Phase
Condition
Crohn's Disease
Inflammatory Bowel Disease
Treatment
Placebo
Ozanimod
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Main Inclusion Criteria for Induction and Maintenance Periods
Subject is a Japanese male or female subjects aged 18 to 75 years at the time ofsigning the informed consent form (ICF) at Screening.
Subject has had Ulcerative Colitis (UC) diagnosed at least 3 months prior to firstinvestigational product administration. The diagnosis should be confirmed byclinical and endoscopic evidence and corroborated by a histopathology report.
Subject has evidence of UC extending ≥ 15 cm from the anal verge as determined byBaseline endoscopy (flexible sigmoidoscopy or colonoscopy).
Subject has active UC defined as Mayo score of 6 to 12 inclusive, with endoscopicsubscore of ≥ 2, a rectal bleeding score of ≥ 1, and a stool frequency score ≥ 1.
Main Inclusion Criteria for Open-label Extension Period
Subjects must satisfy the following criteria to be enrolled in the study:
Must have completed the Week 12 Visit and is non-responder at Week 12
Who completes the IP and enters the MP, completes participation through the laststudy treatment visit at Week 52 with maintaining clinical response, OR experiencesdisease relapse during the MP
Exclusion
Exclusion Criteria:
Main Exclusion Criteria
Subject has severe extensive colitis
Subject has diagnosis of Crohn's disease or indeterminate colitis or the presence orhistory of a fistula consistent with Crohn's disease or microscopic colitis orradiation colitis or ischemic colitis.
Subject has positive stool examination for pathogens (ova and parasites, bacteria)or positive test for toxin producing Clostridium difficile (C. difficile) atScreening.4. Subject is pregnant or breastfeeding
Subject has clinically relevant cardiovascular conditions
Study Design
Study Description
Connect with a study center
Local Institution - 104
Sapporo, Hokkaido 060-8543
JapanSite Not Available
Local Institution - 104
Sapporo 2128295, Hokkaido 2130037 060-8543
JapanSite Not Available
Local Institution - 105
Nishinomiya, Hyogo 663-8501
JapanSite Not Available
Local Institution - 105
Nishinomiya 1855207, Hyōgo 1862047 663-8501
JapanSite Not Available
Local Institution - 156
Okayama-shi, Okayama 700-8558
JapanSite Not Available
Local Institution - 156
Okayama 1854383, Okayama-ken 1854381 700-8558
JapanSite Not Available
Local Institution - 153
Osaka-shi, Osaka 530-0052
JapanSite Not Available
Local Institution - 153
Osaka 1853909, Osaka 1853904 530-0052
JapanSite Not Available
Local Institution - 132
Osaka, Osaka-shi 545-8586
JapanSite Not Available
Local Institution - 132
Osaka 1853909, Osaka-shi 545-8586
JapanSite Not Available
Local Institution - 131
Iruma-gun, Saitama 1853226 3500495
JapanSite Not Available
Local Institution - 138
Bunkyo-ku, Tokyo 1850144 1138519
JapanSite Not Available
Local Institution - 139
Abiko, 270-1168
JapanSite Not Available
Local Institution - 139
Abiko 2113164, 270-1168
JapanSite Not Available
Local Institution - 152
Aki-gun, 735-8585
JapanSite Not Available
Medical Hospital of Tokyo Medical and Dental University
Bunkyo-ku, Tokyo, 113-8519
JapanSite Not Available
Local Institution - 122
Chikushino, 818-8502
JapanSite Not Available
Local Institution - 122
Chikushino-shi 1864572, 818-8502
JapanSite Not Available
Local Institution - 150
Fujiidera, 538-0027
JapanSite Not Available
Local Institution - 150
Fujiidera 6825495, 538-0027
JapanSite Not Available
Local Institution - 114
Fukui, 910-8526
JapanSite Not Available
Local Institution - 124
Fukui, 918-8503
JapanSite Not Available
Local Institution - 114
Fukui 1863986, 910-8526
JapanSite Not Available
Local Institution - 124
Fukui 1863986, 918-8503
JapanSite Not Available
Local Institution - 155
Fukuoka, 815-8555
