Open-label Multi-site Extension Trial in Subjects Who Completed the DELTA 1 or DELTA 2 Trials
- Registration Number
- NCT04949841
- Lead Sponsor
- LEO Pharma
- Brief 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.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 801
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description As-needed treatment with delgocitinib Delgocitinib Subjects will be treated with delgocitinib cream 20 mg/g twice daily as needed.
- Primary Outcome Measures
Name Time Method Number of Treatment-emergent Adverse Events From Baseline up to Week 38 From baseline up to Week 38 An AE will be considered treatment emergent if it started after the baseline visit
- Secondary Outcome Measures
Name Time Method Number of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36 From baseline up to Week 38 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).
Number of Participants With IGA-CHE Score of 0 (Clear) or 1 (Almost Clear) at Each Scheduled Visit From Baseline up to Week 36. From baseline up to Week 38 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).
HECSI Score at Each Scheduled Visit From Baseline up to Week 36 From baseline up to Week 38 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).
Number of Participants With HECSI-75 at Each Scheduled Visit From Baseline up to Week 36 From baseline up to Week 38 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.
Number of Participants With HECSI-90 at Each Scheduled Visit From Baseline up to Week 36 From baseline up to Week 38 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.
Trial Locations
- Locations (6)
LEO investigational Site
🇩🇰Copenhagen, Denmark
LEO Pharma Investigational Site
🇵🇱Rzeszów, Poland
LEO Investigational Sites
🇬🇧Redhill, Surrey, United Kingdom
LEO Investigational Site
🇬🇧Salford, United Kingdom
Leo Investigational Site
🇩🇪Münster, Germany
LEO Investigitional Site
🇪🇸Barcelona, Spain