A Phase III Randomized Controlled Trial Evaluating the Efficacy and Safety of Tofacitinib Combined With Imatinib in Patients With 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 5 mg BID + Imatinib placebo QD

Drug: Tofacitinib; Drug: Imatinib Placebo

Arm 2: Imatinib Monotherapy

ACTIVE COMPARATOR

Drug: Imatinib; Drug: tofacitinib Placebo

Arm 3: Combination Therapy

EXPERIMENTAL

Tofacitinib 5 mg BID + Imatinib 400 mg QD

Drug: Tofacitinib; Drug: Imatinib

Interventions

Tofacitinib DRUG

5 mg tablet; administered orally twice daily (BID)

Arm 1: Tofacitinib Monotherapy; Arm 3: Combination Therapy

Imatinib DRUG

Imatinib 400 mg QD

Arm 2: Imatinib Monotherapy; Arm 3: Combination Therapy

tofacitinib Placebo DRUG

Matching placebo tablet; administered orally twice daily (BID)

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:

• \- 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: 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: April 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: April 15, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)