[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100552780":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":24,"studyPopulation":17,"armGroups":25,"interventions":32,"overallOfficials":39,"centralContacts":44,"locations":54,"responsibleParty":90,"collaborators":17,"id":92,"slug":17,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":17,"eligibilityCriteria":97,"healthyVolunteers":93,"sex":98,"minAge":99,"maxAge":100,"enrollmentInfo":101,"targetDuration":17,"studyType":104,"phases":105,"briefSummary":108,"conditions":109,"keywords":17,"overallStatus":56,"whyStopped":17,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"Shanghai Huaota Biopharmaceutical Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"Safety endpoints include the proportion of subjects with TEAEs","The safety assessment includes monitoring for AEs, SAEs (including SAEs related to protocol procedures from signing of ICF until before the first dose of the study drug) from the first dose of the study drug to end of study (EOS) , as well as changes from baseline in laboratory tests, vital signs, physical examination, and 12-lead electrocardiogram (ECG).","0-24 weeks",[14],{"measure":15,"description":16,"timeFrame":12},"The recurrence of GPP flare during the study","The Proportion of patients who have at least once GPP flare during the study",null,{"allocation":19,"interventionModel":20,"interventionModelDescription":17,"primaryPurpose":21,"observationalModel":17,"timePerspective":17,"maskingInfo":22},"NA","SINGLE_GROUP","TREATMENT",{"masking":23,"maskingDescription":17,"whoMasked":17},"NONE","This study will also evaluate the pharmacokinetic (PK) profile of HB0034 and explore the immunogenicity of HB0034 in subjects with GPP",[26],{"label":27,"type":28,"description":29,"interventionNames":30},"HB0034","EXPERIMENTAL","single-arm and all the patients would receive HB0034 300mg i.v. every other four weeks",[31],"Drug: HB0034",[33],{"type":34,"name":27,"description":35,"armGroupLabels":36,"otherNames":37},"DRUG","300mg, i.v. Q4W",[27],[38],"Anti-IL-36R antibody,Recombinant Humanized anti-IL-36R Monoclonal antibody",[40],{"name":41,"affiliation":42,"role":43},"Jianzhong Zhang, PhD","Peking University People's Hospital (PKUPH)","PRINCIPAL_INVESTIGATOR",[45,50],{"name":46,"role":47,"phone":48,"phoneExt":17,"email":49},"Guodong Zhou","CONTACT","+86 13636638684","guodong.zhou@huaota.com",{"name":51,"role":47,"phone":52,"phoneExt":17,"email":53},"Qiaoxia Qian, Master","+86 18555690860","qiaoxia.qian@huaota.com",[55,73,78],{"facility":42,"status":56,"city":57,"state":17,"zip":17,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"RECRUITING","Beijing","China","CN",{"type":61,"coordinates":62},"Point",[63,64],116.39723,39.9075,{"lat":64,"lon":63},[67,71],{"name":68,"role":47,"phone":69,"phoneExt":17,"email":70},"Jianzhong zhang","+8618555690860","qiaoxia.qian@huata.com",{"name":72,"role":43,"phone":17,"phoneExt":17,"email":17},"Jianzhong zhang, PhD",{"facility":74,"status":56,"city":57,"state":17,"zip":17,"country":58,"countryCode":59,"cosmosGeoPoint":75,"geoPoint":77,"contacts":17},"Peking University People's Hospital",{"type":61,"coordinates":76},[63,64],{"lat":64,"lon":63},{"facility":79,"status":56,"city":80,"state":17,"zip":17,"country":58,"countryCode":59,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"The Second affiliated Hospital zhejiang University School of Medicine","Hangzhou",{"type":61,"coordinates":82},[83,84],120.16142,30.29365,{"lat":84,"lon":83},[87],{"name":88,"role":47,"phone":52,"phoneExt":17,"email":89},"Xiaoyong Man, Phd","xiaoyong.man@gmail.com",{"type":91,"investigatorFullName":17,"investigatorTitle":17,"investigatorAffiliation":17,"oldNameTitle":17,"oldOrganization":17},"SPONSOR","100552780",false,"NCT06477536","Long-Term Safety and Efficacy of HB0034 in Subjects With Generalized Pustular Psoriasis","A Phase IIb, Long-Term Extension Study to Evaluate the Safety and Efficacy of HB0034 in the Treatment of Adult Subjects With Generalized Pustular Psoriasis","Inclusion Criteria:\n\n* Patients participated in the preceding placebo-controlled Phase 2 study （HB0034-04）and completed at least the Week 12 visit of the HB0034-04 study\n* Subject must be a candidate for prolonged GPP treatment according to the Investigator's judgment\n* Men and women of reproductive age who have no parenting plans and are willing to use reliable contraception during the study period and for 6 months after the last dose of the study drug;\n* Patients who fully understand and voluntarily sign an ICF, and are willing and able to follow clinical study and subsequent visit schedules\n\nExclusion Criteria:\n\n* Patients who are experiencing GPP flare","ALL","18 Years","75 Years",{"count":102,"type":103},33,"ESTIMATED","INTERVENTIONAL",[106,107],"PHASE2","PHASE3","This is a Phase IIb, long term extension study to evaluate the safety and efficacy of HB0034 in adult subjects with generalized pustular psoriasis (GPP).",[110],"Generalized Pustular Psoriasis","2025-02-12",{"date":113,"type":114},"2025-02-14","ACTUAL",{"date":116,"type":114},"2024-09-02",{"date":118,"type":103},"2026-06-30",{"name":5,"class":6},3]