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A Study of AC-101 Tablets in Patients With Ulcerative Colitis

NCT07755241 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 153

Last updated 2026-08-10

No results posted yet for this study

Summary

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.

Conditions

  • Ulcerative Colitis (UC)

Interventions

DRUG

AC-101

AC-101 tablets at the high dose will be administered orally twice daily

DRUG

AC-101

AC-101 tablets at the low dose will be administered orally twice daily.

DRUG

Placebo

Placebo tablets will be administered orally twice daily.

Sponsors & Collaborators

  • Accro Bioscience (Suzhou) Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-28
Primary Completion
2027-11-30
Completion
2028-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07755241 on ClinicalTrials.gov