Core Insights - Kyowa Kirin Co., Ltd. announced the presentation of Phase 3 ROCKET HORIZON trial results for rocatinlimab, targeting OX40 receptor in moderate-to-severe atopic dermatitis, at the AAD 2025 Annual Meeting [1][2] Group 1: Clinical Trial Details - ROCKET HORIZON is a Phase 3, randomized, placebo-controlled, double-blind trial involving 726 adult patients, assessing the efficacy, safety, and tolerability of rocatinlimab administered subcutaneously every four weeks for 24 weeks [3] - Co-primary endpoints include achieving a Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-ADTM) score of 0 or 1 with a ≥ 2-point reduction from baseline at week 24, and a ≥ 75% reduction from baseline in Eczema Area and Severity Index score (EASI-75) at week 24 [3] - Key secondary endpoints focus on the impact of rocatinlimab on itch, safety, and tolerability [3] Group 2: Atopic Dermatitis Overview - Atopic dermatitis is a chronic inflammatory disease affecting 15-20% of children and up to 10% of adults, characterized by excessively dry, itchy skin and unpredictable flare-ups [4] - T-cell imbalance is identified as a root cause of atopic dermatitis, contributing to its clinical manifestations [4] Group 3: Rocatinlimab Overview - Rocatinlimab is an anti-OX40 receptor human monoclonal antibody under investigation for moderate-to-severe atopic dermatitis, as well as for moderate to severe uncontrolled asthma and prurigo nodularis [5] - The antibody was discovered through collaboration between Kyowa Kirin and La Jolla Institute for Immunology [5] Group 4: Collaboration with Amgen - Kyowa Kirin and Amgen entered a collaboration agreement on June 1, 2021, for the joint development and commercialization of rocatinlimab, with Amgen leading the global development except in Japan [6] - If approved, both companies will co-promote rocatinlimab in the United States, with Kyowa Kirin having opt-in rights for co-promotion in select markets [6]
Kyowa Kirin Announces Late-Breaking Abstract Presentation at the American Academy of Dermatology Annual Meeting 2025