[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633721":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":32,"centralContacts":44,"locations":50,"responsibleParty":67,"collaborators":32,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":32,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":32,"enrollmentInfo":78,"targetDuration":32,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":89,"whyStopped":32,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Second Affiliated Hospital, School of Medicine, Zhejiang University","OTHER",[8,15,21],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1: Tofacitinib Monotherapy","ACTIVE_COMPARATOR","Tofacitinib 11 mg QD + Imatinib placebo QD",[13,14],"Drug: Tofacitinib","Drug: Imatinib Placebo",{"label":16,"type":10,"description":17,"interventionNames":18},"Arm 2: Imatinib Monotherapy","Imatinib 200mg QD+Tofacitinib placebo QD",[19,20],"Drug: Imatinib","Drug: tofacitinib Placebo",{"label":22,"type":23,"description":24,"interventionNames":25},"Arm 3: Combination Therapy","EXPERIMENTAL","Imatinib 200mg QD+Tofacitinib 11mg QD",[13,19],[27,33,37,41],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","Tofacitinib","11 mg tablet; administered orally once daily (QD)",[9,22],null,{"type":28,"name":34,"description":35,"armGroupLabels":36,"otherNames":32},"Imatinib","200 mg tablet; administered orally once daily (QD)",[16,22],{"type":28,"name":38,"description":39,"armGroupLabels":40,"otherNames":32},"tofacitinib Placebo","Matching placebo tablet; administered orally once daily (QD)",[16],{"type":28,"name":42,"description":39,"armGroupLabels":43,"otherNames":32},"Imatinib Placebo",[9],[45],{"name":46,"role":47,"phone":48,"phoneExt":32,"email":49},"Xiaoyong Man","CONTACT","+86 13600516219","manxy@zju.edu.cn",[51],{"facility":5,"status":32,"city":52,"state":53,"zip":32,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Hangzhou","Zhejiang","China","CN",{"type":57,"coordinates":58},"Point",[59,60],120.16142,30.29365,{"lat":60,"lon":59},[63],{"name":64,"role":47,"phone":65,"phoneExt":32,"email":66},"Xibei Chen","+86 15088611296","chenxb@zju.edu.cn",{"type":68,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100633721","phase-3-tofacitinib-plus-imatinib-in-moderate-to-severe-palmoplantar-pustulosis-100633721",false,"NCT07530367","Tofacitinib Plus Imatinib in Moderate-to-Severe Palmoplantar Pustulosis","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","inclusion Criteria:\n\nAge ≥ 18 years at the time of screening.\n\nDiagnosis of palmoplantar pustulosis (PPP) for at least 12 weeks prior to the screening visit.\n\nMay have a history of or concurrent plaque psoriasis.\n\nPPPASI score ≥ 12 at both the screening and baseline visits.\n\nPPP-IGA score ≥ 3 at both the screening and baseline visits.\n\nPresence of pustules on the palms and\u002For 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.\n\nMust have a confirmed diagnosis of PPP by photographic adjudication.\n\nMale and\u002For female participants.\n\nFemale participants must not be pregnant, not be lactating (including feeding an infant by breast pump).\n\nExclusion Criteria:\n\nSignificant improvement in PPP symptoms between the screening and baseline visits, defined as a reduction in PPPASI score of ≥ 5 units.\n\nPresence 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.\n\nDrug-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).\n\nActive infection or history of infection, as follows:\n\nAny active infection within 14 days prior to the baseline visit.\n\nSevere infection requiring hospitalization or intravenous anti-infective treatment within 8 weeks prior to the baseline visit.\n\nHistory of opportunistic infections, recurrent infections, or chronic infections that, in the investigator's opinion, would make participation in this study harmful to the participant.\n\nPositive test results for acute or chronic hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV). Exclusion is defined as:\n\nHBV positive: 1) hepatitis B surface antigen positive, or 2) anti-hepatitis B core antibody positive.\n\nHCV positive: 1) hepatitis C antibody positive, and 2) confirmed by a confirmatory HCV test (e.g., HCV polymerase chain reaction).\n\nAny of the following tuberculosis (TB)-related conditions:\n\nKnown active TB disease.\n\nHistory of active TB involving any organ system, unless adequately treated per WHO\u002FCDC treatment guidelines and confirmed as fully recovered by consultation with a relevant specialist.\n\nLatent 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\u002FAST still ≤ 3×ULN).\n\nHistory of lymphoproliferative disorders (e.g., lymphoma) or current symptoms suggestive of lymphoproliferative disorders.\n\nCurrent 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.\n\nPresence of other inflammatory diseases, including but not limited to rheumatoid arthritis, hidradenitis suppurativa, inflammatory bowel disease, or systemic lupus erythematosus.\n\nMajor surgery (including joint surgery) within 8 weeks prior to the screening visit, or planned surgery during the study period.\n\nAny 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.\n\nAny 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.\n\nHistory 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.\n\nCurrent or prior use of IL-17A, IL-17A\u002FF, or IL-23 inhibitors.\n\nReceipt of any live vaccine (including attenuated vaccines) within 8 weeks prior to the baseline visit.\n\nVaccination not permitted during the study and within 17 weeks after the last dose of study treatment.\n\nLaboratory abnormalities at the screening visit, including any of the following:\n\nALT, AST, or ALP ≥ 3×ULN.\n\nBilirubin \\> 1.5×ULN (unconjugated bilirubin \\> 1.5×ULN is acceptable if bilirubin is fractionated and direct bilirubin\u002Ftotal bilirubin ratio is \\\u003C 35%).\n\nWhite blood cell count \\\u003C 3.0×10³\u002FμL.\n\nAbsolute neutrophil count \\\u003C 1.5×10³\u002FμL.\n\nLymphocyte count \\\u003C 500 cells\u002FμL.\n\nHemoglobin \\\u003C 8.5 g\u002FdL.\n\nAny 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.","ALL","18 Years",{"count":79,"type":80},135,"ESTIMATED","INTERVENTIONAL",[83],"PHASE3","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.",[86],"Palmoplantar Pustulosis (PPP)",[88,29,34],"Palmoplantar Pustulosis","NOT_YET_RECRUITING","2026-07-30",{"date":92,"type":93},"2026-08-03","ACTUAL",{"date":95,"type":80},"2026-08-01",{"date":97,"type":80},"2030-12-30",{"name":5,"class":6},1]