Amgen and Kyowa Kirin’s Phase III IGNITE trial for atopic dermatitis meets endpoints

Amgen and Kyowa Kirin’s Phase III IGNITE trial of rocatinlimab, a therapy for moderate to severe atopic dermatitis (AD), achieved its primary and secondary endpoints. The 24-week trial involved 769 adults, including those previously treated with biologic or JAK inhibitors.

In the higher dose group, 42.3% of participants saw a 75% reduction in their Eczema Area and Severity Index (EASI-75) scores by week 24, compared to 29.5% in the placebo group. The lower dose group saw 36.3% achieving EASI-75. Additionally, 23.6% in the higher dose group and 19.1% in the lower dose group showed significant improvement in the Investigator’s Global Assessment (vIGA-AD) scores.

The trial also met the revised Investigator’s Global Assessment (rIGA) endpoint, with consistent safety findings. The IGNITE trial is part of the larger Phase III ROCKET program, designed to assess the therapy’s efficacy and safety in adults and adolescents with moderate to severe AD.

14-03-2025

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