About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Delgocitinib cream
- Vehicle cream