US pharmaceutical company Amgen (NASDAQ:AMGN) and Japan-based Kyowa Kirin Co Ltd (TSE:4151) announced on Monday 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 trial (IGNITE, HORIZON, SHUTTLE, ASTRO, ORBIT or VOYAGER). This analysis focused on adults who completed the first 24 weeks of therapy in a ROCKET trial and continued in ASCEND for an additional 32 weeks.

The primary endpoint of the study was to evaluate the long-term safety of rocatinlimab and is descriptive in nature. The most frequent treatment-emergent adverse events (AEs) in adults (5 or more per 100 patient-years in any of the rocatinlimab groups and greater than placebo) included upper respiratory infections (including nasopharyngitis and pharyngitis), 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.

Across the Phase 3 ROCKET programme including ASCEND, the incidence of gastrointestinal ulceration events with rocatinlimab to date is less than 1 per 100 patient-years. The ASCEND study is ongoing and 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.

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-randomised in the ASCEND study. Most 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.

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