An open-label multi-site extension trial in subjects who completed the LP0133-1401 (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: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2020-002962-15-PL
• Lead Sponsor: EO Pharma A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-10
• Last Update Posted: 29 April 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