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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • AC-101

    Drug

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

  • AC-101

    Drug

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

  • Placebo

    Drug

    Placebo tablets will be administered orally twice daily.

Treatment groups

153 Participants
are divided into 3 treatment groups
Group A: AC-101 cohort 1Experimental treatment 1 intervention
Group B: AC-101 cohort 2Experimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

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

Time frame
Week 12

Secondary outcomes

1

Clinical response

Clinical response at Week 12, defined as a decrease from baseline in the modified Mayo Score of greater than or equal to 2 points AND at least a 30 percent reduction from baseline, AND a decrease in RB of greater than or equal to 1 or an absolute rectal bleeding subscore of 0 or 1

Time frame
Week 12
2

Symptomatic remission

Symptomatic remission at Week 12, defined as RB=0 and SF=0, OR RB=0, SF≤1 and at least 1 point reduction from baseline

Time frame
Week 12
3

Adverse Events

Adverse events during the study

Time frame
Up to 56 Weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Accro Bioscience (Suzhou) Limited

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: