Amgen and Kyowa Kirin have shared promising results from a phase 3 programme of their investigational T-cell rebalancing therapy rocatinlimab in atopic dermatitis (AD).

The 24-week IGNITE study, which met its co-primary endpoints and all key secondary endpoints, evaluated two doses of the candidate in more than 760 adults with moderate-to-severe AD, including those previously treated with a biologic or systemic Janus kinase inhibitor medication.

At the end of the trial, 42.3% of patients receiving the higher dose of rocatinlimab achieved at least a 75% reduction from baseline in their Eczema Area and Severity Index score (EASI-75), representing a 29.5% difference against placebo. In the lower dose group, 36.3% of rocatinlimab-treated patients achieved EASI-75, a 23.4% difference versus placebo.

Additionally, 23.6% of patients being treated with higher dose rocatinlimab and 19.1% of those in the lower dose group achieved a validated Investigator’s Global Assessment for Atopic Dermatitis (vIGA-AD) score of zero or one (clear or almost clear skin) with at least a two-point reduction from baseline at week 24, representing a 14.9% and 10.3% difference versus placebo, respectively.

AD, the most common form of eczema, affects up to 20% of children and 10% of adults worldwide. The inflammatory disease causes excessively dry, itchy skin that can be painful, and patients with moderate-to-severe cases experience chronic symptoms and unpredictable flare-ups.

Rocatinlimab is designed to target the OX40 receptor, which is responsible for driving systemic and local inflammatory responses in AD and other conditions, including asthma and prurigo nodularis.

Jay Bradner, executive vice president of research and development at Amgen, said: “Many patients with moderate-to-severe AD struggle with chronic, life-disrupting symptoms. Even with currently available therapies, they may fail to reach or maintain treatment goals.

“We’re pleased with ROCKET programme results to date, which support the potential of rocatinlimab as a new treatment option.”