NCT05219864

Topical Ruxolitinib Evaluation in Chronic Hand Eczema Study 1

Topical Ruxolitinib Evaluation in Chronic Hand Eczema Study 1 (TRuE-CHE1): A Phase 3, Double-Blind, Randomized, 16-Week, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream Followed by an Open-Label Extension Period in Adults With Chronic Hand Eczema

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Incyte Corporation · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in adult participants with diagnosis of chronic hand eczema (CHE) and moderate to severe disease activity (Investigator's Global Assessement (IGA) of CHE score 3 or 4).

Conditions

• Hand Eczema

Interventions

Type	Name	Description
DRUG	Ruxolitinib cream	Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.
DRUG	Vehicle	Vehicle cream is a topical formulation applied as a thin film to affected areas.

Timeline

• Start date: 2023-01-31
• Primary completion: 2024-04-25
• Completion: 2024-09-22
• First posted: 2022-02-02
• Last updated: 2022-11-17

Locations

49 sites across 6 countries: United States, Canada, Czechia, Germany, Poland, Spain

Regulatory

• FDA-regulated drug study