A 16-week Trial to Investigate the Efficacy and Safety of Delgocitinib Cream 20 mg/g in Adult Par… (NCT07013201) | Clinical Trial Compass
RecruitingPhase 2
A 16-week Trial to Investigate the Efficacy and Safety of Delgocitinib Cream 20 mg/g in Adult Participants With Mild to Severe Palmoplantar Pustulosis
United States135 participantsStarted 2025-09-11
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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.
* Confirmed PPP by central evaluation of photographs taken at screening.
* Mild to severe PPP current condition defined by:
* Disease duration of PPP of \>6 months before randomisation.
* PPP-PGA of at least mild severity (PPP-PGA ≥2) at screening and baseline.
* PPPASI ≥8 at screening and baseline.
* Presence of ≥5 well-demarcated fresh pustules (white or yellow pustules) in total across all affected areas at screening and baseline.
* Participants with prior experiences of inadequate response with topical corticosteroid(s) (TCS) or for whom TCS are inadvisable, as judged by the investigators.
* A woman of childbearing potential must use an acceptable form of birth control throughout the trial up until the last administration of investigational medicinal product (IMP).
Exclusion Criteria:
* Presence or known history of drug-induced PPP (e.g., a new onset of PPP or an …
What they're measuring
1
Number of Participants Achieving at Least 75% Improvement in PPP Area and Severity Index (PPPASI) Score from Baseline (PPPASI-75) at Week 16