An Efficacy and Safety Study of Nemolizumab (CD14152) in Participants With Prurigo Nodularis

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Brief Title

An Efficacy and Safety Study of Nemolizumab (CD14152) in Participants With Prurigo Nodularis

Official Title

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Subjects With Prurigo Nodularis

Brief Summary

      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.
    


Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Proportion of Participants with an Improvement of Greater than or Equal to (>=) 4 from Baseline in Peak Pruritus (PP) Numeric Rating Scale (NRS) at Week 16

Secondary Outcome

 Number of Participants with Adverse Events, Treatment Emergent Adverse Events (TEAEs), Adverse Events of Special Interest (AESIs), and Serious Adverse Events (SAEs)

Condition

Prurigo Nodularis

Intervention

Nemolizumab 30 mg

Study Arms / Comparison Groups

 Nemolizumab 30 milligram (mg)
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) and participants >= 90 kg will receive two SC injections of 60 mg nemolizumab at baseline (no loading dose) and two SC injections Q4W up to 24 weeks.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

270

Start Date

September 11, 2020

Completion Date

December 31, 2021

Primary Completion Date

December 31, 2021

Eligibility Criteria

        Inclusion Criteria:

          -  Clinical diagnosis of PN for at least 6 months with: (a) Pruriginous nodular lesions
             on upper limbs, trunk, and/or lower limbs; (b) At least 20 nodules on the entire body
             with a bilateral distribution; (c) Investigator Global Assessment (IGA) score >= 3
             (based on the IGA scale ranging from 0 to 4, in which 3 is moderate and 4 is severe)
             at both the screening and baseline visits

          -  Severe pruritus defined as follows on the PP NRS: (a) at the screening visit (Visit
             1): PP NRS score is >= 7.0 for the 24-hour period immediately preceding the screening
             visit; (b) at the baseline visit (Visit 2): Mean of the daily intensity of the PP NRS
             score is >= 7.0 over the previous week

          -  Female participants of childbearing potential (that is [i.e,], fertile, following
             menarche and until becoming post-menopausal unless permanently sterile) must agree to
             use at least 1 effective and approved method of contraception throughout the study and
             for 12 weeks after the last study drug injection

          -  Participant is willing and able to comply with all of the time commitments and
             procedural requirements of the clinical study protocol, including daily diary
             recordings by the participant using an electronic handheld device provided for this
             study

        Exclusion Criteria:

          -  Body weight < 30 kilogram (kg)

          -  Unilateral lesions of prurigo (eg, only one arm affected)

          -  History of or current confounding skin condition (eg, Netherton syndrome, cutaneous
             T-cell lymphoma [mycosis fungoides or Sezary syndrome], chronic actinic dermatitis,
             dermatitis herpetiformis)

          -  Participants with a current medical history of chronic obstructive pulmonary disease
             and/or chronic bronchitis

          -  Positive serology results (hepatitis B surface antigen [HBsAg] or hepatitis B core
             antibody [HBcAb], hepatitis C (HCV) antibody with positive confirmatory test for HCV
             (eg, polymerase chain reaction [PCR]), or human immunodeficiency virus antibody) at
             the screening visit
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, 817-961-5000, [email protected]

Location Countries

Austria

Location Countries

Austria

Administrative Informations


NCT ID

NCT04501666

Organization ID

RD.06.SPR.202685

Secondary IDs

2019-004293-25

Responsible Party

Sponsor

Study Sponsor

Galderma R&D


Study Sponsor

, , 


Verification Date

March 2020