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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

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;

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05377580
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Innovent Biologics (Suzhou) Co. Ltd.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Ulcerative Colitis (UC)
Additional Details

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

Arms & Interventions

Arms

Placebo Comparator: Placebo

Participants will receive placebo in intravenously (IV) in Induction period. Subsequent study treatment will be determined by the participant's clinical response status at Week 12

Experimental: IBI112 dose 1

Participants will receive IBI112 dose 1 intravenously (IV) in Induction Study 1. Subsequent study treatment will be determined by the participant's clinical response status at Week 12.

Experimental: IBI112 dose 2

Participants will receive IBI112 dose 2 intravenously (IV) in Induction Study 1. Subsequent study treatment will be determined by the participant's clinical response status at Week 12.

Interventions

Drug: - Placebo

Participants will receive placebo IV or SC

Drug: - IBI112

Participants will receive IBI112 IV or SC

Drug: - IBI112

Participants will receive IBI112 IV or SC

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Guangzhou, Guangdong, China

Status

Recruiting

Address

First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510080

Site Contact

Minhu Chen

chenminhu@vip.163.com

020-87755766-8189

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