Actively Recruiting
A Study of AC-101 Tablets in Participants With Moderate to Severe Active Ulcerative Colitis
Led by Accro Bioscience (Suzhou) Limited · Updated on 2025-07-24
24
Participants Needed
1
Research Sites
118 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of AC-101 Tablets in Participants With Moderate to Severe Active Ulcerative Colitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of ulcerative colitis or suspected symptoms for at least 3 months prior to enrollment confirmed by endoscopic and histopathological exams during screening
- Active ulcerative colitis defined by modified Mayo score of 5 to 9 with stool frequency subscore 2; 2, rectal bleeding subscore 2; 1, and endoscopic subscore 2; 2, confirmed by screening endoscopy
- Disease extension of 2; 15 cm from anal verge confirmed by screening endoscopy
- Stable doses of concomitant 5-salicylates or oral corticosteroids (prednisone 2; 20 mg or equivalent, budesonide MMX 2; 9 mg or equivalent) from 2 weeks prior to enrollment through study completion
- Biologic-na�efve or previous biological treatment for more than 5 half-lives
You will not qualify if you...
- Previous or current diagnosis of Crohn's Disease, indeterminate colitis, severe ulcerative colitis requiring hospitalization or corticosteroid pulse therapy, ulcerative proctitis, fulminant colitis, ischemic colitis, or other intestinal diseases
- Previous treatment with 2 or more advanced therapies including biologics (e.g., TNF-b1 antibodies, IL-12/23 antibodies, integrin-b14b27 antibodies) and small molecules (e.g., JAK inhibitors, S1P receptor modulators) deemed treatment failure by investigator
- Intravenous or rectal steroids or topical 5-ASA within 2 weeks prior to enrollment; systemic small molecules (e.g., Tofacitinib, Upadacitinib, Ozanimod) within 4 weeks prior to enrollment
- Clostridium difficile or other enteric pathogen infection within 30 days prior to endoscopy, or positive test for these infections prior to enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital,Sun Yat-sen University
Guangzhou, Guangdong, China, 510080
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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