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

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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
    5 mg tablet; administered orally twice daily (BID)
  • Imatinib — DRUG
    Imatinib 400 mg QD
  • tofacitinib Placebo — DRUG
    Matching placebo tablet; administered orally twice daily (BID)
  • 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

Start date
Apr 1, 2026
Status verified
Mar 2026
Primary completion
Apr 1, 2028
Completion
Dec 30, 2028

Study Design

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

Arms

  • Active Comparator: Arm 1: Tofacitinib Monotherapy
    Tofacitinib 5 mg BID + Imatinib placebo QD
  • Active Comparator: Arm 2: Imatinib Monotherapy
  • Experimental: Arm 3: Combination Therapy
    Tofacitinib 5 mg BID + Imatinib 400 mg QD

Primary Outcome Measure

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

Central Contacts