Topline Results Announced on Rocatinlimab for Adults with Atopic Dermatitis

Preliminary findings from the ASCEND trial suggest that rocatinlimab offers sustained improvements in skin clearance and itch for individuals with moderate to severe atopic dermatitis, with the drug maintaining a favorable long-term safety profile and low discontinuation rates.1

These phase 3, top-line findings on rocatinlimab, a novel T-cell rebalancing therapy directed at the OX40 receptor, were announced by Amgen and Kyowa Kirin Co., Ltd. on September 9, 2025.1 The preliminary findings from the ASCEND trial highlight rocatinlimab’s use among patients with atopic dermatitis, a chronic inflammatory condition characterized by extremely dry, itchy, and sometimes painful skin.

“Atopic dermatitis is a heterogeneous disease where many patients still lack adequate control with current therapies," Jay Bradner, MD, executive vice president of Research and Development at Amgen, said in a statement.1 “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.”

Patients living with moderate to severe atopic dermatitis often live with persistent symptoms and unpredictable flare-ups that can disrupt daily functioning in a substantial way. Over half of such patients report experiencing intense itch, which frequently results in scratching, skin thickening, and susceptibility to infection. The condition impacts 15–20% of children and up to 10% of adults.2

Dysregulation of T-cell activity is a central factor in the skin condition, driving its recurring and unpredictable manifestations. Rocatinlimab, an anti-OX40 monoclonal antibody, is being evaluated due to its potential to be the first and only T-cell rebalancing therapy designed to inhibit and diminish pathogenic effector and memory T cells via the targeting of the OX40 receptor.

The ASCEND trial enrolled close to 2600 participants, assessing the long-term efficacy and safety of this medication given at doses of 150 mg or 300 mg every 4 or 8 weeks. Those eligible to participate had previously been featured in the ROCKET program (IGNITE, HORIZON, SHUTTLE, ASTRO, ORBIT, or VOYAGER). Investigators assessed adults who had completed 24 weeks of therapy in a prior ROCKET study and continued in the ASCEND study for an additional 32 weeks.3

The investigative team’s primary endpoint focused on long-term safety and was descriptive in nature. Overall, the newly-released, preliminary findings suggest the most common treatment-emergent adverse events (≥ 5 per 100 patient-years in any rocatinlimab group and occurring more frequently than with placebo) were upper respiratory tract infections, headache, ulcers, influenza, rhinitis, and cough, consistent with findings from earlier ROCKET studies.1 Any adverse event-related discontinuations remained low across the adult rocatinlimab treatment arms.

Within the entire phase 3 ROCKET program, including ASCEND, the team concluded that the incidence of gastrointestinal ulceration related to rocatinlimab was observed at less than 1 per 100 patient-years. ASCEND is ongoing and is set to continue to track findings related to long-term safety and efficacy outcomes for up to 104 weeks in both adult and adolescent patients with moderate to severe disease.

Clinical response was defined as Eczema Area and Severity Index score improvement of at least 75% from baseline (EASI-75) or Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0 (clear) or 1 (almost clear) without the need for rescue therapy at the 24-week mark.1 Patients attaining such a clinical response in either the HORIZON or IGNITE trials who were subsequently re-randomized in ASCEND, specifically those who remained on rocatinlimab monotherapy, saw sustained clinical benefits.

This was regardless of every-4-week or every-8-week dosing. Such improvements were maintained in skin clearance, itch, and overall disease severity and extent. Amgen and Kyowa Kirin are set to present the complete study data at an upcoming scientific congress or through publication in a peer-reviewed journal.

“People with moderate to severe atopic dermatitis are looking for new options to help them achieve and sustain their treatment goals,” Takeyoshi Yamashita, PhD, Chief Medical Officer at Kyowa Kirin, said in a statement.1 “...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.”

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. Amgen and Kyowa Kirin Co., Ltd. September 9, 2025. https://prnmedia.prnewswire.com/news-releases/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-302549965.html.

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. Epub 2011 May 12. PMID: 21576952; PMCID: PMC4547455. Accessed September 9, 2025.

3. Campbell P. AAD 2025: Rocatinlimab, a T-Cell Rebalancing Therapy, for Atopic Dermatitis. HCPLive. March 8, 2025. https://www.hcplive.com/view/aad-2025-rocatinlimab-a-t-cell-rebalancing-therapy-for-atopic-dermatitis. Accessed September 9, 2025.