (investigational) product.
measure: Proportion of Participants with an Improvement of >= 4 from Baseline in PP NRS at Week 4
time frame: Week 4
measure: Proportion of Participants with Less than (<) 2 PP NRS at Week 16
time frame: Week 16
measure: Proportion of Participants with an Improvement of >= 4 from Baseline in Sleep Disturbance (SD) Numeric Rating Scale (NRS) at Week 16
time frame: Week 16
description: SD NRS is an 11-point scale (0 to10) where 0 is "no sleep loss" and 10 is "I did not sleep at all".
measure: Proportion of Participants with an Improvement of >= 4 from Baseline in SD NRS at Week 4
time frame: Week 4
measure: Proportion of Participants with < 2 PP NRS at Week 4
time frame: Week 4
measure: IGA Success Rate at Each Visit Through Week 16
time frame: At each visit through Week 16
measure: Percentage of Pruriginous Lesions with Excoriations/Crusts (Prurigo Activity Score [PAS] item 5a) at Each Visit Through Week 16
time frame: At each visit through Week 16
description: PAS will include a count of the number of lesions in a representative area and a calculated staging (stage 0 to stage 4) based on the percentage of lesions with excoriations/crusts and healed lesions compared to all lesions. PAS item 5a reflects the current itch/scratch activity. It is used to estimate what percentage of the pruriginous legions show excoriations/crusts. 100 percent (%) = All pruriginous lesions have excoriations/crusts.
measure: Percentage of Healed Prurigo Lesions (PAS Item 5b) at Each Visit Through Week 16
time frame: At each visit through Week 16
description: PAS item 5b item reflects the stage of the prurigo. It is used to estimate what percentage of the pruriginous lesions have healed.100% = all pruriginous lesions have healed.
measure: Change from Baseline in Number of Lesions in Representative Area (PAS Item 4) at Each Visit Through Week 16
time frame: Baseline, at each visit through Week 16
description: PAS Item 4 is measure of number of lesions in representative area.
measure: Proportion of Participants with an Improvement of >=4 from Baseline in PP NRS Through Week 16
time frame: Through Week 16
measure: Proportion of Participants with PP NRS < 2 from Baseline Through Week 16
time frame: Through Week 16
measure: Proportion of Participants with PP NRS < 3 from Baseline Through Week 16
time frame: Through Week 16
measure: Absolute Change from Baseline in PP NRS Through Week 16
time frame: Baseline, through Week 16
measure: Percent Change from Baseline in PP NRS Through Week 16
time frame: Baseline, through Week 16
measure: Proportion of Participants with an Improvement of >= 4 from Baseline in Average Pruritus (AP) Numeric Rating Scale (NRS) Through Week 16
time frame: Through Week 16
description: AP NRS is an 11-point scale (0 to10) where 0 is "no itch" and 10 is the "worst itch imaginable".
measure: Proportion of Participants with AP NRS < 2 from Baseline Through Week 16
time frame: Through Week 16
measure: Absolute Change from Baseline in AP NRS Through Week 16
time frame: Baseline, through Week 16
measure: Percent Change from Baseline in AP NRS Through Week 16
time frame: Baseline, through Week 16
measure: Proportion of Participants with an Improvement of >= 4 from Baseline in Sleep Disturbance (SD) Numeric Rating Scale (NRS) Through Week 16
time frame: Through Week 16
description: SD NRS is an 11-point scale (0 to10) where 0 is "no sleep loss" and 10 is "I did not sleep at all".
measure: Absolute Change from Baseline in SD NRS Through Week 16
time frame: Baseline, through Week 16
measure: Percent Change from Baseline in SD NRS Through Week 16
time frame: Baseline, through Week 16
measure: Change from Baseline in Sleep Onset Latency Through Week 16
time frame: Baseline, through Week 16
description: Change from baseline in sleep onset latency based on recordings from participant's sleep diary.
measure: Change from Baseline in Wakefulness After Sleep Onset (WASO) Through Week 16
time frame: Baseline, through Week 16
description: Change from baseline in WASO, defined as the duration of wakefulness from the onset of persistent sleep. WASO is assessed with 3 questions: 1) How many times did you wake up due to the symptoms of prurigo nodularis (for example itching, burning), not counting the final time you woke up for the day? 2) In total, how long did the awakenings related to the symptoms of prurigo nodularis (for example itching, burning) last and 3) In total, how long did these awakenings related to other things last (for example to drink water, to go to the bathroom).
measure: Change from Baseline in Total Awake Time and Sleep Time Through Week 16
time frame: Baseline, through Week 16
measure: Change from Baseline in Sleep Efficiency Through Week 16
time frame: Baseline, through Week 16
description: The Sleep Efficiency Index is the ratio of total sleep time to time in bed. This shall be assessed by responses from the following questions from participant's sleep diary: 1) What time did you get into bed? 2) What time did you try to go to sleep? 3) How long did it take you to fall asleep? 4) What time did you wake up for the day? 5) What time did you get out of bed for the day?
