Amgen and Kyowa Kirin announced positive results from their Phase 3 IGNITE study evaluating rocatinlimab, an investigational T-cell rebalancing therapy, in adults with moderate to severe atopic dermatitis. The study met its co-primary endpoints and all key secondary endpoints, demonstrating statistical significance for both tested dose strengths compared to placebo.
The 24-week, randomized, placebo-controlled, double-blind study assessed 769 adult patients, including those previously treated with biologics or JAK inhibitors. Results showed that 42.3% of patients in the higher dose group achieved a 75% or greater reduction in Eczema Area and Severity Index score (EASI-75), representing a 29.5% difference versus placebo (p < 0.001). In the lower dose group, 36.3% of patients reached EASI-75, a 23.4% difference versus placebo (p < 0.001).
For the validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) endpoint, 23.6% of patients in the higher dose group achieved a score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline at week 24, showing a 14.9% difference versus placebo (p < 0.001). The lower dose group saw 19.1% of patients achieve this endpoint, a 10.3% difference versus placebo (p = 0.002).
The study also met the more stringent revised Investigator's Global Assessment (rIGA) endpoint, with 22.7% of patients in the higher dose group achieving a score of 0/1 with at least a 2-point reduction from baseline, representing a 14.4% difference versus placebo (p < 0.001).
Safety Profile
Safety findings across the ROCKET program were generally consistent with previously observed data. The most frequent treatment-emergent adverse events (≥5%) with higher occurrence in rocatinlimab groups were pyrexia, chills, and headache. A higher number of patients receiving rocatinlimab versus placebo experienced gastrointestinal ulceration events, though the overall incidence was less than 1%.
Additional Study Results
The ROCKET program also includes results from the SHUTTLE study, which evaluated rocatinlimab in combination with topical corticosteroids and/or topical calcineurin inhibitors in 746 adults. This study also met its co-primary endpoints, with 52.3% of patients in the higher dose group achieving EASI-75, a 28.7% difference versus placebo (p < 0.001).
The VOYAGER study successfully demonstrated that rocatinlimab does not interfere with responses to tetanus and meningococcal vaccinations, an important consideration for immunomodulatory therapies.
Expert Perspectives
"Many patients with moderate to severe atopic dermatitis struggle with chronic, life-disrupting symptoms," said Jay Bradner, M.D., executive vice president of Research and Development at Amgen. "Even with currently available therapies, they may fail to reach or maintain treatment goals. We're pleased with ROCKET program results to date, which support the potential of rocatinlimab as a new treatment option."
Takeyoshi Yamashita, Ph.D., senior managing executive officer and chief medical officer at Kyowa Kirin, noted that future studies will explore the effects of rocatinlimab beyond 24 weeks. "The ASCEND trial will explore the effects of rocatinlimab beyond 24 weeks, including maintenance of clinical response with continued treatment or withdrawal, and the ASTRO and ORBIT trials will evaluate rocatinlimab in adolescent patients," he said. "These findings will help define the full profile of rocatinlimab and its potential to inhibit and reduce pathogenic T cells."
Novel Mechanism of Action
Rocatinlimab represents a potential first-in-class therapy as an anti-OX40 human monoclonal antibody. It works by targeting the OX40 receptor, which is responsible for driving inflammatory responses in atopic dermatitis. By inhibiting and reducing pathogenic T cells, rocatinlimab addresses a root cause of atopic dermatitis—T-cell imbalance—which contributes to the disease's recurring, unpredictable symptoms.
Effector T cells expressing OX40 are present in the lesions of patients with atopic dermatitis and are critical in the disease pathophysiology. Beyond atopic dermatitis, rocatinlimab is also being studied for moderate to severe uncontrolled asthma, prurigo nodularis, and potentially other conditions where T-cell imbalance drives inflammation.
Disease Burden
Atopic dermatitis, the most common form of eczema, is a chronic inflammatory disease affecting 15-20% of children and up to 10% of adults. 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.
Development and Commercialization
The initial antibody was discovered through collaboration between Kyowa Kirin and La Jolla Institute for Immunology. In June 2021, Kyowa Kirin and Amgen entered into an agreement to jointly develop and commercialize rocatinlimab. Under the terms of the agreement, Amgen will lead the development, manufacturing, and commercialization 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.
Results from the HORIZON study will be presented as a late-breaking abstract at the 2025 American Academy of Dermatology Annual Meeting, while findings from IGNITE, SHUTTLE, and VOYAGER will be presented at upcoming congresses or published in peer-reviewed journals.
Rocatinlimab is currently under clinical investigation, and its safety and efficacy have not yet been evaluated by the U.S. FDA or any other regulatory authority.
