The primary objective of this study is to evaluate the efficacy of twice-daily applications of delgocitinib cream 20 mg/g compared with cream vehicle in the treatment of participants with moderate to severe chronic hand eczema (CHE).
The trial comprises of a 16-week double-blind, treatment period, followed by an open label treatment period of 36 weeks. In the double-blind treatment period two thirds of participants will be randomly assigned to receive delgocitinib and one third will receive placebo/vehicle. In the double-blind treatment period, participants will use delgocitinib twice a day. In the open label period, participants will only use delgocitinib when needed (if their CHE flares up). Some participants will also give blood samples at the start of the trial for pharmacokinetic measurements. Participants will visit the clinic every 4 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
362
Topical administration
Topical administration
Investigator Global Assessment for Chronic Hand Eczema Score (IGA-CHE TS) at Week 16
The IGA-CHE score ranges from 0 (clear) to 4 (severe). Treatment response is defined as a score of 0 or 1.
Time frame: Week 16
Hand Eczema Severity Index (HECSI)-90 at Week 16
Defined as at least a 90% improvement in HECSI score from baseline.
Time frame: Week 16
HECSI-75 at Week 16
Defined as at least a 75% improvement in HECSI score from baseline.
Time frame: Week 16
Percentage Change in HECSI Score From Baseline to Week 16
HECSI score is used to rate the severity of hand eczema and ranges from 0 (lowest possible score) to 360 (highest possible score).
Time frame: Baseline and Week 16
Number of Participants With Reduction of Hand Eczema Symptom Diary (HESD) Itch Score by ≥4 Points From Baseline at Week 16
Time frame: Baseline and Week 16
Number of Participants With Reduction of HESD Score by ≥4 Points From Baseline at Week 16
Time frame: Baseline and Week 16
Number of Participants With Reduction of HESD Pain Score by ≥4 Points From Baseline at Week 16
Time frame: Baseline and Week 16
Change in Dermatology Life Quality Index (DLQI) Score From Baseline to Week 16
Time frame: Baseline and Week 16
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Change in HESD Score From Baseline to Week 16
Time frame: Baseline and Week 16
Change in HESD Itch Score From Baseline to Week 16
Time frame: Baseline and Week 16
Change in HESD Pain Score From Baseline to Week 16
Time frame: Baseline and Week 16
Change in Hand Eczema Impact Scale (HEIS) Score
Time frame: Baseline and Week 16
Change in HEIS Proximal Daily Activity Limitations (PDAL) Score
Time frame: Baseline and Week 16
Number of Participants With Reduction of DLQI Score of ≥4 Points From Baseline at Week 16
Time frame: Baseline and Week 16
Number of Treatment-Emergent Adverse Events (AEs)
Time frame: From baseline to Week 16
Number of Treatment-Emergent AEs
Time frame: From Week 16 to Week 54
Area Under the Curve (AUC 0-12)
Time frame: Day 1 and Day 8 post-dose
Maximum Serum Concentration (Cmax)
Time frame: Day 1 and Day 8 (0-12 hours post-dose)
Time to Peak Drug Concentration (Tmax)
Time frame: Day 1 and Day 8 (0-12 hours post-dose)