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Contact Information:

Trial Transparency email recommended (Toll free for US & Canada) 800-633-1610
contact-us@sanofi.com


Study Location:

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Be Part of Research - Trial Details - 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 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

Recruiting

Open to: ALL

Age: 12.0 - N/A

Medical Conditions

Dermatitis, Atopic
Dermatitis


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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).

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

May 2024 Jun 2026

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : Pharmaceutical form: Injection solution

Route of administration: Subcutaneous (SC) injection

Intervention Arm Group : Amlitelimab dose 1;Amlitelimab dose 2;

Intervention Type : DRUG
Intervention Description : Pharmaceutical form: Injection solution

Route of administration: SC injection

Intervention Arm Group : Placebo;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Investigational Site Number : 8262601
    London
    London, City Of
    SE1 9RT
  • Investigational Site Number : 8260006
    Glasgow
    G3 8SJ
  • Investigational Site Number : 8260004
    Leicester
    LE2 0TA
  • Investigational Site Number : 8260003
    Portsmouth
    Hampshire
    PO3 6DW
  • Investigational Site Number : 8262602
    London
    London, City Of
    SE1 9RT

Trial Transparency email recommended (Toll free for US & Canada) 800-633-1610
contact-us@sanofi.com



The study is sponsored by Sanofi




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Read full details for Trial ID: NCT06407934
Last updated 07 July 2025

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