[{"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:":88},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,68],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":4},"100650972","a-study-of-ac-101-tablets-in-patients-with-ulcerative-colitis-100650972",false,"NCT07755241","A Study of AC-101 Tablets in Patients With Ulcerative Colitis","A Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Dose-finding Study to Evaluate the Efficacy and Safety of AC-101 Tablets in Patients With Moderately to Severely Active Ulcerative Colitis","Inclusion Criteria:\n\n1. Male or female participants aged ≥ 18 and ≤ 75 years；\n2. Must sign the Informed Consent Form and be willing to participate in the study.\n3. Diagnosis of UC confirmed at least 3 months prior to screening, supported by both endoscopic and histological evidence.\n4. Evidence of UC extending ≥ 15 cm from the anal verge as assessed by colonoscopy. Moderately to severely active UC, defined as a modified Mayo Score of 5 to 9, with an Endoscopic Subscore ≥ 2.\n5. Documented failure to prior advanced therapies or prior conventional therapies\n6. Female participants must meet either criterion a) or b), and male participants must meet criterion c) to be eligible for enrollment:\n\n   1. Female participants of non-childbearing potential;\n   2. Female participants of childbearing potential who are not pregnant must agree to use highly effective contraception during the treatment period and for at least 1 month after the last dose of study treatment;\n   3. Male participants with a pregnant or non-pregnant female partner of childbearing potential must agree to use contraception during the treatment period and for at least 1 month after the last dose of study treatment.\n\nExclusion Criteria:\n\n1. Severe extensive colitis.\n2. Hospitalization for exacerbation of UC within 12 weeks prior to screening.\n3. History of gastrointestinal dysplasia, or presence of dysplasia detected in any biopsy performed during the screening colonoscopy.\n4. Adenomatous colonic polyps that have not been removed prior to study enrollment.\n5. Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease, or clinical findings suggestive of Crohn's disease.\n6. Positive stool pathogen test or positive test for Clostridioides difficile toxin at screening.\n7. Presence of an ostomy or fistula.\n8. Risk of tuberculosis .\n9. History of current or prior serious opportunistic infection.\n10. Presence of active or chronic recurrent infection.\n11. Patients with any of the following hepatitis B screening results:\n\n    Acute or chronic hepatitis B infection; or Positive hepatitis B virus (HBV) test at screening (HBsAg positive); or HBsAg negative, hepatitis B core antibody (HBcAb) positive, with detectable HBV-DNA.\n12. Current hepatitis C infection, or positive hepatitis C virus (HCV) test at screening.\n13. Human immunodeficiency virus (HIV) infection\u002Facquired immunodeficiency syndrome , or positive HIV antibody test at screening.\n14. Syphilis, or positive syphilis-specific antibody test at screening.\n15. Treatment with advanced therapies for UC within 8 weeks or 5 half-lives prior to randomization.\n16. Treatment with intravenous corticosteroids within 2 weeks prior to randomization.\n17. Treatment with leukocyte apheresis within 12 weeks prior to randomization.\n18. Treatment with intravenous immunoglobulins or plasmapheresis within 12 weeks prior to randomization.\n19. Treatment with lymphocyte-depleting therapy.\n20. History of fecal microbiota transplantation.\n21. Vaccination with live attenuated vaccines within 4 weeks prior to randomization, or a plan to receive such vaccines during the study period.\n22. Requirement for parenteral nutrition.\n23. History of myocardial infarction, acute stroke, transient ischemic attack, thromboembolic events, clinically significant arrhythmia, unstable angina, coronary artery bypass grafting, or severe pulmonary heart disease\u002Fpulmonary hypertension within 3 months prior to randomization, which, in the investigator's judgment, may affect the evaluation of study results.\n24. Presence of any other unstable or uncontrolled cardiovascular, pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine\u002Fmetabolic, neurological\u002Fpsychiatric, or other medical condition that, in the investigator's judgment, may interfere with the study results.\n25. Known history of immunodeficiency; other acquired or congenital immunodeficiency disorders; or history of organ transplantation.\n26. History of malignancy within 5 years prior to screening, with the exception of adequately treated carcinoma in situ of the cervix, or basal cell or squamous cell carcinoma of the skin.\n27. Female patients who are pregnant, lactating, or have a positive serum pregnancy test at screening.\n28. Any other condition that, in the investigator's opinion, may affect the patient's safety or compliance, or preclude the patient from completing the study.","ALL","18 Years","75 Years",{"count":20,"type":21},153,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a Phase Ⅱb, multicenter, randomized, parallel-group, double-blind, placebo-controlled, dose-finding study of AC-101 tablets in patients with moderately to severely active ulcerative colitis (UC). The study will evaluate the efficacy, safety, and pharmacokinetics of AC-101 compared with placebo in patients who have had an inadequate response, loss of response, or intolerance to prior advanced therapies or to prior conventional therapies. The study consists of a screening period (up to 4 weeks), a 12-week induction period, a 40-week extension period, and a 4-week safety follow-up period.",[27],"Ulcerative Colitis (UC)",[29,30,31],"IBD","AC-101","dose finding","NOT_YET_RECRUITING","2026-08-14",{"date":35,"type":36},"2026-08-17","ACTUAL",{"date":38,"type":21},"2026-08-28",{"date":40,"type":21},"2028-02-28",{"name":42,"class":43},"Accro Bioscience (Suzhou) Limited","INDUSTRY",{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},"100598375","phase-1-a-phase-ib-clinical-study-of-ac-003-capsules-in-subjects-with-agvhd-100598375","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)",{"count":52,"type":21},24,[54],"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.",[57],"Acute Graft-versus-Host Disease","RECRUITING","2026-03-13",{"date":61,"type":36},"2026-03-16",{"date":63,"type":36},"2024-07-25",{"date":65,"type":21},"2026-09-30",{"name":42,"class":43},1,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":75,"targetDuration":4,"studyType":22,"phases":76,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":67},"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.",{"count":52,"type":21},[54,24],"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.",[79],"Ulcerative Colitis","2025-07-23",{"date":82,"type":36},"2025-07-24",{"date":84,"type":36},"2025-01-20",{"date":86,"type":21},"2027-04-30",{"name":42,"class":43},""]