Amgen's Rocatinlimab Shows Positive Phase 3 Trial Results for Moderate-to-Severe AD

Amgen and Kyowa Kirin reported preliminary Phase 3 trial results for rocatinlimab in moderate-to-severe atopic dermatitis. The ongoing ASCEND study showed the long-term safety and efficacy of rocatinlimab, with low discontinuation rates due to adverse events. The most frequent AEs included upper respiratory infections and aphthous ulcers. The incidence of gastrointestinal ulceration events was less than 1 per 100 patient-years. The study continues to evaluate the long-term safety and efficacy of rocatinlimab up to 104 weeks.

Amgen and Kyowa Kirin announced preliminary top-line results from the ASCEND study evaluating rocatinlimab, an investigational T-cell rebalancing therapy targeting the OX40 receptor, in adults and adolescents with moderate to severe atopic dermatitis (AD). The ongoing ASCEND study, which includes approximately 2,600 patients, is designed to evaluate the long-term safety and efficacy of rocatinlimab (150 mg and 300 mg) administered every four or eight weeks in individuals who completed a previous ROCKET program trial.

The primary endpoint of the study was to evaluate the long-term safety of rocatinlimab, which is descriptive in nature. The most frequent treatment-emergent adverse events (AEs) in adults included upper respiratory infections, aphthous ulcers, headache, influenza, cough, and rhinitis, which were observed in previous ROCKET trials. The discontinuation rate due to AEs was low across the adult rocatinlimab-treated cohorts. The incidence of gastrointestinal ulceration events with rocatinlimab to date is less than 1 per 100 patient-years.

The ASCEND study continues to evaluate the long-term safety and efficacy of rocatinlimab up to 104 weeks in adult and adolescent patients with moderate to severe AD. 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. The majority of patients in this sub-population, who continued receiving rocatinlimab monotherapy either with Q4W or Q8W dosing, reported continued therapeutic benefit at one year of treatment across measures of improvement in skin clearance, itch, disease extent, and severity.

"Atopic dermatitis is a heterogeneous disease where many patients still lack adequate control with current therapies," said Jay Bradner, M.D., executive vice president of Research and Development at Amgen. "These findings add to our understanding of the role OX40 inhibition can play in addressing the underlying drivers of this chronic disease and provide further information on rocatinlimab's durability of response and long-term safety profile, which we will continue to monitor."

"People with moderate to severe atopic dermatitis are looking for new options to help them achieve and sustain their treatment goals," said Takeyoshi Yamashita, Ph.D., Chief Medical Officer, Kyowa Kirin. "These results mark an important milestone in furthering our understanding of rocatinlimab. The findings from ASCEND characterize rocatinlimab's ongoing therapeutic benefit 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."

Amgen and Kyowa Kirin plan to share full results at an upcoming congress or in a peer-reviewed publication.

References:
[1] https://www.morningstar.com/news/pr-newswire/20250908la68820/amgen-and-kyowa-kirin-announce-top-line-results-from-rocatinlimab-phase-3-ascend-long-term-extension-study-in-adults-with-moderate-to-severe-atopic-dermatitis