Ulcerative Colitis (UC)NCT07271069
Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis
An observational study of Ulcerative Colitis (UC), run by Bristol-Myers Squibb at 18 sites in Japan.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis (UC)
- What is being tested?
- Ozanimod and Azathioprine
- How many people
- 150 participants
- Where
- 18 sitesJapan
- Study dates
- 29 Jan 2026to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
18 sites in 1 country. Contact the study team or a site near you to ask about taking part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
18 sites in 1 country
Japan18 sites, 18 recruiting
- Recruiting
Asahikawa Medical University
Asahikawa, Hokkaido, 078-8510
- Recruiting
Chiba University
Chiba, Chiba, 263-8522
- Not yet recruiting
Fukuoka University Chikushi Hospital
Chikushino-shi, Fukuoka, 818-8502
- Recruiting
Fukuoka University Chikushi Hospital
Fukuoka, Fukuoka, 814-0180
- Recruiting
Hamamatsu University School of Medicine
Hamamatsu, Shizuoka, 431-3192
- Recruiting
Saitama Medical Center, Saitama Medical University
Hidaka-shi, Saitama, 350-1298
- Recruiting
Kansai Medical University
Hirakata, Osaka, 573-1010
- Recruiting
Sapporo Medical University School of Medicine
Hokkaidō
- Recruiting
Tsujinaka Hospital Kashiwanoha
Kashiwa-shi, Chiba, 277-0871
- Not yet recruiting
Ehime Prefectural Central Hospital
Matsuyama, Ehime, 790-0024
- Recruiting
Mebix. Inc.
Minato-ku, Tokyo, 1070052
Takao Fujii, Site 0001, +81-73-441-0875
- Recruiting
Kyorin University School of Medicine
Mitaka-shi, Tokyo, 181-8611
- Recruiting
Hyogo Medical University
Nishinomiya, Hyōgo, 663-8501
- Not yet recruiting
Saga University
Saga, Saga-ken, 840-8502
- Recruiting
Toho University Sakura Hospital
Sakura, Chiba, 285-8741
- Recruiting
Sapporo Higashi Tokushukai Hospital
Sapporo, Hokkaido, 065-0033
- Not yet recruiting
Kagawa Prefectural Central Hospital
Takamatsu, Kagawa-ken, 760-8557
- Not yet recruiting
Tottori University
Tottori-shi, Tottori, 680-8550
About this study
Official title: 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
- Conditions
- Ulcerative Colitis (UC)
- Being tested
- Ozanimod, Azathioprine
- Keywords
- Ulcerative Colitis (UC)
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OzanimodDrug
According to the product label
AzathioprineDrug
According to the product label
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Participants with ulcerative colitis receiving ozanimod Receives: Drug: Ozanimod | |
| Group 2 | Participants with ulcerative colitis receiving azathioprine Receives: Drug: Azathioprine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants achieving steroid-free symptomatic remission
Measured: Week 12; Weeks 24 and 52
Secondary outcomes (5)
Oral steroid dose prescribed
Measured: Week 12; Weeks 24 and 52
Proportion of patients with continuation of ozanimod or azathioprine treatment after oral steroid treatment initiation
Measured: Weeks 24 and 52
Steroid-free maintenance period duration
Measured: Up to Week 52
Time to achieving steroid-free status
Measured: Up to Week 52
Incidence of adverse events (AEs) and treatment-related adverse events (TRAEs)
Measured: Up to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start29 Jan 2026
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative Colitis (UC)Studies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07271069
- Sponsor's protocol ID
- IM047-1120
- Status last verified
- May 2026
- First submitted
- 27 Nov 2025
- Last updated
- 18 May 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis: A Chart Review Study
- ClinicalTrials.gov ID
- NCT07271069
- Acronym / sponsor ID
- IM047-1120
- Conditions
- Ulcerative Colitis (UC)
- Keywords
- Ulcerative Colitis (UC)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 29 Jan 2026 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 8 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: OzanimodParticipants with ulcerative colitis receiving ozanimod |
| Group 2 | – | Drug: AzathioprineParticipants with ulcerative colitis receiving azathioprine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OzanimodAccording to the product label | Drug | Group 1 |
| AzathioprineAccording to the product label | Drug | Group 2 |
Primary outcome
Proportion of participants achieving steroid-free symptomatic remission
Time frame: Week 12; Weeks 24 and 52
5 secondary outcomes
Oral steroid dose prescribed
Time frame: 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
Steroid-free maintenance period duration
Time frame: Up to Week 52
Time to achieving steroid-free status
Time frame: Up to Week 52
Incidence of adverse events (AEs) and treatment-related adverse events (TRAEs)
Time frame: Up to Week 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
Bristol Myers Squibb study director
Bristol-Myers Squibb
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcerative Colitis (UC), run by Bristol-Myers Squibb at 18 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BMS Clinical Trials Contact Center www.BMSClinicalTrials.com (855-907-3286, Clinical.Trials@bms.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants achieving steroid-free symptomatic remission (time frame: Week 12; Weeks 24 and 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026; AzTrials last refreshed its copy on 26 Oct 2026.