Results from phase 3 trials support amlitelimab efficacy for atopic dermatitis in patients 12 years or older

Sanofi announced positive results from 2 global phase 3 clinical trials evaluating amlitelimab, an investigational monoclonal antibody targeting OX40 ligand (OX40L), in adolescents and adults with moderate to severe atopic dermatitis.¹

Data from the SHORE and COAST 2 studies demonstrated statistically significant efficacy at week 24 across several primary and key secondary end points, with a safety profile consistent with previously reported findings. Based on the totality of evidence, the company plans to proceed with global regulatory submissions.¹

Amlitelimab is a fully human monoclonal antibody that does not deplete T cells and is designed to selectively block OX40L signaling, a pathway involved in T-cell–mediated inflammation. The agent is being studied in patients 12 years or older with moderate to severe atopic dermatitis. According to Sanofi, the clinical program is evaluating dosing regimens of both every 4 weeks and every 12 weeks, including the potential for initiating treatment with dosing every 12 weeks.

“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,” said Houman Ashrafian, executive vice president and head of research and development at Sanofi. “The totality of data seen to date reinforces our confidence in amlitelimab’s potential to deliver both q12w [every-12-weeks] dosing from the start and progressive efficacy through week 52.”

SHORE phase 3 study

The SHORE study (NCT06224348) was a randomized, double-blind, placebo-controlled phase 3 trial evaluating amlitelimab in combination with background topical therapies, including medium-potency topical corticosteroids with or without topical calcineurin inhibitors.² The study enrolled 596 participants 12 years or older with moderate to severe atopic dermatitis.

At week 24, amlitelimab met all primary and key secondary end points across both US and European estimands. The primary end point was the proportion of patients achieving a validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0 (clear) or 1 (almost clear) with a reduction of at least 2 points from baseline. Secondary end points included the proportion of patients achieving at least a 75% improvement in the Eczema Area and Severity Index (EASI-75).

In the US estimand analysis using nonresponder imputation, 28.7% of patients receiving amlitelimab every 4 weeks and 32.3% receiving it every 12 weeks achieved vIGA-AD score of 0/1 at week 24 compared with 16.8% in the placebo group. For EASI-75, response rates were 48.1% in the group receiving amlitelimab every 4 weeks and 46.8% in the group receiving it every 12 weeks compared with 32.3% with placebo. Results using the European treatment policy estimand were consistent across both dosing regimens.

COAST 2 phase 3 study

The COAST 2 study (NCT06181435) evaluated amlitelimab as monotherapy in a randomized, double-blind, placebo-controlled phase 3 design involving 547 adolescents and adults with moderate to severe atopic dermatitis.³ For the US and US reference countries, amlitelimab met the primary end point of achieving vIGA-AD score of 0/1 with a reduction of at least 2 points from baseline at week 24.

In the nonresponder imputation analysis, 25.3% of patients receiving amlitelimab every 4 weeks and 25.7% receiving it every 12 weeks achieved the primary end point compared with 14.8% in the placebo group. For the European and European Union reference countries, amlitelimab did not meet statistical significance for the coprimary end points of vIGA-AD score of 0/1 and EASI-75, and subsequent analyses were reported as nominal without adjustment for multiplicity.

Safety findings

Across both phase 3 studies, amlitelimab was generally well tolerated. The most common treatment-emergent adverse events in SHORE included nasopharyngitis, upper respiratory tract infection, and atopic dermatitis, with similar overall rates of adverse events, serious adverse events, and treatment discontinuations between amlitelimab and placebo groups. Safety findings in COAST 2 were consistent, with no new safety signals identified.

Supporting phase 2 data and next steps

Sanofi also reported a preliminary analysis from the ongoing ATLANTIS phase 2 open-label study, which showed continued improvement in skin clearance and disease severity through week 52, with no evidence of a treatment plateau. In this analysis, 50.3% of patients achieved vIGA-AD score of 0/1 and 76.5% achieved EASI-75 at week 52.

Additional phase 3 studies, including AQUA and ESTUARY, are expected to report results in the second half of 2026. Amlitelimab remains investigational, and its safety and efficacy have not yet been evaluated by regulatory authorities. Global regulatory submissions are planned for the second half of 2026.

References

1. Sanofi's amlitelimab confirms its potential in atopic dermatitis. Press release. Sanofi. January 23, 2026. Accessed January 23, 2026. https://www.sanofi.com/en/media-room/press-releases/2026/2026-01-23-06-00-00-3224400
2. A study to evaluate the efficacy and safety of subcutaneous amlitelimab in participants aged 12 years and older with moderate-to-severe atopic dermatitis on background topical corticosteroids (SHORE). ClinicalTrials.gov. Updated December 2, 2025. Accessed January 23, 2026. https://clinicaltrials.gov/study/NCT06224348
3. A study to evaluate the efficacy and safety of subcutaneous amlitelimab monotherapy compared with placebo in participants aged 12 years and older with moderate-to-severe atopic dermatitis (COAST 2). ClinicalTrials.gov. Updated December 10, 2025. Accessed January 23, 2026. https://clinicaltrials.gov/study/NCT06181435