Asivatrep, a TRPV1 antagonist, for the topical treatment of atopic dermatitis: Phase 3, randomized, vehicle-controlled study (CAPTAIN-AD)

Background: 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). Objective: This current study aimed to evaluate the efficacy and safety of asivatrep cream in patients with AD. Methods: 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. Results: 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 21.5 +/- 2.4 for the vehicle group (P = .02). No significant safety issues were reported. Conclusion: Asivatrep improved clinical signs and symptoms of AD and was well tolerated.

Automated summary

Asivatrep cream has shown significant efficacy and good tolerability in patients with AD.