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-ADTM) 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.
The study also reached statistically significant differences from placebo for all key secondary endpoints, which include measurements of skin clearance (vIGA 0/1 and EASI-75 at week 16 and EASI-90 at week 24), the Pruritus Numeric Rating Scale, Atopic Dermatitis Skin Pain Scale, Dermatology Quality of Life Index, and severity scores of hand atopic dermatitis and facial atopic dermatitis.
The study also reached statistically significant differences from placebo for all key secondary endpoints, which include measurements of skin clearance (vIGA 0/1 and EASI-75 at week 16 and EASI-90 at week 24), the Pruritus Numeric Rating Scale, Atopic Dermatitis Skin Pain Scale, Dermatology Quality of Life Index, and severity scores of hand atopic dermatitis and facial atopic dermatitis.
