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

March 25, 2025 updated by: Bristol-Myers Squibb

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of Oral Ozanimod to Evaluate Efficacy and Long-term Safety in Chinese Participants With Moderately to Severely Active Ulcerative Colitis (UC)

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.

Study Overview

Status

Status

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

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.

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.
131

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 3

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.
  • Name: BMS Study Connect Contact Center www.BMSStudyConnect.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Contact Backup

  • Name: First line of the email MUST contain NCT # and Site #.

Study Locations

  • China
      • Fuzhou, China, 350005
        • Local Institution - 0048
      • Shanghai, China, 200120
        • Local Institution - 0053
    • Anhui
      • Hefei, Anhui, China, 230071
        • Local Institution - 0012
      • Wuhu, Anhui, China, 241001
        • Local Institution - 0013
    • Beijing
      • Beijing, Beijing, China, 102206
        • Local Institution - 0052
    • Chongqing
      • Chongqing, Chongqing, China, 400014
        • Local Institution - 0050
    • Fujian
      • Xiamen, Fujian, China, 361004
        • Local Institution - 0011
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Local Institution - 0019
      • Guangzhou, Guangdong, China, 510080
        • Local Institution - 0020
      • Guangzhou, Guangdong, China, 510180
        • Local Institution - 0036
      • Guangzhou, Guangdong, China, 510280
        • Local Institution - 0028
      • Guangzhou, Guangdong, China, 510655
        • Local Institution - 0008
      • Zhanjiang, Guangdong, China, 524004
        • Local Institution - 0004
    • Guangxi
      • Guilin, Guangxi, China, 541001
        • Local Institution - 0051
    • HUB
      • Wuhan, HUB, China, 430060
        • Local Institution - 0033
    • Hebei
      • Shijiazhuang, Hebei, China, 050000
        • Local Institution - 0007
      • Shijiazhuang, Hebei, China, 050011
        • Local Institution - 0006
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Local Institution - 0040
      • Wuhan, Hubei, China, 430030
        • Local Institution - 0037
    • Hunan
      • Changsha, Hunan, China, 410008
        • Local Institution - 0027
      • Changsha, Hunan, China, 410013
        • Local Institution - 0022
    • Jiangsu
      • Changzhou, Jiangsu, China
        • Local Institution - 0061
      • Changzhou, Jiangsu, China, 213003
        • Local Institution - 0046
      • Nanjing, Jiangsu, China, 210000
        • Local Institution - 0024
      • Nanjing, Jiangsu, China, 210029
        • Local Institution - 0045
      • Suzhou, Jiangsu, China, 215004
        • Local Institution - 0018
      • Suzhou, Jiangsu, China, 215006
        • Local Institution - 0009
      • Wuxi, Jiangsu, China, 214023
        • Local Institution - 0044
      • Zhenjiang, Jiangsu, China, 212000
        • Local Institution - 0042
    • Liaoning
      • Shenyang, Liaoning, China, 110004
        • Local Institution - 0010
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Local Institution - 0029
      • Xi'an, Shaanxi, China, 710038
        • Local Institution - 0026
    • Shandong
      • Jinan, Shandong, China, 250014
        • Local Institution - 0039
    • Shanghai
      • Shanghai, Shanghai, China, 200092
        • Local Institution - 0034
      • Shanghai, Shanghai, China, 200025
        • Local Institution - 0035
      • Shanghai, Shanghai, China, 200032
        • Local Institution - 0041
    • Shanxi
      • Taiyuan, Shanxi, China, 030001
        • Local Institution - 0015
    • Sichuan
      • Cheng Du, Sichuan, China, 610041
        • Local Institution - 0032
      • Chengdu, Sichuan, China, 610072
        • Local Institution - 0025
    • Tianjin
      • Tianjin, Tianjin, China, 300052
        • Local Institution - 0031
      • Tianjin, Tianjin, China, 300121
        • Local Institution - 0047
    • Yunnan
      • Kunming, Yunnan, China, 650034
        • Local Institution - 0049
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310016
        • Local Institution - 0030
  • Taiwan
      • New Taipei, Taiwan, 235
        • Local Institution - 0058
      • Taichung, Taiwan, 40447
        • Local Institution - 0001
      • Taichung, Taiwan, 407
        • Local Institution - 0059
      • Taipei, Taiwan, 10002
        • Local Institution - 0056
      • Taipei, Taiwan, 11217
        • Local Institution - 0057
      • Taoyuan, Taiwan, 333
        • Local Institution - 0055
    • Changhua
      • Changhua County, Changhua, Taiwan, 50006
        • Local Institution - 0054
    • Taipei
      • Taipei City, Taipei, Taiwan, 114
        • Local Institution - 0060

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:

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.

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: Triple

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: Arm A: Ozanimod
Drug: Ozanimod
Specified dose on specified days
Other Names:
  • BMS-986374
Placebo Comparator: Arm B: Placebo
Drug: Placebo
Specified dose on specified days

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
Time Frame
Proportion of participants with clinical remission as measured by the 3-component Mayo Score
Time Frame: At week 10
At week 10

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
Time Frame
Proportion of participants with clinical remission as measured by the 3-component Mayo Score
Time Frame: At week 52
At week 52
Proportion of participants with clinical response as measured by the 3-component Mayo Score
Time Frame: At week 10 and at week 52
At week 10 and at week 52
Proportion of participants with endoscopic improvement
Time Frame: At week 10 and at week 52
At week 10 and at week 52
Proportion of participants achieving histologic remission
Time Frame: At week 10 and at week 52
At week 10 and at week 52
Proportion of participants with mucosal healing
Time Frame: At week 10 and at week 52
At week 10 and at week 52
Proportion of participants in remission as measured by the 3-component Mayo Score while off corticosteroids for ≥ 12 weeks
Time Frame: At week 52
At week 52
Proportion of participants with Treatment Emergent Adverse Events (TEAEs)
Time Frame: Up to 78 weeks
Up to 78 weeks
Proportion of participants with Serious Adverse Events (SAEs)
Time Frame: Up to 78 weeks
Up to 78 weeks
Proportion of participants with TEAEs leading to discontinuation of investigational product
Time Frame: Up to 78 weeks
Up to 78 weeks
Proportion of participants with TEAEs of special interest
Time Frame: Up to 78 weeks
Up to 78 weeks
Proportion of participants with clinical laboratory abnormalities
Time Frame: Up to 78 weeks
Up to 78 weeks
Proportion of participants with vital sign abnormalities
Time Frame: Up to 78 weeks
Up to 78 weeks
Proportion of participants with electrocardiogram (ECG) abnormalities
Time Frame: Up to 78 weeks
Up to 78 weeks
Proportion of participants with pulmonary function test abnormalities
Time Frame: Up to 78 weeks
Up to 78 weeks

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.
Bristol-Myers Squibb

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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.
December 9, 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.
March 7, 2025

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.
March 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).
December 1, 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.
December 1, 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.
December 9, 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.
March 26, 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.
March 25, 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.
March 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.
  • IM047-010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

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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