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.
Signed and dated informed consent has been obtained prior to any protocol-related procedures.
Age 18 years or above at the time of informed consent signing.
Participant is able to comply with clinic visits and trial requirements and procedures, as assessed by the investigator.
Diagnosis of PPP in accordance with the consensus diagnostic criteria established by European Rare and Severe Psoriasis Expert Network: primary, persistent (>3 months duration), sterile, macroscopically visible pustules on the palms and/or soles, with or without plaque psoriasis elsewhere on the body.
Presence or known history of drug-induced PPP (e.g., a new onset of PPP or an exacerbation of PPP from beta blockers, calcium channel blockers, lithium, or biologic therapy including infliximab, adalimumab, or etanercept).
Presence of acrodermatitis continua of Hallopeau.
Active dermatologic condition that could confound the diagnosis of PPP or interfere with assessment of the IMP, as assessed by the investigator.
Clinically significant infection on the palms or soles.
Parallel
Delgocitinib cream
DrugTopical application
Vehicle cream
DrugTopical application
Number of Participants Achieving at Least 75% Improvement in PPP Area and Severity Index (PPPASI) Score from Baseline (PPPASI-75) at 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
Change in the Overall Number of Fresh Pustules From Baseline to Week 16
Number of Participants with a ≥1-point Reduction in PPP-PGA Score From Baseline to Week 16
Number of Participants with a ≥2-point Reduction in PPP-PGA Score From Baseline to Week 16
