A Study to Evaluate Efficacy and Long-term Safety of Oral Ozanimod in Chinese Participants With Moderately to Severely Active Ulcerative Colitis (UC)
- Registration Number
- NCT05644665
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 131
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.
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm B: Placebo Placebo - Arm A: Ozanimod Ozanimod -
- Primary Outcome Measures
Name Time Method Proportion of participants with clinical remission as measured by the 3-component Mayo Score At week 10
- Secondary Outcome Measures
Name Time Method Proportion of participants with Treatment Emergent Adverse Events (TEAEs) Up to 78 weeks Proportion of participants with vital sign abnormalities Up to 78 weeks Proportion of participants achieving histologic remission At week 10 and at week 52 Proportion of participants with mucosal healing At week 10 and at week 52 Proportion of participants with clinical laboratory abnormalities Up to 78 weeks Proportion of participants with electrocardiogram (ECG) abnormalities Up to 78 weeks Proportion of participants with clinical response as measured by the 3-component Mayo Score At week 10 and at week 52 Proportion of participants with pulmonary function test abnormalities Up to 78 weeks Proportion of participants in remission as measured by the 3-component Mayo Score while off corticosteroids for ≥ 12 weeks At week 52 Proportion of participants with clinical remission as measured by the 3-component Mayo Score At week 52 Proportion of participants with endoscopic improvement At week 10 and at week 52 Proportion of participants with Serious Adverse Events (SAEs) Up to 78 weeks Proportion of participants with TEAEs leading to discontinuation of investigational product Up to 78 weeks Proportion of participants with TEAEs of special interest Up to 78 weeks
Trial Locations
- Locations (51)
Local Institution - 0012
🇨🇳Hefei, Anhui, China
Local Institution - 0013
🇨🇳Wuhu, Anhui, China
Local Institution - 0052
🇨🇳Beijing, Beijing, China
Local Institution - 0050
🇨🇳Chongqing, Chongqing, China
Local Institution - 0011
🇨🇳Xiamen, Fujian, 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 - 0045
🇨🇳Nanjing, Jiangsu, China
Local Institution - 0018
🇨🇳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, China
Local Institution - 0041
🇨🇳Shanghai, Shanghai, China
Local Institution - 0034
🇨🇳Shanghai, Shanghai, China
Local Institution - 0015
🇨🇳Taiyuan, Shanxi, China
Local Institution - 0032
🇨🇳Cheng Du, Sichuan, China
Local Institution - 0025
🇨🇳Chengdu, Sichuan, China
Local Institution - 0031
🇨🇳Tianjin, Tianjin, China
Local Institution - 0047
🇨🇳Tianjin, Tianjin, 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 - 0058
🇨🇳New Taipei, Taiwan
Local Institution - 0057
🇨🇳Taipei, Taiwan
Local Institution - 0055
🇨🇳Taoyuan, Taiwan
Local Institution - 0020
🇨🇳Guangzhou, Guangdong, China
Local Institution - 0024
🇨🇳Nanjing, Jiangsu, China
Local Institution - 0009
🇨🇳Suzhou, Jiangsu, China
Local Institution - 0060
🇨🇳Taipei City, Taipei, Taiwan
Local Institution - 0001
🇨🇳Taichung, Taiwan
Local Institution - 0059
🇨🇳Taichung, Taiwan
Local Institution - 0056
🇨🇳Taipei, Taiwan