Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis

May 15, 2026 updated by: Bristol-Myers Squibb

Real-world Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis: A Chart Review Study

The purpose of this study is to evaluate the effectiveness and safety of ozanimod vs azathioprine for the treatment of ulcerative colitis (UC) in real-world clinical practice in Japan

Study Overview

Status

Status

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

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.
Observational

Enrollment (Estimated)

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

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

Study Contact Backup

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

Study Locations

  • Japan
      • Hokkaidō, Japan
        • Recruiting
        • Sapporo Medical University School of Medicine
    • Chiba
      • Chiba, Chiba, Japan, 263-8522
        • Recruiting
        • Chiba University
      • Kashiwa-shi, Chiba, Japan, 277-0871
        • Recruiting
        • Tsujinaka Hospital Kashiwanoha
      • Sakura, Chiba, Japan, 285-8741
        • Recruiting
        • Toho University Sakura Hospital
    • Ehime
      • Matsuyama, Ehime, Japan, 790-0024
        • Not yet recruiting
        • Ehime Prefectural Central Hospital
    • Fukuoka
      • Chikushino-shi, Fukuoka, Japan, 818-8502
        • Not yet recruiting
        • Fukuoka University Chikushi Hospital
      • Fukuoka, Fukuoka, Japan, 814-0180
        • Recruiting
        • Fukuoka University Chikushi Hospital
    • Hokkaido
      • Asahikawa, Hokkaido, Japan, 078-8510
        • Recruiting
        • Asahikawa Medical University
      • Sapporo, Hokkaido, Japan, 065-0033
        • Recruiting
        • Sapporo Higashi Tokushukai Hospital
    • Hyōgo
      • Nishinomiya, Hyōgo, Japan, 663-8501
        • Recruiting
        • Hyogo Medical University
    • Kagawa-ken
      • Takamatsu, Kagawa-ken, Japan, 760-8557
        • Not yet recruiting
        • Kagawa Prefectural Central Hospital
    • Osaka
      • Hirakata, Osaka, Japan, 573-1010
        • Recruiting
        • Kansai Medical University
    • Saga-ken
      • Saga, Saga-ken, Japan, 840-8502
        • Not yet recruiting
        • Saga University
    • Saitama
      • Hidaka-shi, Saitama, Japan, 350-1298
        • Recruiting
        • Saitama Medical Center, Saitama Medical University
    • Shizuoka
      • Hamamatsu, Shizuoka, Japan, 431-3192
        • Recruiting
        • Hamamatsu University School of Medicine
    • Tokyo
      • Minato-ku, Tokyo, Japan, 1070052
        • Recruiting
        • Mebix. Inc.
        • Contact:
          • Takao Fujii, Site 0001
          • Phone Number: +81-73-441-0875
      • Mitaka-shi, Tokyo, Japan, 181-8611
        • Recruiting
        • Kyorin University School of Medicine
    • Tottori
      • Tottori-shi, Tottori, Japan, 680-8550
        • Not yet recruiting
        • Tottori 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population will consist of adults diagnosed with ulcerative colitis (UC) who initiated ozanimod or azathioprine treatment after starting oral steroids and concomitant-use oral steroids in Japan

Description

Inclusion Criteria:

  • Participants with Ulcerative Colitis (UC) provided written consent to participate in the study
  • Participants who are aged ≥ 18 years at the earlier date of either initiation of treatment with ozanimod or azathioprine or obtaining consent
  • Starting dose of oral steroid ≥ 30 mg/day (prednisolone equivalent)
  • Administration of ozanimod or azathioprine started after oral steroid administration, and ozanimod or azathioprine administered concomitantly with steroids (excluding patients who started oral steroids and ozanimod or azathioprine on the same day)
  • In the ozanimod group, patients with notable clinical symptoms due to the primary disease (rectal bleeding subscore ≥ 1 point or total PRO2 score ≥ 2 points) remained at the start of ozanimod administration
  • In the azathioprine group, patients who started azathioprine treatment after February 2019

Exclusion Criteria:

  • Participants with symptoms of UC with no change or increase in Patient-Reported Outcome 2 (PRO2) from the time of initiating oral steroid administration after 2 weeks of administration of ≥ 30 mg/day (prednisolone equivalent) of oral steroids
  • Participants with complications requiring continued steroid use (excluding topically acting steroids for inhalation or topical application)
  • Participants who participated in other clinical studies involving interventions during the observation period
  • Participants judged to be inappropriate for enrollment in this study by the investigator at each participating study site

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
Group 1
Participants with ulcerative colitis receiving ozanimod
Drug: Ozanimod
According to the product label
Group 2
Participants with ulcerative colitis receiving azathioprine
Drug: Azathioprine
According to the product label

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 achieving steroid-free symptomatic remission
Time Frame: Week 12; Weeks 24 and 52
Week 12; Weeks 24 and 52

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
Oral steroid dose prescribed
Time Frame: Week 12; Weeks 24 and 52
Week 12; Weeks 24 and 52
Proportion of patients with continuation of ozanimod or azathioprine treatment after oral steroid treatment initiation
Time Frame: Weeks 24 and 52
Weeks 24 and 52
Steroid-free maintenance period duration
Time Frame: Up to Week 52
Up to Week 52
Time to achieving steroid-free status
Time Frame: Up to Week 52
Up to Week 52
Incidence of adverse events (AEs) and treatment-related adverse events (TRAEs)
Time Frame: Up to Week 52
Up to Week 52

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.
January 29, 2026

Primary Completion (Estimated)

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 31, 2027

Study Completion (Estimated)

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.
December 31, 2027

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).
November 27, 2025

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.
November 27, 2025

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 8, 2025

Study Record Updates

Last Update Posted (Actual)

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.
May 18, 2026

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.
May 15, 2026

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.
May 1, 2026

More Information

Terms related to this study

Keywords

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.
  • IM047-1120

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

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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