[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100622678":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":28,"locations":38,"responsibleParty":59,"collaborators":11,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":11,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":11,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":11,"overallStatus":80,"whyStopped":11,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Jiangsu Genscend Biopharmaceutical Co., Ltd","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"GS101 injection","EXPERIMENTAL",null,[13],"Drug: GS101 injection",{"label":15,"type":16,"description":11,"interventionNames":17},"Dupixent®","ACTIVE_COMPARATOR",[18],"Drug: DUPIXENT®",[20,24],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":11},"DRUG","300mg\u002F2.0mL; an initial dose of 600 mg (two 300 mg injections), followed by 300 mg given every other week (Q2W);subcutaneous injection",[9],{"type":21,"name":25,"description":26,"armGroupLabels":27,"otherNames":11},"DUPIXENT®","300mg\u002F2.0mL; an initial dose of 600 mg (two 300 mg injections), followed by 300 mg given every other week (Q2W); subcutaneous injection",[15],[29,34],{"name":30,"role":31,"phone":32,"phoneExt":11,"email":33},"Sinian Li, Master","CONTACT","+086-15800767550","lisinian@jxingbio.com",{"name":35,"role":31,"phone":36,"phoneExt":11,"email":37},"Tao Sun, Master","+086-15921575347","suntao@jxingbio.com",[39],{"facility":40,"status":11,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"The First Hospital of China Medical University","Shenyang","Liaoning","110001","China","CN",{"type":47,"coordinates":48},"Point",[49,50],123.43278,41.79222,{"lat":50,"lon":49},[53,57],{"name":54,"role":31,"phone":55,"phoneExt":11,"email":56},"Xinghua Gao, M.D.","024-83282524","gaobarry@hotmail.com",{"name":54,"role":58,"phone":11,"phoneExt":11,"email":11},"PRINCIPAL_INVESTIGATOR",{"type":60,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100622678","phase-3-a-phase-iii-study-of-gs101-injection-to-dupixent-100622678",false,"NCT07386743","A Phase III Study of GS101 Injection to Dupixent®","A Multicenter, Randomized, Double-blinded, Parallel, Positive-controlled, Phase III Comparative Study to Evaluate GS101 Injection Versus Dupixent® in Participants With Moderate-to-Severe Atopic Dermatitis","Inclusion Criteria:\n\n* Subjects, male or female, between the ages of 18 and 75 years (inclusive)\n* At the time of screening, the diagnosis of atopic dermatitis (AD) meets the Hanifin-Rajka criteria, with a disease history for at least 1 year prior to screening\n* During the screening period and at baseline, patients with moderate-to-severe atopic dermatitis, defined as meeting all of the following 3 criteria concurrently: a. IGA score ≥ 3; b. EASI score ≥ 16; c. BSA ≥ 10%.\n\nExclusion Criteria:\n\n* Hypersensitivity or known allergy to the investigational product(s) or any of their excipients\n* Treatment with any investigational drug, medical device, or other biologic agent within 8 weeks prior to randomization or within 5 half-lives (if the half-life is known), whichever is longer\n* Receipt of any live or live-attenuated vaccine within 3 months prior to randomization, or planned receipt of such vaccines during the study period","ALL","18 Years","75 Years",{"count":72,"type":73},572,"ESTIMATED","INTERVENTIONAL",[76],"PHASE3","This is a a multicenter, randomized, double-blinded, parallel, positive-controlled, Phase III comparative study to evaluate GS101 Injection versus Dupixent® in participants with moderate-to-severe atopic dermatitis. A total of 572 subjects are planned to be included and randomized at a ratio of 1:1 to receive GS101 injection or Dupixent®",[79],"Atopic Dermatitis (AD)","NOT_YET_RECRUITING","2026-02-02",{"date":83,"type":84},"2026-02-04","ACTUAL",{"date":86,"type":73},"2026-02",{"date":88,"type":73},"2028-01",{"name":5,"class":6},1]