Ulcerative ColitisPhase 3NCT05644665
A Study to Evaluate Efficacy and Long-term Safety of Oral Ozanimod in Chinese Participants With Moderately to Severely Active Ulcerative Colitis (UC)
A Phase 3 study testing Ozanimod in people with Ulcerative Colitis, run by Bristol-Myers Squibb at 51 sites in 2 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Ozanimod
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 131 participants
- Where
- 51 sitesin 2 countries
- Study dates
- 9 Dec 2022to 7 Mar 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
51 sites in 2 countries.
51 sites in 2 countries
China43 sites
Local Institution - 0052
Beijing, Beijing Municipality, 102206
Local Institution - 0027
Changsha, Hunan, 410008
Local Institution - 0022
Changsha, Hunan, 410013
Local Institution - 0061
Changzhou, Jiangsu, 0
Local Institution - 0046
Changzhou, Jiangsu, 213003
Local Institution - 0032
Chengdu, Sichuan, 610041
Local Institution - 0025
Chengdu, Sichuan, 610072
Local Institution - 0050
Chongqing, Chongqing Municipality, 400014
Local Institution - 0048
Fuzhou, 350005
Local Institution - 0020
Guangzhou, Guangdong, 510080
Local Institution - 0036
Guangzhou, Guangdong, 510180
Local Institution - 0028
Guangzhou, Guangdong, 510280
Local Institution - 0019
Guangzhou, Guangdong, 510515
Local Institution - 0008
Guangzhou, Guangdong, 510655
Local Institution - 0051
Guilin, Guangxi, 541001
Local Institution - 0030
Hangzhou, Zhejiang, 310016
Local Institution - 0012
Hefei, Anhui, 230071
Local Institution - 0039
Jinan, Shandong, 250014
Local Institution - 0049
Kunming, Yunnan, 650034
Local Institution - 0024
Nanjing, Jiangsu, 210000
Local Institution - 0045
Nanjing, Jiangsu, 210029
Local Institution - 0035
Shanghai, Shanghai Municipality, 200025
Local Institution - 0041
Shanghai, Shanghai Municipality, 200032
Local Institution - 0034
Shanghai, Shanghai Municipality, 200092
Local Institution - 0053
Shanghai, 200120
Local Institution - 0010
Shenyang, Liaoning, 110004
Local Institution - 0007
Shijiazhuang, Hebei, 050000
Local Institution - 0006
Shijiazhuang, Hebei, 050011
Local Institution - 0018
Suzhou, Jiangsu, 215004
Local Institution - 0009
Suzhou, Jiangsu, 215006
Local Institution - 0015
Taiyuan, Shanxi, 030001
Local Institution - 0031
Tianjin, Tianjin Municipality, 300052
Local Institution - 0047
Tianjin, Tianjin Municipality, 300121
Local Institution - 0040
Wuhan, Hubei, 430022
Local Institution - 0037
Wuhan, Hubei, 430030
Local Institution - 0033
Wuhan, HUB, 430060
Local Institution - 0013
Wuhu, Anhui, 241001
Local Institution - 0044
Wuxi, Jiangsu, 214023
Local Institution - 0029
Xi'an, Shaanxi, 710032
Local Institution - 0026
Xi'an, Shaanxi, 710038
Local Institution - 0011
Xiamen, Fujian, 361004
Local Institution - 0004
Zhanjiang, Guangdong, 524004
Local Institution - 0042
Zhenjiang, Jiangsu, 212000
Taiwan8 sites
Local Institution - 0054
Changhua County, Changhua, 50006
Local Institution - 0058
New Taipei City, 235
Local Institution - 0001
Taichung, 40447
Local Institution - 0059
Taichung, 407
Local Institution - 0056
Taipei, 10002
Local Institution - 0057
Taipei, 11217
Local Institution - 0060
Taipei City, Taipei, 114
Local Institution - 0055
Taoyuan, 333
About this study
Official title: 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.
