Immuno-dermatology biotech Arcutis announced this week that its phase 3 trial for atopic dermatitis (AD) drug roflumilast had met its primary and secondary endpoints, inching it closer to approval for this indication.
The trial, called INTEGUMENT-2 (INterventional Trial EvaluatinG roflUMilast cream for the treatmENt of aTopic Dermatitis”) is a phase 3, double-blind, vehicle-controlled trial that included a total of 683 individuals. During the trial, the drug was applied once daily for four weeks to individuals 6 years of age and older with mild to moderate AD involving more than 3% of their body surface area.
The study’s primary endpoint was for patients to achieve IGA success. IGA is a five-point scale that provides a global clinical assessment of AD severity ranging from 0 to 4, where 0 indicates clear, 2 is mild, 3 is moderate, and 4 indicates severe AD. A decrease in score relates to an improvement in signs and symptoms. According to the recently shared data, 28.9% of individuals treated with roflumilast achieved IGA Success, achieving a score of ‘clear’ or ‘almost clear’ plus a 2-grade improvement from baseline at Week 4, compared to 12% of individuals treated with vehicle.
Topical roflumilast is a small molecule inhibitor of phosphodiesterase-4 (PDE4) — an intracellular enzyme that has been implicated in a wide range of inflammatory diseases, including psoriasis, atopic dermatitis, and chronic obstructive pulmonary disease (COPD). The drug was first approved this summer as a topical treatment for plaque psoriasis, under the brand name Zoryve.
