Rocatinlimab Shows Significant Efficacy in Moderate to Severe Atopic Dermatitis: Phase 3 IGNITE Trial Results

©MQ-Illustrations/ stock.adobe.com

Rocatinlimab, an investigational T-cell rebalancing therapy targeting the OX40 receptor, for moderate to severe atopic dermatitis (AD), significantly improved key clinical endpoints in patients with moderate to severe atopic dermatitis, according to findings presented at the 2025 American Academy of Dermatology meeting. The study cohort included adults previously treated with a biologic or systemic Janus kinase (JAK) inhibitor medication, according to drug developers Amgen and Kyowa Kirin who announced the new results from the ongoing ROCKET phase 3 clinical trial program.1

Specifically, results from the 24-week, randomized, placebo-controlled, double-blind phase 3 IGNITE trial showed that at week 24, 42.3% of participants in the group receiving the higher dose of rocatinlimab achieved a 75% or greater reduction in Eczema Area and Severity Index (EASI-75), a 29.5% improvement over placebo (P <.001). This robust response, along with significant improvements in validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) score and the revised IGA (rIGA) score, underscores the potential for the novel treatment as an effective treatment for patients who may not have responded to previous biologics or systemic JAK inhibitors.

In IGNITE, which evaluated 2 dose strengths of rocatinlimab, the investigational OX40 inhibitor met its coprimary and all key secondary endpoints, achieving statistical significance across evaluated measures among 769 adults with moderate to severe AD

For the vIGA-AD score of 0 (clear) or 1 (almost clear) with a 2-point or greater reduction from baseline, 23.6% of participants in the higher dose group achieved this endpoint (14.9% difference vs. placebo; P <.001), while 19.1% in the lower dose group reached this result (10.3% difference vs placebo; P =.002). A more stringent endpoint, the rIGA score of 0/1 with a 2 -point or greater reduction, was achieved by 22.7% in the higher dose group (14.4% difference vs. placebo; P < .001) and 16.3% in the lower dose group (8.0% difference vs. placebo; P =.01).

Across ROCKET program results to date, safety findings have been generally consistent with the safety profile of rocatinlimab observed in previous studies. The most frequent treatment-emergent adverse events (5% or greater) 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%, according to the statement from Kyowa Kirin.

"Many patients with moderate to severe atopic dermatitis struggle with chronic, life-disrupting symptoms," Jay Bradner, MD, executive vice president of Research and Development at Amgen, said in the statement. "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."

The Phase 3 ROCKET Trials

Results from the SHUTTLE study, which evaluated rocatinlimab combined with topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) in 746 adults, also demonstrated positive outcomes. At week 24, 52.3% of patients in the higher dose group achieved EASI-75, a 28.7% difference versus placebo (P <.001), and 54.1% in the lower dose group achieved EASI-75, a 30.4% difference versus placebo (P <.001). For vIGA-AD 0/1, 26.1% in the higher dose group achieved this endpoint (13.8% difference vs. placebo; P <.001), and 25.8% in the lower dose group achieved this result (13.5% difference vs placebo; P <.001). For rIGA 0/1, 23.3% in the higher dose group met the endpoint (11.5% difference vs. placebo; P <.001), and 22.7% in the lower dose group achieved this result (10.9% difference vs placebo; P =.002).

"Looking ahead, the ASCEND trial will explore the effects of rocatinlimab beyond 24 weeks, including maintenance of clinical response with continued treatment or withdrawal," Takeyoshi Yamashita, PhD, senior managing executive officer and chief medical officer at Kyowa Kirin, said in the statement. "These findings will help define the full profile of rocatinlimab and its potential to inhibit and reduce pathogenic T cells."

Atopic dermatitis (all severities) affects 15% to 20% of children and up to 10% of adults.2 T-cell imbalance is a root cause of atopic dermatitis, contributing to clinical manifestations including the disease's recurring, unpredictable symptoms.3

The ROCKET phase 3 development program includes 8 studies designed to evaluate the efficacy and safety of rocatinlimab in adults and adolescents with moderate to severe AD, as well as multiple dosing regimens. Rocatinlimab is also being studied for other conditions driven by T-cell imbalance, including moderate to severe uncontrolled asthma and prurigo nodularis. Rocatinlimab remains investigational, with its safety and efficacy yet to be evaluated by the FDA or other regulatory authorities.

References

1. Amgen and Kyowa Kirin provide top-line results from rocatinlimab phase 3 IGNITE study in adults with moderate to severe atopic dermatitis. News release. Amgen and Kyowa Kirin. March , 2025. Accessed March 8, 2025. https://prnmedia.prnewswire.com/news-releases/amgen-and-kyowa-kirin-provide-top-line-results-from-rocatinlimab-phase-3-ignite-study-in-adults-with-moderate-to-severe-atopic-dermatitis-302396165.html
2. Ständer S. Atopic dermatitis. N Engl J Med. 2021;384:1136-1143DOI: 10.1056/NEJMra2023911
3. Agrawal R, Wisniewski JA, Woodfolk JA. The role of regulatory T cells in atopic dermatitis. Curr Probl Dermatol. 2011;41:112-124. doi:10.1159/000323305