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

Moderate-to-Severe Atopic Dermatitis Clinical Trial

Official title:
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis

Clinical Trial 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.

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03985943
Study type Interventional
Source Galderma R&D
Contact
Status Completed
Phase Phase 3
Start date June 30, 2019
Completion date August 11, 2022
View Details
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