RecruitingPhase 2interventionalRules rewrite

Phase 2: testing AC-101 for Ulcerative Colitis (UC)

This is a Phase Ⅱb, multicenter, randomly assigned, parallel-group, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, dose-finding study of AC-101 tablets in patients with moderately to severely active ulcerative colitis (UC). The study will measure the how well it works, safety, and pharmacokinetics of AC-101 compared with dummy treatment (placebo) in patients who have had an inadequate response, loss of response, or intolerance to prior advanced therapies or to prior conventional therapies.

Official registry: https://clinicaltrials.gov/study/NCT07755241 · Accro Bioscience (Suzhou) Limited · enrollment listed as 153

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are AC-101, AC-101, or Placebo. The registry lists allocation as randomized. This is a Phase Ⅱb, multicenter, randomly assigned, parallel-group, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, dose-finding study of AC-101 tablets in patients with moderately to severely active ulcerative colitis (UC).

They plan to enroll about 153 people at Guangzhou. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: AC-101, AC-101, Placebo

Primary outcome (registry wording): Clinical Remission

Who it is for (from inclusion criteria)

Ages 18 Years to 75 Years
Male or female participants aged ≥ 18 and ≤ 75 years；
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;

Who the registry excludes

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

Public study contact (from the registry)

Yin Lin

86-020-87330631

zsyyiec2020@mail.sysu.edu.cn

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

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

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FAQ about this NCT record

Is NCT07755241 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07755241?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07755241?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary