Kyowa Kirin's rocatinlimab, an investigational therapy targeting the OX40 receptor, has demonstrated positive top-line results in the Phase 3 ROCKET HORIZON trial for adults with moderate to severe atopic dermatitis. The randomized, placebo-controlled, double-blind study met its co-primary endpoints, showing significant improvements in skin clearance and disease severity at week 24.
The ROCKET HORIZON trial included 726 adult patients who received rocatinlimab or placebo via subcutaneous injection every four weeks for 24 weeks, with a loading dose at week two. The co-primary endpoints were achievement of a Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0 (clear) or 1 (almost clear) with a ≥ 2-point reduction from baseline, and achievement of ≥ 75% reduction from baseline in Eczema Area and Severity Index score (EASI-75) at week 24.
Key Efficacy Results
The trial demonstrated that 19.3% of patients treated with rocatinlimab achieved a vIGA-AD score of 0 or 1, compared to 6.6% in the placebo group (p<0.001). Additionally, 32.8% of rocatinlimab-treated patients achieved EASI-75, compared to 13.7% in the placebo group (p<0.001). The study also met the revised Investigator Global Assessment (rIGA 0/1), a more stringent measure of efficacy, with 16.4% in the rocatinlimab group versus 4.9% in the placebo group (p<0.001).
Secondary Endpoints and Safety
The study also reached statistically significant differences from placebo for all key secondary endpoints, including 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. Overall safety findings in ROCKET HORIZON were comparable to those seen in the Phase 2b study.
Expert Commentary
"We are very pleased to have achieved statistically significant efficacy results over placebo which are consistent for co-primary endpoints and all key secondary endpoints," said Takeyoshi Yamashita, Ph.D., senior managing executive officer and chief medical officer at Kyowa Kirin. "We look forward to further demonstrating that rocatinlimab, a potential T-cell rebalancing therapy, may help patients with moderate to severe atopic dermatitis as a new therapeutic option."
Rocatinlimab's Mechanism of Action
Rocatinlimab is an anti-OX40 human monoclonal antibody being investigated for the treatment of moderate to severe atopic dermatitis. It aims to rebalance T-cell activity by inhibiting and reducing pathogenic T cells through targeting the OX40 receptor, which drives inflammatory responses in atopic dermatitis.
About the ROCKET Program
ROCKET is a comprehensive, global Phase 3 clinical trial program comprised of eight studies intended to establish the safety and efficacy profile of rocatinlimab in adults and adolescents with moderate to severe atopic dermatitis (AD) as well as multiple dosing regimens. Detailed results of HORIZON will be provided at a future medical congress. Amgen and Kyowa Kirin plan to review HORIZON and forthcoming results from the other seven studies in the ROCKET program as part of ongoing discussions with global regulatory authorities.
