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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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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)

Conditions
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Chronic Hand Eczema

Intervention / Treatment
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* Drug: Delgocitinib


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: As-needed treatment with delgocitinib<br>Subjects will be treated with delgocitinib cream 20 mg/g twice daily as needed. | Drug: Delgocitinib<br>* Delgocitinib cream 20 mg/g<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of treatment-emergent adverse events from baseline up to Week 38 |  | From baseline to Week 38 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IGA-CHE score at each scheduled visit from baseline up to Week 36 | The Investigator's Global Assessment for chronic hand eczema (IGA-CHE) is an instrument used in clinical trials to rate the severity of the participant's chronic hand eczema (CHE) and is based on a 5-point scale ranging from 0 (clear) to 4 (severe). | From baseline to Week 36 | 
| IGA-CHE score of 0 (clear) or 1 (almost clear) at each scheduled visit from baseline up to Week 36. | The Investigator's Global Assessment for chronic hand eczema (IGA-CHE) is an instrument used in clinical trials to rate the severity of the participant's chronic hand eczema (CHE) and is based on a 5-point scale ranging from 0 (clear) to 4 (severe). | From baseline to Week 36 | 
| HECSI score at each scheduled visit from baseline up to Week 36 | The Hand Eczema Severity Index (HECSI) is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers [except fingertips], palm of hands, back of hands, and wrists) by use of standard scales. The HECSI score will range from 0 (lowest possible score) to 360 (highest possible score). | From baseline to Week 36 | 
| HECSI-75 at each scheduled visit from baseline up to Week 36 | The Hand Eczema Severity Index (HECSI) is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers [except fingertips], palm of hands, back of hands, and wrists) by use of standard scales. The HECSI score will range from 0 (lowest possible score) to 360 (highest possible score). HECSI-75 is defined as at least 75% improvement in HECSI score from parent trial baseline. | From baseline to Week 36 | 
| HECSI-90 at each scheduled visit from baseline up to Week 36 | The Hand Eczema Severity Index (HECSI) is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers [except fingertips], palm of hands, back of hands, and wrists) by use of standard scales. The HECSI score will range from 0 (lowest possible score) to 360 (highest possible score). HECSI-90 is defined as at least 90% improvement in HECSI score from parent trial baseline. | From baseline to Week 36 |