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Open-label Multi-site Extension Trial in Subjects Who Completed the DELTA 1 or DELTA 2 Trials — DELTA3  

Chronic Hand Eczema Clinical Trial

Official title:
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)

Clinical Trial 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.

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04949841
Study type Interventional
Source LEO Pharma
Contact
Status Completed
Phase Phase 3
Start date August 23, 2021
Completion date September 18, 2023
View Details
See also
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