NCT07530367

A Phase III Randomized Controlled Trial Evaluating the Efficacy and Safety of Tofacitinib Combined With Imatinib in Patients With Moderate-to-Severe Palmoplantar Pustulosis

A Phase III Randomized Controlled Trial Evaluating the Efficacy and Safety of Tofacitinib Combined With Imatinib (Investigational Therapy) in Patients With Moderate-to-Severe Palmoplantar Pustulosis

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 135 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Palmoplantar pustulosis (PPP) is a rare, chronic inflammatory skin disease primarily affecting the palms and soles. Currently, no treatment is specifically approved for PPP globally. This study aims to evaluate the efficacy and safety of tofacitinib combined with imatinib in patients with moderate-to-severe PPP.

Detailed description

This is a Phase III, randomized, double-blind, three-arm parallel-controlled trial. A total of 135 patients will be randomly assigned to one of three groups: tofacitinib monotherapy, imatinib monotherapy, or combination therapy. The primary endpoint is the proportion of patients achieving PPPASI 90 response at Week 16.

Conditions

• Palmoplantar Pustulosis (PPP)

Interventions

Type	Name	Description
DRUG	Tofacitinib	5 mg tablet; administered orally twice daily (BID)
DRUG	Imatinib	Imatinib 400 mg QD
DRUG	tofacitinib Placebo	Matching placebo tablet; administered orally twice daily (BID)
DRUG	Imatinib Placebo	Matching placebo tablet; administered orally once daily (QD)

Timeline

• Start date: 2026-04-01
• Primary completion: 2028-04-01
• Completion: 2028-12-30
• First posted: 2026-04-15
• Last updated: 2026-04-15

Locations

1 site across 1 country: China