Positive Topline Results on Long-Term Safety Reported for Rocatinlimab in Moderate to Severe Atopic Dermatitis

Amgen and Kyowa Kirin announced descriptive preliminary findings from ASCEND, a phase 3 long-term extension study evaluating the investigational T-cell rebalancing therapy rocatinlimab in adults and adolescents with moderate to severe atopic dermatitis (AD). The early data, released on September 8, suggest that the monoclonal antibody targeting the OX40 receptor, provides sustained skin clearance and improvements in pruritis, disease extent, and severity while demonstrating a favorable safety profile.1

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“Atopic dermatitis is a heterogeneous disease where many patients still lack adequate control with current therapies,” Jay Bradner, MD, Amgen executive vice president of research and development, said in an Amgen statement. “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

T-cell dysregulation is a root cause of atopic dermatitis, contributing to clinical manifestations including the disease's recurring, unpredictable symptoms.2 Rocatinlimab is designed to rebalance T-cell activity by inhibiting and reducing pathogenic effector and memory T cells, quelling both systemic and local inflammatory responses central to disease pathophysiology.2

The ASCEND LTE Trial

The ASCEND trial includes approximately 2,600 participants and is evaluating the long-term safety and efficacy of rocatinlimab administered every 4 or every 8 weeks in individuals who completed a previous study in the phase 3 ROCKET development program. The current analysis focused on adults who completed 24 weeks of therapy in a parent study3,4 and received an additional 32 weeks of treatment in the ASCEND trial.

Against the primary descriptive endpoint, the OX40 inhibitor's long-term safety, rocatinlimab demonstrated a consistent profile, according to the statement. The the most frequent treatment-emergent adverse events (ie, reported as or greater than 5 per 100 patient-years and higher than placebo) observed were upper respiratory infections, aphthous ulcers, headache, influenza, cough, and rhinitis, all consistent with previous ROCKET studies.1 The discontinuation rate due to adverse events remained low across cohorts. Importantly, the incidence of gastrointestinal ulceration events across the ROCKET program remained below 1 per 100 patient-years.1

Potential to Reduce Disease Burden

ASCEND secondary endpoints were assessed in participants who achieved an Eczema Area and Severity Index score improvement of at least 75% from baseline or Validated Investigator Global Assessment for Atopic Dermatitis score of 0 (clear) or 1 (almost clear) without the need for rescue therapy at the 24-week mark in the HORIZON3 or IGNITE4 trials. Among these participants, continued treatment with rocatinlimab monotherapy every 4 or 8 weeks was associated with sustained clinical benefit at 1 year, with ongoing improvement in skin clearance, itch, and disease severity measures, Amgen reported.1

“People with moderate to severe atopic dermatitis are looking for new options to help them achieve and sustain their treatment goals,” Takeyoshi Yamashita, PhD, Kyowa Kirin chief medical officer said in the statement. He noted further that the ongoing therapeutic benefit seen after 1 year of treatment in ASCEND, including maintenance dosing as infrequently as every 8 weeks, suggest an "approach that may lessen the ongoing burden of [AD] treatment.”1

Atopic dermatitis, the most common type of eczema, is a chronic inflammatory skin disease marked by persistent dryness, itching, and pain. The condition affects an estimated 15 to 20% of children and up to 10% of adults worldwide.5 People with moderate to severe disease experience ongoing symptoms and unpredictable flare-ups that significantly affect quality of life. More than half report severe itching that leads to repeated scratching, skin thickening, and increased risk of infection.6

The ASCEND study will continue through 104 weeks to evaluate long-term efficacy and safety. Rocatinlimab is also in development for moderate to severe uncontrolled asthma, prurigo nodularis, and other inflammatory conditions driven by T-cell imbalance.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. September 8, 2025. Accessed Septmber 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

2. Agrawal R, Wisniewski JA, Woodfolk JA. The role of regulatory T cells in atopic dermatitis. Curr Probl Dermatol. 2011;41:112-124. doi:10.1159/000323305

3. Halsey G. Rocatinlimab, an OX40 inhibitor, achieves positive results in atopic dermatitis treatment: ROCKET-Horizon topline findings. Patient Care. March 9, 2025. https://www.patientcareonline.com/view/rocatinlimab-an-ox40-inhibitor-achieves-positive-results-in-atopic-dermatitis-treatment-rocket-horizon-topline-findings

4. PCO Editorial Staff. Rocatinlimab shows significant efficacy in moderate to severe atopic dermatitis: Phase 3 IGNITE trial results. Patient Care. March 8, 2025. https://www.patientcareonline.com/view/rocatinlimab-shows-significant-efficacy-in-moderate-to-severe-atopic-dermatitis-phase-3-ignite-trial-results

5. Atopic dermatitis. National Eczema Association. Updated January 27, 2025. Accessed September 9, 2025. https://nationaleczema.org/eczema/types-of-eczema/atopic-dermatitis/

6. Ständer, M.D. Atopic dermatitis. N Engl J Med. 2021;384:1136-1143. doi: 10.1056/NEJMra2023911