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)

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 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).

Key facts

Study ID: NCT06181435
Run by: Sanofi
People needed: 589
Starts: 2023-12-21
Expected to finish: 2026-03-12
Last updated by the study team: 2026-03-19

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 either inadequate response or inadvisability 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 patient's potential participation in a clinical trial.

Where it is running

Eclipse Clinical Research- Site Number : 8401158 — Tucson, Arizona, United States
Torrance Clinical Research- Site Number : 8401027 — Lomita, California, United States
Dermatology Research Associates - Los Angeles- Site Number : 8401092 — Los Angeles, California, United States
Allergy & Asthma Associates of Southern California - Mission Viejo- Site Number : 8401079 — Mission Viejo, California, United States
Cura Clinical Research - Oxnard- Site Number : 8401142 — Oxnard, California, United States
Clinical Science Institute- Site Number : 8401028 — Santa Monica, California, United States
University of Connecticut Health Center- Site Number : 8401115 — Farmington, Connecticut, United States
Pediatric Skin Research- Site Number : 8401198 — Coral Gables, Florida, United States
Skin Care Research - Hollywood- Site Number : 8401071 — Hollywood, Florida, United States
Savin Medical Group - Miami- Site Number : 8401085 — Miami, Florida, United States
Anchor Medical Research- Site Number : 8401300 — Miami, Florida, United States
Accel Research - Nona Pediatric Center- Site Number : 8401081 — Orlando, Florida, United States
Nuline Clinical Trial Center- Site Number : 8401161 — Pompano Beach, Florida, United States
Clinical Research Trials of Florida- Site Number : 8401023 — Tampa, Florida, United States
AllerVie Clinical Research - Columbus- Site Number : 8401104 — Columbus, Georgia, United States
First Georgia Physician Group- Site Number : 8401190 — Fayetteville, Georgia, United States
Access Dermatology- Site Number : 8401296 — Bowling Green, Kentucky, United States
MedPharmics - Covington- Site Number : 8401137 — Covington, Louisiana, United States
Care Access Research - Marriottsville- Site Number : 8401126 — Marriottsville, Maryland, United States
Tufts Medical Center Site Number : 8401201 — Boston, Massachusetts, United States
University Of Mississippi Medical Center- Site Number : 8401184 — Jackson, Mississippi, United States
Care Access - Hoboken- Site Number : 8401132 — Hoboken, New Jersey, United States
University of New Mexico Comprehensive Cancer Center- Site Number : 8401263 — Albuquerque, New Mexico, United States
OmeraNY- Site Number : 8401156 — Brooklyn, New York, United States
Center for Dermatology and Plastic Surgery- Site Number : 8401119 — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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