110: Amlitelimab (an anti-OX40 ligand antibody) vs placebo in patients with moderate-to-severe atopic dermatitis: Study design of phase 3 OCEANA clinical trials COAST1/2, SHORE, AQUA, and ESTUARY

Document Type

Conference Proceeding

Publication Date

7-21-2025

Publication Title

J Invest Dermatol

Keywords

amlitelimab, biological marker, calcineurin inhibitor, corticosteroid, OX40 ligand, oxelumab, placebo, adolescent, adult, antibody therapy, atopic dermatitis, conference abstract, controlled study, double blind procedure, drug therapy, estuary, female, human, major clinical study, male, open study, pharmacology, phase 2 clinical trial, phase 3 clinical trial, randomized controlled trial, side effect, subcutaneous tissue, systemic therapy, treatment withdrawal

Abstract

Abstract: Amlitelimab, a fully human nondepleting anti-OX40 ligand (OX40L) monoclonal antibody, has demonstrated safety and efficacy in patients with atopic dermatitis (AD) in phase 2a and 2b trials. The phase 2b STREAM-AD trial showed improvements in AD signs, symptoms, and biomarkers over 24 weeks of amlitelimab treatment in adults with AD. Most clinical responders maintained improvements after a 28-week treatment withdrawal, indicating potential for extended dosing. The OCEANA phase 3 randomized, double-blind, placebo-controlled trials (COAST1, COAST2, SHORE, AQUA, and ESTUARY) assess two subcutaneous amlitelimab dosing regimens (every 4 or 12 weeks) in adults and adolescents. Key inclusion criteria for COAST1/2, SHORE, and AQUA include patients (≥12y; ≥25kg) with AD ≥1y and inadequate response to topical and/or systemic therapies. SHORE and AQUA evaluate amlitelimab in patients on background topical corticosteroids/calcineurin inhibitors, with AQUA restricted to patients with inadequate prior response to AD biologics or oral Janus kinase inhibitors. Doses for patients <40kg are halved compared to patients ≥40kg. Primary endpoints include proportion of participants with validated Investigator Global Assessment-AD 0/1 and reduction from baseline of ≥2 points. Primary endpoints are evaluated at Week 24 (COAST1/2, SHORE) or 36 (AQUA). Patients completing COAST1/2 or SHORE can enter ESTUARY, a blinded extension study; patients completing AQUA can enter RIVER-AD, a phase 2/3 open-label study. ESTUARY and RIVER-AD will evaluate long-term safety and efficacy, including maintenance of effect with treatment withdrawal. Enrollment began Q4 2023. Results will explore different dosing regimens, including extended dosing, and evaluate response durability on- and off-treatment in adults and adolescents. Layperson Summary: Amlitelimab is an antibody therapy that targets an important protein in the immune system called OX40 Ligand (OX40L) and is being evaluated for treatment of moderate-to-severe atopic dermatitis (AD). By blocking OX40L, amlitelimab helps normalize the immune system by reducing inflammatory signals in the body. Phase 2 trials have shown that patients with moderate-to-severe AD receiving amlitelimab every 4 weeks had improvements in AD signs and symptoms. These improvements were maintained through 28 weeks following discontinuation of amlitelimab, indicating the possibility of extended-interval dosing, which helps to ease patient burden. Ongoing phase 3 trials are evaluating the efficacy and safety of amlitelimab treatment every 4 or 12 weeks in adolescent (≥12 years old) and adult patients, both alone (COAST1/2 trials) and in combination with topical medications (SHORE, AQUA). Patients completing these trials can enter ESTUARY or RIVER-AD, which are longer studies that will assess long-term safety and efficacy.

Volume

145

Issue

3

First Page

e27

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