Photo Credit: Alexey Yaremenko
The phase 3 ROCKET-Horizon trial testing rocatinlimab, a first-in-class investigational T-cell rebalancing therapy, meets its co-primary end points in week 24: EASI75 response was 32.8% for rocatinlimab versus 13.7% for moderate-to-severe atopic dermatitis (AD).
The ROCKET-Horizon trial (NCT05651711), presented by Emma Guttman, MD, PhD, Icahn School of Medicine at Mount Sinai, New York, New York, evaluated rocatinlimab against placebo in adults living with inadequate response to topical corticosteroids.1 Adults (n=726) were randomized 3:1 to subcutaneous rocatinlimab 300 mg every 4 weeks (plus loading dose at week 2) or placebo for 24 weeks. The study population had a mean age of 38.4 years, with 45.3% female participants and a mean disease duration of 24.8 years.
At week 24, the trial met all co-primary end points, with 32.8% of the rocatinlimab group achieving EASI75 compared with 13.7% in the placebo group, reflecting a 19.1% difference (P<0.001). Additionally, 19.3% of the rocatinlimab arm achieved a validated Investigator Global Assessment for AD (vIGA-AD) score of 0 or 1, compared with 6.6% in the placebo group, a difference of 12.8% (P<0.001). Key secondary end points, including EASI90 and a reduction of 4 points or more in the Worst Pruritus Numerical Rating Scale (WP-NRS), also showed significant improvements.
These findings suggest that rocatinlimab has potential as an effective new treatment option for patients with moderate-to-severe AD, particularly those who have not responded adequately to existing therapies. These phase 3 trial results expand upon and support the phase 2b study previously published.2 By targeting OX40 receptor+ T cells, rocatinlimab offers a novel mechanism of action that could address an important unmet need in managing this chronic and debilitating condition.
Medical writing support was provided by Dr. Rachel Giles.
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