AAD 2025: Rocatinlimab, a T-Cell Rebalancing Therapy, for Atopic Dermatitis

Results of the ROCKET-Horizon trial examining rocatinlimab suggest use of the T-Cell rebalancing therapy was associated with significantly reduced signs and symptoms of moderate to severe atopic dermatitis in adult patients.

“So the key takeaways, the ROCKET-Horizon trial met all the coprimary and the key secondary endpoints, with highly favorable treatment experience,” explained Emma Guttman, MD, PhD, the Waldman Professor of Dermatology and Immunology and health system chair of the Department of Dermatology at the Icahn School of Medicine at Mount Sinai, during her presentation at the 2025 American Academy of Dermatology (AAD) Annual Meeting.

Launched in 2022 and conducted at 197 sites across multiple continents, the ROCKET-Horizon trial examined rocatinlimab, an investigational T-cell rebalancing therapy targeting the OX40 receptor developed by Kyowa Kirin, against placebo therapy in adults with moderate to severe atopic dermatitis and inadequate response to topical corticosteroid of medium or higher potency or for whom topical treatments are otherwise medically inadvisable. The trial enrolled and randomized 726 patients to rocatinlimab or placebo, with 543 patients receiving rocatinlimab and 183 receiving placebo.1,2,3

The trial had coprimary endpoints of a validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0 or 1 with a 2-point reduction from baseline and achievement of Eczema Area and Severity Index (EASI)-75, with both measured at week 24. Key secondary endpoints for the trial included achievement of EASI-90 and a 4-point or greater reduction in Worst Pruritus Numerical Rating Scale (WP-NRS), with both measured at week 24 as well.1,3

Of note, for the purpose of the primary analysis, patients who used rescue therapy in the trial were considered nonresponders regardless of clinical response.1,3

The overall study cohort had a mean age of 38.4 years, 45.3% were female, and 59.5% were non-Hispanic White. During her presentation, Gutmann highlighted the study population had a mean age at disease onset of 13.6 (SD, 18.0) years, mean disease duration of 24.8 (SD, 15.6) years, and mean EASI total score of 28.5 (SD, 11.0).1

Results presented at AAD 2025 indicated the ROCKET-Horizon met its coprimary and all key secondary endpoints. In the primary analysis, EASI-75 at week 24 was achieved by 32.8% of the rocatinlimab group relative to 13.7% of the placebo group, which represents a 19.1% between-group difference (P <.001). Analysis of vIGA-AD at week 24 indicated 19.3% of the rocatinlimab arm and 6.6% of the placebo group achieved a score of 0 or 1, which represents a 12.8% between-group difference (P <.001).1

On the day ROCKET-Horizon was presented at AAD 2025, Kyowa Kirin and Amgen also announced topline data from the IGNITE trial, which is also part of the ROCKET program. IGNITE was a 24-week, randomized, placebo-controlled, double-blind trial assessing rocatinlimab every 4 weeks relative to placebo in 769 adults with moderate to severe atopic dermatitis, including those previously treated with biologics or systemic Janus kinase (JAK) inhibitors.2

At 24 weeks, 42.3% of patients in the higher dose group achieved EASI-75, a 29.5% difference relative to placebo (P < .001). Among lower dose group, 36.3% achieved EASI-75, which represents a 23.4% difference relative to placebo (P < .001). Additionally, topline results indicated 22.7% of the higher dose group and 16.3% of the lower dose group achieved revised Investigator's Global Assessment 0 or 1 with a 2-point or greater reduction from baseline, which are differences of 14.4% (P < .001) and 8.0% (P = .01) versus placebo, respectively.2

"Many patients with moderate to severe atopic dermatitis struggle with chronic, life-disrupting symptoms," said Jay Bradner, MD, executive vice president of Research and Development at Amgen.2 "Even with currently available therapies, they may fail to reach or maintain treatment goals. We're pleased with ROCKET program results to date, which support the potential of rocatinlimab as a new treatment option."

References:

1. Guttman E. Rocatinlimab Significantly Improved Clinical Signs and Symptoms by Targeting OX40R+ T cells in Patients with Moderate-to-Severe Atopic Dermatitis: Results from the Phase 3 ROCKET HORIZON Trial.Presented at the 2025 American Academy of Dermatology (ADA) Annual Meeting. Orlando, FL. March 07-11, 2025.

2. Amgen. Amgen and Kyowa Kirin provide top-line results from ROCATINLIMAB Phase 3 ignite study in adults with moderate to severe atopic dermatitis. Amgen. March 8, 2025. Accessed March 8, 2025. https://www.amgen.com/newsroom/press-releases/2025/03/amgen-and-kyowa-kirin-provide-top-line-results-from-rocatinlimab-phase-3-ignite-study-in-adults-with-moderate-to-severe-atopic-dermatitis.

3. ClinicalTrials.gov. A Study Assessing Rocatinlimab (AMG 451) Monotherapy in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Horizon) (ROCKET-Horizon). Clinicaltrials.gov. January 23, 2025. Accessed March 8, 2025. https://clinicaltrials.gov/study/NCT05651711.