Asivatrep, a TRPV1 antagonist, for the topical treatment of atopic dermatitis: A phase III, randomized, vehicle-controlled study (CAPTAIN-AD).

ABSTRACT Background Asivatrep is a potent and selective antagonist of TRPV1, which plays an important role in itch and inflammation in atopic dermatitis (AD). Objective This current study aimed to evaluate the efficacy and safety of asivatrep cream in patients with AD. Methods For this phase III, double-blind, vehicle-controlled study, patients aged ≥ 12 years with mild-to-moderate AD were enrolled and randomly assigned 2:1 to the 1.0% asivatrep or vehicle group for 8 weeks of twice-daily application (n=240). The primary end point was the proportion of patients with an IGA score of 0 or 1 in the score at week 8. Standard safety assessments were conducted. Results At week 8, significantly more patients in the asivatrep group (36.0%) than in the vehicle group (12.8%) achieved IGA scores of 0 or 1 (P Conclusion Asivatrep improved clinical signs and symptoms of AD and was well tolerated. Clinical Implications Asivatrep cream ameliorated signs and symptoms, with a favorable safety profile in patients with AD. The first-in-class topical TRPV1 antagonist, asivatrep, might be a promising therapeutic option for AD.