NCT06407934

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

A Phase 3, Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group 52-week Extension Study to Evaluate the Treatment Response and Safety of Two Amlitelimab Dose Regimens Administered by Subcutaneous Injection in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,541 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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 68 weeks including a 52-week randomized double-blind period, and a 16-week safety follow-up for participants not entering the LTS17367 (RIVER-AD). The study duration will be up to 52 weeks for participants entering the LTS17367 \[RIVER-AD\] study at the Week 52 visit of EFC17600 (ESTUARY). The total treatment duration will be up to 52 weeks. The total number of visits will be up to 15 visits (or 14 visits for those entering LTS17367 \[RIVER-AD\] study).

Conditions

• Dermatitis Atopic

Interventions

Type	Name	Description
DRUG	Amlitelimab	Pharmaceutical form: Injection solution Route of administration: Subcutaneous (SC) injection
DRUG	Placebo	Pharmaceutical form: Injection solution Route of administration: SC injection

Timeline

• Start date: 2024-05-08
• Primary completion: 2026-06-29
• Completion: 2027-03-17
• First posted: 2024-05-09
• Last updated: 2025-12-18

Locations

326 sites across 27 countries: United States, Argentina, Australia, Brazil, Bulgaria, Canada, Chile, China, Czechia, Denmark, France, Germany, Greece, India, Israel, Italy, Japan, Mexico, Poland, Portugal, South Africa, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study