The first two global Phase 3 trials show durable improvements in skin clearance, itch, and quality of life among patients with moderate-to-severe eczema taking the OX-40 blocker rocatinlimab.
The findings from the ROCKET-IGNITE and ROCKET-HORIZON studies appear in The Lancet.
Across the two trials, nearly 1,500 patients were followed for 24 weeks, and rocatinlimab showed robust and lasting benefits. Patients receiving the treatment were three times more likely to achieve significant improvement in eczema severity, as measured by Eczema Area and Severity Index (EASI) and Validated Investigator’s Global Assessment for Atopic Dermatitis (vIGA-AD) scores, compared to those on placebo.
Improvements continued beyond Week 24, suggesting that the benefits strengthen over time. Rocatinlimab also led to meaningful reductions in itch, pain, and sleep disturbances, enhancing overall quality of life. Importantly, rocatinlimab was well tolerated, with adverse events comparable to placebo, and demonstrated high selectivity by reducing only the OX40R+ CD4+ T cells responsible for eczema’s persistence, without off-target effects.
“These findings represent a major advance for patients living with eczema, who often face years of uncontrolled symptoms and few effective options,” says study author Emma Guttman-Yassky, MD, PhD, Waldman Professor and System Chair of the Kimberly and Eric J. Waldman Department of Dermatology at the Icahn School of Medicine at Mount Sinai in New York City, in a news release. “By targeting memory T cells through OX40, rocatinlimab not only clears the skin and relieves itch, but continues to improve patients’ lives over time with a strong safety profile. This is the first Phase 3 proof that rebalancing these immune cells can transform how we treat atopic dermatitis.”
The results establish OX40 as a validated treatment target in eczema and position rocatinlimab as a potential first-in-class therapy. Patients from the phase 3 trials are now being followed in the ROCKET-ASCEND extension study, which will track outcomes for up to two years. Additional research will explore its role in pediatric patients, in combination with other therapies, and in direct comparisons to existing systemic treatments.
