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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05644665
Other study ID # IM047-010
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date December 9, 2022
Est. completion date April 14, 2027

Study information

Verified date May 2024
Source Bristol-Myers Squibb
Contact BMS Study Connect Contact Center www.BMSStudyConnect.com
Phone 855-907-3286
Email Clinical.Trials@bms.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 the opportunity to participate in an optional open label extension.


Recruitment information / eligibility

Status Recruiting
Enrollment 240
Est. completion date April 14, 2027
Est. primary completion date April 14, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Ozanimod
Specified dose on specified days
Placebo
Specified dose on specified days

Locations

Country Name City State
China Peking University International Hospital Beijing Beijing
China The Third Xiangya Hospital of Central South University Changsha Hunan
China Xiangya Hospital Central South University Changsha Hunan
China Local Institution - 0061 Changzhou Jiangsu
China The First People's Hospital of Changzhou Changzhou Jiangsu
China West China Hospital of Sichuan University Cheng Du Sichuan
China Sichuan Provincial People's Hospital Chengdu Sichuan
China Chongqing General Hospital Chongqing Chongqing
China The First Affiliated Hospital Of Fujian Medical University Fuzhou
China Guangzhou First People's Hospital Guangzhou Guangdong
China Local Institution - 0008 Guangzhou Guangdong
China Local Institution - 0020 Guangzhou Guangdong
China Local Institution - 0028 Guangzhou Guangdong
China Southern Medical University Nanfang Hospital Guangzhou Guangdong
China Affiliated Hospital of Guilin Medical University Guilin Guangxi
China Sir Run Run Shaw Hospital of Zhejiang University School of Medicine Hangzhou Zhejiang
China Anhui Provincial Hospital Hefei Anhui
China Qilu Hospital of Shandong University (Qingdao) Jinan Shandong
China The First People's Hospital of Yunnan Province Kunming Yunnan
China Jiangsu Province Hospital Nanjing Jiangsu
China Local Institution - 0024 Nanjing Jiangsu
China Local Institution - 0023 Nanning Guangxi
China Ruijin Hospital Shanghai Jiaotong University School of Medicine Shanghai Shanghai
China Shanghai East Hospital Shanghai
China Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine Shanghai Shanghai
China Zhongshan Hospital,Fudan University Shanghai Shanghai
China Shengjing Hospital of China Medical University Shenyang Liaoning
China Local Institution - 0006 Shijiazhuang Hebei
China The Second Afilliated Hospital of Hebei Medical University Shijiazhuang Hebei
China Local Institution - 0009 Suzhou Jiangsu
China The Second Affiliated Hospital of Soochow University Suzhou Jiangsu
China Second Hospital of Shanxi Medical University Taiyuan Shanxi
China Tianjin Medical University General Hospital Tianjin Tianjin
China Tianjin People' s Hospital Tianjin Tianjin
China Renmin Hospital of Wuhan University Wuhan HUB
China Tongji Hospital Tongji Medical,Science & Technology Wuhan Hubei
China Union Hospital Tongji Medical College Huazhong University of Science and Technology Wuhan Hubei
China Wannan Medical College Yijishan Hospital Wuhu Anhui
China Wuxi People's Hospital Wuxi Jiangsu
China Tangdu Hospital of Fourth Military Medical University of Chinese People's Liberation Army Xi'an Shaanxi
China Xijing Hospital Xi'an Shaanxi
China Zhongshan Hospital Affiliated to Xiamen University Xiamen Fujian
China Affiliated Hospital of Guangdong Medical University Zhanjiang Guangdong
China Affiliated Hospital of Jiangsu University Zhenjiang Jiangsu
Taiwan Changhua Christian Hospital Changhua County Changhua
Taiwan Taipei Medical University Shuang Ho Hospital New Taipei
Taiwan Local Institution - 0001 Taichung
Taiwan Local Institution - 0059 Taichung
Taiwan Local Institution - 0056 Taipei
Taiwan Taipei Veterans General Hospital Taipei
Taiwan Local Institution - 0060 Taipei City Taipei
Taiwan Chang Gung Medical Foundation-Linkou Branch Taoyuan

Sponsors (1)

Lead Sponsor Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

China,  Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of participants with clinical remission as measured by the 3-component Mayo Score At week 10
Secondary Proportion of participants with clinical remission as measured by the 3-component Mayo Score At week 52
Secondary Proportion of participants with clinical response as measured by the 3-component Mayo Score At week 10 and at week 52
Secondary Proportion of participants with endoscopic improvement At week 10 and at week 52
Secondary Proportion of participants achieving histologic remission At week 10 and at week 52
Secondary Proportion of participants with mucosal healing At week 10 and at week 52
Secondary Proportion of participants in remission as measured by the 3-component Mayo Score while off corticosteroids for = 12 weeks At week 52
Secondary Proportion of participants with Treatment Emergent Adverse Events (TEAEs) Up to 78 weeks
Secondary Proportion of participants with Serious Adverse Events (SAEs) Up to 78 weeks
Secondary Proportion of participants with TEAEs leading to discontinuation of investigational product Up to 78 weeks
Secondary Proportion of participants with TEAEs of special interest Up to 78 weeks
Secondary Proportion of participants with clinical laboratory abnormalities Up to 78 weeks
Secondary Proportion of participants with vital sign abnormalities Up to 78 weeks
Secondary Proportion of participants with electrocardiogram (ECG) abnormalities Up to 78 weeks
Secondary Proportion of participants with pulmonary function test abnormalities Up to 78 weeks
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