Clinical trial NCT07000630: Efficacy and Tolerability of Deucravacitinib in the Management of Palmoplantar Pustulosis
Official title: Efficacy and Tolerability of Deucravacitinib in the Management of Palmoplantar Pustulosis; A Nonrandomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Palmoplantar Pustulosis
Keywords: Palmoplantar pustulosis
Deucravacitinib
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2025-06-03
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Primary efficacy endpoint
timeFrame: From enrollment to the end of treatment at 16 weeks
Secondary outcomes:
measure: Effect of Deucravacitinib on overall severity of palmoplantar pustulosis
timeFrame: From enrollment to the end of treatment at 16 weeks
measure: Effect of Deucravacitinib on quality of life: Dermatology Life Quality Index (DLQI)
timeFrame: From enrollment to the end of treatment at 16 weeks
Other outcomes:
measure: Tolerability of Deucravacitinib in patients with palmoplantar pustulosis
timeFrame: From enrollment to the end of treatment at 16 weeks
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
Study officials:
References: