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

NCT07083193 | Recruiting Phase 1

• 1 other identifier: AC101-004
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Incidence and Severity of Adverse Events

  An Adverse Event (AE) is defined as any new untoward medical condition or worsening of a pre-existing medical condition following or during exposure to an investigation product, whether or not considered causally related to the product.

  Up to Week 13

Secondary Outcomes (2)

• Proportion of Participants Achieved Clinical Response

  Week 12

• Proportion of Participants achieved Clinical Remission

  Week 12

Study Arms (2)

AC-101 Dose 1

EXPERIMENTAL

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

Drug: AC-101

AC-101 Dose 2

EXPERIMENTAL

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

Drug: AC-101

Interventions

AC-101 DRUG

AC-101 tablets will be administered orally.

AC-101 Dose 1; AC-101 Dose 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Accro Bioscience (Suzhou) Limited: lead

Study Sites (1)

The First Affiliated Hospital,Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2025
• First Posted: July 24, 2025
• Study Start: January 20, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: July 24, 2025

Record last verified: 2025-07

Locations

CN (1)