Asivatrep, a TRPV1 antagonist, for the topical treatment of atopic dermatitis: Phase 3, randomized, vehicle-controlled study (CAPTAIN-AD)
Chun Wook Park, Beom Joon Kim, Yang Won Lee, Chong Hyun Won, Chang Ook Park, Bo Young Chung, Dong Hun Lee, Kyoung-Mi Jung, Hyun-Jin Nam, Gyeyoung Choi, Youngho Park, Kyu Han Kim, Miyoung Park
Abstract
BackgroundAsivatrep is a potent and selective antagonist of transient receptor potential vanilloid subfamily V member 1 (TRPV1), which plays an important role in itch and inflammation in atopic dermatitis (AD).ObjectiveThis current study aimed to evaluate the efficacy and safety of asivatrep cream in patients with AD.MethodsFor this phase 3 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 Investigator’s Global Assessment score (IGA) of 0 or 1 at week 8. Standard safety assessments were conducted.ResultsAt week 8, significantly more patients in the asivatrep group (36.0%) than in the vehicle group (12.8%) had IGA scores of 0 or 1 (P < .001); significantly more had ≥2 points of improvement on the IGA from baseline score (20.3% vs 7.7%; P = .01). The mean percentage reduction in the Eczema Area and Severity Index (EASI) score was 44.3% for the asivatrep group and 21.4% for the vehicle group at week 8 (P < .001). Significantly more asivatrep-treated patients experienced an improvement of at least 50%, 75%, and 90% on the EASI than the vehicle group. The mean ± SD change in the pruritus visual analog scale score at week 8 was −2.3 ± 2.4 for the asivatrep group and −1.5 ± 2.4 for the vehicle group (P = .02). No significant safety issues were reported.ConclusionAsivatrep improved clinical signs and symptoms of AD and was well tolerated. Asivatrep is a potent and selective antagonist of transient receptor potential vanilloid subfamily V member 1 (TRPV1), which plays an important role in itch and inflammation in atopic dermatitis (AD). This current study aimed to evaluate the efficacy and safety of asivatrep cream in patients with AD. For this phase 3 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 Investigator’s Global Assessment score (IGA) of 0 or 1 at week 8. Standard safety assessments were conducted. At week 8, significantly more patients in the asivatrep group (36.0%) than in the vehicle group (12.8%) had IGA scores of 0 or 1 (P < .001); significantly more had ≥2 points of improvement on the IGA from baseline score (20.3% vs 7.7%; P = .01). The mean percentage reduction in the Eczema Area and Severity Index (EASI) score was 44.3% for the asivatrep group and 21.4% for the vehicle group at week 8 (P < .001). Significantly more asivatrep-treated patients experienced an improvement of at least 50%, 75%, and 90% on the EASI than the vehicle group. The mean ± SD change in the pruritus visual analog scale score at week 8 was −2.3 ± 2.4 for the asivatrep group and −1.5 ± 2.4 for the vehicle group (P = .02). No significant safety issues were reported. Asivatrep improved clinical signs and symptoms of AD and was well tolerated.