To Evaluate Efficacy and Long-term Safety of Ozanimod in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis

Last updated: October 13, 2025
Sponsor: Celgene
Overall Status: Completed

Phase

3

Condition

Crohn's Disease

Inflammatory Bowel Disease

Treatment

Placebo

Ozanimod

Clinical Study ID

NCT03915769
RPC01-3103
U1111-1230-3228
  • Ages 18-75
  • All Genders

Study Summary

Japanese patients with moderate or severe active ulcerative colitis as a subject when ozanimod 0.46 mg or 0.92 mg is orally administered is evaluated about dose response, efficacy and safety with placebo as a control.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Main Inclusion Criteria for Induction and Maintenance Periods

  1. Subject is a Japanese male or female subjects aged 18 to 75 years at the time ofsigning the informed consent form (ICF) at Screening.

  2. 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.

  3. Subject has evidence of UC extending ≥ 15 cm from the anal verge as determined byBaseline endoscopy (flexible sigmoidoscopy or colonoscopy).

  4. 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:

  1. Must have completed the Week 12 Visit and is non-responder at Week 12

  2. 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

  1. Subject has severe extensive colitis

  2. 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.

  3. 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

  4. Subject has clinically relevant cardiovascular conditions

Study Design

Total Participants: 198
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
June 03, 2019
Estimated Completion Date:
September 30, 2025

Study Description

Following the up to 5-week Screening Period, eligible subjects will be randomized to enter the 12 weeks placebo-controlled Induction Period (IP). Subjects who are responders at Week 12 will continue on their assigned treatment in the 40-week Maintenance Period (MP). Non responders at Week 12 have the option to enter the Open-label Extension (OLE). Subjects who complete the MP will be given the option to participate in the OLE. Subjects that enter the MP and experience disease relapse will also have the option to enter the OLE. The OLE will continue until marketing launch (about 4 years of ozanimod for Ulcerative colitis (UC), or until the Sponsor discontinues the development program.

Connect with a study center

  • Local Institution - 104

    Sapporo, Hokkaido 060-8543
    Japan

    Site Not Available

  • Local Institution - 104

    Sapporo 2128295, Hokkaido 2130037 060-8543
    Japan

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  • Local Institution - 105

    Nishinomiya, Hyogo 663-8501
    Japan

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  • Local Institution - 105

    Nishinomiya 1855207, Hyōgo 1862047 663-8501
    Japan

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  • Local Institution - 156

    Okayama-shi, Okayama 700-8558
    Japan

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  • Local Institution - 156

    Okayama 1854383, Okayama-ken 1854381 700-8558
    Japan

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  • Local Institution - 153

    Osaka-shi, Osaka 530-0052
    Japan

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  • Local Institution - 153

    Osaka 1853909, Osaka 1853904 530-0052
    Japan

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  • Local Institution - 132

    Osaka, Osaka-shi 545-8586
    Japan

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  • Local Institution - 132

    Osaka 1853909, Osaka-shi 545-8586
    Japan

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  • Local Institution - 131

    Iruma-gun, Saitama 1853226 3500495
    Japan

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  • Local Institution - 138

    Bunkyo-ku, Tokyo 1850144 1138519
    Japan

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  • Local Institution - 139

    Abiko, 270-1168
    Japan

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  • Local Institution - 139

    Abiko 2113164, 270-1168
    Japan

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  • Local Institution - 152

    Aki-gun, 735-8585
    Japan

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  • Medical Hospital of Tokyo Medical and Dental University

    Bunkyo-ku, Tokyo, 113-8519
    Japan

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  • Local Institution - 122

    Chikushino, 818-8502
    Japan

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    Chikushino-shi 1864572, 818-8502
    Japan

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  • Local Institution - 150

    Fujiidera, 538-0027
    Japan

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    Fujiidera 6825495, 538-0027
    Japan

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  • Local Institution - 114

    Fukui, 910-8526
    Japan

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    Fukui, 918-8503
    Japan

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    Fukui 1863986, 910-8526
    Japan

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    Fukui 1863986, 918-8503
    Japan

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  • Local Institution - 155

    Fukuoka, 815-8555
    Japan

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    Fukuoka, 810-0001
    Japan

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    Fukuoka, 812-0033
    Japan

