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

Chronic Hand Eczema Clinical Trial

Official title:
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

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06004050
Study type Interventional
Source LEO Pharma
Contact Clinical Disclosure
Phone (+1) 877-557-1168
Email disclosure@leo-pharma.com
Status Recruiting
Phase Phase 3
Start date September 5, 2023
Completion date September 18, 2025
View Details
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