Topline Findings
- Durable Efficacy: Rocatinlimab maintains long-term clinical benefit in adults with moderate to severe atopic dermatitis (AD), supporting sustained improvements in skin clearance, itch, and disease severity.
- Favorable Safety Profile: Across the Phase III ASCEND and ROCKET programs, rocatinlimab showed low discontinuation rates, rare gastrointestinal ulceration, and treatment-related adverse events reports that were consistent with previous trials.
- Convenient Dosing Potential: ASCEND data indicate rocatinlimab may be administered every four to eight weeks after initial therapy, potentially reducing treatment burden for patients with moderate to severe AD.
Results from the Phase III ASCEND trial (NCT05882877) showed that Amgen and Kyowa Kirin’s rocatinlimab achieved sustained clinical benefits and demonstrated a favorable long-term safety profile in adults with moderate to severe atopic dermatitis (AD). According to the company, the investigational therapy is designed to rebalance T-cell activity via OX40 inhibition, aiming to address chronic inflammation and reduce treatment burden through less frequent dosing.1
How does Rocatinlimab Work to Manage Chronic Inflammation in AD?
"Atopic dermatitis is a heterogeneous disease where many patients still lack adequate control with current therapies," said Jay Bradner, MD, EVP, research and development, Amgen, in a press release. "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."
ASCEND Trial Design and Endpoints
- The multicenter, double-blind, ASCEND maintenance trial is currently evaluating the efficacy, tolerability, and long-term safety of rocatinlimab administered every four or eight weeks in approximately 2,200 patients with AD.
- All patients were required to be over 12 years of age at the start of the trial.
- Additionally, all patients were required to have achieved an improvement in Eczema Area and Severity Index (EASI) scores of at least 60% during the parent ROCKET-ORBIT trial.
- The primary endpoint of the trial was the number of patients with treatment-emergent adverse events (TEAEs).
- Key secondary endpoints included maintaining EASI 90 at week 32 among patients who achieved it at day one and maintaining validated investigator’s global assessment for AD 0/1 response at week 32.2
- Full results are expected to be shown at an upcoming medical congress or published in a peer-reviewed journal.
Safety and Adverse Events
- The most common TEAEs included upper respiratory infections, aphthous ulcers, headache, influenza, cough and rhinitis, which were all observed in the ROCKET trials.
- In patients treated with rocatinlimab, discontinuation rates were low.
Across the Phase III ROCKET program, which includes the ASCEND trial, gastrointestinal ulceration events with rocatinlimab have been very rare, occurring in fewer than one out of every 100 patients. The ASCEND trial is ongoing to assess the long-term safety and efficacy of rocatinlimab for up to two years in adults and adolescents with moderate to severe AD.1
Atopic Dermatitis Prevalence
- The National Eczema Association estimates that around 16.5 million adults in the United States are currently living with AD, with 6.6 million meeting the criteria for moderate to severe disease.
- AD is considered the most common form of eczema.
- An estimated 9.6 million children in the United States under 18 years of age are currently living with AD.
- Approximately 80% of people with AD experience onset before they reach six years of age; however, one in four adults report onset as they get older.3
"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, Kyowa Kirin, in the press release. "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."
References
- 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. Amgen. September 8, 2025. Accessed September 9, 2025. https://www.amgen.com/newsroom/press-releases/2025/09/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
- A Study to Assess Long-term Safety, Tolerability, and Efficacy of Rocatinlimab in Adult and Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-ASCEND). Clinicaltrials.gov. Accessed September 9, 2025. https://clinicaltrials.gov/study/NCT05882877?term=NCT05882877&rank=1
- Eczema Stats. NEA. Accessed September 9, 2025. https://nationaleczema.org/eczema-facts/
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