A Phase III Randomized Controlled Trial Evaluating the Efficacy and Safety of Tofacitinib Combine… (NCT07530367) | Clinical Trial Compass
Not Yet RecruitingPhase 3
A Phase III Randomized Controlled Trial Evaluating the Efficacy and Safety of Tofacitinib Combined With Imatinib in Patients With Moderate-to-Severe Palmoplantar Pustulosis
China135 participantsStarted 2026-04-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of Participants Achieving PPPASI 90 Response at Week 16
Timeframe: 16 weeks
Trial details
NCT IDNCT07530367
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University