Rocatinlimab Met Co-Primary Endpoints of vIGA-AD TM 0/1 with a ≥ 2-Point Reduction from Baseline, EASI-75, and All Key Secondary Endpoints HORIZON is the First of Eight Phase 3 Trials in the ROCKET Program TOKYO , Sept. 25, 2024 /PRNewswire/ -- Kyowa Kirin Co., Ltd.
(Kyowa Kirin) (TSE:4151) (President and CEO: Masashi Miyamoto ) announced top-line results of the Phase 3 ROCKET HORIZON trial of rocatinlimab, an investigational therapy targeting the OX40 receptor. HORIZON met its co-primary endpoints: achievement of a validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD TM ) score of 0 (clear) or 1 (almost clear) with a ≥ 2-point reduction from baseline [19.3% rocatinlimab vs.
6.6% placebo (12.8% difference, p<0.
001)] and achievement of ≥ 75% reduction from baseline in Eczema Area and Severity Index score (EASI-75) [32.8% rocatinlimab vs. 13.
7% placebo (19.1% difference, p<0.001)], both at week 24.
The trial also met the revised Investigator Global Assessment (rIGA 0/1) * [1], a more stringent measure of efficacy than vIGA 0/1 based on a narrower definition of 1 (almost clear), at week 24 [16.4% rocatinlimab vs. 4.
9% placebo (11.5% difference, p<0.001)].
HORIZON is a Phase 3, 24-week, randomized, placebo-controlled, double-blind study to assess the efficacy, safety and tolerability of rocatinlimab monotherapy in adults with moderate to severe atopic dermatitis (eczema). HORIZON is one of eight studies in the global ROCKET Phase 3 clinical trial program..