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

Study on the Effectiveness of an Investigational Medication for Atopic Dermatitis, a Skin Condition Causing Itchy and Inflamed Skin

Recruiting
12 years or above
All
Phase 3
961 participants needed
7 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 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).

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 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.

Updated on 24 Apr 2025. Study ID: NCT06407934

The purpose of this study is to investigate the effectiveness of an investigational medication for individuals with moderate-to-severe atopic dermatitis, a skin condition that causes itchy and inflamed skin. This study is designed for participants who have previously responded to a specific treatment in earlier studies and will examine if they can maintain their response on different doses or after treatment withdrawal.

Participants in this study will undergo a series of procedures, including being randomly assigned to different treatment arms. Some will continue their current dose, some will switch doses, and others will stop treatment to see how their condition responds. The study uses a placebo, which is an inactive substance that looks like the investigational medication but does not contain any medicine.

  • Who can participate: Participants must be at least 12 years old and have completed a previous related study without stopping treatment. They should weigh at least 25 kg and be able to attend study visits and procedures.
  • Study details: Participants will be randomly assigned to different treatment arms, which may include continuing their current dose, switching doses, or stopping treatment.
  • Study Timelines and Visits: The study will last up to 64 weeks. The study requires up to 14 visits.

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