drugset / Trial / NCT03725722

Dose-ranging Trial to Evaluate Delgocitinib Cream 1, 3, 8, and 20 mg/g Compared to Delgocitinib Cream Vehicle Over an 8-week Treatment Period in Adult Subjects With Atopic Dermatitis.

NCT03725722 ↗

Phase 2 Completed 251 enrolled LEO Pharma
RandomizedParallel-groupDouble-blindTreatment

Summary

This is a double-blind, multi-centre, randomised, 5-arm, vehicle-controlled, parallel-group trial. The trial is designed to establish a dose-response signal and investigate the efficacy and safety of delgocitinib cream in the treatment of adult subjects with mild to severe atopic dermatitis (AD).

Timeline

Start
2018-12-28
Primary completion
2020-05-19
Completion
2020-05-19

Outcome

Met primary endpoint

registry analysis (superiority test); Delgocitinib Cream 20 mg/g vs Delgocitinib Cream Vehicle; p <0.0001; Median Difference (Net) -5.7 (95% CI -7.5 to -3.9) NCT03725722 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Delgocitinib Small molecule 1 unknown Topical
Subject Delgocitinib Small molecule 3 unknown Topical
Subject Delgocitinib Small molecule 8 unknown Topical
Subject Delgocitinib Small molecule 20 unknown Topical

Indications