[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Accro Bioscience (Suzhou) Limited\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":62},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,40],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100598375","phase-1-a-phase-ib-clinical-study-of-ac-003-capsules-in-subjects-with-agvhd-100598375",false,"NCT07070674","A Phase Ib Clinical Study of AC-003 Capsules in Subjects With aGVHD.","A Phase Ib Clinical Trial to Investigate the Safety, Tolerability, Preliminary Efficacy, and Pharmacokinetic Profile of AC-003 Capsules in Patients With Acute GraftVersus-Host Disease (aGVHD)","Inclusion Criteria:\n\n1. Male or female patients age ≥ 18 years.\n2. Patients who have undergone allogeneic hematopoietic stem cell transplantation (HSCT) from any donor source (including matched unrelated donor, haplo-identical).\n3. Diagnosis of grade II-IV aGVHD as per MAGIC criteria within 100 days after HSCT.\n4. Diagnosis of steroid-refractory or steroid-dependent aGVHD in at least one of the following criteria:\n\n   1. Progressive Disease, defined as any target organ worsening, after 3 days of initial treatment with methylprednisolone 1\\~2 mg\u002Fkg\u002Fday (or equivalent corticosteroid)\n   2. Not partial response after 7 days of initial treatment with methylprednisolone 1\\~2 mg\u002Fkg\u002Fday (or equivalent corticosteroid)\n   3. Not complete response after 14 days of initial treatment with methylprednisolone 1\\~2 mg\u002Fkg\u002Fday (or equivalent corticosteroid)\n   4. Relapse of aGVHD when corticosteroid tapering.\n\nExclusion Criteria:\n\n1. Evidence of aGVHD relapsed.\n2. Evidence of chronic GVHD or overlap syndrome\n3. Receipt of more than one allogeneic HSCT\n4. Receipt of more than one systemic treatment for aGVHD in addition to corticosteroid\n5. Any corticosteroid therapy for indications other than aGvHD at doses \\>= 1 mg\u002Fkg\u002Fday methylprednisolone (or equivalent corticosteroid) within 7 days prior to enrolment\n6. Severe organ dysfunction unrelated to aGVHD\n7. Uncontrolled active infection (i.e., bacterial, fungal, or viral)","ALL","18 Years",{"count":19,"type":20},24,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The study was an open-label, single-arm, dose-escalation, Phase Ib, multi-center study to investigate safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of AC-003 in patients with grade II-IV SR-aGVHD.",[26],"Acute Graft-versus-Host Disease","RECRUITING","2026-03-13",{"date":30,"type":31},"2026-03-16","ACTUAL",{"date":33,"type":31},"2024-07-25",{"date":35,"type":20},"2026-09-30",{"name":37,"class":38},"Accro Bioscience (Suzhou) Limited","INDUSTRY",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":49,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":39},"100599338","phase-1-a-study-of-ac-101-tablets-in-participants-with-moderate-to-severe-active-ulcerative-colitis-100599338","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.","75 Years",{"count":19,"type":20},[23,50],"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.",[53],"Ulcerative Colitis","2025-07-23",{"date":56,"type":31},"2025-07-24",{"date":58,"type":31},"2025-01-20",{"date":60,"type":20},"2027-04-30",{"name":37,"class":38},""]