AC-101 tablets for adults with moderate to severe ulcerative colitis

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

This study will test whether AC-101 tablets are safe and help adults with moderate-to-severe ulcerative colitis.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Accro Bioscience (Suzhou) Limited (Industry-sponsored)
• Drugs / interventions: Tofacitinib, Upadacitinib, prednisone
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT07083193 on ClinicalTrials.gov

What this trial studies

This phase 1/2 interventional study will enroll about 24 participants and lasts up to 17 weeks (4-week screening, 12-week treatment, 1-week safety follow-up). Participants must have confirmed moderate-to-severe active ulcerative colitis by modified Mayo score and endoscopy and will receive oral AC-101 tablets while undergoing safety, efficacy, and pharmacokinetic monitoring. The study collects clinical symptom scores, endoscopic findings, and blood drug-level data to characterize tolerability and potential clinical effect. Results will inform dosing and whether larger trials are warranted.

Who should consider this trial

Good fit: Ideal candidates are adults with confirmed moderate-to-severe ulcerative colitis (modified Mayo score 5–9 with specific subscores), disease extending at least 15 cm, symptoms for ≥3 months, and stable background 5-ASA or low-dose oral corticosteroids.

Not a fit: Patients with mild disease, disease outside the specified severity or extent, recent disallowed treatments, or significant comorbidities excluded by the protocol are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, AC-101 could become a new oral option to reduce inflammation and improve symptoms for people with moderate-to-severe ulcerative colitis.

How similar studies have performed: Other oral small-molecule therapies for ulcerative colitis have shown benefit in prior trials, but AC-101 is a novel compound with limited prior human data.

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.

Where this trial is running

Guangzhou, Guangdong

• The First Affiliated Hospital,Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)

Conditions Ulcerative Colitis