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

Study on Treatment Response in Moderate-to-Severe Atopic Dermatitis

Recruiting
12 years or above
All
Phase 3
1500 participants needed
5 Locations

Study Overview

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).

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Dermatitis Atopic
  • Age: 12 years or above
  • Gender: All

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 Exclusion Criteria or 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.

This study investigates the treatment response and safety of two dose regimens of an investigational medication compared with treatment withdrawal in individuals aged 12 years and older with moderate-to-severe atopic dermatitis. The study aims to see if participants who responded to the investigational medication in earlier studies can maintain their response when continuing with the same dose, switching to a different dose, or stopping the medication.

In this study, participants will be randomly assigned to one of the study arms, where they will receive either one of the two doses of the investigational medication or a placebo. A placebo is an inactive substance that looks like the investigational medicine but does not contain any medicine. Participants will undergo regular assessments to monitor their condition and any side effects. The study will include a double-blind period, meaning neither the participants nor the researchers will know who is receiving the investigational medication or placebo.

  • Who can participate: Participants aged 12 years and older who have completed one of the parent studies for moderate-to-severe atopic dermatitis may be eligible. They must have a body weight of at least 25 kg and be able to comply with study procedures.
  • Study details: Participants will be randomly assigned to receive either one of two doses of the investigational medication or a placebo. A placebo is an inactive substance that looks like the investigational medicine but does not contain any medicine. They will be monitored regularly through assessments to check their skin condition and overall health.
  • Study timelines and visits: The study will last up to 68 weeks. The study requires 15 visits.
Updated on 31 Oct 2025. Study ID: NCT06407934

Find a study site near you

We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
United States Only: Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Other language