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

• Status: Enrolling by invitation
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: LEO Pharma

Criteria

Inclusion Criteria:

• Participants must have met eligibility criteria at screening and baseline in the parent trial (DELTA 1 or DELTA 2).

• Participants must have completed the treatment period in the parent trial (to be assessed at baseline visit in this extension trial).

• Participants must have complied with the clinical trial protocol in the parent trial to the satisfaction of the investigator.

• A woman of childbearing potential must use an acceptable method of birth control throughout the trial up until the end-of-treatment/early termination visit.

Exclusion Criteria:

• Participants who prematurely discontinued treatment with IMP or initiated rescue medication in the parent trial.

• Participants who experienced any adverse event (AE) during participation in the parent trial, which precludes further treatment with delgocitinib cream 20 mg/g in the judgement of the investigator.

• Any medical or psychiatric condition that could put the participant at undue risk by participating in the trial, or which, by the investigator's judgment, makes the participant inappropriate for the trial.