The main objective of the study is to evaluate the efficacy of twice daily applications of delgocitinib cream 20 mg/g compared with cream vehicle in the treatment of adult participants with mild to severe palmoplantar pustulosis (PPP). Total study duration for each participants will be approximately 18 weeks, for an approximate total of 9 visits.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
135
Topical application
Topical application
Number of Participants Achieving at Least 75% Improvement in PPP Area and Severity Index (PPPASI) Score from Baseline (PPPASI-75) at Week 16
Time frame: Baseline to Week 16
Number of Participants with PPP-Physician Global Assessment (PGA) Score of 0 or 1 with at Least a 2-step Improvement from Baseline at Week 16
Time frame: Baseline to Week 16
Change in the Overall Number of Fresh Pustules From Baseline to Week 16
Time frame: Baseline to Week 16
Number of Participants with a ≥1-point Reduction in PPP-PGA Score From Baseline to Week 16
Time frame: Baseline to Week 16
Number of Participants with a ≥2-point Reduction in PPP-PGA Score From Baseline to Week 16
Time frame: Baseline to Week 16
Change in PPPASI Score From Baseline to Week 16
Time frame: Baseline to Week 16
Percentage Change in PPPASI Score From Baseline to Week 16
Time frame: Baseline to Week 16
Number of Participants Achieving PPPASI-50 at Week 16
Time frame: Week 16
Number of Participants Achieving PPPASI-90 at Week 16
Time frame: Week 16
Change from Baseline to Week 16 in PPP-symptoms assessment (SA) Score
Time frame: Baseline to Week 16
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LEO Pharma Investigational Site
Fountain Valley, California, United States
RECRUITINGLEO Pharma Investigational Site
Douglasville, Georgia, United States
RECRUITINGLEO Pharma Investigational Site
West Bloomfield, Michigan, United States
RECRUITINGLEO Pharma Investigational Site
Elmhurst, New York, United States
RECRUITINGLEO Pharma Investigation Site
Mayfield Heights, Ohio, United States
RECRUITINGLEO Pharma Investigational Site
Portland, Oregon, United States
RECRUITINGLEO Pharma Investigational Site
Philadelphia, Pennsylvania, United States
RECRUITINGLEO Pharma Investigational Site
Surrey, British Columbia, Canada
RECRUITINGLEO Pharma Investigational Site
Winnipeg, Manitoba, Canada
RECRUITINGLEO Pharma Investigational Site
Fredericton, New Brunswick, Canada
RECRUITING...and 25 more locations
Percentage Change in PPP-SA Score from Baseline to Week 16
Time frame: Baseline to Week 16
Change from Baseline to Week 16 in PPP-SA Itch Score for the Hands
Time frame: Baseline to Week 16
Change from Baseline to Week 16 in PPP-SA Itch Score for the Feet
Time frame: Baseline to Week 16
Change from Baseline to Week 16 in PPP-SA Pain Score for the Hands
Time frame: Baseline to Week 16
Change from Baseline to Week 16 in PPP-SA Pain Score for the Feet
Time frame: Baseline to Week 16
Change in Fresh Pustules at Weeks 1, 2, 4, 8, and 12
Time frame: Baseline to Week 12
Number of Fresh Pustules Overall at Weeks 1, 2, 4, 8, 12, and 16
Time frame: Baseline to Week 16
Number of Participants who Experienced Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) is any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. TEAEs are any event that occurred after the participant received study treatment. Any clinically significant changes in vital signs, electrocardiograms, and clinical laboratory tests that occurred after study treatment administration were recorded as TEAEs. A serious TEAE is any untoward medical occurrence in a clinical study participant after first dose irrespective of a causal relationship with the study treatment(s) that resulted in death, was immediately life threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or another medically important serious event.
Time frame: Baseline to Week 18
Number of Participants with a ≥4-point Reduction in Dermatology Life Quality Index (DQLI) Score From Baseline to Week 16
Time frame: Baseline to Week 16
Change from Baseline to Week 16 in DLQI Score
Time frame: Baseline to Week 16
Percentage Change from Baseline to Week 16 in DLQI Score
Time frame: Baseline to Week 16
Change from Baseline to Week 16 in PPP-Impact Assessment (IA) Score
Time frame: Baseline to Week 16
Percentage Change from Baseline to Week 16 in PPP-IA Score
Time frame: Baseline to Week 16
Change in Work Productivity and Activity (WPAI) PPP Absenteeism Score from Baseline to Week 16
Time frame: Baseline to Week 16
Change in Work WPAI:PPP Presenteeism Score from Baseline to Week 16
Time frame: Baseline to Week 16
Change in WPAI:PPP work Productivity Score from Baseline to Week 16
Time frame: Baseline to Week 16
Change in WPAI:PPP Activity Impairment Score from Baseline to Week 16
Time frame: Baseline to Week 16