Amlitelimab Effective, Safe for Atopic Dermatitis in Patients 12 Years and Older

Results from 2 global phase 3 studies suggest amliteli­mab therapy may offer clinical benefit for individuals with moderate-to-severe atopic dermatitis, although prespecified secondary endpoints, including measures of erythema, were not met in all analyses.1

These new results were announced by Sanofi on January 23. Encouraging findings from the COAST 1 phase 3 trial (NCT06130566) had been reported in September 2025.2 The new data resulted from 2 additional global phase 3 studies, namely SHORE (NCT06224348) and COAST 2 (NCT06181435), strengthening the evidence base supporting amlitelimab as a potential medication option for adolescents and adults with atopic dermatitis.

"Importantly, these results validate amlitelimab’s novel mechanism of action to block OX40-ligand without T-cell depletion and its promise to normalize the immune system over time," Houman Ashrafian, executive vice president and head of Research & Development at Sanofi, said in a statement.1

Amlitelimab is a fully human monoclonal antibody designed not to deplete T cells, selectively targeting OX40 ligand (OX40L). OX40L is an important regulator of immune activation, and this inhibition of OX40L signaling early in the inflammatory cascade is designed to modulate excessive T-cell–driven inflammation while also preserving immune cell populations.

The SHORE and COAST 2 studies evaluated efficacy at the 24-week mark in patients with moderate-to-severe disease who were treated with amlitelimab every 4 weeks (Q4W) or every 12 weeks (Q12W). The primary endpoint for the US and US reference countries, was the proportion of participants attaining a validated Investigator Global Assessment for AD (vIGA-AD) score of 0 or 1, with at least an improvement of 2 points from baseline. This was analyzed via non-responder imputation. Within the European Union, EU reference countries, and Japan, the studies’ co-primary endpoints included the same vIGA-AD response as well as attainment a 75% improvement at least in the Eczema Area and Severity Index (EASI-75).

The SHORE trial was a randomized, double-blind, placebo-controlled, 3-arm phase 3 analysis involving 596 patients aged 12 years and older. Those evaluated were given amlitelimab Q4W or Q12W in combination with medium-potency topical corticosteroids, with or without the use of topical calcineurin inhibitors. By the 24-week mark, both amlitelimab regimens had met all of the studies’ primary and key secondary endpoints versus placebo across US and EU analyses.

COAST 2 involved a similar design, with 547 participants treated with amlitelimab as monotherapy. Both dosing schedules used in this study in the US and US reference countries also met their primary endpoint at Week 24 as opposed to placebo. However, a key secondary endpoint assessing vIGA-AD 0/1 with barely perceptible erythema did not attain statistical significance. Within EU and EU reference regions, neither regimen was successful in attaining statistical significance for the co-primary vIGA-AD and EASI-75 endpoints. Subsequent secondary endpoint P-values were described as nominal.

Findings related to safety were comparable between amlitelimab and placebo in both trials. In SHORE, the most frequently reported treatment-emergent adverse events (TEAEs) included upper respiratory tract infection (7.9% versus 4.4%), nasopharyngitis (9.5% with amlitelimab versus 12.5% with placebo), and atopic dermatitis (2.7% versus 5.6%). In the COAST 2 trial, common TEAEs were upper respiratory tract infection (4.8% versus 4.0%), nasopharyngitis (5.9% versus 7.4%), and atopic dermatitis (5.3% versus 2.7%).

Sanofi’s release described rates of serious AEs and discontinuations as similar between treatment and placebo arms in both studies. Additional long-term data were drawn from a preliminary analysis of the ongoing open-label ATLANTIS phase 2 study (NCT05769777). This phase 2 trial followed 591 subjects provided amlitelimab treatment Q4W through Week 52. Findings highlighted indicated continued improvements in skin clearance and atopic dermatitis severity beyond the 24-week mark, with strong tolerability.

The most common TEAEs were headache (10.3%), nasopharyngitis (19.1%), influenza (9.1%), upper respiratory tract infection (7.2%), atopic dermatitis (8.6%), and accidental overdose connected to scheduling errors (5.1%). Serious adverse events occurred in 4.7% of patients, and 2.9% discontinued treatment. One case of cutaneous Kaposi’s sarcoma was reported in an individual with known risk factors, leading to treatment cessation; the patient was described as recovering.

"The totality of data seen to date reinforce our confidence in amlitelimab’s potential to deliver both Q12W dosing from the start and progressive efficacy through Week 52,” Ashrafian said in a statement.1 “We look forward to sharing additional results, including longer-term data, as we move toward global regulatory submissions.”

The results from COAST 1, COAST 2, SHORE, and the interim ATLANTIS analysis are slated to be presented during upcoming medical conferences.

References

1. Press Release: Sanofi's amlitelimab confirms its potential in atopic dermatitis. Sanofi. January 23, 2026. https://www.sanofi.com/en/media-room/press-releases/2026/2026-01-23-06-00-00-3224400.

2. Smith T. Phase 3 Data Show Amlitelimab Effective in Adults, Adolescents with Atopic Dermatitis. HCPLive. September 4, 2025. Accessed January 23, 2026. https://www.hcplive.com/view/phase-3-data-amlitelimab-effective-adults-adolescents-atopic-dermatitis.