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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

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 Efficacy and Safety of Subcutaneous Amlitelimab on Background Topical Corticosteroids Therapy in Participants Aged 12 Years and Older With Moderate-to-severe AD Who Have Had an Inadequate Response to Prior Biologic Therapy or an Oral JAK Inhibitor
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A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab on Background Topical Corticosteroids Therapy in Participants Aged 12 Years and Older With Moderate-to-severe AD Who Have Had an Inadequate Response to Prior Biologic Therapy or an Oral JAK Inhibitor

Recruiting

Open to: ALL

Age: 12.0 - N/A

Plymouth Leeds Liverpool Portsmouth Nottingham Bristol London London

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 study for treatment of participants diagnosed with moderate-to-severe AD on background TCS who have had inadequate response to prior biologic or oral JAKi therapy.

The purpose of this study is to measure the efficacy and safety of treatment with amlitelimab solution for subcutaneous (SC) injection compared with placebo in participants with moderate-to-severe AD aged 12 years and older on background TCS and have had an inadequate response to prior biologic or an oral JAKi therapy.

Study details include:

At the end of the treatment period, participants will have the option to enter the Long-Term Safety Study LTS17367 (RIVER-AD).

The study duration will be up to 56 weeks for participants not entering the long-term safety study (LTS17367 \[RIVER-AD\]) including a 2 to 4-week screening, a 36-week randomized double-blind period, and a 16-week safety follow-up.

The study duration will be up to 40 weeks for participants entering the long-term safety study (LTS17367 \[RIVER-AD\]) including a 2 to 4-week screening and a 36-week randomized double-blind period.

The total treatment duration will be up to 36 weeks. The total number of visits will be up to 13 visits (or 12 visits for those entering the long-term safety study 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:

Feb 2024 Mar 2026

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : Pharmaceutical form: Injection solution Route of administration: Subcutaneous

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

Intervention Type : DRUG
Intervention Description : Pharmaceutical form: Injection solution Route of administration: Subcutaneous

Intervention Arm Group : Placebo;

Intervention Type : DRUG
Intervention Description : Pharmaceutical form: Various Topical formulation Route of administration: Topical

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

Intervention Type : DRUG
Intervention Description : Pharmaceutical form: Various Topical formulation Route of administration: Topical

Intervention Arm Group : Amlitelimab dose 1;Amlitelimab dose 2;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 : 8260012
    Plymouth
    Devon
    PL6 8DH
  • Investigational Site Number : 8260009
    Leeds
    North Yorkshire
    LS7 4SA
  • Investigational Site Number : 8260008
    Liverpool
    L7 8XP
  • Investigational Site Number : 8260003
    Portsmouth
    Hampshire
    PO3 6DW
  • Investigational Site Number : 8260010
    Nottingham
    Nottinghamshire
    NG17 4JL
  • Investigational Site Number : 8260013
    Bristol
    Bristol, City Of
    BS2 8HW
  • Investigational Site Number : 8262603
    London
    England
    E11 1NR
  • Investigational Site Number : 8260015
    London
    England
    SW10 9NH

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: NCT06241118
Last updated 16 June 2025

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