TOP Financial (TOP) Prnewswire·2025-03-08 11:00Core Insights - Amgen and Kyowa Kirin announced positive results from the ROCKET Phase 3 clinical trial program for rocatinlimab, a T-cell rebalancing therapy for moderate to severe atopic dermatitis [1][2] Study Results - The IGNITE study demonstrated that both dose strengths of rocatinlimab met co-primary and key secondary endpoints, showing statistical significance against placebo [2] - At week 24, 42.3% of patients in the higher dose group achieved ≥75% reduction in Eczema Area and Severity Index (EASI-75), a 29.5% improvement over placebo (p < 0.001) [3] - In the lower dose group, 36.3% achieved EASI-75, a 23.4% improvement over placebo (p < 0.001) [3] - For the validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD™), 23.6% of the higher dose group achieved a score of 0 or 1, a 14.9% difference from placebo (p < 0.001) [4] - The lower dose group had 19.1% achieving this endpoint, a 10.3% difference from placebo (p = 0.002) [4] - The revised Investigator's Global Assessment (rIGA™) score of 0/1 was achieved by 22.7% of the higher dose group, a 14.4% difference from placebo (p < 0.001) [5] - In the lower dose group, 16.3% achieved this endpoint, an 8.0% difference from placebo (p = 0.01) [5] Safety Profile - Safety findings were consistent with previous observations, with common treatment-emergent adverse events including pyrexia, chills, and headache [6] - Gastrointestinal ulceration events were reported in a higher number of patients receiving rocatinlimab compared to placebo, with an overall incidence of less than 1% [6] Future Trials - The ASCEND trial will investigate the long-term effects of rocatinlimab beyond 24 weeks, including maintenance of clinical response [6] - The ASTRO and ORBIT trials will evaluate rocatinlimab in adolescent patients [6] Additional Studies - The SHUTTLE study also met its co-primary endpoints, showing significant efficacy for rocatinlimab in combination with topical corticosteroids [7] - In SHUTTLE, 52.3% of patients in the higher dose group achieved EASI-75, a 28.7% difference from placebo (p < 0.001) [7] - The VOYAGER study confirmed that rocatinlimab does not interfere with responses to certain vaccinations [9] About Rocatinlimab - Rocatinlimab is an anti-OX40 human monoclonal antibody targeting T-cell imbalance in atopic dermatitis and other conditions [13] - It is being studied for multiple indications, including moderate to severe uncontrolled asthma and prurigo nodularis [13]