Efficacy & Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis

  • STATUS
    Recruiting
  • End date
    Dec 30, 2022
  • participants needed
    750
  • sponsor
    Galderma R&D
Updated on 19 July 2021

Summary

The main purpose of the study is to assess the efficacy and safety of nemolizumab after a 16-week treatment period in adult and adolescent subjects with moderate-to-severe atopic dermatitis (AD) not adequately controlled with topical treatments.

Description

This is a randomized, double-blind, placebo-controlled, multi-center, parallel-group study in adult and adolescent subjects of age 12 years and above with moderate-to-severe AD. Eligible subjects must have a documented history of inadequate response to topical AD medication(s). Approximately 750 subjects will be randomized in 2:1 to receive either nemolizumab or placebo, stratified by baseline disease severity (Investigator's Global Assessment (IGA) = 3, moderate; IGA = 4, severe) and peak pruritus numeric rating scale (PP NRS) severity (PP NRS = 7; PP NRS < 7).

Details
Condition Moderate to Severe Atopic Dermatitis
Treatment Placebo, Nemolizumab
Clinical Study IdentifierNCT03989349
SponsorGalderma R&D
Last Modified on19 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female subjects aged 12 years at the screening visit Note: Enrollment of subjects aged 12 to 17 years has been opened after the IDMC has assessed interim safety data from the phase 2 study (Protocol 116912) and provided recommendations to the sponsor, who then determined the eligibility of this age group for enrollment in the study
Chronic AD that has been documented for at least 2 years
EASI score 16
IGA score 3
AD involvement 10% of BSA
PPNRS score of at least 4.0 at the screening and baseline visit
Documented recent history of inadequate response to topical medications (TCS with or without TCI)
Female subjects of childbearing potential (that is, fertile, following menarche and until becoming postmenopausal unless permanently sterile) must agree either to be strictly abstinent throughout the study and for 12 weeks after the last study drug injection, or to use an adequate and approved method of contraception throughout the study and for 12 weeks after the last study drug injection

Exclusion Criteria

Cutaneous infection within 1 week before the baseline visit, any infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics or antifungals within 2 weeks before the baseline visit, or any confirmed or suspected coronavirus disease (COVID)-19 infection within 2 weeks before the screening or baseline visit Note: Subjects with chronic, stable use of prophylactic treatment for recurrent herpes viral infection can be included in this clinical study
History of hypersensitivity (including anaphylaxis) to an immunoglobulin product (plasma-derived or recombinant, eg, monoclonal antibody) or to any of the study drug excipients
Any clinically significant issue, based on investigator judgement
Body weight < 30 kg
Pregnant women, breastfeeding women, or women planning a pregnancy during the clinical study
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