Ignite Creation Date:
2025-12-25 @ 1:09 AM
Ignite Modification Date:
2025-12-31 @ 9:25 PM
Study NCT ID:
NCT07083193
Status:
RECRUITING
Last Update Posted:
2025-07-24
First Post:
2025-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of AC-101 Tablets in Participants With Moderate to Severe Active Ulcerative Colitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-23', 'studyFirstSubmitDate': '2025-07-16', 'studyFirstSubmitQcDate': '2025-07-23', 'lastUpdatePostDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence and Severity of Adverse Events', 'timeFrame': 'Up to Week 13', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Proportion of Participants Achieved Clinical Response', 'timeFrame': 'Week 12', 'description': "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)"}, {'measure': 'Proportion of Participants achieved Clinical Remission', 'timeFrame': 'Week 12', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ulcerative Colitis']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "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/current 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-12/23 antibodies, integrin-α4β7 antibodies) and small molecule (e.g., JAK inhibitors, S1P receptor modulator), and all deemed by investigator as treatment failure.\n* Intravenous/rectal 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."}, 'identificationModule': {'nctId': 'NCT07083193', 'briefTitle': 'A Study of AC-101 Tablets in Participants With Moderate to Severe Active Ulcerative Colitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Accro Bioscience (Suzhou) Limited'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'AC101-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AC-101 Dose 1', 'description': 'Participants will receive AC-101 Dose 1 as tablets orally twice daily from Week 0 through W12', 'interventionNames': ['Drug: AC-101']}, {'type': 'EXPERIMENTAL', 'label': 'AC-101 Dose 2', 'description': 'Participants will receive AC-101 Dose 2 as tablets orally once daily from Week 0 through W12', 'interventionNames': ['Drug: AC-101']}], 'interventions': [{'name': 'AC-101', 'type': 'DRUG', 'description': 'AC-101 tablets will be administered orally.', 'armGroupLabels': ['AC-101 Dose 1', 'AC-101 Dose 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'RenMao', 'role': 'CONTACT', 'email': 'zsyyiec2020@mail.sysu.edu.cn', 'phone': '+86 020-87330631'}], 'facility': 'The First Affiliated Hospital,Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Accro Bioscience (Suzhou) Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}