THOUSAND OAKS (dpa-AFX) - Amgen (AMGN) and Kyowa Kirin Co., Ltd. announced new results from the ongoing ROCKET Phase 3 clinical trial program evaluating rocatinlimab, an investigational T-cell rebalancing therapy targeting the OX40 receptor, in moderate to severe atopic dermatitis (AD).
The companies noted that the IGNITE study, which evaluated two dose strengths of rocatinlimab, met its co-primary endpoints and all key secondary endpoints, achieving statistical significance for both rocatinlimab dose strengths versus placebo.
IGNITE was a 24-week, randomized, placebo-controlled, double-blind study to assess the efficacy, safety and tolerability of rocatinlimab monotherapy every 4 weeks in 769 adults with moderate to severe AD, including patients previously treated with a biologic or systemic Janus kinase (JAK) inhibitor medication.
At week 24, 42.3% of patients in the higher dose group achieved greater than or equal to 75% reduction from baseline in Eczema Area and Severity Index score (EASI-75), a 29.5% difference vs. placebo. In the lower dose group, 36.3% of patients achieved EASI-75, a 23.4% difference vs. placebo.
In the higher dose group, 23.6% of patients achieved a validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0 (clear) or 1 (almost clear) with a ?2-point reduction from baseline (vIGA-AD 0/1) at week 24, representing a 14.9% difference vs. placebo. In the lower dose group, 19.1% of patients achieved this endpoint, a 10.3% difference vs. placebo.
In addition, IGNITE met the endpoint of revised Investigator's Global Assessment (rIGA) score of 0/1 with a ?2-point reduction from baseline, a more stringent measure of efficacy than vIGA-AD 0/1. At week 24, 22.7% of patients in the higher dose group achieved this endpoint, a 14.4% difference vs. placebo. In the lower dose group, 16.3% of patients achieved this endpoint, an 8.0% difference vs. placebo.
Across ROCKET program results to date, safety findings were generally consistent with the safety profile of rocatinlimab previously observed. The most frequent treatment-emergent adverse events (?5%) with higher observed proportion in rocatinlimab groups were pyrexia, chills and headache. A higher number of patients receiving rocatinlimab vs. placebo experienced gastrointestinal ulceration events, with an overall incidence of less than 1%.
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