Tofacitinib Plus Imatinib in Moderate-to-Severe Palmoplantar Pustulosis

NCT07530367 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: 2026-0173
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Palmoplantar Pustulosis (PPP)

Keywords

Palmoplantar Pustulosis; Tofacitinib; Imatinib

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants Achieving PPPASI 90 Response at Week 16

  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.

  16 weeks

Secondary Outcomes (5)

• Proportion of Participants Achieving PPPASI 100 Response at Week 16

  week 16

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

  week 16

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

  Week 16

• Incidence of Treatment-Emergent Adverse Events (TEAEs)

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

• Incidence of Serious Adverse Events (SAEs)

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

Other Outcomes (5)

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

  Weeks 2, 4, 8, 12, and 24

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

  Weeks 4, 8, 12, 16, and 24

• Change from Baseline in Palmoplantar Itch NRS Score

  Weeks 2, 4, 8, 12, 16, and 24

Study Arms (3)

Arm 1: Tofacitinib Monotherapy

ACTIVE COMPARATOR

Tofacitinib 11 mg QD + Imatinib placebo QD

Drug: Tofacitinib; Drug: Imatinib Placebo

Arm 2: Imatinib Monotherapy

ACTIVE COMPARATOR

Imatinib 200mg QD+Tofacitinib placebo QD

Drug: Imatinib; Drug: tofacitinib Placebo

Arm 3: Combination Therapy

EXPERIMENTAL

Imatinib 200mg QD+Tofacitinib 11mg QD

Drug: Tofacitinib; Drug: Imatinib

Interventions

Tofacitinib DRUG

11 mg tablet; administered orally once daily (QD)

Arm 1: Tofacitinib Monotherapy; Arm 3: Combination Therapy

Imatinib DRUG

200 mg tablet; administered orally once daily (QD)

Arm 2: Imatinib Monotherapy; Arm 3: Combination Therapy

tofacitinib Placebo DRUG

Matching placebo tablet; administered orally once daily (QD)

Arm 2: Imatinib Monotherapy

Imatinib Placebo DRUG

Matching placebo tablet; administered orally once daily (QD)

Arm 1: Tofacitinib Monotherapy

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years at the time of screening.
• Diagnosis of palmoplantar pustulosis (PPP) for at least 12 weeks prior to the screening visit.
• May have a history of or concurrent plaque psoriasis.
• PPPASI score ≥ 12 at both the screening and baseline visits.
• PPP-IGA score ≥ 3 at both the screening and baseline visits.
• Presence of pustules on the palms and/or soles at both the screening and baseline visits, defined as pustule severity ≥ 2 in at least one region (one palm or one sole) based on the PPPASI.
• Must have a confirmed diagnosis of PPP by photographic adjudication.
• Male and/or female participants.
• Female participants must not be pregnant, not be lactating (including feeding an infant by breast pump).

You may not qualify if:

• Significant improvement in PPP symptoms between the screening and baseline visits, defined as a reduction in PPPASI score of ≥ 5 units.
• Presence of any of the following conditions: guttate psoriasis, erythrodermic psoriasis, generalized pustular psoriasis, acrodermatitis continua of Hallopeau, atopic dermatitis, dyshidrotic eczema, chronic hand eczema, or folliculitis.
• Drug-induced psoriasis (e.g., first onset or current flare triggered by beta-blockers, calcium channel inhibitors, lithium preparations, or TNF inhibitors) or drug-induced pustular psoriasis (e.g., acute generalized exanthematous pustulosis, acute localized exanthematous pustulosis).
• Active infection or history of infection, as follows:
• Any active infection within 14 days prior to the baseline visit.
• Severe infection requiring hospitalization or intravenous anti-infective treatment within 8 weeks prior to the baseline visit.
• History of opportunistic infections, recurrent infections, or chronic infections that, in the investigator's opinion, would make participation in this study harmful to the participant.
• HBV positive: 1) hepatitis B surface antigen positive, or 2) anti-hepatitis B core antibody positive.
• HCV positive: 1) hepatitis C antibody positive, and 2) confirmed by a confirmatory HCV test (e.g., HCV polymerase chain reaction).
• Any of the following tuberculosis (TB)-related conditions:
• Known active TB disease.
• History of active TB involving any organ system, unless adequately treated per WHO/CDC treatment guidelines and confirmed as fully recovered by consultation with a relevant specialist.
• Latent TB infection (LTBI): Participants with LTBI may be rescreened once after receiving at least 4 weeks of appropriate LTBI treatment, provided that no treatment-related hepatotoxicity is evident prior to the first dose of investigational medicinal product (ALT/AST still ≤ 3×ULN).
• History of lymphoproliferative disorders (e.g., lymphoma) or current symptoms suggestive of lymphoproliferative disorders.
• Current active malignancy or history of malignancy within 5 years prior to the screening visit, except for squamous cell carcinoma or basal cell carcinoma of the skin, or treated and considered cured in situ cervical cancer.

Sponsors & Collaborators

• Second Affiliated Hospital, Zhejiang University, School of Medicine: lead

Study Sites (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Psoriasis

Interventions

tofacitinib; Imatinib Mesylate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Central Study Contacts

Xiaoyong Man

CONTACT

+86 13600516219; manxy@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 15, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): December 30, 2030
• Last Updated: August 3, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)