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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| E6007 30 mg | Experimental | Participants will receive E6007 30 milligrams (mg) once daily after breakfast. |
|
| E6007 60 mg | Experimental | Participants will receive E6007 60 mg once daily after breakfast. |
|
| Placebo | Placebo Comparator | Participants will receive matching placebo once daily after breakfast. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E6007 | Drug | once daily administration |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Mayo score at 8 weeks | Baseline; 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with abnormal, clinically significant laboratory values | up to 8 weeks | |
| Change from Baseline in body temperature at 8 weeks | Baseline; 8 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| EA Pharma Trial Site #1 | Nagakute | Aichi-ken | Japan | |||
| EA Pharma Trial Site #1 |
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| Placebo |
| Drug |
once daily administration |
|
| Change from Baseline in diastolic blood pressure and systolic blood pressure at 8 weeks |
| Baseline; 8 weeks |
| Change from Baseline in heart rate at 8 weeks | Baseline; 8 weeks |
| Change from Baseline in respiratory rate at 8 weeks | Baseline; 8 weeks |
| Change from Baseline in standard 12-lead electrocardiogram (ECG) values | Baseline; 8 weeks |
| Number of participants with abnormal, clinically significant chest X-ray findings | up to 8 weeks |
| Number of participants with any serious adverse event and number of participants with any non-serious adverse event | up to 8 weeks |
| 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 |
| EA Pharma Trial Site #1 | Matsuyama | Ehime | Japan |
| EA Pharma Trial Site #1 | Ōgaki | Gifu | Japan |
| EA Pharma Trial Site #1 | Takasaki | Gunma | Japan |
| EA Pharma Trial Site #1 | Fukuyama | Hiroshima | Japan |
| EA Pharma Trial Site #1 | Obihiro | Hokkaido | Japan |
| EA Pharma Trial Site #1 | Sapporo | Hokkaido | Japan |
| EA Pharma Trial Site #2 | Sapporo | Hokkaido | Japan |
| EA Pharma Trial Site #1 | Nishinomiya | Hyōgo | Japan |
| EA Pharma Trial Site #1 | Kanazawa | Ishikawa-ken | Japan |
| EA Pharma Trial Site #2 | Kanazawa | Ishikawa-ken | Japan |
| EA Pharma Trial Site #1 | Morioka | Iwate | Japan |
| EA Pharma Trial Site #1 | Takamatsu | Kagawa-ken | Japan |
| EA Pharma Trial Site #2 | Takamatsu | Kagawa-ken | Japan |
| EA Pharma Trial Site #1 | Kamakura | Kanagawa | Japan |
| EA Pharma Trial Site #1 | Kawasaki | Kanagawa | Japan |
| EA Pharma Trial Site #1 | Sagamihara | Kanagawa | Japan |
| EA Pharma Trial Site #1 | Yokohama | Kanagawa | Japan |
| EA Pharma Trial Site #1 | Tsu | Mie-ken | Japan |
| EA Pharma Trial Site #1 | Sendai | Miyagi | Japan |
| EA Pharma Trial Site #2 | Sendai | Miyagi | Japan |
| EA Pharma Trial Site #1 | Nagaoka | Niigata | Japan |
| EA Pharma Trial Site #1 | Kurashiki | Okayama-ken | Japan |
| EA Pharma Trial Site #1 | Sayama | Osaka | Japan |
| EA Pharma Trial Site #1 | Suita | Osaka | Japan |
| EA Pharma Trial Site #1 | Kawagoe | Saitama | Japan |
| EA Pharma Trial Site #1 | Izumo | Shimane | Japan |
| EA Pharma Trial Site #1 | Shimotsuga | Tochigi | Japan |
| EA Pharma Trial Site #1 | Bunkyo | Tokyo | Japan |
| EA Pharma Trial Site #1 | Chūō | Tokyo | Japan |
| EA Pharma Trial Site #1 | Hachiōji | Tokyo | Japan |
| EA Pharma Trial Site #1 | Minato | Tokyo | Japan |
| EA Pharma Trial Site #2 | Minato | Tokyo | Japan |
| EA Pharma Trial Site #1 | Mitaka | Tokyo | Japan |
| EA Pharma Trial Site #1 | Shinagawa | Tokyo | Japan |
| EA Pharma Trial Site #1 | Shinjuku | Tokyo | Japan |
| EA Pharma Trial Site #1 | Ube | Yamaguchi | Japan |
| EA Pharma Trial Site #1 | Kofu | Yamanashi | Japan |
| EA Pharma Trial Site #1 | Chiba | Japan |
| EA Pharma Trial Site #1 | Fukuoka | Japan |
| EA Pharma Trial Site #2 | Fukuoka | Japan |
| EA Pharma Trial Site #1 | Hiroshima | Japan |
| EA Pharma Trial Site #2 | Hiroshima | Japan |
| EA Pharma Trial Site #1 | Kagoshima | Japan |
| EA Pharma Trial Site #1 | Kumamoto | Japan |
| EA Pharma Trial Site #1 | Kyoto | Japan |
| EA Pharma Trial Site #2 | Kyoto | Japan |
| EA Pharma Trial Site #1 | Nagasaki | Japan |
| EA Pharma Trial Site #1 | Niigata | Japan |
| EA Pharma Trial Site #1 | Okayama | Japan |
| EA Pharma Trial Site #1 | Osaka | Japan |
| EA Pharma Trial Site #2 | Osaka | Japan |
| EA Pharma Trial Site #1 | Saga | Japan |
| EA Pharma Trial Site #2 | Saga | Japan |
| EA Pharma Trial Site #1 | Toyama | Japan |