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A Study to Evaluate the Treatment Response and Safety of Two Dose Regimens of Subcutaneous Amlitelimab Monotherapy Compared With Treatment Withdrawal in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis — ESTUARY  

Dermatitis Atopic Clinical Trial

Official title:
A Phase 3, Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group 48-week Extension Study to Evaluate the Treatment Response and Safety of Two Amlitelimab Dose Regimens Administered as Monotherapy by Subcutaneous Injection in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis

Clinical Trial Summary

This is a multinational, multicenter, randomized, double-blind, placebo-controlled, parallel, Phase 3 study for treatment of participants aged 12 years and older diagnosed with moderate-to-severe atopic dermatitis (AD). The main objective of this study is to evaluate if those participants who received amlitelimab dose 1 in the parent studies (EFC17559 [COAST-1], EFC17560 [COAST 2], EFC17561 [SHORE]) and were responders can maintain their response either remaining at dose 1 or switching to dose 2 of amlitelimab compared to treatment withdrawal. Study details include: The study duration will be up to 64 weeks (for participants not entering the LTS17367 [RIVER-AD] study) including a 48-week randomized double-blind period, and a 16-week safety follow-up. The study duration will be up to 48 weeks for participants entering the LTS17367 [RIVER-AD] study at the Week 48 visit of EFC17600 (ESTUARY). The total treatment duration will be up to 48 weeks. The total number of visits will be up to 14 visits (or 13 visits for those entering LTS17367 [RIVER-AD] study).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06407934
Study type Interventional
Source Sanofi
Contact Trial Transparency email recommended (Toll free for US & Canada)
Phone 800-633-1610
Email Contact-US@sanofi.com
Status Recruiting
Phase Phase 3
Start date May 8, 2024
Completion date January 5, 2027
View Details
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