Amgen Rocatinlimab's Data Shows Potential As Long-Term Therapy For Atopic Dermatitis - Amgen (NASDAQ:AMGN)
Rocatinlimab showed sustained therapeutic benefits and a low discontinuation rate due to adverse events in about 2,600 patients treated for up to two and a half years, Amgen and Kyowa Kirin reported.
- On September 8, 2025, Amgen and Kyowa Kirin released initial top-line findings from the ASCEND trial, which is assessing rocatinlimab in a group of roughly 2,600 adolescent and adult participants experiencing significant symptoms of atopic dermatitis.
- This announcement follows the June 1, 2021 collaboration where the companies agreed to jointly develop and commercialize rocatinlimab, an investigational anti-OX40 monoclonal antibody targeting T-cell imbalance, a key driver of atopic dermatitis.
- The ASCEND trial evaluates the long-term safety and effectiveness of dosing every four or eight weeks following an initial 24-week treatment period, with patients continuing on monotherapy demonstrating sustained improvements in symptom control, itching, and overall disease involvement and intensity.
- The most frequently reported adverse effects included infections of the upper respiratory tract, mouth sores, headaches, flu-like symptoms, coughing, and nasal inflammation. Additionally, gastrointestinal ulceration occurred at a rate below one event per 100 patient-years, and few patients discontinued treatment due to side effects.
- These findings represent a key advancement in understanding the therapeutic potential of rocatinlimab for atopic dermatitis. Amgen and Kyowa Kirin intend to present comprehensive data at a forthcoming scientific meeting or publish it in a peer-reviewed journal.
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Amgen Rocatinlimab's Data Shows Potential As Long-Term Therapy For Atopic Dermatitis - Amgen (NASDAQ:AMGN)
Amgen Inc. (NASDAQ:AMGN) and Kyowa Kirin released preliminary topline results from the ASCEND study evaluating rocatinlimab in adults and adolescents with moderate to severe atopic dermatitis (AD) on Tuesday. 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 previ…
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
THOUSAND OAKS, Calif. and TOKYO, Sept. 09, 2025 (GLOBE NEWSWIRE) -- Amgen (NASDAQ:AMGN) and Kyowa Kirin Co., Ltd. (TSE:4151) today announced preliminary...

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
THOUSAND OAKS, Calif. and TOKYO, Sept. 8, 2025 /PRNewswire/ -- Amgen (NASDAQ: AMGN) and Kyowa Kirin Co., Ltd. (TSE: 4151) today announced preliminary top-line results from the ASCEND study evaluating rocatinlimab, an investigational T-cell rebalancing therapy targeting the OX40 receptor,…
Amgen and Kyowa Kirin report preliminary outcomes from AD treatment trial
Amgen and Kyowa Kirin reported findings from the Phase III ASCEND trial of rocatinlimab for moderate to severe atopic dermatitis (AD).The post Amgen and Kyowa Kirin report preliminary outcomes from AD treatment trial appeared first on Clinical Trials Arena.
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