Palmoplantar Pustulosis
Conditions
Keywords
Palmoplantar pustulosis, Deucravacitinib
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 the study and receive Deucravacitinib 6mg per day for four months. This study will begin June 2025 and is expected to last 14 months.
Interventions
DRUGDeucravacitinib
25 subjects with palmoplantar pustulosis will be allocated to receive oral Deucravacitinib 6mg everyday for 16 weeks.
Sponsors
Peking University First Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary efficacy endpoint | From enrollment to the end of treatment at 16 weeks | The primary efficacy endpoint was percentage change from baseline in Palmoplantar Pustular Area and Severity Index (PPPASI) at W16. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of Deucravacitinib on overall severity of palmoplantar pustulosis | From enrollment to the end of treatment at 16 weeks | Mean change in erythema and pustules from Baseline to week 16 will be evaluated by Palmoplantar Pustular Physician's Global Assessment (PPPGA). |
| Effect of Deucravacitinib on quality of life: Dermatology Life Quality Index (DLQI) | From enrollment to the end of treatment at 16 weeks | Mean change in quality of life from Baseline to week 16 will be evaluated by Dermatology Life Quality Index (DLQI) |
Countries
China
Outcome results
None listed