Phase 2: testing Delgocitinib cream for Palmoplantar Pustulosis
The main objective of the study is to measure the how well it works 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 you would be approximately 18 weeks, for an approximate total of 9 visits.
Official registry: https://clinicaltrials.gov/study/NCT07013201 · LEO Pharma · enrollment listed as 135
What this phase means
Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Delgocitinib cream, or Vehicle cream. The registry lists allocation as randomized. The main objective of the study is to measure the how well it works 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).
They plan to enroll about 135 people at 38 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
A Proof-of-concept Phase 2a, Double-blind, 2-arm Trial to Investigate the Efficacy and Safety of Twice Daily Delgocitinib Cream 20 mg/g Compared With Cream Vehicle During a 16-week Treatment Period in Adult Subjects With Mild to Severe Palmoplantar Pustulosis
Interventions: Delgocitinib cream, Vehicle cream
Primary outcome (registry wording): Number of Participants Achieving at Least 75% Improvement in PPP Area and Severity Index (PPPASI) Score from Baseline (PPPASI-75) at Week 16
Who it is for (from inclusion criteria)
- Ages 18 Years to any
- Participant is able to comply with clinic visits and trial requirements and procedures, as assessed by the investigator
- 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
Who the registry excludes
- 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
- A systemic infection
- A serious skin infection requiring parenteral (intravenous or intramuscular) antibiotics, antiviral, or antifungal medication
Public study contact (from the registry)
Clinical Disclosure
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
38 listed- LEO Pharma Investigational Site — Fountain Valley, California (recruiting)
- LEO Pharma Investigational Site — Douglasville, Georgia (recruiting)
- LEO Pharma Investigational Site — West Bloomfield, Michigan (recruiting)
- LEO Pharma Investigational Site — Elmhurst, New York (recruiting)
- LEO Pharma Investigation Site — Mayfield Heights, Ohio (recruiting)
- LEO Pharma Investigational Site — Portland, Oregon (recruiting)
- LEO Pharma Investigational Site — Philadelphia, Pennsylvania (recruiting)
+ 31 sites outside the US on the same record
FAQ about this NCT record
Is NCT07013201 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07013201?
Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07013201?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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