JapanSite Not Available
Local Institution - 161
Fukuoka, 810-0001
JapanSite Not Available
Local Institution - 164
Fukuoka, 812-0033
JapanSite Not Available
Local Institution - 155
Fukuoka 1863967, 815-8555
JapanSite Not Available
Local Institution - 161
Fukuoka 1863967, 810-0001
JapanSite Not Available
Local Institution - 164
Fukuoka 1863967, 812-0033
JapanSite Not Available
Local Institution - 140
Gifu, 500-8717
JapanSite Not Available
Local Institution - 140
Gifu 1863641, 500-8717
JapanSite Not Available
Local Institution - 151
Hakodate, 040-8611
JapanSite Not Available
Local Institution - 151
Hakodate 2130188, 040-8611
JapanSite Not Available
Hirosaki University Hospital
Hirosaki, 036-8203
JapanSite Not Available
Local Institution - 133
Hirosaki, 036-8203
JapanSite Not Available
Local Institution - 133
Hirosaki 2130057, 036-8203
JapanSite Not Available
Local Institution - 106
Hiroshima, 734-8551
JapanSite Not Available
Local Institution - 160
Hiroshima, 734-8530
JapanSite Not Available
Local Institution - 106
Hiroshima 1862415, 734-8551
JapanSite Not Available
Local Institution - 160
Hiroshima 1862415, 734-8530
JapanSite Not Available
Local Institution - 126
Hitachi, Ibaraki, 317-0077
JapanSite Not Available
Aso Iizuka Hospital
Iizuka, 820-8505
JapanSite Not Available
Local Institution - 162
Iizuka, 820-8505
JapanSite Not Available
Local Institution - 162
Iizuka 1861835, 820-8505
JapanSite Not Available
Local Institution - 134
Isehara City, Kanagawa, 259-1193
JapanSite Not Available
Local Institution - 120
Kahoku-gun, 920-0293
JapanSite Not Available
Local Institution - 135
Kannonji, 769-1695
JapanSite Not Available
Local Institution - 135
Kannonji 1860167, 769-1695
JapanSite Not Available
Local Institution - 101
Kashihara, 634-8522
JapanSite Not Available
Local Institution - 101
Kashihara 1859952, 634-8522
JapanSite Not Available
Local Institution - 158
Kashiwa, 277-0871
JapanSite Not Available
Local Institution - 158
Kashiwa 1859924, 277-0871
JapanSite Not Available
Local Institution - 157
Kawagoe, 350-8550
JapanSite Not Available
Local Institution - 157
Kawagoe 1859740, 350-8550
JapanSite Not Available
Local Institution - 130
Kobe, 650-0017
JapanSite Not Available
Local Institution - 163
Kobe, 650-0015
JapanSite Not Available
Local Institution - 130
Kobe 1859171, 650-0017
JapanSite Not Available
Local Institution - 163
Kobe 1859171, 650-0015
JapanSite Not Available
Local Institution - 121
Komatsu, 923-8560
JapanSite Not Available
Local Institution - 121
Komatsu 1858910, 923-8560
JapanSite Not Available
Local Institution - 144
Koriyama, 963-8501
JapanSite Not Available
Local Institution - 142
Kurume, 830-8543
JapanSite Not Available
Local Institution - 165
Kurume, 839-0809
JapanSite Not Available
Local Institution - 142
Kurume 1858088, 830-8543
JapanSite Not Available
Local Institution - 165
Kurume 1858088, 839-0809
JapanSite Not Available
Local Institution - 111
Kurume, Fukuoka, 830-0011
JapanSite Not Available
Local Institution - 141
Kyoto 1857910, 602-8566
JapanSite Not Available
Local Institution - 141
Kyoto-city, 602-8566
JapanSite Not Available
Local Institution - 144
Kōriyama 2112141, 963-8501
JapanSite Not Available
Local Institution - 118
Matsuyama, 790-0024
JapanSite Not Available
Local Institution - 118
Matsuyama 1926099, 790-0024
JapanSite Not Available
Local Institution - 107
Minato-ku, 108-8642
JapanSite Not Available
Local Institution - 108
Minato-ku, 105-8471
JapanSite Not Available
Local Institution - 107
Minatoku 11191118, 108-8642
JapanSite Not Available
Local Institution - 108
Minatoku 11191118, 105-8471
JapanSite Not Available
Local Institution - 109
Mitaka, 181-8611
JapanSite Not Available
Local Institution - 109
Mitaka 11790343, 181-8611
JapanSite Not Available
Local Institution - 110
Morioka, 020-8505
