Sanofi (SNYNF) announced an update on their ongoing clinical study.
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Sanofi’s latest update covers COAST 2, a Phase 3 trial testing amlitelimab in people 12 and older with moderate to severe atopic dermatitis whose disease is not controlled by standard creams. The study aims to show if amlitelimab, given alone by injection, can ease symptoms and stay safe, which could support a new systemic option in a large chronic skin market.
The trial tests amlitelimab, also known as SAR445229, as a subcutaneous injection solution versus placebo. It is designed as monotherapy, meaning patients receive amlitelimab alone, to see its direct effect on eczema control without other systemic drugs.
The study is randomized, so participants are assigned by chance to two amlitelimab dose groups or placebo, and it runs in parallel across these arms. It is double blind with four-way masking, meaning patients, doctors, site staff, and assessors do not know who gets the drug, and the main goal is to treat disease rather than just observe it.
Participants go through screening, a 24-week blinded treatment period, and follow-up, with some eligible to move into an extension trial called ESTUARY. The trial is now listed as completed, and the record was last updated on Mar. 18, 2026, signaling that top-line data may be near and could be prepared for future disclosure.
The completion of this Phase 3 program is a key milestone for Sanofi as it seeks to build on its position in immunology beyond Dupixent. Positive data could support a new biologic-like asset in atopic dermatitis, lifting sentiment on Sanofi’s pipeline versus peers such as Regeneron and AbbVie, while weak results could pressure valuation given high expectations in this crowded field.
The amlitelimab Phase 3 program in atopic dermatitis is now completed and recently updated, and further details are available on the ClinicalTrials.gov portal.
To learn more about SNYNF’s potential, visit the Sanofi drug pipeline page.