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

NCT ID: NCT07083193

Last Updated: 2025-07-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-20
• Study Completion Date: 2027-04-30

Brief Summary

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

Ulcerative Colitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

AC-101 Dose 1

Participants will receive AC-101 Dose 1 as tablets orally twice daily from Week 0 through W12

Group Type: EXPERIMENTAL

AC-101

Intervention Type: DRUG

AC-101 tablets will be administered orally.

AC-101 Dose 2

Participants will receive AC-101 Dose 2 as tablets orally once daily from Week 0 through W12

Group Type: EXPERIMENTAL

AC-101

Intervention Type: DRUG

AC-101 tablets will be administered orally.

Interventions

AC-101

AC-101 tablets will be administered orally.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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:

1. Stool frequency (SF) subscore of .≥ 2 points, and

2. Rectal bleeding (RB) subscore of .≥ 1 points, and

3. 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Accro Bioscience (Suzhou) Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Affiliated Hospital,Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Facility Contacts

RenMao

Role: primary

zsyyiec2020@mail.sysu.edu.cn

+86 020-87330631

Other Identifiers

AC101-004

Identifier Type: -

Identifier Source: org_study_id