[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627134":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":29,"responsibleParty":50,"collaborators":11,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":11,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":11,"enrollmentInfo":61,"targetDuration":11,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":11,"overallStatus":70,"whyStopped":11,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Guangdong Hengrui Pharmaceutical Co., Ltd","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"SHR-1139 Injection Group","EXPERIMENTAL",null,[13],"Drug: SHR-1139 Injection",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DRUG","SHR-1139 Injection","SHR-1139 injection.",[9],[21,26],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},"Xin Gao","CONTACT","+86-0518-82342973","xin.gao.xg26@hengrui.com",{"name":27,"role":23,"phone":24,"phoneExt":11,"email":28},"Caihong Huang","caihong.huang.ch57@hengrui.com",[30],{"facility":31,"status":11,"city":32,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Shandong First Medical University Affiliated Dermatology Hospital","Jinan","Shandong","250022","China","CN",{"type":38,"coordinates":39},"Point",[40,41],116.99722,36.66833,{"lat":41,"lon":40},[44,48],{"name":45,"role":23,"phone":46,"phoneExt":11,"email":47},"Furen Zhang","+86-0531-87298808","zhangfurenlcsy@163.com",{"name":45,"role":49,"phone":11,"phoneExt":11,"email":11},"PRINCIPAL_INVESTIGATOR",{"type":51,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100627134","phase-2-a-study-to-evaluate-shr-1139-injection-in-patients-with-pyoderma-gangrenosum-100627134",false,"NCT07444684","A Study to Evaluate SHR-1139 Injection in Patients With Pyoderma Gangrenosum","A Phase II Clinical Study to Evaluate the Efficacy, Safety and Pharmacokinetics of SHR-1139 Injection in Adult Patients With Pyoderma Gangrenosum","Inclusion Criteria:\n\n1. Aged ≥18 years at the time of signing the informed consent form, regardless of gender;\n2. Confirmed as having ulcerative pyoderma gangrenosum (PG) with a PARACELSUS score of ≥10 points at screening;\n3. At screening and baseline, having at least one measurable PG ulcer (defined as an ulcer with a measured area of ≥ 5 cm²);\n4. The participant voluntarily signs the informed consent form before the initiation of any study-related procedures, is able to communicate smoothly with the investigator, and understands and is willing to strictly comply with the requirements of this clinical study protocol to complete the study;\n5. Female participants of childbearing potential or male participants whose female partners are of childbearing potential have no plans for childbirth, sperm\u002Fegg donation from the time of signing the informed consent form, and voluntarily adopt highly effective contraceptive measures (including by the partner). Female participants must have a negative pregnancy test result during the screening period and before randomization and dosing, and must not be breastfeeding.\n\nExclusion Criteria:\n\n1. Non-pyoderma gangrenosum (PG) diseases presenting with other ulcers or other similar skin lesions at screening;\n2. The measured area of the target PG ulcer exceeding 80 cm² at screening;\n3. Participants with chronic, non-inflammatory PG wounds or ulcers judged by the investigator to be unresponsive to immunosuppressive therapy at screening;\n4. Participants with active infection in the PG ulcer(s) at screening;\n5. A history of lymphoproliferative disorders, including lymphoma or signs and symptoms of potential lymphoproliferative diseases;\n6. A history of any active malignant tumor or malignant neoplasm within 5 years prior to the screening visit, except for curatively treated cutaneous squamous cell carcinoma, basal cell carcinoma, or carcinoma in situ of the uterine cervix;\n7. Any condition judged by the investigator to interfere with the assessment of the study drug's safety and efficacy.","ALL","18 Years",{"count":62,"type":63},20,"ESTIMATED","INTERVENTIONAL",[66],"PHASE2","This study aims to evaluate the efficacy, safety, pharmacokinetics (PK) and immunogenicity of SHR-1139 Injection in patients with pyoderma gangrenosum.",[69],"Pyoderma Gangrenosum","NOT_YET_RECRUITING","2026-02-26",{"date":73,"type":74},"2026-03-03","ACTUAL",{"date":76,"type":63},"2026-03-05",{"date":78,"type":63},"2028-04",{"name":5,"class":6},1]