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New drug cocktail aims to clear stubborn hand and foot pustules

NCT ID NCT07530367

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 04, 2026 · Updated 2 times

Summary

This Phase 3 trial tests whether combining two drugs, tofacitinib and imatinib, can safely clear the painful pustules of palmoplantar pustulosis (PPP), a rare chronic skin disease on the palms and soles. About 135 adults with moderate-to-severe PPP will receive either the combo or a placebo for 16 weeks. The main goal is to see if at least 90% of the skin improves.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tofacitinib and imatinib
What this could lead to
If it works, this could provide the first approved treatment for palmoplantar pustulosis, significantly clearing skin lesions on hands and feet.
What could go wrong
This is an early-stage Phase 3 trial with only 135 participants. The combination therapy may cause side effects or fail to show better results than placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 135 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

inclusion Criteria: 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). Exclusion Criteria: 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. 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    Hangzhou, Zhejiang, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.