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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
24
AC-101 tablets will be administered orally.
The First Affiliated Hospital,Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGIncidence 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.
Time frame: Up to Week 13
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)
Time frame: Week 12
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
Time frame: Week 12
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