Rocatinlimab Phase III Results Announced

The IGNITE study, which evaluated two dose strengths of rocatinlimab, met its co-primary endpoints and all key secondary endpoints, achieving statistical significance for both rocatinlimab dose strengths versus placebo. IGNITE was a 24-week, randomized, placebo-controlled, double-blind study to assess the efficacy, safety and tolerability of rocatinlimab monotherapy every 4 weeks in 769 adults with moderate to severe AD, including patients previously treated with a biologic or systemic Janus kinase (JAK) inhibitor medication.

At week 24, 42.3% of patients in the higher dose group achieved ≥75% reduction from baseline in Eczema Area and Severity Index score (EASI-75), a 29.5% difference vs. placebo (p < 0.001). In the lower dose group, 36.3% of patients achieved EASI-75, a 23.4% difference vs. placebo (p < 0.001).

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

In addition, IGNITE met the endpoint of revised Investigator's Global Assessment (rIGA) score of 0/1 with a ≥2-point reduction from baseline, a more stringent measure of efficacy than vIGA-AD 0/1. At week 24, 22.7% of patients in the higher dose group achieved this endpoint, a 14.4% difference vs. placebo (p < 0.001). In the lower dose group, 16.3% of patients achieved this endpoint, an 8.0% difference vs. placebo (p = 0.01).

Across ROCKET program results to date, safety findings were generally consistent with the safety profile of rocatinlimab previously observed. The most frequent treatment-emergent adverse events (≥5%) with higher observed proportion in rocatinlimab groups were pyrexia, chills and headache. A higher number of patients receiving rocatinlimab vs. placebo experienced gastrointestinal ulceration events, with an overall incidence of less than 1%.

The ROCKET program is also informed by the results of the SHUTTLE and VOYAGER studies. The SHUTTLE study, which evaluated two dose strengths of rocatinlimab in combination with topical corticosteroids (TCS) and/or topical calcineurin inhibitors (TCI) in 746 adults using the same co-primary endpoints as IGNITE, met its co-primary endpoints and all key secondary endpoints, achieving statistical significance for both rocatinlimab dose strengths plus TCS/TCI versus placebo plus TCS/TCI at week 24.

For EASI-75, 52.3% of patients in SHUTTLE's higher dose group achieved the endpoint, a 28.7% difference vs. placebo (p < 0.001), while 54.1% of patients in the lower dose group achieved the endpoint, a 30.4% difference vs. placebo (p<0.001).

For vIGA-AD 0/1, 26.1% of SHUTTLE patients in the higher dose group achieved the endpoint, a 13.8% difference vs. placebo (p<0.001). In the lower dose group, 25.8% of patients achieved the endpoint, a 13.5% difference vs. placebo (p<0.001). 

For rIGA 0/1, 23.3% of SHUTTLE patients in the higher dose group achieved the endpoint, an 11.5% difference vs. placebo (p<0.001). In the lower dose group, 22.7% of patients achieved the endpoint, a 10.9% difference vs. placebo (p = 0.002). The higher rocatinlimab dose used in IGNITE and SHUTTLE was identical to the dose used in HORIZON.

The VOYAGER study successfully demonstrated that rocatinlimab does not interfere with responses to tetanus and meningococcal vaccinations.

HORIZON, top-line results of which were previously shared, will be presented as a late-breaking abstract at the 2025 American Academy of Dermatology Annual Meeting. Results from IGNITE, SHUTTLE and VOYAGER will be presented at upcoming congresses or published in peer-reviewed journals.

"Many patients with moderate to severe atopic dermatitis struggle with chronic, life-disrupting symptoms," said  Dr. Jay Bradner, 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."

 "Looking ahead, 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," said Dr. Takeyoshi Yamashita,  senior managing executive officer and chief medical officer at Kyowa Kirin. "These findings will help define the full profile of rocatinlimab and its potential to inhibit and reduce pathogenic T cells."