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NOT YET RECRUITING
NCT07755241
PHASE2

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

Sponsor: Accro Bioscience (Suzhou) Limited

View on ClinicalTrials.gov

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.

Official title: A Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Dose-finding Study to Evaluate the Efficacy and Safety of AC-101 Tablets in Patients With Moderately to Severely Active Ulcerative Colitis

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

153

Start Date

2026-08-28

Completion Date

2028-02-28

Last Updated

2026-08-10

Healthy Volunteers

No

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.