Palmoplantar Pustulosis (PPP)Phase 3NCT07530367
Tofacitinib Plus Imatinib in Moderate-to-Severe Palmoplantar Pustulosis
A Phase 3 study testing Tofacitinib and Imatinib in people with Palmoplantar Pustulosis (PPP), run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Palmoplantar Pustulosis (PPP)
- What is being tested?
- Tofacitinib and Imatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 135 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2026to 30 Dec 2030
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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).
Who cannot join
- 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.
Show all 32Show fewer
- 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.
- Positive test results for acute or chronic hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV). Exclusion is defined as:
- 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.
- Presence of other inflammatory diseases, including but not limited to rheumatoid arthritis, hidradenitis suppurativa, inflammatory bowel disease, or systemic lupus erythematosus.
- Major surgery (including joint surgery) within 8 weeks prior to the screening visit, or planned surgery during the study period.
- Any systemic disease (e.g., cardiovascular, neurological, renal, hepatic, metabolic, gastrointestinal, hematological, coagulation disorders, immune system disease) that, in the investigator's opinion, is uncontrolled, unstable, or likely to progress to a clinically significant degree during the study.
- Any medical or psychiatric condition (including ongoing major depression or active suicidal ideation) that, in the investigator's opinion, may impair the participant's ability to participate in the study.
- History of chronic alcohol or drug abuse within 6 months prior to the screening visit, as determined by the investigator based on medical history, interview, and examination findings.
- Current or prior use of IL-17A, IL-17A/F, or IL-23 inhibitors.
- Receipt of any live vaccine (including attenuated vaccines) within 8 weeks prior to the baseline visit.
- Vaccination not permitted during the study and within 17 weeks after the last dose of study treatment.
- Laboratory abnormalities at the screening visit, including any of the following:
- ALT, AST, or ALP ≥ 3×ULN.
- Bilirubin > 1.5×ULN (unconjugated bilirubin > 1.5×ULN is acceptable if bilirubin is fractionated and direct bilirubin/total bilirubin ratio is < 35%).
- White blood cell count < 3.0×10³/μL.
- Absolute neutrophil count < 1.5×10³/μL.
- Lymphocyte count < 500 cells/μL.
- Hemoglobin < 8.5 g/dL.
- Any other laboratory abnormality that, in the investigator's opinion, may interfere with the participant's ability to complete the study or confound the interpretation of study results.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang
Xibei Chen, +86 15088611296, chenxb@zju.edu.cn
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Palmoplantar Pustulosis (PPP)
- Being tested
- Tofacitinib, Imatinib, tofacitinib Placebo, Imatinib Placebo
- Keywords
- Palmoplantar Pustulosis, Tofacitinib, Imatinib
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TofacitinibDrug
11 mg tablet; administered orally once daily (QD)
ImatinibDrug
200 mg tablet; administered orally once daily (QD)
tofacitinib PlaceboDrug
Matching placebo tablet; administered orally once daily (QD)
Imatinib PlaceboDrug
Matching placebo tablet; administered orally once daily (QD)
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Tofacitinib Monotherapy | Active comparator | Tofacitinib 11 mg QD + Imatinib placebo QD Receives: Drug: Tofacitinib; Drug: Imatinib Placebo |
| Arm 2: Imatinib Monotherapy | Active comparator | Imatinib 200mg QD+Tofacitinib placebo QD Receives: Drug: Imatinib; Drug: tofacitinib Placebo |
| Arm 3: Combination Therapy | Experimental | Imatinib 200mg QD+Tofacitinib 11mg QD Receives: Drug: Tofacitinib; Drug: Imatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 16 weeks
Secondary outcomes (5)
Proportion of Participants Achieving PPPASI 100 Response at 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.
Measured: week 16
Proportion of Participants Achieving at Least 4-Point Improvement in Palmoplantar Pain NRS Score at 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.
Measured: week 16
Change from Baseline in Dermatology Life Quality Index (DLQI) Total Score at 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.
Measured: Week 16
Incidence of Treatment-Emergent Adverse Events (TEAEs)
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.
Measured: Baseline through end of safety follow-up (up to Week 32)
Incidence of Serious Adverse Events (SAEs)
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.
Measured: Baseline through end of safety follow-up (up to Week 32)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Aug 2028 (estimated)
- Study completion30 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palmoplantar Pustulosis (PPP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07530367
- Sponsor's protocol ID
- 2026-0173
- Status last verified
- Mar 2026
- First submitted
- 8 Apr 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared.