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

November 16, 2025 updated by: Innovent Biologics (Suzhou) Co. Ltd.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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)
Time Frame: week 12
Percentage of subjects who achieved clinical remission at week 12.
week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The proportion of participants achieving a clinical response at Week 12.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: week 52
week 52
The proportion of participants achieving clinical response at Week 52 during the maintenance treatment period.
Time Frame: week 52
week 52
The proportion of participants achieving symptomatic relief at Week 52 during the maintenance treatment period.
Time Frame: week 52
week 52
The proportion of participants achieving mucosal healing at Week 52 during the maintenance treatment period.
Time Frame: week 52
week 52
The proportion of participants achieving endoscopic remission at Week 52 during the maintenance treatment period.
Time Frame: week 52
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.
Time Frame: Week 12, Week 52，Weeks 24 and 64
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.
Time Frame: Week 12, Week 52，Weeks 24 and 64
Week 12, Week 52，Weeks 24 and 64

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Innovent Biologics (Suzhou) Co. Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 21, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 7, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 6, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 17, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 19, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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