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.
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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
801
Delgocitinib cream 20 mg/g
Number of Treatment-emergent Adverse Events From Baseline up to Week 38
An AE will be considered treatment emergent if it started after the baseline visit
Time frame: From baseline up to Week 38
Number of Participants With 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).
Time frame: From baseline up to Week 38
Number of Participants With 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).
Time frame: From baseline up to Week 38
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).
Time frame: From baseline up to Week 38
Number of Participants With 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.
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LEO Investigational Site
Brussels, Belgium
LEO Investigational Site
Ghent, Belgium
LEO Investigational Site
Kortrijk, Belgium
LEO Investigational Site
Leuven, Belgium
LEO Investigational Site
Loverval, Belgium
LEO Investigational Site
Maldegem, Belgium
LEO Investigational Site
Calgary, Alberta, Canada
LEO Investigational Site
Calgary, Alberta, Canada
LEO Investigational Site
Edmonton, Alberta, Canada
LEO Investigational Site
Edmonton, Alberta, Canada
...and 85 more locations
Time frame: From baseline up to Week 38
Number of Participants With 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.
Time frame: From baseline up to Week 38