A Study of AC-101 Tablets in Participants With Moderate to Severe Active Ulcerative Colitis
Phase 1 / Phase 2 · Testing AC-101 · 1 site · Accro Bioscience (Suzhou) Limited
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing AC-101 (a drug) as a possible treatment. Condition(s) listed: Ulcerative Colitis.
Participants are assigned to groups by chance (randomized).
It is single-blind: participants do not know which group they are in.
Phase 2 studies test whether a treatment shows signs of working, and keep checking safety, in a larger group of people with the condition.
Who can join
- Ages 18 to 75
- Any sex
Some of the main requirements, copied from the record:
- 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
Plus 5 more requirement(s). There are also 4 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 24 participants are expected to take part.
- Start date: 2025-01-20.
- Main results expected around 2026-09-30 (estimate from the record).
- 1 study site listed (1 marked recruiting) in China.
Main thing being measured
- Incidence and Severity of Adverse Events (Up to Week 13)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Phase 1 / Phase 2 |
| Study type | Interventional |
| Conditions | Ulcerative Colitis |
| Lead sponsor | Accro Bioscience (Suzhou) Limited |
| Enrollment | 24 (estimated) |
| Start date | 2025-01-20 |
| Primary completion (est.) | 2026-09-30 |
| First posted | 2025-07-24 |
| Last updated | 2025-07-24 |
| 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 |
| ClinicalTrials.gov ID | NCT07083193 |
Interventions
- AC-101 (Drug)
AC-101 tablets will be administered orally.
Full eligibility criteria (from the record)
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.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital,Sun Yat-sen University | Guangzhou, Guangdong | China | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.