Sanofi reported detailed outcomes from two pivotal phase 3 trials—SHORE and COAST 2—evaluating amlitelimab in patients aged 12 years and older with moderate-to-severe atopic dermatitis. In the SHORE study of 596 participants, amlitelimab administered every four weeks (Q4W) or every 12 weeks (Q12W) alongside medium-potency topical corticosteroids achieved vIGA-AD 0/1 (clear or almost clear skin) rates of 28.7%–32.9% versus 16.8% for placebo, and EASI-75 responses of 46.8%–50.9% compared with approximately 33.2% for placebo. Conversely, the COAST 2 trial in 547 patients reached its primary endpoint for the US estimand, showing non-responder imputation rates of 25.3% and 25.7% for Q4W and Q12W monotherapy versus 14.8% for placebo, but did not achieve statistical significance in its co-primary vIGA-AD 0/1 and EASI-75 measures for the EU estimand, nor in a key secondary endpoint of vIGA-AD 0/1 with barely perceptible erythema for the US estimand.

Despite the mixed data, Sanofi affirmed plans to submit global regulatory filings for amlitelimab in the second half of 2026. Two additional phase 3 trials—AQUA and ESTUARY—are scheduled to report results in H2 2026, providing further evidence for the drug’s efficacy and safety profile. The company is targeting both U.S. Food and Drug Administration and European Medicines Agency approvals based on the totality of data from four phase 3 studies and supporting phase 2 results.

Across all studies, amlitelimab was well tolerated, with a safety profile consistent with earlier clinical data. A preliminary analysis of the phase 2 ATLANTIS trial in 591 patients demonstrated progressive improvements in skin clearance and disease severity through Week 52, suggesting sustained benefit beyond the 24-week primary assessment period. No new safety signals emerged, reinforcing Sanofi’s confidence in the monoclonal antibody’s risk-benefit balance as a potential successor to Dupixent.