Status:
NOT_YET_RECRUITING
Efficacy and Tolerability of Deucravacitinib in the Management of Palmoplantar Pustulosis
Lead Sponsor:
Peking University First Hospital
Conditions:
Palmoplantar Pustulosis
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The goal of this clinical trial is to investigate the efficacy and safety of Deucravacitinib in patients with moderate-to-severe palmoplantar pustulosis. Approximately 25 subjects will be included in ...
Eligibility Criteria
Inclusion
- Men and women between ages 18 - 65 years who have suffered from palmoplantar pustulosis (PPP) for at least 6 months.
- Patients were required to have over 10 well-demarcated white or yellow pustules across all regions, with or without plaque psoriasis
- Patients were required to have a Palmoplantar Pustular Physician's Global Assessment (PPPGA) score of at least moderate severity (≥3) and a minimum PPPASI score of 12.
- Signed and dated written informed consent in accordance with ICH GCP and local legislation prior to admission to the trial.
- Further criteria apply.
Exclusion
- Systemic treatment for PPP ended less than five half-lives or 12 weeks ago
- Topical treatment for PPP ended less 4 weeks ago
- Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
- Severe, progressive, or uncontrolled condition such as renal, hepatic, haematological, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease, or signs and symptoms thereof.
- Presence or known history of anti-TNF-induced PPP-like disease.
- Patient with a transplanted organ (with exception of a corneal transplant \>12 weeks Prior to screening) or who have ever received stem cell therapy.
- Known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly.
- Further criteria apply.
Key Trial Info
Start Date :
June 4 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2027
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT07000630
Start Date
June 4 2025
End Date
February 1 2027
Last Update
June 3 2025
Active Locations (1)
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1
Peking University First Hospital
Beijing, China, 100034