Back to resultsA Study to Evaluate Efficacy and Long-term Safety of Oral Ozanimod in Chinese Participants With Moderately to Severely Active Ulcerative Colitis (UC)
Primary Purpose
Ulcerative Colitis
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ozanimod
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Ulcerative Colitis
Eligibility Criteria
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.
Sites / Locations
- Local Institution - 0012Recruiting
- Local Institution - 0013Recruiting
- Local Institution - 0052Recruiting
- Local Institution - 0050Recruiting
- Local Institution - 0011Recruiting
- Local Institution - 0036Recruiting
- Local Institution - 0028Recruiting
- Local Institution - 0019Recruiting
- Local Institution - 0004Recruiting
- Local Institution - 0051Recruiting
- Local Institution - 0007Recruiting
- Local Institution - 0040Recruiting
- Local Institution - 0037Recruiting
- Local Institution - 0033Recruiting
- Local Institution - 0027Recruiting
- Local Institution - 0022Recruiting
- Local Institution - 0046Recruiting
- Local Institution - 0018Recruiting
- Local Institution - 0044Recruiting
- Local Institution - 0042Recruiting
- Local Institution - 0010Recruiting
- Local Institution - 0026Recruiting
- Local Institution - 0039Recruiting
- Local Institution - 0035Recruiting
- Local Institution - 0041Recruiting
- Local Institution - 0034Recruiting
- Local Institution - 0015Recruiting
- Local Institution - 0032Recruiting
- Local Institution - 0025Recruiting
- Local Institution - 0031Recruiting
- Local Institution - 0047Recruiting
- Local Institution - 0049Recruiting
- Local Institution - 0030Recruiting
- Local Institution - 0048Recruiting
- Local Institution - 0053Recruiting
- Local Institution - 0054Recruiting
- Local Institution - 0060Recruiting
- Local Institution - 0058Recruiting
- Local Institution - 0001Recruiting
- Local Institution - 0059Recruiting
- Local Institution - 0056Recruiting
- Local Institution - 0002
- Local Institution - 0057Recruiting
- Local Institution - 0055Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Arm A: Ozanimod
Arm B: Placebo
Arm Description
Outcomes
Primary Outcome Measures
Proportion of participants with clinical remission as measured by the 3-component Mayo Score
Secondary Outcome Measures
Proportion of participants with clinical remission as measured by the 3-component Mayo Score
Proportion of participants with clinical response as measured by the 3-component Mayo Score
Proportion of participants with endoscopic improvement
Proportion of participants achieving histologic remission
Proportion of participants with mucosal healing
Proportion of participants in remission as measured by the 3-component Mayo Score while off corticosteroids for ≥ 12 weeks
Proportion of participants with Treatment Emergent Adverse Events (TEAEs)
Proportion of participants with Serious Adverse Events (SAEs)
Proportion of participants with TEAEs leading to discontinuation of investigational product
Proportion of participants with TEAEs of special interest
Proportion of participants with clinical laboratory abnormalities
Proportion of participants with vital sign abnormalities
Proportion of participants with electrocardiogram (ECG) abnormalities
Proportion of participants with pulmonary function test abnormalities
Full Information
NCT ID
NCT05644665
First Posted
December 1, 2022
Last Updated
September 29, 2023
Sponsor
Bristol-Myers Squibb
1. Study Identification
Unique Protocol Identification Number
NCT05644665
Brief Title
A Study to Evaluate Efficacy and Long-term Safety of Oral Ozanimod in Chinese Participants With Moderately to Severely Active Ulcerative Colitis (UC)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 9, 2022 (Actual)
Primary Completion Date
April 14, 2027 (Anticipated)
Study Completion Date
April 14, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 the opportunity to participate in an optional open label extension.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm A: Ozanimod
Arm Type
Experimental
Arm Title
Arm B: Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Ozanimod
Other Intervention Name(s)
BMS-986374
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Proportion of participants with clinical remission as measured by the 3-component Mayo Score
Time Frame
At week 10
Secondary Outcome Measure Information:
Title
Proportion of participants with clinical remission as measured by the 3-component Mayo Score
Time Frame
At week 52
Title
Proportion of participants with clinical response as measured by the 3-component Mayo Score
Time Frame
At week 10 and at week 52
Title
Proportion of participants with endoscopic improvement
Time Frame
At week 10 and at week 52
Title
Proportion of participants achieving histologic remission
Time Frame
At week 10 and at week 52
Title
Proportion of participants with mucosal healing
Time Frame
At week 10 and at week 52
Title
Proportion of participants in remission as measured by the 3-component Mayo Score while off corticosteroids for ≥ 12 weeks
Time Frame
At week 52
Title
Proportion of participants with Treatment Emergent Adverse Events (TEAEs)
Time Frame
Up to 78 weeks
Title
Proportion of participants with Serious Adverse Events (SAEs)
Time Frame
Up to 78 weeks
Title
Proportion of participants with TEAEs leading to discontinuation of investigational product
Time Frame
Up to 78 weeks
Title
Proportion of participants with TEAEs of special interest
Time Frame
Up to 78 weeks
Title
Proportion of participants with clinical laboratory abnormalities
Time Frame
Up to 78 weeks
Title
Proportion of participants with vital sign abnormalities
Time Frame
Up to 78 weeks
Title
Proportion of participants with electrocardiogram (ECG) abnormalities
Time Frame
Up to 78 weeks
Title
Proportion of participants with pulmonary function test abnormalities
Time Frame
Up to 78 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BMS Study Connect Contact Center www.BMSStudyConnect.com
Phone
855-907-3286
Email
Clinical.Trials@bms.com
First Name & Middle Initial & Last Name or Official Title & Degree
First line of the email MUST contain NCT # and Site #.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution - 0012
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230071
