Efficacy and safety of topical JTE JTE ‐052, a Janus kinase inhibitor, in Japanese adult patients with moderate‐to‐severe atopic dermatitis: a phase II II , multicentre, randomized, vehicle‐controlled clinical study

摘要

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 ofJTE 052 ointment in Japanese adult patients withAD .Methods Patients with moderatetosevereAD were randomized (2: 2: 2: 2: 1: 1) to receiveJTE 052 ointment at 0?5%, 0?%, 1% or 3%, the vehicle ointment or tacrolimus 0?% ointment (reference) twice daily for 4 weeks. The primary efficacy end point was the percentage change in modified Eczema Area Severity Index (mEASI ) score from baseline at the end of treatment (EOT ). Secondary efficacy end points included change from baseline in the pruritus numerical rating scale (NRS ) score.Results In total, 327 patients were enrolled. AtEOT , the leastsquares mean percentage changes from baseline inmEASI score forJTE 052 at 0?5%, 0?%, 1% and 3% and the vehicle ointment were 41?%, 57?%, 54?%, 72?% and 12?%, respectively. AllJTE 052 groups showed significant reductions ofmEASI score vs. the vehicle group (P 0?01 for all). In the tacrolimus group, the mean percentage change inmEASI score was 62?%. TheJTE 052 groups also showed significant improvement in other parameters; notably, the pruritusNRS score was reduced as early as day 1 nighttime.JTE 052 ointment at doses up to 3% was safe and well tolerated.Conclusions TopicalJTE 052 markedly and rapidly improved clinical signs and symptoms in Japanese adult patients with moderatetosevereAD , with a favourable safety profile. The study results indicate that topicalJTE 052 is a promising therapeutic option forAD . The trial registration number is JapicCTI 152887.