An open-label multi-site extension trial in subjects who completed theLP0133-1401 (DELTA 1) or LP0133-1402 (DELTA 2) trials

Phase 1

• Conditions: Chronic Hand Eczema; MedDRA version: 23.1Level: LLTClassification code 10084778Term: Chronic hand eczemaSystem Organ Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2020-002962-15-IT
• Lead Sponsor: EO PHARMA A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-07
• Last Update Posted: 12 March 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• Signed and dated informed consent has been obtained prior to any
protocol related procedures.
• The baseline visit in this extension trial must coincide with the Week
16 (end-of-treatment) visit in the parent trial.
• Subjects must have met eligibility criteria at screening and baseline in
the parent trial.
• Subjects must have completed the treatment period in the parent trial
(to be assessed at baseline visit in this extension trial).
• Subjects 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 540
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

• Subjects who prematurely discontinued treatment with the
investigational medicinal product (IMP) or initiated rescue medication in
the parent trial.
• Subjects who experienced any 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 subject at
undue risk by participating in the trial, or which, by the investigator's judgment, makes the subject inappropriate for the trial.
• Current participation in any other interventional clinical trial, except
for parent trials.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the long-term safety of an as-needed treatment with twicedaily<br>applications of delgocitinib cream 20 mg/g.;Secondary Objective: To evaluate the long-term efficacy of an as-needed treatment with<br>twice-daily applications of delgocitinib cream 20 mg/g.;Primary end point(s): Number of treatment-emergent AEs from baseline up to Week 38;Timepoint(s) of evaluation of this end point: 38 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): IGA-CHE score at each scheduled visit from baseline up to Week 36.<br>• IGA-CHE score of 0 (clear) or 1 (almost clear) at each scheduled visit<br>from baseline up to Week 36.<br>• HECSI score at each scheduled visit from baseline up to Week 36.<br>• HECSI-75 at each scheduled visit from baseline up to Week 36.<br>• HECSI-90 at each scheduled visit from baseline up to Week 36.;Timepoint(s) of evaluation of this end point: Timepoint for evaluation described in each endpoint.