ASCEND Trial Reports Long-Term Safety of Amgen’s Rocatinlimab in Atopic Dermatitis Patients

A phase 3 trial of rocatinlimab for adult and adolescent patients with moderate to severe atopic dermatitis (AD) is underway and topline results from Amgen and Kyowa Kirin report the safety and efficacy of the investigational T-cell rebalancing therapy that targets the OX40 receptor.¹

The ongoing ASCEND study includes 2,600 patients, all of whom completed a previous ROCKET program trial (IGNITE, HORIZON, SHUTTLE, ASTRO, ORBIT, or VOYAGER). In this analysis, patients participated in the prior ROCKET trial for 24 weeks before moving to the ASCEND study for an additional 32 weeks. Participants received either 150 mg or 300 mg of rocatinlimab every 4 or 8 weeks.

The primary endpoint was to assess the long-term safety of the drug. The most common treatment-emergent adverse effects were upper respiratory infections (including nasopharyngitis and pharyngitis), aphthous ulcers, headache, influenza, cough, and rhinitis. This aligns with what was found in previous ROCKET trials.² Throughout the entire ROCKET program, the incidence of gastrointestinal ulceration events with rocatinlimab to date is less than 1 per 100 patient-years. The discontinuation rate due to adverse events was low, particularly in adult patients.

The secondary endpoint measured effectiveness after achieving significant clinical response (EASI 75 or vIGA-AD 0/1 without rescue use at week 24) in either the HORIZON or IGNITE studies. These patients were then re-randomized in the ASCEND trial and observed continued response at 1 year of treatment with the monotherapy. Improvements in skin clearance, itch, disease extent, and severity were noted.

"Atopic dermatitis is a heterogeneous disease where many patients still lack adequate control with current therapies," said Jay Bradner, MD, 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.”¹

Rocatinlimab is an anti-OX40 monoclonal antibody that has the potential to become the first and only T-cell rebalancing therapy that inhibits and reduces pathogenic effector and memory T cells by targeting the OX40 receptor. The drug is also being studied in patients with asthma and prurigo nodularis, focusing on conditions in which T-cell imbalance is a root cause of inflammation.

The ASCEND study will continue for up to 104 weeks. Including all the parent studies, patients will be treated for up to 2 and a half years. Amgen and Kyowa Kirin plan to present full results either in a peer-reviewed publication or at an upcoming congress.

"People with moderate to severe atopic dermatitis are looking for new options to help them achieve and sustain their treatment goals," said Takeyoshi Yamashita, PhD, Chief Medical Officer of 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."¹

References

1. 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. News release. Amgen. Published September 8, 2025. Accessed September 9, 2025. https://investors.amgen.com/news-releases/news-release-details/amgen-and-kyowa-kirin-announce-top-line-results-rocatinlimab

2. Guttman-Yassky E, Esfandiari E, Mano H, Chong C, Kabashima K. Rocatinlimab improves SCORAD compared with placebo in adults with moderate-to-severe atopic dermatitis regardless of baseline demographics in a phase 2b trial. Poster presented at: Fall Clinical Dermatology Conference; October 24-27, 2024; Las Vegas, Nevada.