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

Investigating Treatment Options for Moderate-to-Severe Atopic Dermatitis, a Skin Condition Causing Red, Itchy Patches

Recruiting
12 years or above
All
Phase 3
961 participants needed
1 Location

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<strong>(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 06 Feb 2025. Study ID: NCT06407934

This study investigates treatment options for people with moderate-to-severe atopic dermatitis, a skin condition that causes red, itchy patches. The purpose of the study is to see if participants who responded to an investigational medication in earlier studies can maintain their response by either continuing the same dose or switching to a different dose.

Participants will be randomly assigned to receive either a continued dose, a different dose, or a placebo, which is an inactive substance that looks like the investigational medication but does not contain any active medicine. The study will have a double-blind design, meaning neither the participants nor the researchers will know who is receiving which treatment. This helps to ensure the results are not biased.

  • Who can participate: Participants must be at least 12 years old, have completed one of the previous studies for atopic dermatitis, weigh at least 25 kg, and be able to attend study visits.
  • Study details: Participants will either continue their current dose or switch to a different dose.
  • Study Timelines and Visits: The study will last up to 64 weeks, with a 48-week duration for participants entering the LTS17367 study. The study requires 14 visits for participants entering the LTS17367 study.

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