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

NCT07755241 | Not Yet Recruiting Phase 2

• 1 other identifier: AC-101-UC-Ⅱ-01
• Study Type: interventional
• Target: 153
• Locations: 0 countries
• Sites: N/A

Brief 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)

Keywords

IBD，AC-101 ，dose-finding

Outcome Measures

Primary Outcomes (1)

• Clinical Remission

  Clinical remission at Week 12, defined as stool frequency subscore of 0 or 1, rectal bleeding subscore of 0, AND centrally read endoscopy subscore of 0 or 1

  Week 12

Secondary Outcomes (3)

• Clinical response

  Week 12

• Symptomatic remission

  Week 12

• Adverse Events

  Up to 56 Weeks

Study Arms (3)

AC-101 cohort 1

EXPERIMENTAL

Patients will receive AC-101 Dose 1 as tablets orally twice daily

Drug: AC-101

AC-101 cohort 2

EXPERIMENTAL

Patients will receive AC-101 Dose 2 as tablets orally twice daily

Drug: AC-101

Placebo

PLACEBO COMPARATOR

Patients will receive oral placebo tablets twice daily

Drug: Placebo

Interventions

AC-101 DRUG

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

AC-101 cohort 1

Placebo DRUG

Placebo tablets will be administered orally twice daily.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Documented failure to prior advanced therapies or prior conventional therapies
• Female participants must meet either criterion a) or b), and male participants must meet criterion c) to be eligible for enrollment:
• Female participants of non-childbearing potential;
• Female participants of childbearing potential who are not pregnant must agree to use highly effective contraception during the treatment period and for at least 1 month after the last dose of study treatment;
• Male participants with a pregnant or non-pregnant female partner of childbearing potential must agree to use contraception during the treatment period and for at least 1 month after the last dose of study treatment.

You may not qualify if:

• 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.
• Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease, or clinical findings suggestive of Crohn's disease.
• Positive stool pathogen test or positive test for Clostridioides difficile toxin at screening.
• Presence of an ostomy or fistula.
• Risk of tuberculosis .
• History of current or prior serious opportunistic infection.
• Presence of active or chronic recurrent infection.
• Patients with any of the following hepatitis B screening results:
• Acute or chronic hepatitis B infection; or Positive hepatitis B virus (HBV) test at screening (HBsAg positive); or HBsAg negative, hepatitis B core antibody (HBcAb) positive, with detectable HBV-DNA.
• Current hepatitis C infection, or positive hepatitis C virus (HCV) test at screening.
• Human immunodeficiency virus (HIV) infection/acquired immunodeficiency syndrome , or positive HIV antibody test at screening.
• Syphilis, or positive syphilis-specific antibody test at screening.

Sponsors & Collaborators

• Accro Bioscience (Suzhou) Limited: lead

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Central Study Contacts

Yin Lin

CONTACT

86-020-87330631; zsyyiec2020@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 10, 2026
• Study Start (Estimated): August 28, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): February 28, 2028
• Last Updated: August 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share