Amlitelimab demonstrates significant efficacy and favorable safety across three Phase 3 trials (COAST 1, COAST 2, SHORE) in moderate-to-severe atopic dermatitis.
Written By: Karthik Teja Macharla, PharmD
Reviewed By: Pharmacally Editorial Team
Sanofi reported positive results from three Phase 3 studies COAST 1, COAST 2, and SHORE evaluating amlitelimab in adolescents and adults with moderate-to-severe atopic dermatitis. The data were presented at the American Academy of Dermatology Annual Meeting 2026. These findings build on previously reported topline Phase 3 results announced in January 2026, which first established amlitelimab’s efficacy and supported planned regulatory submissions.
Amlitelimab, a fully human monoclonal antibody targeting OX40-ligand (OX40L), significantly improved skin clearance, disease severity, and itch compared with placebo, both as monotherapy and in combination with topical therapies. Across all studies, the treatment was generally well tolerated.
Amlitelimab selectively blocks OX40L, a key immune regulator involved early in the inflammatory cascade. By targeting upstream immune activation without depleting T cells, it aims to provide sustained disease control while enabling less frequent dosing, including every 12 weeks.
Across COAST 1 (NCT06130566), COAST 2 (NCT06181435), and SHORE (NCT06224348), amlitelimab consistently met the primary endpoint at Week 24, demonstrating higher rates of clear or almost clear skin (vIGA-AD 0/1) compared with placebo, with response rates in the 21–32% range versus 9–17% for placebo. Improvements were also observed across key secondary measures, including eczema severity (EASI-75), where response rates were 36–48% with amlitelimab compared with 19–32% for placebo, along with meaningful reductions in itch.
In the monotherapy studies (COAST 1 and COAST 2), amlitelimab showed clinically meaningful and statistically significant improvements across most endpoints, with consistent efficacy across both every-4-week and every-12-week dosing regimens. While one secondary endpoint in COAST 2 did not reach statistical significance, the overall efficacy profile remained robust.
In the SHORE study, where amlitelimab was used alongside topical corticosteroids with or without calcineurin inhibitors, the treatment demonstrated even greater improvements in clinical signs and symptoms, with vIGA-AD 0/1 responses reaching 29–32% versus 17% for placebo and EASI-75 responses approaching 47–48% versus 32%, with significant benefits across all primary and key secondary endpoints.
Overall, the data show a consistent and progressive treatment effect across studies, supporting the potential for flexible dosing, including Q12W from initiation.
Amlitelimab demonstrated a favorable and consistent safety profile across all three trials. The most commonly reported adverse events were mild to moderate infections such as nasopharyngitis and upper respiratory tract infections, along with atopic dermatitis flares.
Serious adverse events were low, and no new safety signals were identified. Malignancy rates were rare and comparable to placebo. Two cases of Kaposi’s sarcoma were reported in the broader development program, both in patients with known risk factors and with recovery following treatment discontinuation.
Sanofi highlighted the progressive efficacy observed over time and the potential to initiate treatment with every-12-week dosing, which could offer a more convenient long-term option for patients.
Amlitelimab remains investigational, with results from the Phase 3 extension study (ESTUARY), assessing long-term safety and maintenance dosing, expected in the second half of 2026.
Amlitelimab delivers consistent Phase 3 efficacy, a clean safety profile, and the possibility of infrequent dosing. If confirmed in longer-term studies and approved, it could become a meaningful addition to the treatment landscape for moderate-to-severe atopic dermatitis.
Reference
Press Release: AAD: new results from Sanofi’s amlitelimab phase 3 studies in atopic dermatitis presented in late-breaking research session, 28 March 2026, https://www.sanofi.com/en/media-room/press-releases/2026/2026-03-28-15-00-00-3264184
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 1), ClinicalTrials.gov ID NCT06130566, https://clinicaltrials.gov/study/NCT06130566
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 ID NCT06181435, https://clinicaltrials.gov/study/NCT06181435
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 ID NCT06224348, https://clinicaltrials.gov/study/NCT06224348
About the Writer
Karthik Teja Macharla, PharmD is a Pharm.D. graduate with a strong interest in clinical research, pharmacovigilance, and medical writing. In his words, he is passionate about converting complex medical information into clear, evidence-based scientific communication, committed to contributing to patient safety and advancing healthcare through accurate and impactful medical content.