Kyowa Kirin Co., Ltd. announced that results from the Phase 3 ROCKET IGNITE trial of rocatinlimab will be presented at the European Academy of Dermatology and Venereology (EADV) 2025 Annual Meeting in Paris, France from September 17-20, 2025. The investigational therapy targets the OX40 receptor in patients with moderate-to-severe atopic dermatitis.
Dr. Emma Guttman-Yassky will present the findings titled "Efficacy & Safety of OX-40 Receptor Targeting with Rocatinlimab in Moderate-to-Severe Atopic Dermatitis: Results from the Phase 3 ROCKET-IGNITE Trial" on Friday, September 19th at 4:40-4:50 pm CEST during the FC 08 Atopic Dermatitis session.
Novel Mechanism Targets T-Cell Imbalance
Rocatinlimab is an anti-OX40 human monoclonal antibody being investigated for moderate to severe atopic dermatitis treatment. The therapy has the potential to be the first and only T-cell rebalancing treatment that inhibits and reduces pathogenic T cells by targeting the OX40 receptor.
According to the company, OX40 is a co-stimulatory receptor responsible for driving systemic and local inflammatory responses in atopic dermatitis and other conditions. Effector T cells expressing OX40 are present in the lesions of patients with atopic dermatitis and are critical in the disease pathophysiology.
Atopic dermatitis is driven by skin barrier disruption and T-cell-dependent inflammatory pathways, with expansion of OX40R+ pathogenic T cells leading to T-cell imbalance, which represents a root cause of inflammatory diseases including atopic dermatitis.
Comprehensive Phase 3 Program
The ROCKET program represents a comprehensive, global Phase 3 clinical trial initiative comprised of eight studies intended to establish the safety and efficacy profile of rocatinlimab in adults and adolescents with moderate to severe atopic dermatitis, as well as multiple dosing regimens.
Beyond atopic dermatitis, rocatinlimab is also being studied for prurigo nodularis, moderate to severe uncontrolled asthma and potentially other conditions where T-cell imbalance is a root cause of inflammation. The initial antibody was discovered through collaboration between Kyowa Kirin and La Jolla Institute for Immunology.
Significant Disease Burden
Atopic dermatitis, the most common form of eczema, is a chronic inflammatory disease that causes excessively dry, itchy skin that can be painful. People with moderate to severe atopic dermatitis experience chronic symptoms, intensified by unpredictable flare-ups that can be painful and disruptive to everyday life.
More than half of these patients report severe itching, leading to repeated scratching which can cause the skin to thicken and become vulnerable to infection. Atopic dermatitis affects 15-20% of children and up to 10% of adults across all severities. T-cell imbalance is a root cause of atopic dermatitis, contributing to clinical manifestations including the disease's recurring, unpredictable symptoms.
Strategic Partnership
Kyowa Kirin and Amgen entered into an agreement on June 1, 2021, to jointly develop and commercialize rocatinlimab. Under the terms of the agreement, Amgen will lead the development, manufacturing, and commercialization for KHK4083/AMG 451 for all markets globally, except Japan, where Kyowa Kirin will retain all rights. If approved, the companies will co-promote the asset in the United States and Kyowa Kirin has opt-in rights to co-promote in certain other markets including Europe and Asia.
Rocatinlimab is currently under clinical investigation, and its safety and efficacy have not been evaluated by the U.S. FDA or any other regulatory authority.
