[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100575965":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":55,"collaborators":24,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":24,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":24,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":39,"whyStopped":24,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Shanghai Mabgeek Biotech.Co.Ltd","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"MG-K10 Humanized Monoclonal Antibody Injection","EXPERIMENTAL","Every four weeks, subcutaneous injection ，total of 56W",[13],"Drug: Placebo",{"label":15,"type":16,"description":17,"interventionNames":18},"placebo","PLACEBO_COMPARATOR","Every four weeks, subcutaneous injection，Switch to MG-K10 treatment after 24 weeks of administration",[13],[20],{"type":21,"name":22,"description":17,"armGroupLabels":23,"otherNames":24},"DRUG","Placebo",[9,15],null,[26],{"name":27,"affiliation":28,"role":29},"Jianzhong Zhang, Medical Ph.D","Feking University People's Hospital","STUDY_DIRECTOR",[31],{"name":32,"role":33,"phone":34,"phoneExt":24,"email":35},"xiaofeng xiao Cai, bachelor","CONTACT","02151371305","xiaofeng.cai@mabgeek.com",[37],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Peking University People's Hospital, Beijing,","RECRUITING","Beijing","Bejing","100009","China","CN",{"type":46,"coordinates":47},"Point",[48,49],116.39723,39.9075,{"lat":49,"lon":48},[52],{"name":27,"role":33,"phone":53,"phoneExt":24,"email":54},"010-88326666","rmzjz@126.com",{"type":56,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100575965","phase-3-phase-iii-clinical-study-of-mg-k10-humanized-mab-injection-in-subjects-with-prurigo-nodularis-100575965",false,"NCT06779136","Phase III Clinical Study of MG-K10 Humanized Mab Injection in Subjects With Prurigo Nodularis","A Randomized, Double-blind, Placebo-controlled Phase III Study Evaluating the Efficacy and Safety of a Humanized MG-K10 Mab Injection in Subjects With Prurigo Nodularis.","eligibility criteria:\n\n1. voluntarily sign the ICF and comply with all the visits and research-related procedures required by the protocol;\n2. Both men and women were required to be ≥ 18 and ≤ 80 years old at the time of signing the informed consent;\n3. the duration of PN diagnosed by a dermatologist at the time of screening was ≥ 3 months;\n4. In the range of 1-10, WI-NRS≥7 in the past 24 h at screening; WI-NRS in the week before the baseline visit The average weekly score was ≥ 7 points.\n\nExclusion criteria：\n\n1. There are skin diseases other than PN and mild atopic dermatitis (AD) that may interfere with the assessment of research outcomes.\n2. Patients who had a history of moderate to severe AD during the 6 months prior to the screening visit or screening visit.\n3. Receiving potent or super-potent TCS\u002FTCI treatment within 2 weeks before or during screening.\n\n4\\) Evidence of active tuberculosis. 5) Participation in any other clinical study within 12 weeks or 5 half-lives prior to screening","ALL","18 Years","80 Years",{"count":68,"type":69},160,"ESTIMATED","INTERVENTIONAL",[72],"PHASE3","A phase III clinical study to evaluate the efficacy and safety of a humanized MG-K10 mab injection in subjects with prurigo nodularis.administered every 4 weeks for 56 weeks.",[75],"Prurigo Nodularis",[77],"Prurigo nodularis","2025-04-15",{"date":80,"type":81},"2025-04-18","ACTUAL",{"date":83,"type":81},"2025-02-26",{"date":85,"type":69},"2026-11",{"name":5,"class":6},1]