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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
Led by Accro Bioscience (Suzhou) Limited · Updated on 2025-07-24
24
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, effectiveness, and how the body processes AC-101 tablets in adults with moderate to severe active ulcerative colitis. This study is a Phase 1b, open-label, randomized trial that plans to enroll about 24 participants aged 18 to 75 years. The goal is to better understand the treatment's impact on this condition over a 17-week period. Participants will be randomly assigned to receive one of two dosing schedules of AC-101 tablets: either twice daily or once daily, taken orally for 12 weeks. Before treatment starts, there is a 4-week screening period to confirm eligibility, followed by a 1-week safety follow-up after treatment ends. This setup allows researchers to compare the effects of the two dosing regimens. During the study, participants will undergo assessments to monitor any side effects and measure how well the treatment controls their ulcerative colitis symptoms. The main focus is on the occurrence and severity of adverse events up to week 13. Researchers will also evaluate the proportion of participants who achieve clinical response and remission by week 12. Regular evaluations and safety monitoring will ensure participants' well-being throughout the trial.
CONDITIONS
Brief 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 ulcerative colitis symptoms for at least 3 months before enrollment, confirmed by endoscopic and histopathological exams during screening
- Active ulcerative colitis with modified Mayo score between 5 and 9, including stool frequency subscore of at least 2, rectal bleeding subscore of at least 1, and endoscopic subscore of at least 2 (excluding friability)
- Disease extends 15 cm or more from the anal verge, confirmed by endoscopy
- Stable doses of 5-salicylates or oral corticosteroids (up to 20 mg prednisone or equivalent, up to 9 mg budesonide MMX or equivalent) for at least 2 weeks before enrollment and throughout the study
- Biologic-naive or previous biological treatment completed more than 5 half-lives before enrollment
You will not qualify if you...
- 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 failure with two or more advanced treatments including biologics (e.g., TNF-alpha antibodies, IL-12/23 antibodies, integrin-alpha4beta7 antibodies) and small molecules (e.g., JAK inhibitors, S1P receptor modulators)
- Intravenous or rectal steroids, or topical 5-ASA within 2 weeks before enrollment; systemic small molecule treatments within 4 weeks before enrollment
- Clostridium difficile or other enteric pathogen infection within 30 days before endoscopy or positive test before enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 12 weeks
Participants receive AC-101 tablets orally either twice daily or once daily from Week 0 through Week 12.
Weekly visits for up to 12 weeks
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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