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

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

Study Overview

• Status: Completed
• Conditions: Ulcerative Colitis (UC)
• Intervention / Treatment: Drug: Period 2 IBI112 dose 4; Drug: Period 1 IBI112 Placebo; Drug: Period 2 IBI112 dose 3; Drug: Period 2 IBI112 Placebo; Drug: Period 1 IBI112 dose 2; Drug: Period 1 IBI112 dose 1

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

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • First Affiliated Hospital of Sun Yat-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Period 2 IBI112 dose 4	Drug: Period 2 IBI112 dose 4; Intravenous Injection; Other Names: IBI112 dose 4
Placebo Comparator: Period 1 IBI112 Placebo	Drug: Period 1 IBI112 Placebo; Intravenous Injection; Other Names: Placebo
Experimental: Period 2 IBI112 dose 3	Drug: Period 2 IBI112 dose 3; Subcutaneous injections; Other Names: IBI112 dose 3; Drug: Period 2 IBI112 Placebo; Subcutaneous injections; Other Names: Placebo
Experimental: Period 1 IBI112 dose 2	Drug: Period 1 IBI112 dose 2; Intravenous Injection; Other Names: IBI112 dose 2
Placebo Comparator: Period 2 IBI112 Placebo	Drug: Period 2 IBI112 Placebo; Subcutaneous injections; Other Names: Placebo
Experimental: Period 1 IBI112 dose 1	Drug: Period 1 IBI112 Placebo; Intravenous Injection; Other Names: Placebo; Drug: Period 1 IBI112 dose 1; Intravenous Injection; Other Names: IBI112 dose 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the effectiveness of IBI112 in inducing clinical remission in patients with moderately to severely active ulcerative colitis (UC)	Percentage of subjects who achieved clinical remission at week 12.	week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of participants achieving a clinical response at Week 12.	Clinical response is defined as a relative decrease from baseline in the modified Mayo score of ≥30% and ≥2 points, along with a relative decrease in the rectal bleeding subscore of ≥1 point or an absolute subscore of 0 or 1.	week 12
The proportion of participants achieving symptomatic relief at Week 12.	Symptomatic relief is defined as a stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0.	week 12
The proportion of participants achieving endoscopic remission at Week 12.	Endoscopic remission is defined as an endoscopic subscore of 0 or 1 within the modified Mayo score.	week 12
The proportion of participants achieving mucosal healing at Week 12.	Mucosal healing is defined as endoscopic remission, which means an endoscopic subscore of 0 or 1 within the modified Mayo score, and central Geboes histopathological index remission.	week 12
The proportion of participants achieving clinical remission at Week 52 during the maintenance treatment period.		week 52
The proportion of participants achieving clinical response at Week 52 during the maintenance treatment period.		week 52
The proportion of participants achieving symptomatic relief at Week 52 during the maintenance treatment period.		week 52
The proportion of participants achieving mucosal healing at Week 52 during the maintenance treatment period.		week 52
The proportion of participants achieving endoscopic remission at Week 52 during the maintenance treatment period.		week 52
The change from baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) scores at Week 12, Week 52 during the maintenance treatment period, and Weeks 24 and 64 during the extension treatment period.		Week 12, Week 52，Weeks 24 and 64
The change from baseline in the 36-item Short Form Health Survey (SF-36) scores at Week 12, Week 52 during the maintenance treatment period, and Weeks 24 and 64 during the extension treatment period.		Week 12, Week 52，Weeks 24 and 64

Collaborators and Investigators

• Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Actual): June 21, 2024
• Study Completion (Actual): August 7, 2025

Study Registration Dates

• First Submitted: May 6, 2022
• First Submitted That Met QC Criteria: May 15, 2022
• First Posted (Actual): May 17, 2022

Study Record Updates

• Last Update Posted (Estimated): November 19, 2025
• Last Update Submitted That Met QC Criteria: November 16, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: CIBI112B201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No