A Study of AC-101 Tablets in Patients With Ulcerative Colitis
ConditionUlcerative Colitis (UC)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAccro Bioscience (Suzhou) Limited
About this trial
This is a Phase Ⅱb, multicenter, randomized, parallel-group, double-blind, placebo-controlled, dose-finding study of AC-101 tablets in patients with moderately to severely active ulcerative colitis (UC). The study will evaluate the efficacy, safety, and pharmacokinetics of AC-101 compared with placebo in patients who have had an inadequate response, loss of response, or intolerance to prior advanced therapies or to prior conventional therapies. The study consists of a screening period (up to 4 weeks), a 12-week induction period, a 40-week extension period, and a 4-week safety follow-up period.
Eligibility criteria
Qualifiers
Male or female participants aged ≥ 18 and ≤ 75 years；
Must sign the Informed Consent Form and be willing to participate in the study.
Diagnosis of UC confirmed at least 3 months prior to screening, supported by both endoscopic and histological evidence.
Evidence of UC extending ≥ 15 cm from the anal verge as assessed by colonoscopy. Moderately to severely active UC, defined as a modified Mayo Score of 5 to 9, with an Endoscopic Subscore ≥ 2.
Disqualifiers
Severe extensive colitis.
Hospitalization for exacerbation of UC within 12 weeks prior to screening.
History of gastrointestinal dysplasia, or presence of dysplasia detected in any biopsy performed during the screening colonoscopy.
Adenomatous colonic polyps that have not been removed prior to study enrollment.
Trial design
Treatments tested in this trial
- AC-101
- AC-101
- Placebo
Treatment groups
153 Participants
are divided into 3 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov