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A Study to Evaluate IBI112 in the Treatment of Moderate to Severe Active Ulcerative Colitis | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

A Multicenter, Randomized, Double-blind, Parallel, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of IBI112 in Patients With Moderate to Severe Active Ulcerative Colitis

NCT05377580•Innovent Biologics (Suzhou) Co. Ltd.

View on ClinicalTrials.gov

Summary

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

Detailed 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

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Diagnosis of ulcerative colitis at least 3 months ago, including endoscopy evidence supporting 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 biological agent:

Exclusion Criteria

•1. Diagnosis of ischemic colitis, infectious colitis, radiation colitis, microscopic colitis, 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 (not removed before entering the study) or gastrointestinal tumors;

Locations (1)

First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Key Dates

Start Date

July 1, 2022

Primary Completion Date

June 21, 2024

Completion Date

August 7, 2025

Last Updated

November 19, 2025

Enrollment

150

ACTUAL participants

Conditions

Ulcerative Colitis (UC)

Interventions

Period 1 IBI112 Placebo

DRUG

Period 2 IBI112 dose 3

DRUG

Period 1 IBI112 dose 1

DRUG

Period 1 IBI112 dose 2

DRUG

Period 2 IBI112 dose 4

DRUG

Period 2 IBI112 Placebo

DRUG

Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis

NCT07271069

Ulcerative Colitis (UC)

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RECRUITING

Switching to the IL-23 Inhibitor Guselkumab for People With Active IBD Who Previously Used Ustekinumab (SHIFT-IBD)

NCT07245394

Inflammatory Bowel Disease (IBD)Crohn Disease (CD)+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 19, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis

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