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

Accro Bioscience (Suzhou) Limited

Status and phase

Enrolling

Phase 2

Phase 1

Conditions

Ulcerative Colitis

Treatments

Drug: AC-101

Study type

Interventional

Funder types

Industry

Identifiers

NCT07083193

AC101-004

Details and patient eligibility

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.

Enrollment

24 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.