Amlitelimab (an anti-OX40 Ligand Antibody) vs Placebo in Patients With Moderate-to-severe Atopic Dermatitis: Study Design of Phase 3 OCEANA Clinical Trials COAST 1/2, SHORE, AQUA, and ESTUARY
Linda Stein Gold1, Davide Dondi2*, Stephan Weidinger3, Delphine Staumont-Salle4, Saeko Nakajima5, Eric L. Simpson6, Marjolein de Bruin Weller7, Sonya Davey8, Kassim Rahawi8, Charlotte Bernigaud9
Introduction
Phase 2a and 2b trials showed the clinical efficacy of amlitelimab in achieving lesional and symptomatic (pruritus) endpoints. Phase 3 trials will determine the efficacy and safety of amlitelimab every four weeks (Q4W) and 12 weeks (Q12W) dosing in patients with moderate-to-severe AD with treatment histories.
Methods
OCEANA Phase 3 clinical trials (COAST 1/2, SHORE, AQUA, and ESTUARY) are multinational, multicenter, randomized, double-blind, parallel group, placebo-controlled trials evaluating efficacy and safety of subcutaneous amlitelimab with two different dosing regimens.
Key inclusion criteria for COAST 1/2, SHORE, and AQUA include: adults and adolescents (≥12 years old) having AD ≥1 year with inadequate response to topical and/or systemic treatments (before screening), validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) baseline score of 3 or 4, Eczema Area and Severity Index (EASI) baseline score of ≥16. Primary endpoints for COAST 1/2, SHORE, and AQUA include vIGA-AD 0/1 and a reduction from baseline of ≥2 points (for US and US reference countries); vIGA-AD 0/1 and EASI-75 (for Japan, EU, and EU reference countries).
Adult patients will be randomized to amlitelimab 250 mg Q4W + 500 mg loading dose (LD), 250 mg Q12W + 500 mg LD, or placebo. Primary endpoints will be evaluated at Week 24 for COAST 1/2 and SHORE and at Week 36 for AQUA, with expected enrollment of 420, 420, 496, and 249 patients, respectively. Patients who completed AQUA, can enter RIVER-AD study; patients completing COAST 1/2 or SHORE, can enter the ESTUARY study.
Results
Enrollment for the OCEANA phase 3 trials began Q4 2023. COAST 1/2, SHORE, and AQUA trials are expected to be completed in 2026.
Conclusion
Results should further demonstrate the efficacy and safety of amlitelimab in treating moderate-to-severe AD using two different dosing regimens, in patients with various treatment histories.
Davide Dondi