Amgen and Kyowa Kirin Co., Ltd. unveiled preliminary top-line results from the ASCEND study evaluating rocatinlimab, an investigational T-cell rebalancing therapy targeting the OX40 receptor, in adults as well as adolescents with moderate to severe atopic dermatitis (AD).
The ASCEND study watches participants who finished earlier rocatinlimab trials for a longer time. About 2,200 to 2,600 people are taking part in this trial. It tests if the rocatinlimab treatment stays safe and helpful over time. Participants from past Phase 3 trials, including IGNITE, HORIZON, SHUTTLE, ASTRO, ORBIT, or VOYAGER, are included. After 24 weeks in these earlier trials, they continue in ASCEND for an extra 32 weeks.
The study checks their reactions to different doses: 150 mg or 300 mg given either every four or every eight weeks.
The primary endpoint of the study was to evaluate the long-term safety of rocatinlimab and is descriptive in nature.
Across the Phase 3 ROCKET program, including ASCEND, the incidence of gastrointestinal ulceration events with rocatinlimab to date is less than 1 per 100 patient-years.
The secondary endpoints of the study were evaluated in adults who achieved a clinical response (EASI 75 or vIGA-AD 0/1 without rescue use at week 24) in either the HORIZON or IGNITE trials and were re-randomized in the ASCEND study.
Executive Statement
According to Takeyoshi Yamashita, Ph.D., Chief Medical Officer, Kyowa Kirin, people with moderate to severe atopic dermatitis are looking for new options to help them achieve and sustain their treatment goals. These results hold a major achievement in initiating their understanding of rocatinlimab. The findings from ASCEND characterize ongoing therapeutic benefit of rocatinlimab at one year of treatment in adult patients with moderate to severe AD, with possible maintenance dosing as infrequently as every eight weeks following initial 24-week dosing, an approach that may lessen the ongoing burden of treatment. We look forward to sharing further updates.