Amgen and Kyowa Kirin Announce Positive Topline Results from Phase 3 IGNITE Trial of Rocatinlimab in Adults with Moderate-to-Severe Atopic Dermatitis

On March 8, 2025, Amgen and Kyowa Hakko Kirin announced new results from the ongoing ROCKET Phase 3 clinical trial program. The program aims to evaluate the efficacy of rocatinlimab (an experimental T-cell balancing therapy targeting the OX40 receptor) in treating moderate to severe atopic dermatitis (AD).

The IGNITE study evaluated two different doses of rocatinlimab and met both co-primary endpoints and all key secondary endpoints, with statistically significant results achieved for both doses compared to placebo. The IGNITE study is a 24-week randomized, placebo-controlled, double-blind trial designed to assess the efficacy, safety, and tolerability of rocatinlimab monotherapy administered every four weeks in 769 adult patients with moderate to severe AD, including those previously treated with biologics or systemic Janus kinase (JAK) inhibitors.

At Week 24, 42.3% of patients in the high-dose group achieved a ≥75% reduction in Eczema Area and Severity Index score (EASI-75) from baseline, with a difference of 29.5% compared to the placebo group (p<0.001). In the low-dose group, 36.3% of patients reached EASI-75, showing a difference of 23.4% compared to the placebo group (p<0.001).

In the high-dose group, 23.6% of patients achieved a validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD™) score of 0 (clear skin) or 1 (almost clear skin) with a reduction of ≥2 points from baseline at week 24 (vIGA-AD 0/1), representing a difference of 14.9% compared to the placebo group (p<0.001). In the low-dose group, 19.1% of patients reached this endpoint, showing a difference of 10.3% compared to the placebo group (p=0.002).

Moreover, the IGNITE study also met the endpoint of achieving a score of 0/1 on the revised Investigator's Global Assessment (rIGA™) with a reduction of ≥2 points from baseline, a metric that is more stringent in measuring efficacy than vIGA-AD 0/1. At week 24, 22.7% of patients in the high-dose group reached this endpoint, showing a difference of 14.4% compared to the placebo group (p<0.001). In the low-dose group, 16.3% of patients achieved this endpoint, with a difference of 8.0% compared to the placebo group (p=0.01).

To date, the safety results of the ROCKET program are generally consistent with the previously observed safety profile of rocatinlimab. In the rocatinlimab treatment group, the most common adverse events (≥5%) during treatment were fever, chills, and headache. More patients receiving rocatinlimab experienced gastrointestinal ulcer events compared to the placebo group, but the overall incidence was less than 1%.

About the ROCKET Phase 3 Project

ROCKET is a comprehensive global Phase 3 clinical trial program consisting of eight studies designed to evaluate the safety and efficacy of rocatinlimab in adults and adolescents with moderate to severe atopic dermatitis (AD), as well as multiple dosing regimens.

Currently, rocatinlimab is still in the clinical trial stage, and its safety and efficacy have not been evaluated by the U.S. FDA or any other regulatory authority.