According to the company, 42.3% of the subjects in the higher dose arm reported more than a 75% decrease from baseline in EASI-75 at week 24. Credit: Kmpzzz/Shutterstock.
Amgen and Kyowa Kirin have reported that the 24-week Phase III IGNITE trial assessing two dose strengths of the T-cell rebalancing therapy, rocatinlimab, in individuals with moderate to severe atopic dermatitis (AD), met the co-primary endpoints.
All the key secondary endpoints of the trial were also met, demonstrating the “statistical significance” of the therapy compared to placebo.
The double-blind, randomised, placebo-controlled trial involved 769 adult subjects, including those who had been treated with biologic or systemic Janus kinase (JAK) inhibitor medications before.
According to the company, 42.3% of the subjects in the higher dose arm reported more than a 75% decrease from baseline in Eczema Area and Severity Index score (EASI-75) at week 24, marking a 29.5% difference compared to placebo.
Also, 36.3% of subjects in the lower dose arm showed achievements in EASI-75.
Furthermore, it was observed that in the higher dose group, 23.6% of them saw over a two-point decrease from baseline at week 24 in the validated Investigator’s Global Assessment for Atopic Dermatitis (vIGA-AD) score of clear (0) or almost clear (1).
The lower dose group saw 19.1% of subjects reaching this endpoint.
The trial also met the endpoint for the revised Investigator’s Global Assessment (rIGA) score of 0/1, with 22.7% of the higher dose group and 16.3% of the lower dose group achieving this measure.
Across the Phase III ROCKET programme, the safety findings have been consistent with the known safety profile of the therapy.
This programme consists of eight trials, aiming to “establish” the therapy’s efficacy and safety profile in both the adult population and adolescents with moderate to severe AD across various dosing regimens.
Amgen research and development executive vice-president Jay Bradner said: “Many patients with moderate to severe atopic dermatitis 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.”
Recently, Amgen and AstraZeneca reported complete results from the registrational Phase III WAYPOINT trial of Tezspire for the treatment of chronic rhinosinusitis with nasal polyps.
Editorial content is independently produced and follows thehighest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content.
Email newsletter icon
Sign up for our daily news round-up!
Give your business an edge with our leading industry insights.