A Study to Evaluate Efficacy and Long-term Safety of Oral Ozanimod in Chinese Participants With Moderately to Severely Active Ulcerative Colitis (UC)

Study Purpose

The purpose of this study is to evaluate the efficacy and safety of ozanimod compared with placebo in participants with ulcerative colitis (UC) in mainland China and Taiwan. The main study is composed of an induction period, maintenance period, safety follow-up, and participants meeting certain criteria will be given the opportunity to participate in an optional open label extension.

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:

Main Study:
  • - Eligible participants must be Chinese.
  • - Participant has had moderately to severely active UC diagnosed at least 3 months prior to first investigational product administration.
Open-label Extension Period:
  • - Participants who have completed the Week 10 Visit and are non-responders at Week 10.
  • - Participants who have completed the Induction Period and entered the Maintenance Period experienced disease relapse during the Maintenance Period, or who have completed the Maintenance Period at Week 52.

Exclusion Criteria:

Main Study and Open-label Extension Period:
  • - Participant has severe extensive colitis, diagnosis of CD, indeterminate colitis, presence or history of a fistula consistent with CD, microscopic colitis, radiation colitis, or ischemic colitis.
Open-label Extension Period:
  • - Participant has clinically relevant hepatic, neurological, pulmonary, ophthalmological, endocrine, psychiatric, or other major systemic disease making implementation of the protocol or interpretation of the study difficult or that would put the participant at risk by continuing the study or that would have required a participant to discontinue treatment were observed during the Induction Period or Maintenance Period.
  • - Participant has clinically relevant cardiovascular conditions, including history or presence of recent myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, Class III/IV heart failure, sick sinus syndrome, or severe untreated sleep apnea were observed during the Induction Period or Maintenance Period.

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.

NCT05644665
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 3
Lead Sponsor

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

Bristol-Myers Squibb
Principal Investigator

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

Bristol-Myers Squibb
Principal Investigator Affiliation Bristol-Myers Squibb
Agency Class

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

Industry
Overall Status Recruiting
Countries China, Taiwan
Conditions

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

Ulcerative Colitis
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: Arm A: Ozanimod

Placebo Comparator: Arm B: Placebo

Interventions

Drug: - Ozanimod

Specified dose on specified days

Drug: - Placebo

Specified dose on specified days

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

Local Institution - 0013, WuHu, Anhui, China

Status

Not yet recruiting

Address

Local Institution - 0013

WuHu, Anhui, 241001

Site Contact

Site 0013

Clinical.Trials@bms.com

855-907-3286

Local Institution - 0048, Fuzhou, Fujian, China

Status

Not yet recruiting

Address

Local Institution - 0048

Fuzhou, Fujian, 350005

Site Contact

Site 0048

Clinical.Trials@bms.com

855-907-3286

Local Institution - 0019, Guangzhou, Guangdong, China

Status

Recruiting

Address

Local Institution - 0019

Guangzhou, Guangdong, 510515

Site Contact

Site 0019

Clinical.Trials@bms.com

855-907-3286

Local Institution - 0051, Guilin, Guangxi, China

Status

Recruiting

Address

Local Institution - 0051

Guilin, Guangxi, 541001

Site Contact

Site 0051

Clinical.Trials@bms.com

855-907-3286

Local Institution - 0007, Jiazhuang, Hebei, China

Status

Not yet recruiting

Address

Local Institution - 0007

Jiazhuang, Hebei, 050000

Site Contact

Site 0007

Clinical.Trials@bms.com

855-907-3286

Local Institution - 0040, Wuhan, Hubei, China

Status

Not yet recruiting

Address

Local Institution - 0040

Wuhan, Hubei, 430022

Site Contact

Site 0040

Clinical.Trials@bms.com

855-907-3286

Local Institution - 0046, Changzhou, Jiangsu, China

Status

Recruiting

Address

Local Institution - 0046

Changzhou, Jiangsu, 213003

Site Contact

Site 0046

Clinical.Trials@bms.com

855-907-3286

Local Institution - 0018, Suzhou, Jiangsu, China

Status

Not yet recruiting

Address

Local Institution - 0018

Suzhou, Jiangsu, 215004

Site Contact

Site 0018

Clinical.Trials@bms.com

855-907-3286

Local Institution - 0042, Zhenjiang, Jiangsu, China

Status

Recruiting

Address

Local Institution - 0042

Zhenjiang, Jiangsu, 212000

Site Contact

Site 0042

Clinical.Trials@bms.com

855-907-3286

Local Institution - 0010, Shenyang, Liaoning, China

Status

Not yet recruiting

Address

Local Institution - 0010

Shenyang, Liaoning, 110020

Site Contact

Site 0010

Clinical.Trials@bms.com

855-907-3286

Local Institution - 0039, Jinan, Shandong, China

Status

Recruiting

Address

Local Institution - 0039

Jinan, Shandong, 250014

Site Contact

Site 0039

Clinical.Trials@bms.com

855-907-3286

Local Institution - 0034, Shanghai, Shanghai, China

Status

Not yet recruiting

Address

Local Institution - 0034

Shanghai, Shanghai, 200092

Site Contact

Site 0034

Clinical.Trials@bms.com

855-907-3286

Local Institution - 0053, Shanghai, Shanghai, China

Status

Not yet recruiting

Address

Local Institution - 0053

Shanghai, Shanghai, 200120

Site Contact

Site 0053

Clinical.Trials@bms.com

855-907-3286

Local Institution - 0025, Chengdu, Sichuan, China

Status

Recruiting

Address

Local Institution - 0025

Chengdu, Sichuan, 610072

Site Contact

Site 0025

Clinical.Trials@bms.com

855-907-3286

Local Institution - 0030, Hangzhou, Zhejiang, China

Status

Recruiting

Address

Local Institution - 0030

Hangzhou, Zhejiang, 310016

Site Contact

Site 0030

Clinical.Trials@bms.com

855-907-3286

Local Institution - 0060, Taipei City, Taipei, Taiwan

Status

Not yet recruiting

Address

Local Institution - 0060

Taipei City, Taipei, 114

Site Contact

Site 0060

Clinical.Trials@bms.com

855-907-3286

Local Institution - 0056, Taipei, Taiwan

Status

Not yet recruiting

Address

Local Institution - 0056

Taipei, , 10002

Site Contact

Site 0056

Clinical.Trials@bms.com

855-907-3286

Local Institution - 0002, Taipei, Taiwan

Status

Withdrawn

Address

Local Institution - 0002

Taipei, , 11217

Local Institution - 0057, Taipei, Taiwan

Status

Not yet recruiting

Address

Local Institution - 0057

Taipei, , 11217

Site Contact

Site 0057

Clinical.Trials@bms.com

855-907-3286