- Conditions
- Ulcerative Colitis
- Being tested
- Ozanimod, Placebo
- 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
Also called BMS-986374
Specified dose on specified days
PlaceboDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Ozanimod | Experimental | Not described Receives: Drug: Ozanimod |
| Arm B: Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with clinical remission as measured by the 3-component Mayo Score
Measured: At week 10
Secondary outcomes (14)
Proportion of participants with clinical remission as measured by the 3-component Mayo Score
Measured: At week 52
Proportion of participants with clinical response as measured by the 3-component Mayo Score
Measured: At week 10 and at week 52
Proportion of participants with endoscopic improvement
Measured: At week 10 and at week 52
Proportion of participants achieving histologic remission
Measured: At week 10 and at week 52
Proportion of participants with mucosal healing
Measured: 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
Measured: At week 52
Proportion of participants with Treatment Emergent Adverse Events (TEAEs)
Measured: Up to 78 weeks
Proportion of participants with Serious Adverse Events (SAEs)
Measured: Up to 78 weeks
Proportion of participants with TEAEs leading to discontinuation of investigational product
Measured: Up to 78 weeks
Proportion of participants with TEAEs of special interest
Measured: Up to 78 weeks
Proportion of participants with clinical laboratory abnormalities
Measured: Up to 78 weeks
Proportion of participants with vital sign abnormalities
Measured: Up to 78 weeks
Proportion of participants with electrocardiogram (ECG) abnormalities
Measured: Up to 78 weeks
Proportion of participants with pulmonary function test abnormalities
Measured: Up to 78 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start9 Dec 2022
- Primary completion7 Mar 2025
- Study completion7 Mar 2025
Why it stopped: Business objectives have changed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 131 participants (actual)
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
- NCT05644665
- Sponsor's protocol ID
- IM047-010
- Status last verified
- Mar 2025
- First submitted
- 1 Dec 2022
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT05644665
- Acronym / sponsor ID
- IM047-010
- Conditions
- Ulcerative Colitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business objectives have changed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 9 Dec 2022 (actual)
- Primary completion
- 7 Mar 2025 (actual)
- Study completion
- 7 Mar 2025 (actual)
- First posted
- 9 Dec 2022 (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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Ozanimod | Experimental | Drug: Ozanimod |
| Arm B: Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Eligible participants must be Chinese.
- Participant has had moderately to severely active UC diagnosed at least 3 months prior to first investigational product administration.
- 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.
Key exclusion criteria (5 listed)
- 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.
- 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.
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 |
|---|---|---|
| OzanimodAlso: BMS-986374Specified dose on specified days | Drug | Arm A: Ozanimod |
| PlaceboSpecified dose on specified days | Drug | Arm B: Placebo |
Primary outcome
Proportion of participants with clinical remission as measured by the 3-component Mayo Score
Time frame: At week 10
14 secondary outcomes
Proportion of participants with clinical remission as measured by the 3-component Mayo Score
Time frame: 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
Proportion of participants with endoscopic improvement
Time frame: At week 10 and at week 52
Proportion of participants achieving histologic remission
Time frame: At week 10 and at week 52
Proportion of participants with mucosal healing
Time frame: 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
Proportion of participants with Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to 78 weeks
Proportion of participants with Serious Adverse Events (SAEs)
Time frame: Up to 78 weeks
Proportion of participants with TEAEs leading to discontinuation of investigational product
Time frame: Up to 78 weeks
Proportion of participants with TEAEs of special interest
Time frame: Up to 78 weeks
Proportion of participants with clinical laboratory abnormalities
Time frame: Up to 78 weeks
Proportion of participants with vital sign abnormalities
Time frame: Up to 78 weeks
Proportion of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to 78 weeks
Proportion of participants with pulmonary function test abnormalities
Time frame: Up to 78 weeks
Results and safety
The study was stopped early (reason given: Business objectives have changed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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
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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. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
51 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ozanimod in people with Ulcerative Colitis, run by Bristol-Myers Squibb at 51 sites in 2 countries.
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 5 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: stopped early, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in China, Taiwan. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Business objectives have changed). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with clinical remission as measured by the 3-component Mayo Score (time frame: At week 10). 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 26 Mar 2025.