Efficacy and 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 18 August 2021
Investigator
Galderma R&D
Primary Contact
Galderma Investigational Site (3.5 mi away) Contact
+458 other location

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 IdentifierNCT03985943
SponsorGalderma R&D
Last Modified on18 August 2021

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