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Be Part of Research - Trial Details - A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis (COAST 2)

A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis (COAST 2)

Not 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 parallel group, Phase 3, multinational, multicenter, randomized, double-blind, placebo-controlled, 3-arm monotherapy study for treatment of participants diagnosed with moderate to severe atopic dermatitis (AD), whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

The purpose of this study is to measure the efficacy and safety of treatment with amlitelimab solution for SC injection compared with placebo in participants with moderate to severe AD aged 12 years and older.

Study details include:

At the end of the treatment period, participants will have an option to enter a separate study: the blinded extension study EFC17600 (ESTUARY).

For participants not entering the blinded extension Study EFC17600 (ESTUARY), the study duration will be up to 44 weeks including a 2 to 4-week screening, a 24-week randomized double-blind period, and a 16-week safety follow-up.

For participants entering the blinded extension Study EFC17600 (ESTUARY), the study duration will be up to 28 weeks including a 2 to 4-week screening and a 24-week randomized double-blind period.

The total treatment duration will be up to 24 weeks. The total number of visits will be up to 10 visits (or 9 visits for those entering the blinded extension study EFC17600 (ESTUARY).

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:

Dec 2023 Nov 2025

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : Pharmaceutical form: Injection solution Route of administration: 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 : 8262602
    London
    London, City Of
    SE1 7EH
  • Investigational Site Number : 8260003
    Portsmouth
    Hampshire
    PO3 6DW


The study is sponsored by Sanofi




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Read full details for Trial ID: NCT06181435
Last updated 26 June 2025

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