NCT04365387

A Study to Assess Immunization Responses in Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis Treated With Nemolizumab

A Randomized, Double-Blind, Placebo-Controlled Study to Assess Immunization Responses in Adult and Adolescent Subjects With Moderate-to-Severe Atopic Dermatitis Treated With Nemolizumab

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 242 (actual)
• Sponsor: Galderma R&D · Industry
• Sex: All
• Age: 12 Years – 54 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the effect of nemolizumab (CD14152) on humoral immune responses to tetanus and meningococcal vaccination in adult and adolescent participants with moderate-to-severe atopic dermatitis (AD).

Detailed description

This is a randomized, double-blind, placebo-controlled, multi-center, parallel-group study in adult and adolescent participants (≥ 12 to 54 years) with moderate-to-severe AD. Eligible participants must have a documented history of inadequate response to topical AD medication(s). Approximately 200 participants were randomized 1:1 to receive either 30 mg nemolizumab (with a 60 mg loading dose) or placebo, stratified by baseline disease severity Investigator Global Assessment (IGA) (IGA = 3, moderate; IGA = 4, severe). The study consisted of a 2- to 4-week screening period, a 16-week treatment period, and an 8-week follow-up period (12 weeks after the last study drug injection).

Conditions

• Dermatitis, Atopic

Interventions

Type	Name	Description
DRUG	Nemolizumab	Nemolizumab was administered by 2 SC injections as 60-mg loading dose at baseline and a single 30-mg dose at Weeks 4, 8, and 12.
DRUG	Placebo	Placebo was administered by 2 SC injections at baseline and a single dose at Weeks 4, 8, and 12.

Timeline

• Start date: 2020-03-05
• Primary completion: 2023-07-07
• Completion: 2023-07-07
• First posted: 2020-04-28
• Last updated: 2025-06-05
• Results posted: 2025-06-05

Locations

64 sites across 1 country: United States

Regulatory

• FDA-regulated drug study