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Evaluating Amlitelimab for 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

PHASE3 · Sanofi · NCT06407934

This study is testing if different doses of amlitelimab can help people aged 12 and older with moderate-to-severe atopic dermatitis keep their skin improvements over time.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment961 (estimated)
Ages12 Years and up
SexAll
SponsorSanofi (industry)
Drugs / interventionsamlitelimab
Locations310 sites (Birmingham, Alabama and 309 other locations)
Trial IDNCT06407934 on ClinicalTrials.gov

What this trial studies

This clinical trial is a multinational, multicenter, randomized, double-blind, placebo-controlled Phase 3 study aimed at participants aged 12 years and older with moderate-to-severe atopic dermatitis. The study evaluates the treatment response and safety of two different dose regimens of amlitelimab compared to treatment withdrawal for those who previously responded to the medication in earlier studies. Participants will be monitored over a period of up to 68 weeks, including a 52-week randomized phase and a 16-week safety follow-up. The goal is to determine if maintaining or switching doses of amlitelimab can sustain treatment benefits.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals aged 12 years and older who have previously participated in specific parent studies and responded positively to amlitelimab.

Not a fit: Patients who have developed medical conditions that preclude participation or who have discontinued treatment due to adverse effects may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients suffering from moderate-to-severe atopic dermatitis.

How similar studies have performed: Previous studies involving amlitelimab have shown promising results, indicating that this approach may be effective.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Participants must be at least 12 years of age inclusive, at the time the informed consent is signed.
* Must have participated, received study treatment without permanent investigational medicinal product (IMP) discontinuation, and adequately completed the assessments required for the treatment period in one of the three 24-week parent studies EFC17559 (COAST-1), EFC17560 (COAST-2) or EFC17561 (SHORE) for moderate-to-severe AD.
* Able and willing to comply with requested study visit and procedures.
* Body weight must be ≥ 25 kg.

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

* Developed a medical condition that would preclude participation as described in Permanent Discontinuation of EFC17559 (COAST-1)/EFC17560 (COAST-2)/EFC17561 (SHORE) clinical trial protocols.
* Having received any prohibited medication or procedure for AD that resulted in IMP discontinuation in the parent study EFC17559 (COAST-1), EFC17560 (COAST-2) or EFC17561 (SHORE).
* Participants who, during their participation in the parent study EFC17559 (COAST-1) /EFC17560 (COAST-2)/EFC17561 (SHORE), developed an adverse event (AE) or a serious adverse event (SAE) deemed related to amlitelimab, which in the opinion of the Investigator could indicate that continued treatment with amlitelimab may present an unreasonable risk for the participant.
* Participants who have had IMP permanently discontinued for any reason before or at the time of the planned first dose in the EFC17600 (ESTUARY) study.
* Conditions in the parent study EFC17559 (COAST-1)/EFC17560 (COAST-2)/EFC17561 (SHORE) that led to Investigator - or Sponsor-initiated withdrawal of participant from the study (eg, non-compliance, inability to complete study assessments, etc.).
* Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Where this trial is running

Birmingham, Alabama and 309 other locations

+260 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Dermatitis Atopic

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.