Sanofi presents new Phase 3 results for atopic dermatitis drug amlitelimab
Sanofi presented new Phase 3 study results for its amlitelimab drug, showing continued efficacy improvements in treating moderate-to-severe atopic dermatitis.
Sanofi announced on March 28, 2026, new clinical results from three Phase 3 studies of its investigational drug amlitelimab for moderate-to-severe atopic dermatitis. The studies, COAST 1, COAST 2, and SHORE, were presented at the American Academy of Dermatology (AAD) Annual Meeting in Denver, Colorado. Amlitelimab was evaluated both as monotherapy and in combination with topical therapies.
The drug, amlitelimab, is a fully human monoclonal antibody targeting OX40-ligand (OX40L) without depleting T-cells. The studies demonstrated progressively increasing efficacy across all trials, with no evidence of a plateau at Week 24. The data also reinforce the potential for Q12W (every 12 weeks) dosing from the start.
Both the COAST 1 and COAST 2 studies met their primary endpoints, which measured a significant improvement in skin clearance. In the SHORE study, amlitelimab combined with topical corticosteroids and/or topical calcineurin inhibitors showed significant improvements in clinical signs and symptoms of atopic dermatitis compared to placebo.
Amlitelimab was generally well-tolerated in the studies. Sanofi stated that the data support amlitelimab’s potential as a meaningful treatment option for patients with atopic dermatitis, a chronic condition with existing unmet needs.