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NCT Number: 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

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.

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Key information

Conditions

Palmoplantar Pustulosis (PPP) Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Location contact

Xibei Chen

CONTACT

[email protected]

+86 15088611296

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants aged ≥ 18 years.

Diagnosis of PPP for at least 12 weeks prior to screening.

PPPASI ≥ 12 at screening and baseline.

PPP-IGA ≥ 3 at screening and baseline.

Presence of pustules on palms and/or soles at screening and baseline.

Confirmed diagnosis of PPP by photographic adjudication.

Exclusion criteria

  • Significant improvement of PPP symptoms between screening and baseline (PPPASI decrease ≥ 5).

Presence of other forms of psoriasis or inflammatory skin diseases.

Active infection or history of serious infection within specified timeframes.

Positive for hepatitis B, hepatitis C, or HIV.

Active or latent tuberculosis.

History of malignancy within 5 years (except certain skin cancers).

Laboratory abnormalities meeting exclusion criteria (e.g., ALT/AST ≥ 3×ULN, ANC < 1.5×10³/μL, etc.).

Treatment and study plan

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)

Primary outcomes

  1. Proportion of Participants Achieving PPPASI 90 Response at Week 16

    Time frame: 16 weeks

    PPPASI 90 response is defined as at least 90% improvement from baseline in the Palmoplantar Pustulosis Area and Severity Index (PPPASI) score. Participants who discontinue study treatment or receive prohibited concomitant therapy prior to Week 16 will be considered non-responders.

Secondary outcomes

  1. Proportion of Participants Achieving PPPASI 100 Response at Week 16

    Time frame: week 16

    PPPASI 100 response is defined as complete clearance (100% improvement from baseline) in the Palmoplantar Pustulosis Area and Severity Index (PPPASI) score at Week 16.

  2. Proportion of Participants Achieving at Least 4-Point Improvement in Palmoplantar Pain NRS Score at Week 16

    Time frame: week 16

    The Palmoplantar Pain Numeric Rating Scale (NRS) is an 11-point scale (0 = no pain, 10 = worst possible pain) used to assess pain intensity on the palms and soles. Response is defined as a ≥4-point improvement from baseline.

  3. Change from Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 16

    Time frame: Week 16

    The Dermatology Life Quality Index (DLQI) is a 10-item questionnaire that assesses the impact of skin disease on quality of life over the past week. Total score ranges from 0 to 30, with higher scores indicating greater impairment. A negative change indicates improvement.

  4. Incidence of Treatment-Emergent Adverse Events (TEAEs)

    Time frame: Baseline through end of safety follow-up (up to Week 32)

    Treatment-emergent adverse events are defined as any adverse event that occurs after the first dose of study treatment up to 28 days after the last dose. All TEAEs will be summarized by system organ class and preferred term.

  5. Incidence of Serious Adverse Events (SAEs)

    Time frame: Baseline through end of safety follow-up (up to Week 32)

    Serious adverse events are defined as any adverse event that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.

Other outcomes

  1. Proportion of Participants Achieving PPPASI 50/75/90/100 Response at Various Time Points

    Time frame: Weeks 2, 4, 8, 12, and 24

    Exploratory analysis of PPPASI response rates at intermediate and follow-up time points. PPPASI response is defined as the percentage improvement from baseline in Palmoplantar Pustulosis Area and Severity Index score.

    Safety Issue

  2. Change from Baseline in EQ-5D-5L Health Status Score

    Time frame: Weeks 4, 8, 12, 16, and 24

    The EQ-5D-5L is a standardized instrument for measuring health-related quality of life. It comprises a descriptive system (5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and a visual analog scale (0-100).

  3. Change from Baseline in Palmoplantar Itch NRS Score

    Time frame: Weeks 2, 4, 8, 12, 16, and 24

    The Palmoplantar Itch Numeric Rating Scale (NRS) is an 11-point scale (0 = no itch, 10 = worst imaginable itch) used to assess itch intensity on the palms and soles.

  4. Change from Baseline in Serum Biomarker Levels

    Time frame: Baseline and Week 16

    Exploratory analysis of changes in serum biomarkers associated with palmoplantar pustulosis pathogenesis, including but not limited to IL-17, IL-22, IL-36, and stem cell factor (SCF).

  5. Incidence of Adverse Events of Special Interest (AESIs)

    Time frame: Baseline through end of safety follow-up (up to Week 32)

    Adverse events of special interest include: serious infections, opportunistic infections, tuberculosis, neutropenia, hypersensitivity reactions, suicidal ideation/behavior, major adverse cardiovascular events (MACE), hepatic enzyme elevation/liver function abnormalities, malignancies, and inflammatory bowel disease.

    Safety Issue

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaoyong Man

CONTACT

[email protected]

+86 13600516219

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 15, 2026
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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