NCT04949841

Open-label Multi-site Extension Trial in Subjects Who Completed the DELTA 1 or DELTA 2 Trials

A Phase 3 Extension Trial of DELTA 1 and DELTA 2 to Evaluate the Long-term Safety of a Twice-daily Treatment With Delgocitinib Cream 20 mg/g as Needed for up to 36 Weeks in Adult Subjects With Chronic Hand Eczema (DELTA 3)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 801 (actual)
• Sponsor: LEO Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this extension trial is to evaluate the long-term safety of delgocitinib. Subjects will visit the clinic every 4 week to assess the safety and efficacy of the treatment, until Week 36. A final follow-up phone call is planned on Week 38.

Detailed description

Subject who completed 16 weeks of treatment with delgocitinib cream 20 mg/g or vehicle cream twice daily in trials DELTA 1 or DELTA 2 will be offered to roll-over to this extension trial. Subjects will be treated with delgocitinib cream 20 mg/g twice daily only if they need it to control their chronic hand eczema. In the periods when the disease is controlled, no treatment will be administered. Clinic visits every 4 weeks are planned (with the possibility of unscheduled visits) to investigate safety and efficacy of treatment, as well as its effect on patient-reported outcomes (PROs).

Conditions

• Chronic Hand Eczema

Interventions

Type	Name	Description
DRUG	Delgocitinib	Delgocitinib cream 20 mg/g

Timeline

• Start date: 2021-08-23
• Primary completion: 2023-09-18
• Completion: 2023-09-18
• First posted: 2021-07-02
• Last updated: 2025-04-08
• Results posted: 2025-01-20

Locations

95 sites across 10 countries: Belgium, Canada, Denmark, France, Germany, Italy, Netherlands, Poland, Spain, United Kingdom