A Study of AC-101 Tablets in Participants With Moderate to Severe Active Ulcerative Colitis

Recruiting now · Phase 1/Phase 2

Conditions studied: Ulcerative Colitis

In brief

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.

Key facts

Study ID

NCT07083193

Run by

Accro Bioscience (Suzhou) Limited

People needed

24

Starts

2025-01-20

Expected to finish

2027-04-30

Last updated by the study team

2025-07-24

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Evidence of active UC defined by modified Mayo score of 5 to 9 points (inclusive) with 3 subscores meeting the followings:
• 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
• Disease extension of ≥ 15cm from anal verge, confirmed by screening endoscopy
• 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.
• Biologic-naïve or previous biological treatment for more than 5 half-lives.

You may not qualify if…

• 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.

Where it is running

• The First Affiliated Hospital,Sun Yat-sen University — Guangzhou, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

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