Rocatinlimab, an OX40 Inhibitor, Achieves Positive Results in Atopic Dermatitis Treatment: ROCKET-Horizon Topline Findings
Approximately one-third of participants treated with rocatinlimab achieved EASI-75 at 24 weeks, more than 2 times the proportion in the placebo group, among other robust findings.
Rocatinlimab, an investigational T-cell rebalancing therapy targeting the OX40 receptor, demonstrated significant efficacy in reducing signs and symptoms of moderate to severe atopic dermatitis (AD) in adults, according to results from the phase 3 ROCKET-Horizon trial released at the 2025 American Academy of Dermatology (AAD) Annual Meeting, being held March 7-11, 2025, Saturday, March 8, in Orlando, FL.1
Lead author 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 in New York, NY, presented the findings during a late breaking research session on Saturday, March 8.1
The ROCKET-Horizon trial met its coprimary endpoints and all key secondary endpoints, Guttman said. At week 24, 32.8% of patients treated with rocatinlimab achieved Eczema Area and Severity Index (EASI)-75, more than 2 times the proportion in the placebo group of 13.7%, representing difference of 19.1% between groups (P <.001).1 The proportion of participants achieving a validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0 or 1 with a 2-point reduction from baseline was more than 3 times greater in the rocatinlimab-treated group (19.3%) compared with the placebo group (6.6%), a difference of 12.8% (P <.001).1
The randomized, placebo-controlled, double-blind ROCKET-Horizon trial was launched in 2022 and is 1 of 8 studies in the phase 3 ROCKET development program evaluating the safety and efficacy of rocatinlimab, an investigational OX40 receptor antagonist developed by Kyowa Kirin and Amgen.2 The study compared the novel agent against placebo therapy in adults with moderate to severe AD and inadequate response to medium or high dose topical corticosteroids or for whom topical treatments are medically inadvisable. The trial enrolled and randomly assigned 726 adults to rocatinlimab (n = 543) or placebo (n = 183).1,2,3
Mean age of the Horizon cohort was 38.4 years, 45.3% were women and 59.5% were non-Hispanic White. The mean age at disease onset was 13.6 years, mean disease duration 24.8 years and mean and mean baseline EASI score was 28.5. Participants received a subcutaneous injection every 4 weeks for 24 weeks with a loading dose administered at week 2.1
The trial’s co-primary endpoints were achievement of a vIGA-ADTM score of 0 (clear) or 1 (almost clear) with a 2-point or greater reduction from baseline at week 24 and achievement of EASI-75 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, both also measured at week 24.1,3 Guttman pointed out that participants who used rescue therapy at any time during the study were considered nonresponders, regardless of their clinical response.1,3
In addition to the ROCKET-Horizon results, Kyowa Kirin and Amgen announced topline data from the IGNITE trial, also part of the ROCKET program.
"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, in a statement.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."2
The ASCEND study will explore the effects of rocatinlimab beyond 24 weeks, including maintenance of clinical response with continued treatment or withdrawal, according to the statement. Two trials, ASTRO and ORBIT, are planned to evaluate rocatinlimab in adolescents with atopic dermatitis. "These findings will help define the full profile of rocatinlimab and its potential to inhibit and reduce pathogenic T cells," Takeyoshi Yamashita, PhD, senior managing executive officer and chief medical officer at Kyowa Kirin, said in the statement.2
Rocatinlimab is also being studied for other conditions driven by T-cell imbalance, including moderate to severe uncontrolled asthma and prurigo nodularis. Rocatinlimab remains investigational, with its safety and efficacy yet to be evaluated by the FDA or other regulatory authorities.
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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. Poster presented at: 2025 American Academy of Dermatology Annual Meeting; Orlando, FL; March 7-11, 2025.
2. Amgen and Kyowa Kirin provide top-line results from rocatinlimab phase 3 Ignite study in adults with moderate to severe atopic dermatitis. News release. 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. A study assessing rocatinlimab (AMG 451) monotherapy in moderate to severe atopic dermatitis (AD) (ROCKET-Horizon). ClinicalTrials.gov identifier: NCT05651711. Updated January 23, 2025. Accessed March 8, 2025. https://clinicaltrials.gov/study/NCT05651711.
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