Sanofi announced positive results from COAST 1, a global phase 3 trial (NCT06130566) evaluating amlitelimab in patients aged 12 and older with moderate-to-severe atopic dermatitis (AD).
The antibody, which targets OX40-ligand (OX40L) without depleting T cells, met all primary and key secondary endpoints at Week 24, demonstrating significant skin clearance and disease severity improvements compared to placebo.
Trial Highlights
- Dosing schedules: Every 4 weeks (Q4W) or every 12 weeks (Q12W).
- Endpoints met:
- US & reference countries: vIGA-AD 0/1 (clear or almost clear) + ≥2-point reduction.
- EU, Japan & reference countries: vIGA-AD 0/1 with ≥2-point reduction and EASI-75 (≥75% improvement in eczema area and severity index). - Key secondary endpoints achieved:
- vIGA-AD 0/1 with only minimal erythema.
- ≥4-point reduction in peak pruritus numerical rating scale (PP-NRS) for patients with baseline PP-NRS ≥4.
Safety Profile
- Well tolerated with no new safety concerns.
- Most common TEAEs (≥5%): AD, nasopharyngitis, upper respiratory tract infection — more frequent in placebo arm.
- Injection site reactions: 2.2% (amlitelimab) vs. 0.7% (placebo); all mild.
- Other low-frequency events: pyrexia (1.1% vs. 0.7%), chills (0.4% vs. 0%).
- Rates of serious adverse events and treatment discontinuation were comparable between amlitelimab and placebo.
Executive Commentary
Houman Ashrafian, EVP, Head of R&D, Sanofi
“These first phase 3 results reinforce the potential of targeting OX40L to normalize the immune system without depleting T cells. Amlitelimab could represent a significant advance in AD treatment with the possibility of quarterly dosing. The diverse study population, including patients previously treated with advanced therapies, underscores its broad applicability.”
Study Design
- Type: Randomized, double-blind, placebo-controlled, parallel-group, 3-arm global phase 3 study.
- Population: 601 adolescents and adults (≥12 years) with moderate-to-severe AD.
- Intervention: Amlitelimab monotherapy, 250 mg Q4W or Q12W after loading dose (weight-adjusted for <40 kg).
- Geography: 15 countries across North America, Latin America, Europe, Asia-Pacific, and Middle East.
- Primary objective: Efficacy and safety vs. placebo at Week 24.
Broader Clinical Program
- OCEANA program: Five phase 3 trials (COAST 1, COAST 2, SHORE, AQUA, ESTUARY).
- Results expected through 2026 to support potential global regulatory submissions.
About Amlitelimab
- Type: Fully human, non-T cell depleting mAb.
- Mechanism: Blocks OX40L, a regulator of immune activation.
- Potential indications: Moderate-to-severe AD (anchor), asthma, systemic sclerosis, celiac disease, alopecia areata.
- Development stage: Investigational; not yet approved by regulatory authorities.
About Sanofi
Sanofi is a global, R&D-driven, AI-powered biopharma company focused on delivering innovative medicines and sustainable growth.
