[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100599338":3},{"organization":4,"outcomesModule":7,"designInfo":22,"detailedDescription":21,"studyPopulation":21,"armGroups":30,"interventions":41,"overallOfficials":21,"centralContacts":21,"locations":47,"responsibleParty":68,"collaborators":21,"id":70,"slug":21,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":21,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":21,"studyType":82,"phases":83,"briefSummary":86,"conditions":87,"keywords":21,"overallStatus":50,"whyStopped":21,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Accro Bioscience (Suzhou) Limited","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":21},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence and Severity of Adverse Events","An Adverse Event (AE) is defined as any new untoward medical condition or worsening of a pre-existing medical condition following or during exposure to an investigation product, whether or not considered causally related to the product.","Up to Week 13",[14,18],{"measure":15,"description":16,"timeFrame":17},"Proportion of Participants Achieved Clinical Response","Clinical response is defined as achieving the following changes in the modified Mayo score (excludes the physicians' global assessment)\n\n1. A decrease from baseline in modified Mayo score of ≥ 2 points, and\n2. A decrease from baseline in modified Mayo score of ≥ 30%, and\n3. A decrease from baseline in rectal bleeding (RB) subscore of ≥ 1 point or absolute RB subscore ≤ 1 point\n\nThe modified Mayo score is a sum of the following 3 subscores:\n\n1. Stool frequency (SF) subscore (0-3)\n2. Rectal bleeding (RB) subscore (0-3)\n3. Endoscopic (ES) subscore (0-3)","Week 12",{"measure":19,"description":20,"timeFrame":17},"Proportion of Participants achieved Clinical Remission","Clinical remission is defined as achieving the following changes in the modified Mayo score\n\n1. Absolute modified Mayo score ≤ 2 points, and\n2. Absolute SF subscore ≤ 1 point, and\n3. Absolute RB subscore = 0 point, and\n4. Absolute ES subscore ≤ 1 point",null,{"allocation":23,"interventionModel":24,"interventionModelDescription":21,"primaryPurpose":25,"observationalModel":21,"timePerspective":21,"maskingInfo":26},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":27,"maskingDescription":21,"whoMasked":28},"SINGLE",[29],"OUTCOMES_ASSESSOR",[31,37],{"label":32,"type":33,"description":34,"interventionNames":35},"AC-101 Dose 1","EXPERIMENTAL","Participants will receive AC-101 Dose 1 as tablets orally twice daily from Week 0 through W12",[36],"Drug: AC-101",{"label":38,"type":33,"description":39,"interventionNames":40},"AC-101 Dose 2","Participants will receive AC-101 Dose 2 as tablets orally once daily from Week 0 through W12",[36],[42],{"type":43,"name":44,"description":45,"armGroupLabels":46,"otherNames":21},"DRUG","AC-101","AC-101 tablets will be administered orally.",[32,38],[48],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"The First Affiliated Hospital,Sun Yat-sen University","RECRUITING","Guangzhou","Guangdong","510080","China","CN",{"type":57,"coordinates":58},"Point",[59,60],113.25,23.11667,{"lat":60,"lon":59},[63],{"name":64,"role":65,"phone":66,"phoneExt":21,"email":67},"RenMao","CONTACT","+86 020-87330631","zsyyiec2020@mail.sysu.edu.cn",{"type":69,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100599338",false,"NCT07083193","A Study of AC-101 Tablets in Participants With Moderate to Severe Active Ulcerative Colitis","A Phase 1b, Multicenter, Open-label, Randomized Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of AC-101 Tablets in Participants With Moderate to Severe Active Ulcerative Colitis","Inclusion Criteria:\n\n* Diagnosis of Ulcerative Colitis (UC) or suspected UC symptom for at least 3 months prior to enrolment and confirmed diagnosis of UC by endoscopic and histopathological examinations during screening.\n* Evidence of active UC defined by modified Mayo score of 5 to 9 points (inclusive) with 3 subscores meeting the followings:\n\n  1. Stool frequency (SF) subscore of .≥ 2 points, and\n  2. Rectal bleeding (RB) subscore of .≥ 1 points, and\n  3. Endoscopic (ES) subscore of ≥ 2 points (excluding friability), confirmed by screening endoscopy\n* Disease extension of ≥ 15cm from anal verge, confirmed by screening endoscopy\n* Currently using concomitant 5-salicylates (5-ASA) or oral corticosteroid (≤ 20 mg prednisone or equivalent, ≤ 9 mg budesonide MMX or equivalent) should keep stable doses from 2 weeks prior to enrolment till study completion.\n* Biologic-naïve or previous biological treatment for more than 5 half-lives.\n\nExclusion Criteria:\n\n* Previous\u002Fcurrent documented diagnosis of Crohn's Disease (CD), indeterminate colitis, severe UC required hospitalization or corticosteroid pulse therapy, ulcerative proctitis, fulminant colitis, ischemic colitis and other intestinal diseases.\n* Previous received 2 or more types of advanced treatment including biologics (e.g., TNF-α antibodies, IL-12\u002F23 antibodies, integrin-α4β7 antibodies) and small molecule (e.g., JAK inhibitors, S1P receptor modulator), and all deemed by investigator as treatment failure.\n* Intravenous\u002Frectal administration of steroids or topical administration of 5-ASA within 2 weeks prior to enrolment; systemic administration of small molecule (e.g., Tofacitinib, Upadacitinib, Ozanimod) within 4 weeks prior to enrolment.\n* Clostridium difficile infection or other enteric pathogen infection within 30 days prior to endoscopy, or positive for Clostridium difficile or other enteric pathogens prior to enrolment.","ALL","18 Years","75 Years",{"count":80,"type":81},24,"ESTIMATED","INTERVENTIONAL",[84,85],"PHASE1","PHASE2","The purpose of the study is to evaluate the safety, efficacy, and pharmacokinetics of AC-101 tablets in participants with moderate-to-severe ulcerative colitis.\n\nThe total study duration is up to 17 weeks, including 4-week screening, 12-week treatment period, and 1-week safety follow-up.\n\nThe study will enroll approximately 24 participants with moderate to severe active ulcerative colitis.",[88],"Ulcerative Colitis","2025-07-23",{"date":91,"type":92},"2025-07-24","ACTUAL",{"date":94,"type":92},"2025-01-20",{"date":96,"type":81},"2027-04-30",{"name":5,"class":6},1]