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

Official title

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

Overview

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.

Interventions

• Drug AC-101
  AC-101 tablets will be administered orally.

Primary outcome measures

• Incidence and Severity of Adverse Events [Time frame: Up to Week 13]

Secondary outcome measures (2)

• Proportion of Participants Achieved Clinical Response [Time frame: Week 12]
• Proportion of Participants achieved Clinical Remission [Time frame: Week 12]

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:

• 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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

China · 1 center

• The First Affiliated Hospital,Sun Yat-sen University — Guangzhou

Identifiers

NCT: NCT07083193 · AC101-004

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