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.
The total study duration is up to 17 weeks, including 4-week screening, 12-week treatment period, and 1-week safety follow-up.
The study will enroll approximately 24 participants with moderate to severe active ulcerative colitis.
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.
Stool frequency (SF) subscore of .≥ 2 points, and
Rectal bleeding (RB) subscore of .≥ 1 points, and
Endoscopic (ES) subscore of ≥ 2 points (excluding friability), confirmed by screening endoscopy
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.
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.
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.
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.
Parallel
AC-101
DrugAC-101 tablets will be administered orally.
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.
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) 1. A decrease from baseline in modified Mayo score of ≥ 2 points, and 2. A decrease from baseline in modified Mayo score of ≥ 30%, and 3. A decrease from baseline in rectal bleeding (RB) subscore of ≥ 1 point or absolute RB subscore ≤ 1 point The modified Mayo score is a sum of the following 3 subscores: 1. Stool frequency (SF) subscore (0-3) 2. Rectal bleeding (RB) subscore (0-3) 3. Endoscopic (ES) subscore (0-3)
Proportion of Participants achieved Clinical Remission
Clinical remission is defined as achieving the following changes in the modified Mayo score 1. Absolute modified Mayo score ≤ 2 points, and 2. Absolute SF subscore ≤ 1 point, and 3. Absolute RB subscore = 0 point, and 4. Absolute ES subscore ≤ 1 point
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