A Study to Evaluate IBI112 in the Treatment of Moderate to Severe Active Ulcerative Colitis

Last updated: November 16, 2025
Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Overall Status: Completed

Phase

2

Condition

Inflammatory Bowel Disease

Crohn's Disease

Treatment

Period 1 IBI112 dose 1

Period 1 IBI112 dose 2

Period 2 IBI112 dose 4

Clinical Study ID

NCT05377580
CIBI112B201
  • Ages 18-75
  • All Genders

Study Summary

To evaluate the efficacy of IBI112 induction therapy in patients with moderate and severe active Ulcerative Colitis (UC) to achieve clinical remission.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Diagnosis of ulcerative colitis at least 3 months ago, including endoscopy evidencesupporting UC and histopathological evidence supporting UC diagnosis;

  2. Patients with moderate to severe ulcerative colitis, defined as modified Mayo Score ≥4 and endoscopic score ≥2;

  3. Subject must have received at least one prior treatment or first use of a biologicalagent:

Exclusion

Exclusion Criteria:

  1. Diagnosis of ischemic colitis, infectious colitis, radiation colitis, microscopiccolitis, uncertain colitis, etc., or crohn's disease;

  2. UC lesions were limited to rectum or involved colon < 15cm;

  3. Evidence of toxic hirschsprung's disease was found during screening;

  4. History or evidence of atypical hyperplasia of the colon, adenomatous polyps (notremoved before entering the study) or gastrointestinal tumors;

Study Design

Total Participants: 150
Treatment Group(s): 8
Primary Treatment: Period 1 IBI112 dose 1
Phase: 2
Study Start date:
July 01, 2022
Estimated Completion Date:
August 07, 2025

Study Description

This is a phase 2 randomized,double-blind, placebo-controlled study to evaluate the efficacy and safety of IBI112 induction and maintenance therapy in subjects with moderate to severe active ulcerative colitis

Connect with a study center

  • First Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong 510080
    China

    Site Not Available

  • First Affiliated Hospital of Sun Yat-sen University

    Guangzhou 1809858, Guangdong 1809935 510080
    China

    Site Not Available

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