This is a randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy and safety of E6007 once daily for 8 weeks in Japanese participants with moderate active ulcerative colitis. Participants will be stratified by prior therapeutic treatment and Mayo score at Baseline, and will be randomized 1:1:1 to receive E6007 30 milligrams (mg), E6007 60 mg or placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
147
Change from Baseline in Mayo score at 8 weeks
Time frame: Baseline; 8 weeks
Number of participants with abnormal, clinically significant laboratory values
Time frame: up to 8 weeks
Change from Baseline in body temperature at 8 weeks
Time frame: Baseline; 8 weeks
Change from Baseline in diastolic blood pressure and systolic blood pressure at 8 weeks
Time frame: Baseline; 8 weeks
Change from Baseline in heart rate at 8 weeks
Time frame: Baseline; 8 weeks
Change from Baseline in respiratory rate at 8 weeks
Time frame: Baseline; 8 weeks
Change from Baseline in standard 12-lead electrocardiogram (ECG) values
Time frame: Baseline; 8 weeks
Number of participants with abnormal, clinically significant chest X-ray findings
Time frame: up to 8 weeks
Number of participants with any serious adverse event and number of participants with any non-serious adverse event
Time frame: up to 8 weeks
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EA Pharma Trial Site #1
Nagakute, Aichi-ken, Japan
EA Pharma Trial Site #1
Nagoya, Aichi-ken, Japan
EA Pharma Trial Site #2
Nagoya, Aichi-ken, Japan
EA Pharma Trial Site #3
Nagoya, Aichi-ken, Japan
EA Pharma Trial Site #1
Toyoake, Aichi-ken, Japan
EA Pharma Trial Site #1
Toyota, Aichi-ken, Japan
EA Pharma Trial Site #1
Hirosaki, Aomori, Japan
EA Pharma Trial Site #2
Hirosaki, Aomori, Japan
EA Pharma Trial Site #1
Sakura, Chiba, Japan
EA Pharma Trial Site #1
Urayasu, Chiba, Japan
...and 54 more locations