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)

Phase 3

Completed

Conditions: Chronic handeczema
10014982

Registration Number: NL-OMON51146

Lead Sponsor: eo Pharma

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 29

Inclusion Criteria

1. Signed and dated informed consent has been obtained prior to any
protocol-related procedures.
2. The baseline visit in this extension trial must coincide with the Week 16
(end-of-treatment) visit in the parent trial.
3. Subjects must have met eligibility criteria at screening and baseline in the
parent trial.
4. Subjects must have completed the treatment period in the parent trial (to be
assessed at
baseline visit in this extension trial).
5. Subjects must have complied with the clinical trial protocol in the parent
trial to the
satisfaction of the investigator.
6. 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

1. Subjects who prematurely discontinued treatment with IMP or initiated rescue
medication in the parent trial.
2. Subjects 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.
3. Any medical or psychiatric condition that could put the subject at undue
risk by participating in the trial, or which, by the investigator's judgment,
makes the subject inappropriate for the trial.
4. Current participation in any other interventional clinical trial, except for
parent trial.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Number of treatment-emergent AEs from baseline up to Week 38.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• IGA-CHE score at each scheduled visit from baseline up to Week 36.<br /><br>• IGA-CHE score of 0 (clear) or 1 (almost clear) at each scheduled visit from<br /><br>baseline up to Week 36.<br /><br>• HECSI score at each scheduled visit from baseline up to Week 36.<br /><br>• HECSI-75 at each scheduled visit from baseline up to Week 36<br /><br>• HECSI-90 at each scheduled visit from baseline up to Week 36.</p><br>