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.
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |