Sanofi’s Amlitelimab Hits Key Endpoints in Phase 3 Atopic Dermatitis Trial

Sanofi’s Amlitelimab Hits Key Endpoints in Phase 3 Atopic Dermatitis Trial

By, Admin 5 September 2025

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.

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