Press Release: AAD: new results from Sanofi's amlitelimab phase 3 studies in atopic dermatitis presented in late-breaking research session

AAD: new results from Sanofi's amlitelimab phase 3 studies in atopic dermatitis presented in late-breaking research session

• Across the COAST 1, COAST 2, and SHORE phase 3 studies, amlitelimab, dosed either Q4W or Q12W, showed progressively increasing efficacy, with no evidence of plateau at Week 24 across endpoints
• Data reinforce potential for Q12W dosing from the start

Paris, March 28, 2026. Positive results from three phase 3 studies of amlitelimab, a fully human non-T cell depleting monoclonal antibody that selectively targets OX40-ligand (OX40L), in moderate-to-severe atopic dermatitis (AD) as a monotherapy and in combination with topical therapies, showed improvements in skin clearance and disease severity with amlitelimab treatment compared to placebo in patients aged 12 years and older. The studies, COAST 1 (clinical study identifier: NCT06130566), COAST 2 (clinical study identifier: NCT06181435) and SHORE (clinical study identifier: NCT06224348) were presented during the late-breaking research session at the 2026 American Academy of Dermatology (AAD) Annual Meeting in Denver, Colorado, US. In these studies, amlitelimab was generally well-tolerated.

“The totality of data shared at AAD reinforce the progressive improvement in efficacy seen with amlitelimab over the course of treatment and the potential for Q12W dosing from the start,” said Houman Ashrafian, Executive Vice President, Head of Research & Development at Sanofi. “These data contribute to the body of evidence supporting amlitelimab’s potential to be a meaningful option for patients with atopic dermatitis, a chronic, heterogenous disease where unmet needs still exist.”

Primary and key secondary endpoints in COAST 1, COAST 2, and SHORE were assessed at Week 24 in patients who received amlitelimab either every four weeks (Q4W) or every 12 weeks (Q12W) with or without topical medications. For US and US reference countries, the primary endpoint for all studies was the proportion of patients with a validated investigator global assessment scale for AD (vIGA-AD) of 0 (clear) or 1 (almost clear) and a reduction from baseline score of ≥2 points.

“Despite current medicines, a critical medical gap remains for moderate-to-severe atopic dermatitis patients and additional treatment options are needed,” said Eric Simpson, MD, Professor of Dermatology and Director of Clinical Research at Oregon Health & Science University. “These data, which show that amlitelimab delivers potentially progressive efficacy over time, further illustrate the potential of non-T cell depleting OX40L inhibition to help reduce disease severity and burdensome symptoms with less frequent dosing.”

In the COAST 1 and COAST 2 studies, amlitelimab met the primary endpoint. In COAST 1, key secondary endpoints, including vIGA-AD 0/1 with barely perceptible erythema (BPE), the proportion of patients reaching a 75% or greater improvement in the eczema area, severity index total score (EASI-75), and a ≥4-point reduction in peak pruritus-numerical rating scale (PP-NRS) were statistically significant. In COAST 2, EASI-75 and PP-NRS≥4 reached nominal significance; vIGA-AD 0/1 with BPE did not reach statistical significance.

In the SHORE study, amlitelimab in combination with topical corticosteroids (TCS) with or without topical calcineurin inhibitors (TCI), dosed at both Q4W and Q12W, demonstrated significant improvements in AD clinical signs and symptoms versus placebo as measured across primary and key secondary endpoints at Week 24.