Amgen and Kyowa Kirin announced positive top-line results from the Phase 3 IGNITE study evaluating rocatinlimab, an investigational T-cell rebalancing therapy, for moderate to severe atopic dermatitis. The study met its co-primary and key secondary endpoints, showing significant improvements over placebo. At week 24, 42.3% of patients in the higher dose group achieved a 75% reduction in Eczema Area and Severity Index (EASI-75), while 23.6% had a clear or almost clear skin assessment (vIGA-AD 0/1). Safety results were consistent with prior findings, with the most common adverse events being fever, chills, and headache.

The ROCKET clinical program also includes the SHUTTLE study, which demonstrated efficacy when rocatinlimab was combined with topical treatments, and the VOYAGER study, which confirmed no interference with vaccine responses. Further trials, including ASCEND and ASTRO, will examine long-term effects and adolescent patients. Rocatinlimab, targeting the OX40 receptor, is being explored for other inflammatory conditions such as asthma and prurigo nodularis.

Amgen and Kyowa Kirin are jointly developing and commercializing rocatinlimab, with Amgen leading global efforts outside Japan. The findings will be presented at upcoming medical conferences.