RecruitingPalmoplantar Pustulosis
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
Eligible age
18+ yrs
Accepts
All genders
Locations
7 states
Healthy volunteers
No
See if you qualify for this study
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About this study
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.
Sponsor: LEO Pharma
You may qualify if…
- ✓ 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.
You may not qualify if…
- ✕ 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.
- ✕ Concurrent plaque psoriasis covering \>5% of body surface area.
- ✕ Clinically significant infection within 4 weeks prior to baseline, which, in the opinion of the investigator, may compromise the safety of the participant in the trial, interfere with evaluation of the IMP, or reduce the participant's ability to participate in the trial. Clinically significant infections are defined as:
- ✕ A systemic infection.
- ✕ A serious skin infection requiring parenteral (intravenous or intramuscular) antibiotics, antiviral, or antifungal medication.
Where it's recruiting
California
Fountain Valley
Georgia
Douglasville
Michigan
West Bloomfield
New York
Elmhurst
Ohio
Mayfield Heights
Oregon
Portland
Pennsylvania
Philadelphia
Source: ClinicalTrials.gov · NCT07013201 · last updated 2026-06-05