measure: Change from Baseline in WASO related to PN Through Week 16
time frame: Baseline, through Week 16
measure: Change from Baseline in Number of WASO related to PN Through Week 16
time frame: Baseline, through Week 16
measure: Change from Baseline in PN-associated Pain Frequency Through Week 16
time frame: Baseline, through Week 16
description: The pain frequency will be assessed on a 6 point scale of 0 to 5 where 0 = never, 1 = less than once a week, 2 = 1-2 days a week, 3 = 3-4 days a week, and 4 = 5-6 days a week, 5 = every day.
measure: Change from Baseline in PN-associated Pain Intensity Through Week 16
time frame: Baseline, through Week 16
description: The pain intensity will be assessed on a scale of 0 to 10, with 0 being "no pain" and 10 being "the worst unbearable pain".
measure: Proportion of Participants Reporting low Disease Activity (Clear, Almost clear, or Mild) Based on Patient Global Assessment of Disease (PGAD) at Week 16
time frame: Week 16
description: For the PGAD, participants will be asked to rate their overall impression of their skin disease (prurigo nodularis) severity using a 5-point scale from "0=clear" to "5=severe".
measure: Proportion of Participants Satisfied with Study Treatment (Good, Very good, or Excellent) Based on Patient Global Assessment of Treatment (PGAT) at Week 16
time frame: Week 16
description: The PGAT utilizes a 5-point scale with ratings: poor, fair, good, very good, or excellent, for participants to rate the way they feel their skin disease (prurigo nodularis) is responding to the study treatment.
measure: Proportion of Participants with an Improvement of >= 4 in Dermatology Life Quality Index (DLQI) Through Week 16
time frame: Through Week 16
description: The DLQI is a validated 10-item questionnaire covering domains including symptoms/feelings, daily activities, leisure, work/school, personal relationships, and treatment. The participant will rate each question ranging from 0 (not at all) to 3 (very much). A higher total score indicates a poorer quality of life (QoL).
measure: Change From Baseline in Dermatology Life Quality Index (DLQI) Through Week 16
time frame: Baseline, through Week 16
measure: Change from Baseline in Hospital Anxiety and Depression Scale (HADS) for each Subscale (Depression and Anxiety) at Week 16
time frame: Baseline, Week 16
description: Hospital Anxiety and Depression Scale (HADS) is a 14-question validated questionnaire completed by the participant for each subscale (i.e. depression and anxiety). Each question has a multiple choice answer which is scored between 0 and 3. Questions are identified as relating to anxiety (A) or depression (D) and a summation for each area is performed leading to a total score of 0 to 21 for each area. Scores of 0 to 7 are considered normal, 8 to 10 are borderline, and >= 11 indicates clinical effects.
measure: Change from Baseline in EuroQoL 5-Dimension (EQ-5D) at Week 16
time frame: Baseline, Week 16
description: The EQ-5D instrument is a validated questionnaire, completed by the participant that consists of 2 parts. The first part consists of 5 multiple choice QoL questions and the second is a 100 point visual analogue scale (VAS) with 0 being "Worst imaginable health state" and 100 being "Best imaginable health state".
measure: Observed Ctrough of Nemolizumab in Serum
time frame: Pre-infusion, Post infusion on Day 8, 29, 57, 85, 113, 169
measure: Number of Participants with Positive Anti-drug antibody (ADA) for Nemolizumab
time frame: Baseline, Day 57, Day 113/ Early Termination (ET)
measure: Proportion of subjects with PP NRS improvement ≥ 4 from baseline and IGA success
time frame: Week 16
measure: Nemolizumab (CD14152) serum concentrations
time frame: Week 4, 8, 12, 16, 24, ET
arm group label: Nemolizumab
arm group type: Experimental
description: Participants weighing less than (<) 90 kilogram (kg) will receive two subcutaneous (SC) injections of 30 milligrams (mg) nemolizumab (60 mg loading dose) at baseline then one SC injection once for every 4 weeks (Q4W). Participants weighing greater than or equal to (>=) 90 kg will receive two SC injections of 60 mg nemolizumab at baseline (no loading dose) and two SC injections Q4W throughout the treatment period of 16 weeks.
arm group label: Placebo
arm group type: Placebo Comparator
description: Participants weighing < 90 kg will receive two SC injections of matching placebo at baseline, then one SC injection Q4W. Participants weighing >= 90 kg will receive two SC injections of matching placebo at baseline, then two SC injections Q4W throughout the treatment period of 16 weeks.
intervention type: Drug
intervention name: Nemolizumab
description: Participants will receive either 30 mg or 60 mg dose of nemolizumab as SC injection.
arm group label: Nemolizumab
other name: CD14152
intervention type: Drug
intervention name: Placebo
description: Participants will receive matching placebo as SC injection.
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Belgium
country: Canada
country: France
country: Korea, Republic of
country: Netherlands
country: Poland
country: Spain
country: Switzerland
country: United States
responsible party type: Sponsor
mesh term: Prurigo
mesh term: Neurodermatitis