NCT06004050

A Trial to Evaluate Efficacy, Safety, and Pharmacokinetics of Delgocitinib Cream in Chinese Adults and Adolescents With Moderate to Severe Chronic Hand Eczema

A Phase 3 Trial to Evaluate Efficacy, Safety, and Pharmacokinetics of Twice-Daily Applications of Delgocitinib Cream 20 mg/g in Chinese Adults and Adolescents (12-17 Years of Age) With Moderate to Severe Chronic Hand Eczema

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 362 (actual)
• Sponsor: LEO Pharma · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the efficacy of twice-daily applications of delgocitinib cream 20 mg/g compared with cream vehicle in the treatment of participants with moderate to severe chronic hand eczema (CHE).

Detailed description

The trial comprises of a 16-week double-blind, treatment period, followed by an open label treatment period of 36 weeks. In the double-blind treatment period two thirds of participants will be randomly assigned to receive delgocitinib and one third will receive placebo/vehicle. In the double-blind treatment period, participants will use delgocitinib twice a day. In the open label period, participants will only use delgocitinib when needed (if their CHE flares up). Some participants will also give blood samples at the start of the trial for pharmacokinetic measurements. Participants will visit the clinic every 4 weeks.

Conditions

• Chronic Hand Eczema

Interventions

Type	Name	Description
DRUG	Delgocitinib	Topical administration
OTHER	Vehicle cream	Topical administration

Timeline

• Start date: 2023-09-05
• Primary completion: 2024-12-16
• Completion: 2025-09-12
• First posted: 2023-08-22
• Last updated: 2025-09-25

Locations

37 sites across 1 country: China