JapanSite Not Available
Local Institution - 110
Morioka 2111834, 020-8505
JapanSite Not Available
Local Institution - 125
Nagaoka, 940-8653
JapanSite Not Available
Local Institution - 125
Nagaoka 1856199, 940-8653
JapanSite Not Available
Local Institution - 167
Nagoya 1856057, 466-8560
JapanSite Not Available
Local Institution - 167
Nagoya-shi, 466-8560
JapanSite Not Available
Local Institution - 119
Ogaki, 503-8502
JapanSite Not Available
Local Institution - 159
Oita, 870-0823
JapanSite Not Available
Local Institution - 136
Okayama, 700-0013
JapanSite Not Available
Local Institution - 156
Okayama, 700-8558
JapanSite Not Available
Local Institution - 136
Okayama 1854383, 700-0013
JapanSite Not Available
Local Institution - 153
Osaka, 533-0022
JapanSite Not Available
Local Institution - 127
Osaki-shi, 989-6183
JapanSite Not Available
Osaki Citizen Hospital
Osaki-shi, 989-6183
JapanSite Not Available
Local Institution - 113
Otsu, 520-2192
JapanSite Not Available
Local Institution - 154
Saga, 849-8501
JapanSite Not Available
Local Institution - 154
Saga 1853303, 849-8501
JapanSite Not Available
Local Institution - 116
Saitama, 336-0963
JapanSite Not Available
Local Institution - 116
Saitama 6940394, 336-0963
JapanSite Not Available
Local Institution - 145
Sakai, 591-8025
JapanSite Not Available
Local Institution - 145
Sakai 1853195, 591-8025
JapanSite Not Available
Local Institution - 102
Sakura, 285-8741
JapanSite Not Available
Local Institution - 102
Sakura 2111220, 285-8741
JapanSite Not Available
Local Institution - 103
Sapporo, 060-0033
JapanSite Not Available
Local Institution - 147
Sapporo, 062-8618
JapanSite Not Available
Local Institution - 103
Sapporo 2128295, 060-0033
JapanSite Not Available
Local Institution - 147
Sapporo 2128295, 062-8618
JapanSite Not Available
Local Institution - 104
Sapporo, Hokkaidô, 060-8543
JapanSite Not Available
IMS Meirikai Sendai General Hospital
Sendai, 980-0021
JapanSite Not Available
Local Institution - 146
Sendai, 980-0021
JapanSite Not Available
Local Institution - 146
Sendai 2111149, 980-0021
JapanSite Not Available
Local Institution - 128
Shinagawa-ku, Tokyo, 141-8625
JapanSite Not Available
Local Institution - 128
Shinagawa-ku, Tokyo 1850147, 141-8625
JapanSite Not Available
Local Institution - 117
Shinju-ku, 169-0073
JapanSite Not Available
Local Institution - 117
Shinjuku 11790353, 169-0073
JapanSite Not Available
Local Institution - 137
Shizuoka 1851717, 420-8630
JapanSite Not Available
Local Institution - 137
Shizuoka-shi, 420-8630
JapanSite Not Available
Local Institution - 149
Sunto-gun, 411-8611
JapanSite Not Available
Local Institution - 112
Takamatsu, 760-8557
JapanSite Not Available
Local Institution - 112
Takamatsu 1851100, 760-8557
JapanSite Not Available
Local Institution - 115
Takatsuki, 569-0086
JapanSite Not Available
Local Institution - 143
Takatsuki, 569-1096
JapanSite Not Available
Local Institution - 115
Takatsuki 1850910, 569-0086
JapanSite Not Available
Local Institution - 143
Takatsuki 1850910, 569-1096
JapanSite Not Available
Local Institution - 166
Toshima-ku, 171-0021
JapanSite Not Available
Local Institution - 129
Toyama, 939-8511
JapanSite Not Available
Local Institution - 129
Toyama 1849876, 939-8511
JapanSite Not Available
Local Institution - 123
Tsu, 514-8507
JapanSite Not Available
Local Institution - 123
Tsu 1849796, 514-8507
JapanSite Not Available
Local Institution - 148
Utsunomiya, 320-0003
JapanSite Not Available
Local Institution - 148
Utsunomiya 1849053, 320-0003
JapanSite Not Available
Local Institution - 119
Ōgaki 1854703, 503-8502
JapanSite Not Available
Local Institution - 159
Ōita 1854487, 870-0823
JapanSite Not Available
Local Institution - 113
Ōtsu 1853574, 520-2192
JapanSite Not Available

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