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On March 9, 2025, we reported on results from the phase 3 ROCKET-Horizon trial released at the 2025 American Academy of Dermatology (AAD) Annual Meeting in Orlando, FL.
The study
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. 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).
The findings
The ROCKET-Horizon trial met its coprimary endpoints and all key secondary endpoints. 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). 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).
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