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.

A Phase 2b, Double-blind, Randomised, 5-arm, Vehicle-controlled, Dose Ranging Trial to Evaluate the Efficacy and Safety of Twice Daily Topical Applications of Delgocitinib Cream 1, 3, 8, 20 mg/g for 8 Weeks in Adult Subjects With Mild to Severe Atopic Dermatitis.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 251 (actual)
• Sponsor: LEO Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	Delgocitinib cream	Cream for topical application
DRUG	Delgocitinib cream vehicle	The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.

Timeline

• Start date: 2018-12-28
• Primary completion: 2020-05-19
• Completion: 2020-05-19
• First posted: 2018-10-31
• Last updated: 2025-03-12
• Results posted: 2021-07-08

Locations

31 sites across 3 countries: United States, Australia, Canada

Regulatory

• FDA-regulated drug study