Efficacy and Tolerability of Deucravacitinib in the Management of Palmoplantar Pustulosis

NCT07000630 | Terminated

• 1 other identifier: 2024-452
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Palmoplantar Pustulosis

Keywords

Palmoplantar pustulosis; Deucravacitinib

Outcome Measures

Primary Outcomes (1)

• Primary efficacy endpoint

  The primary efficacy endpoint was percentage change from baseline in Palmoplantar Pustular Area and Severity Index (PPPASI) at W16.

  From enrollment to the end of treatment at 16 weeks

Secondary Outcomes (2)

• Effect of Deucravacitinib on overall severity of palmoplantar pustulosis

  From enrollment to the end of treatment at 16 weeks

• Effect of Deucravacitinib on quality of life: Dermatology Life Quality Index (DLQI)

  From enrollment to the end of treatment at 16 weeks

Other Outcomes (1)

• Tolerability of Deucravacitinib in patients with palmoplantar pustulosis

  From enrollment to the end of treatment at 16 weeks

Study Arms (1)

Deucravacitinib treatment

EXPERIMENTAL

25 subjects with palmoplantar pustulosis will be allocated to receive oral Deucravacitinib 6mg everyday for 16 weeks.

Drug: Deucravacitinib

Interventions

Deucravacitinib DRUG

25 subjects with palmoplantar pustulosis will be allocated to receive oral Deucravacitinib 6mg everyday for 16 weeks.

Deucravacitinib treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Peking University First Hospital

Beijing, 100034, China

Location

MeSH Terms

Conditions

Psoriasis

Interventions

deucravacitinib

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending doctor

Study Record Dates

• First Submitted: May 24, 2025
• First Posted: June 3, 2025
• Study Start: June 20, 2025
• Primary Completion: November 30, 2025
• Study Completion: December 1, 2025
• Last Updated: March 11, 2026

Record last verified: 2026-03

Locations

CN (1)