A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis on Background Topical Corticosteroids

Completed · Phase 3 · Has a placebo group

Conditions studied: Dermatitis Atopic

In brief

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 atopic dermatitis (AD) with a history of inadequate response of topical treatment, on background topical corticosteroid (TCS) and/or topical calcineurin inhibitor (TCI). 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/or TCI. 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).

Key facts

Study ID

NCT06224348

Run by

Sanofi

People needed

643

Starts

2024-01-18

Expected to finish

2025-11-01

Last updated by the study team

2025-12-02

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants must be 12 years of age (when signing informed consent form)
• Diagnosis of AD for at least 1 year (defined by the American Academy of Dermatology Consensus Criteria)
• Documented history (within 6 months before screening) of inadequate response to topical treatments, and/or inadequate response to systemic therapies (within 12 months before screening)
• v-IGA-AD of 3 or 4 at baseline visit
• EASI score of 16 or higher at baseline
• AD involvement of 10% or more of BSA at baseline
• Weekly average of daily PP-NRS of ≥ 4 at baseline visit.
• Able and willing to comply with requested study visits and procedures
• Body weight ≥25 kg

You may not qualify if…

• Participants are excluded from the study if any of the following criteria apply:
• Skin co-morbidity that would adversely affect the ability to undertake AD assessments
• Known history of or suspected significant current immunosuppression
• Any malignancies or history of malignancies prior to baseline (with the exception of non-melanoma skin cancer excised and cured >5 years prior to baseline)
• History of solid organ or stem cell transplant
• Any active or chronic infection including helminthic infection requiring systemic treatment within 4 weeks prior to baseline
• Positive for human immunodeficiency virus (HIV), Hepatitis B or hepatitis C at screening visit
• Having active tuberculosis (TB), latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection, or who are at high risk of contracting TB
• Having received any of the specified therapy within the specified timeframe(s) prior to the baseline visit
• In the Investigator's opinion, any clinically significant laboratory results or protocol specified laboratory abnormalities at screening
• History of hypersensitivity or allergy to any of the excipients or investigational medicinal product (IMP)
• The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial

Where it is running

• Johnson Dermatology- Site Number : 8401076 — Fort Smith, Arkansas, United States
• Encino Research Center- Site Number : 8401042 — Encino, California, United States
• Marvel Clinical Research- Site Number : 8401102 — Huntington Beach, California, United States
• LA Universal Research Center- Site Number : 8401064 — Los Angeles, California, United States
• Cura Clinical Research- Site Number : 8401141 — Palmdale, California, United States
• Integrative Skin Science and Research- Site Number : 8401275 — Sacramento, California, United States
• Southern California Dermatology- Site Number : 8401043 — Santa Ana, California, United States
• Skin Care Research - Hollywood- Site Number : 8401071 — Hollywood, Florida, United States
• Clever Medical Research- Site Number : 8401160 — Miami, Florida, United States
• Acevedo Clinical Research Associates- Site Number : 8401088 — Miami, Florida, United States
• Palm Springs Community Health Center- Site Number : 8401264 — Miami Lakes, Florida, United States
• Global Clinical Professionals (GCP)- Site Number : 8401045 — St. Petersburg, Florida, United States
• University of South Florida- Site Number : 8401070 — Tampa, Florida, United States
• Avita Clinical Research- Site Number : 8401073 — Tampa, Florida, United States
• Cleaver Medical Group- Site Number : 8401138 — Dawsonville, Georgia, United States
• NorthShore University HealthSystem - Skokie Hospital- Site Number : 8401038 — Skokie, Illinois, United States
• Dawes Fretzin Clinical Research- Site Number : 8401015 — Indianapolis, Indiana, United States
• BRCR Global Gretna- Site Number : 8401243 — Gretna, Louisiana, United States
• Velocity Clinical Research - New Orleans- Site Number : 8401155 — New Orleans, Louisiana, United States
• Oakland Medical Center- Site Number : 8401116 — Troy, Michigan, United States
• Allergy & Immunology Associates of Ann Arbor- Site Number : 8401078 — Ypsilanti, Michigan, United States
• Dermatology and Skin Cancer Lee's Summit- Site Number : 8401157 — Lee's Summit, Missouri, United States
• Skin Specialists- Site Number : 8401068 — Omaha, Nebraska, United States
• Jubilee Clinical Research- Site Number : 8401054 — Las Vegas, Nevada, United States
• Cahaba Dermatology & Skin Health Center- Site Number : 8401066 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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