A Study to Evaluate Efficacy and Long-term Safety of Oral Ozanimod in Chinese Participants With Moderately to Severely Active Ulcerative Colitis (UC)
NCT ID: NCT05644665
Last Updated: 2025-03-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
131 participants
INTERVENTIONAL
2022-12-09
2025-03-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Arm A: Ozanimod
Ozanimod
Specified dose on specified days
Arm B: Placebo
Placebo
Specified dose on specified days
Interventions
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Ozanimod
Specified dose on specified days
Placebo
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 0012
Hefei, Anhui, China
Local Institution - 0013
Wuhu, Anhui, China
Local Institution - 0052
Beijing, Beijing Municipality, China
Local Institution - 0050
Chongqing, Chongqing Municipality, China
Local Institution - 0011
Xiamen, Fujian, China
Local Institution - 0020
Guangzhou, Guangdong, China
Local Institution - 0036
Guangzhou, Guangdong, China
Local Institution - 0028
Guangzhou, Guangdong, China
Local Institution - 0019
Guangzhou, Guangdong, China
Local Institution - 0008
Guangzhou, Guangdong, China
Local Institution - 0004
Zhanjiang, Guangdong, China
Local Institution - 0051
Guilin, Guangxi, China
Local Institution - 0007
Shijiazhuang, Hebei, China
Local Institution - 0006
Shijiazhuang, Hebei, China
Local Institution - 0040
Wuhan, Hubei, China
Local Institution - 0037
Wuhan, Hubei, China
Local Institution - 0033
Wuhan, HUB, China
Local Institution - 0027
Changsha, Hunan, China
Local Institution - 0022
Changsha, Hunan, China
Local Institution - 0061
Changzhou, Jiangsu, China
Local Institution - 0046
Changzhou, Jiangsu, China
Local Institution - 0024
Nanjing, Jiangsu, China
Local Institution - 0045
Nanjing, Jiangsu, China
Local Institution - 0018
Suzhou, Jiangsu, China
Local Institution - 0009
Suzhou, Jiangsu, China
Local Institution - 0044
Wuxi, Jiangsu, China
Local Institution - 0042
Zhenjiang, Jiangsu, China
Local Institution - 0010
Shenyang, Liaoning, China
Local Institution - 0029
Xi'an, Shaanxi, China
Local Institution - 0026
Xi'an, Shaanxi, China
Local Institution - 0039
Jinan, Shandong, China
Local Institution - 0035
Shanghai, Shanghai Municipality, China
Local Institution - 0041
Shanghai, Shanghai Municipality, China
Local Institution - 0034
Shanghai, Shanghai Municipality, China
Local Institution - 0015
Taiyuan, Shanxi, China
Local Institution - 0032
Chengdu, Sichuan, China
Local Institution - 0025
Chengdu, Sichuan, China
Local Institution - 0031
Tianjin, Tianjin Municipality, China
Local Institution - 0047
Tianjin, Tianjin Municipality, China
Local Institution - 0049
Kunming, Yunnan, China
Local Institution - 0030
Hangzhou, Zhejiang, China
Local Institution - 0048
Fuzhou, , China
Local Institution - 0053
Shanghai, , China
Local Institution - 0054
Changhua County, Changhua, Taiwan
Local Institution - 0060
Taipei City, Taipei, Taiwan
Local Institution - 0058
New Taipei City, , Taiwan
Local Institution - 0001
Taichung, , Taiwan
Local Institution - 0059
Taichung, , Taiwan
Local Institution - 0056
Taipei, , Taiwan
Local Institution - 0057
Taipei, , Taiwan
Local Institution - 0055
Taoyuan District, , Taiwan
Countries
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Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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IM047-010
Identifier Type: -
Identifier Source: org_study_id
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