Efficacy and Safety of Delgocitinib Cream in Discoid Lupus Erythematosus.

Phase 2 Terminated 27 enrolled LEO Pharma

RandomizedParallel-groupDouble-blindTreatment

Summary

This was a double-blind, multi-centre, randomised, vehicle-controlled, within-subject phase 2a trial. The trial was designed to establish the efficacy and safety of delgocitinib cream in the treatment of adult subjects with discoid lupus erythematosus (DLE).

Timeline

Start: 2019-07-09
Primary completion: 2020-04-15
Completion: 2020-04-30

Outcome

Missed primary endpoint

Stopped (Enrollment): “Terminated due to recruitment challenges.”

registry analysis (superiority test); Delgocitinib Cream 20 mg/g vs Delgocitinib Cream Vehicle; p = 0.4531 NCT03958955 ↗

Publications

Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Delgocitinib	Small molecule	20 unknown	Topical