An international team of investigators has reported results from the first Phase III clinical trials of rocatinlimab, a novel treatment for moderate-to-severe atopic dermatitis (eczema).
The findings from the ROCKET-IGNITE and ROCKET-HORIZON studies were published in The Lancet, and the researchers were led by Emma Guttman-Yassky, MD, Ph.D., Waldman Professor and System Chair of the Kimberly and Eric J. Waldman Department of Dermatology at the Icahn School of Medicine at Mount Sinai.
Why eczema is difficult to treat
Eczema affects hundreds of millions of people worldwide and is notoriously difficult to treat due to its complex and chronic inflammatory pathways. Current biologics focus on blocking “allergy” cytokines but fail to address the memory T cells that sustain disease activity.
Rocatinlimab is the first antibody to selectively block the OX40 receptor on effector and memory T cells, rebalancing the immune system and altering the long-term course of disease.
Key findings from the clinical trials
Across the two global, double-blind, placebo-controlled randomized Phase III clinical 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 EASI and vIGA-AD scores, compared to those on placebo. Improvements continued beyond week 24, suggesting that the benefits strengthen over time.
The therapy 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.
Future directions
“These findings represent a major advance for patients living with eczema, who often face years of uncontrolled symptoms and few effective options,” said physician scientist, Dr. Guttman-Yassky, lead author of the study.
“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 III 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 III 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.
More information:
Emma Guttman-Yassky et al, Efficacy and safety of rocatinlimab for the treatment of moderate-to-severe atopic dermatitis in ROCKET-IGNITE and ROCKET-HORIZON: two global, double-blind, placebo-controlled, randomised phase 3 clinical trials, The Lancet (2025). DOI: 10.1016/s0140-6736(25)01865-3
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