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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
131
Proportion of participants with clinical remission as measured by the 3-component Mayo Score
Time frame: At week 10
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
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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
...and 41 more locations
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