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0012
Facility Name
Local Institution - 0013
City
Wuhu
State/Province
Anhui
ZIP/Postal Code
241001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0013
Facility Name
Local Institution - 0052
City
Beijing
State/Province
Beijing
ZIP/Postal Code
102206
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0052
Facility Name
Local Institution - 0050
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400014
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0050
Facility Name
Local Institution - 0011
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361004
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0011
Facility Name
Local Institution - 0036
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510180
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0036
Facility Name
Local Institution - 0028
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510280
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0028
Facility Name
Local Institution - 0019
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0019
Facility Name
Local Institution - 0004
City
Zhanjiang
State/Province
Guangdong
ZIP/Postal Code
524004
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0004
Facility Name
Local Institution - 0051
City
Guilin
State/Province
Guangxi
ZIP/Postal Code
541001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0051
Facility Name
Local Institution - 0007
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0007
Facility Name
Local Institution - 0040
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0040
Facility Name
Local Institution - 0037
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0037
Facility Name
Local Institution - 0033
City
Wuhan
State/Province
HUB
ZIP/Postal Code
430060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0033
Facility Name
Local Institution - 0027
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0027
Facility Name
Local Institution - 0022
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0022
Facility Name
Local Institution - 0046
City
Changzhou
State/Province
Jiangsu
ZIP/Postal Code
213003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0046
Facility Name
Local Institution - 0018
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215004
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0018
Facility Name
Local Institution - 0044
City
Wuxi
State/Province
Jiangsu
ZIP/Postal Code
214023
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0044
Facility Name
Local Institution - 0042
City
Zhenjiang
State/Province
Jiangsu
ZIP/Postal Code
212000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0042
Facility Name
Local Institution - 0010
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110004
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0010
Facility Name
Local Institution - 0026
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710038
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0026
Facility Name
Local Institution - 0039
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250014
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0039
Facility Name
Local Institution - 0035
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0035
Facility Name
Local Institution - 0041
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0041
Facility Name
Local Institution - 0034
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200092
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0034
Facility Name
Local Institution - 0015
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0015
Facility Name
Local Institution - 0032
City
Cheng Du
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0032
Facility Name
Local Institution - 0025
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610072
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0025
Facility Name
Local Institution - 0031
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300052
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0031
Facility Name
Local Institution - 0047
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300121
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0047
Facility Name
Local Institution - 0049
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650034
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0049
Facility Name
Local Institution - 0030
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310016
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0030
Facility Name
Local Institution - 0048
City
Fuzhou
ZIP/Postal Code
350005
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0048
Facility Name
Local Institution - 0053
City
Shanghai
ZIP/Postal Code
200120
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0053
Facility Name
Local Institution - 0054
City
Changhua County
State/Province
Changhua
ZIP/Postal Code
50006
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0054
Facility Name
Local Institution - 0060
City
Taipei City
State/Province
Taipei
ZIP/Postal Code
114
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0060
Facility Name
Local Institution - 0058
City
New Taipei
ZIP/Postal Code
235
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0058
Facility Name
Local Institution - 0001
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0001
Facility Name
Local Institution - 0059
City
Taichung
ZIP/Postal Code
407
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0059
Facility Name
Local Institution - 0056
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0056
Facility Name
Local Institution - 0002
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Individual Site Status
Withdrawn
Facility Name
Local Institution - 0057
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0057
Facility Name
Local Institution - 0055
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0055
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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 URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
Learn more about this trial
A Study to Evaluate Efficacy and Long-term Safety of Oral Ozanimod in Chinese Participants With Moderately to Severely Active Ulcerative Colitis (UC)
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