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Amlitelimab Reaches Phase 2b Primary Endpoint in AD Management


Sanofi’s investigational anti-OX40-ligand monoclonal antibody showed statistically significant improvement in signs and symptoms of AD in adults.

Florence Piot/AdobeStock
Florence Piot/AdobeStock

Sanofi recently announced the positive topline data of its phase 2b study, STREAM-AD, of amlitelimab, a potential first novel investigational anti-OX40-ligand monoclonal antibody for the treatment of moderate-to-severe atopic dermatitis (AD) in adults. Amlitelimab met its primary endpoint of percentage change in Eczema Severity Index (EASI) score from baseline at 16 weeks, with continued improvement observed through 24 weeks. Amlitelimab is being studied in adults with moderate-to-severe AD that cannot be controlled with topical treatments or for whom topical treatments are not recommended.

Improvements in average EASI scores were seen at 16 weeks compared to placebo for all 4 subcutaneous doses that were studied. Key secondary points included change in EASI from baseline at 24 weeks, percentage of patients with at least a 75% reduction from baseline in EASI at 16 and 24 weeks, percentage of patients with a response of Investigator Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) and a reduction from baseline ≥ 2 points at 16 and 24 weeks, and a proportion of patients with reduction of a weekly average of pruritus NRS ≥ 4 with a baseline pruritus of ≥ 4 from baseline at 16 and 24 weeks.

Overall, there were demonstrated improvements in key secondary points and continued improvements were observed through week 24 in primary and key secondary outcomes. Biomarker results support an effect on both type 2 and non-type 2 pathways. Amlitelimab was well-tolerated across all dose arms and no new safety concerns were reported.

According to Sanofi, “Amlitelimab is a fully human non-depleting monoclonal antibody that binds to OX40-ligand, a key immune regulator, and has the potential to be a first-in-class treatment for a range of immune-mediated diseases and inflammatory disorders, including moderate-to-severe atopic dermatitis and asthma. By targeting OX40-Ligand, amlitelimab aims to restore immune homeostasis between pro-inflammatory and regulatory T cells.”

STREAM-AD (NCT05131477) was a phase 2b, randomized double-blind, placebo-controlled study, evaluating the safety and efficacy of amlitelimab in adult patients with AD that enrolled 390 patients in Australia, Bulgaria, Canada, Czechia, Germany, Hungary, Japan, Poland, Spain, Taiwan, the United Kingdom and the United States.


1. Positive topline phase 2b data in atopic dermatitis support amlitelimab as a potential first and best-in-class novel investigational anti-OX40-ligand monoclonal antibody. Sanofi. June 27, 2023. Accessed June 29, 2023. https://www.sanofi.com/en/media-room/press-releases/2023/2023-06-27-05-30-00-2694938

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