Efficacy and safety of topical JTE-052, a Janus kinase inhibitor, in Japanese adult patients with moderate-to-severe atopic dermatitis: A phase 2, multi-centre, randomised, vehicle-controlled clinical study

Summary

Background

JTE-052 is a novel Janus kinase inhibitor presently under clinical development for the topical treatment of atopic dermatitis (AD).

Objectives

To evaluate the efficacy and safety of JTE-052 ointment in Japanese adult patients with AD.

Methods Patients with moderate-to-severe AD were randomised (2:2:2:2:1:1) to receive JTE-052 ointment at 0.25%, 0.5%, 1% or 3%, the vehicle ointment or 0.1% tacrolimus ointment (reference) twice daily for 4 weeks. The primary efficacy endpoint was the percent change in modified Eczema Area Severity Index (m-EASI) score from the baseline at the end of treatment (EOT). Secondary efficacy endpoints included change from baseline in the pruritus numeric rating scale (NRS) score.

Results

A total of 327 patients were enrolled. At EOT, the least-squares mean percent change from baseline in m-EASI score for JTE-052 0.25%, 0.5%, 1%, 3% and the vehicle ointment was –41.7%, –57.1%, –54.9%, –72.9% and –12.2%, respectively. All JTE-052 groups showed significant reductions of m-EASI score versus the vehicle group (p <0.001 for all). In the tacrolimus group, the mean percent change in m-EASI score was –62.0%. JTE-052 groups also showed significant improvement in other parameters; notably, the pruritus NRS score was reduced as early as Day 1 night-time. JTE-052 ointment at doses up to 3% was safe and well tolerated.

Conclusions

Topical JTE-052 markedly and rapidly improved clinical signs and symptoms in Japanese adult patients with moderate-to-severe AD with a favourable safety profile. The study results indicate that topical JTE-052 is a promising therapeutic option for AD.

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Trial registration number: JapicCTI-152887