NCT03989349

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 787 (actual)
• Sponsor: Galderma R&D · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of the study was 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.

Detailed description

This was 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 had documented history of inadequate response to topical AD medication(s). Approximately 750 subjects were 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). A minimum of 250 subjects were randomized in each PP NRS strata. All nemolizumab-treated subjects who were clinical responders at Week 16 (i.e., the end of initial treatment \[Initial Treatment Period\]/beginning of Maintenance Period) were re-randomized (1:1:1) to different treatment regimens (nemolizumab injections Q4W or every 8 weeks (Q8W) \[with placebo injections at Weeks 20, 28, 36, and 44 to maintain the blind\] or placebo Q4W). A clinical responder was defined as a subject at Week 16 with an IGA of 0 (clear) or 1 (almost clear) or a \>=75% improvement in EASI from baseline (EASI-75). All placebo-treated subjects who responded to placebo during the Initial Treatment Period continued to receive placebo Q4W in the Maintenance Period.

Conditions

• Moderate-to-Severe Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	Placebo	Placebo
DRUG	Nemolizumab	Nemolizumab

Timeline

• Start date: 2019-06-30
• Primary completion: 2022-02-23
• Completion: 2022-09-26
• First posted: 2019-06-18
• Last updated: 2024-08-14
• Results posted: 2024-08-14

Locations

138 sites across 11 countries: United States, Belgium, Bulgaria, Estonia, France, Georgia, Germany, Hungary, Italy, Poland, Singapore

Regulatory

• FDA-regulated drug study