[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100618702":3},{"organization":4,"outcomesModule":7,"designInfo":26,"detailedDescription":11,"studyPopulation":11,"armGroups":37,"interventions":51,"overallOfficials":11,"centralContacts":60,"locations":66,"responsibleParty":87,"collaborators":89,"id":92,"slug":11,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":11,"eligibilityCriteria":97,"healthyVolunteers":93,"sex":98,"minAge":99,"maxAge":100,"enrollmentInfo":101,"targetDuration":11,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":11,"overallStatus":69,"whyStopped":11,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"Haisco Pharmaceutical Group Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"The proportion of patients with clinical response",null,"Week 12",[14,16,18,20,22,24],{"measure":15,"description":11,"timeFrame":12},"The proportion of patients with clinical remission",{"measure":17,"description":11,"timeFrame":12},"The proportion of patients with symptomatic remission",{"measure":19,"description":11,"timeFrame":12},"The proportion of patients with endoscopic remission",{"measure":21,"description":11,"timeFrame":12},"Proportion of patients with Mayo endoscopic subscore 0",{"measure":23,"description":11,"timeFrame":12},"Percent change from baseline in Mayo score and modified Mayo score",{"measure":25,"description":11,"timeFrame":12},"Percent change from baseline in partial Mayo score",{"allocation":27,"interventionModel":28,"interventionModelDescription":11,"primaryPurpose":29,"observationalModel":11,"timePerspective":11,"maskingInfo":30},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":31,"maskingDescription":11,"whoMasked":32},"QUADRUPLE",[33,34,35,36],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[38,43,46],{"label":39,"type":40,"description":11,"interventionNames":41},"HSK47388-Dose level 1","EXPERIMENTAL",[42],"Drug: HSK47388",{"label":44,"type":40,"description":11,"interventionNames":45},"HSK47388-Dose level 2",[42],{"label":47,"type":48,"description":11,"interventionNames":49},"Placebo","PLACEBO_COMPARATOR",[50],"Drug: Placebo",[52,57],{"type":53,"name":54,"description":55,"armGroupLabels":56,"otherNames":11},"DRUG","HSK47388","Participants will be randomized to receive HSK47388, orally starting at Week 0 . At Week-12, all participants will be evaluated for clinical response and responders will enter the maintenance study.",[39,44],{"type":53,"name":47,"description":58,"armGroupLabels":59,"otherNames":11},"Participants will be randomized to receive Placebo, orally starting at Week 0 . At Week-12, all participants will be evaluated for clinical response and responders will enter the maintenance study.",[47],[61],{"name":62,"role":63,"phone":64,"phoneExt":11,"email":65},"Yongrui Wang","CONTACT","028-67258840","wangyr@haisco.com",[67],{"facility":68,"status":69,"city":70,"state":11,"zip":11,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":79},"Sir Run Run Shaw Hospital","RECRUITING","Hangzhou","China","CN",{"type":74,"coordinates":75},"Point",[76,77],120.16142,30.29365,{"lat":77,"lon":76},[80,84],{"name":81,"role":63,"phone":82,"phoneExt":11,"email":83},"Xu","0571-86006811","xm@srrsh.com",{"name":85,"role":86,"phone":11,"phoneExt":11,"email":11},"Qian Cao","PRINCIPAL_INVESTIGATOR",{"type":88,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[90],{"name":91,"class":6},"Haisco-USA Pharmaceuticals, Inc.","100618702",false,"NCT07335055","A Study for HSK47388 in Participants With Ulcerative Colitis","A Phase 2 Randomized, Double-blind, Placebo-Controlled, Multicenter Clinical Study to Evaluate the Efficacy and Safety of HSK47388 in Participants With Moderately to Severely Active Ulcerative Colitis","Inclusion Criteria:\n\n1. Written informed consent must be obtained\n2. Male or female, ≥18 years old and ≤75 years old\n3. Willing and able to comply with study-specific procedures and the requirements of study protocol.\n4. Diagnosis of ulcerative colitis (UC)\n5. Baseline modified Mayo score of 5 to 9 and the endoscopy subscore 2 to 3\n6. Demonstrated an inadequate response, loss of response, or failure to tolerate previous conventional therapy or advanced therapy.\n\nExclusion Criteria:\n\n1. Subjects have used treatments within the time frame specified in protocol prior to the baseline visit\n2. Diagnosis of indeterminate colitis, ischemic colitis, Crohn's colitis or clinical findings suggestive of Crohn's disease\n3. Participants with current or prior diagnosis of fulminant colitis and\u002For toxic megacolon\n4. Presence of a stoma\n5. Presence or history of a fistula\n6. Intra-abdominal or other major surgery performed within 12 weeks before baseline\n7. History of extensive colonic resection\n8. Subjects have laboratory values meeting the criteria in protocol\n9. Concurrent conditions and history of other diseases as described in protocol","ALL","18 Years","75 Years",{"count":102,"type":103},150,"ESTIMATED","INTERVENTIONAL",[106],"PHASE2","The purpose of this protocol is to evaluate the efficacy and safety of HSK47388 as therapy in participants with moderately to severely active ulcerative colitis .",[109],"Ulcerative Colitis (UC)","2026-03-03",{"date":112,"type":113},"2026-03-05","ACTUAL",{"date":115,"type":113},"2026-02-03",{"date":117,"type":103},"2029-02-02",{"name":5,"class":6},1]