[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633721":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":17,"centralContacts":44,"locations":50,"responsibleParty":67,"collaborators":17,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":17,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":17,"enrollmentInfo":78,"targetDuration":17,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":89,"whyStopped":17,"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 5 mg BID + Imatinib placebo QD",[13,14],"Drug: Tofacitinib","Drug: Imatinib Placebo",{"label":16,"type":10,"description":17,"interventionNames":18},"Arm 2: Imatinib Monotherapy",null,[19,20],"Drug: Imatinib","Drug: tofacitinib Placebo",{"label":22,"type":23,"description":24,"interventionNames":25},"Arm 3: Combination Therapy","EXPERIMENTAL","Tofacitinib 5 mg BID + Imatinib 400 mg QD",[13,19],[27,32,36,40],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":17},"DRUG","Tofacitinib","5 mg tablet; administered orally twice daily (BID)",[9,22],{"type":28,"name":33,"description":34,"armGroupLabels":35,"otherNames":17},"Imatinib","Imatinib 400 mg QD",[16,22],{"type":28,"name":37,"description":38,"armGroupLabels":39,"otherNames":17},"tofacitinib Placebo","Matching placebo tablet; administered orally twice daily (BID)",[16],{"type":28,"name":41,"description":42,"armGroupLabels":43,"otherNames":17},"Imatinib Placebo","Matching placebo tablet; administered orally once daily (QD)",[9],[45],{"name":46,"role":47,"phone":48,"phoneExt":17,"email":49},"Xiaoyong Man","CONTACT","+86 13600516219","manxy@zju.edu.cn",[51],{"facility":5,"status":17,"city":52,"state":53,"zip":17,"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":17,"email":66},"Xibei Chen","+86 15088611296","chenxb@zju.edu.cn",{"type":68,"investigatorFullName":17,"investigatorTitle":17,"investigatorAffiliation":17,"oldNameTitle":17,"oldOrganization":17},"SPONSOR","100633721","phase-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-100633721",false,"NCT07530367","A Phase III Randomized Controlled Trial Evaluating the Efficacy and Safety of Tofacitinib Combined With Imatinib in Patients With 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\n\\- Participants aged ≥ 18 years.\n\nDiagnosis of PPP for at least 12 weeks prior to screening.\n\nPPPASI ≥ 12 at screening and baseline.\n\nPPP-IGA ≥ 3 at screening and baseline.\n\nPresence of pustules on palms and\u002For soles at screening and baseline.\n\nConfirmed diagnosis of PPP by photographic adjudication.\n\nExclusion Criteria:\n\n* Significant improvement of PPP symptoms between screening and baseline (PPPASI decrease ≥ 5).\n\nPresence of other forms of psoriasis or inflammatory skin diseases.\n\nActive infection or history of serious infection within specified timeframes.\n\nPositive for hepatitis B, hepatitis C, or HIV.\n\nActive or latent tuberculosis.\n\nHistory of malignancy within 5 years (except certain skin cancers).\n\nLaboratory abnormalities meeting exclusion criteria (e.g., ALT\u002FAST ≥ 3×ULN, ANC \\\u003C 1.5×10³\u002FμL, etc.).","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)",[88,29,33],"Palmoplantar Pustulosis","NOT_YET_RECRUITING","2026-04-08",{"date":92,"type":93},"2026-04-15","ACTUAL",{"date":95,"type":80},"2026-04-01",{"date":97,"type":80},"2028-12-30",{"name":5,"class":6},1]