Tofacitinib Plus Imatinib in Moderate-to-Severe Palmoplantar Pustulosis

Sponsor
Second Affiliated Hospital, Zhejiang University, School of Medicine
Study ID
NCT07530367
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Palmoplantar Pustulosis (PPP)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tofacitinib — DRUG
    11 mg tablet; administered orally once daily (QD)
  • Imatinib — DRUG
    200 mg tablet; administered orally once daily (QD)
  • tofacitinib Placebo — DRUG
    Matching placebo tablet; administered orally once daily (QD)
  • Imatinib Placebo — DRUG
    Matching placebo tablet; administered orally once daily (QD)

Study Details

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.

Key Dates

First listed
Apr 15, 2026
Start date
Aug 1, 2026
Status verified
Mar 2026
Primary completion
Aug 1, 2028
Completion
Dec 30, 2030

Study Design

Enrollment
135 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm 1: Tofacitinib Monotherapy
    Tofacitinib 11 mg QD + Imatinib placebo QD
  • Active Comparator: Arm 2: Imatinib Monotherapy
    Imatinib 200mg QD+Tofacitinib placebo QD
  • Experimental: Arm 3: Combination Therapy
    Imatinib 200mg QD+Tofacitinib 11mg QD

Primary Outcome Measure

Proportion of Participants Achieving PPPASI 90 Response at Week 16 [ Time Frame: 16 weeks ]

Central Contacts