An international team led by Dr. Emma Guttman-Yassky, the Waldman Professor and System Chair of Dermatology at the Icahn School of Medicine at Mount Sinai, has announced results from the first phase 3 clinical trials of rocatinlimab for moderate-to-severe atopic dermatitis (eczema). The findings from the ROCKET-IGNITE and ROCKET-HORIZON studies have been published in The Lancet.
Eczema is a chronic inflammatory skin condition affecting millions globally. Current biologic treatments focus on blocking cytokines related to allergic responses but do not address memory T cells that help sustain disease activity. Rocatinlimab is a new antibody therapy that selectively blocks the OX40 receptor found on effector and memory T cells, which may help rebalance the immune system and alter how eczema progresses over time.
The two phase 3 studies followed nearly 1,500 patients over 24 weeks using a double-blind, placebo-controlled design. Patients who received rocatinlimab were three times more likely to see significant improvement in eczema severity scores compared to those on placebo. These improvements continued beyond week 24. The treatment also reduced itch, pain, and sleep problems while maintaining a safety profile similar to placebo. Rocatinlimab showed high selectivity by targeting only the specific T cells responsible for ongoing eczema without affecting other cell types.
“These findings represent a major advance for patients living with eczema, who often face years of uncontrolled symptoms and few effective options,” said 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 3 proof that rebalancing these immune cells can transform how we treat atopic dermatitis.”
The trial results confirm OX40 as an important treatment target in eczema and suggest rocatinlimab could become a first-in-class therapy for this condition. Researchers will continue tracking patient outcomes in an extension study called ROCKET-ASCEND for up to two years. Additional research will look into use among children, combinations with other therapies, and comparisons against current systemic treatments.
The trials involved international collaborators and were funded by Amgen Inc. and Kyowa Kirin Co., Ltd.
The Icahn School of Medicine at Mount Sinai is recognized internationally for its research programs as well as education and clinical care initiatives across New York City through its partnership with seven member hospitals within one of the country’s largest academic health systems.
