Efficacy and Tolerability of Deucravacitinib in the Management of Palmoplantar Pustulosis

Peking University

Status

Not yet enrolling

Conditions

Palmoplantar Pustulosis

Treatments

Drug: Deucravacitinib

Study type

Interventional

Funder types

Other

Identifiers

NCT07000630

2024-452

Details and patient eligibility

About

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.

Enrollment

25 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.