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    Fukuoka 1863967, 815-8555
    Japan

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    Fukuoka 1863967, 810-0001
    Japan

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    Fukuoka 1863967, 812-0033
    Japan

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    Gifu, 500-8717
    Japan

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    Gifu 1863641, 500-8717
    Japan

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  • Local Institution - 151

    Hakodate, 040-8611
    Japan

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  • Local Institution - 151

    Hakodate 2130188, 040-8611
    Japan

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  • Hirosaki University Hospital

    Hirosaki, 036-8203
    Japan

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    Hirosaki, 036-8203
    Japan

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    Hirosaki 2130057, 036-8203
    Japan

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    Hiroshima, 734-8551
    Japan

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    Hiroshima, 734-8530
    Japan

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    Hiroshima 1862415, 734-8551
    Japan

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  • Local Institution - 160

    Hiroshima 1862415, 734-8530
    Japan

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  • Local Institution - 126

    Hitachi, Ibaraki, 317-0077
    Japan

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  • Aso Iizuka Hospital

    Iizuka, 820-8505
    Japan

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    Iizuka, 820-8505
    Japan

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    Iizuka 1861835, 820-8505
    Japan

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  • Local Institution - 134

    Isehara City, Kanagawa, 259-1193
    Japan

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    Kahoku-gun, 920-0293
    Japan

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    Kannonji, 769-1695
    Japan

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    Kannonji 1860167, 769-1695
    Japan

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    Kashihara, 634-8522
    Japan

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    Kashihara 1859952, 634-8522
    Japan

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    Kashiwa, 277-0871
    Japan

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    Kashiwa 1859924, 277-0871
    Japan

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    Kawagoe, 350-8550
    Japan

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    Kawagoe 1859740, 350-8550
    Japan

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  • Local Institution - 130

    Kobe, 650-0017
    Japan

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    Kobe, 650-0015
    Japan

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    Kobe 1859171, 650-0017
    Japan

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  • Local Institution - 163

    Kobe 1859171, 650-0015
    Japan

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    Komatsu, 923-8560
    Japan

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    Komatsu 1858910, 923-8560
    Japan

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  • Local Institution - 144

    Koriyama, 963-8501
    Japan

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    Kurume, 830-8543
    Japan

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    Kurume, 839-0809
    Japan

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    Kurume 1858088, 830-8543
    Japan

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    Kurume 1858088, 839-0809
    Japan

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  • Local Institution - 111

    Kurume, Fukuoka, 830-0011
    Japan

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  • Local Institution - 141

    Kyoto 1857910, 602-8566
    Japan

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    Kyoto-city, 602-8566
    Japan

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    Kōriyama 2112141, 963-8501
    Japan

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    Matsuyama, 790-0024
    Japan

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    Matsuyama 1926099, 790-0024
    Japan

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    Minato-ku, 108-8642
    Japan

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    Minato-ku, 105-8471
    Japan

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    Minatoku 11191118, 108-8642
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    Minatoku 11191118, 105-8471
    Japan

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    Mitaka, 181-8611
    Japan

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    Mitaka 11790343, 181-8611
    Japan

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    Morioka, 020-8505
    Japan

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    Morioka 2111834, 020-8505
    Japan

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    Nagaoka, 940-8653
    Japan

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    Nagaoka 1856199, 940-8653
    Japan

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    Nagoya 1856057, 466-8560
    Japan

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    Nagoya-shi, 466-8560
    Japan

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    Ogaki, 503-8502
    Japan

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    Oita, 870-0823
    Japan

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    Okayama, 700-0013
    Japan

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    Okayama, 700-8558
    Japan

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    Okayama 1854383, 700-0013
    Japan

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  • Local Institution - 153

    Osaka, 533-0022
    Japan

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    Osaki-shi, 989-6183
    Japan

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  • Osaki Citizen Hospital

    Osaki-shi, 989-6183
    Japan

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    Otsu, 520-2192
    Japan

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    Saga, 849-8501
    Japan

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    Saga 1853303, 849-8501
    Japan

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    Saitama, 336-0963
    Japan

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    Saitama 6940394, 336-0963
    Japan

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  • Local Institution - 145

    Sakai, 591-8025
    Japan

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    Sakai 1853195, 591-8025
    Japan

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    Sakura, 285-8741
    Japan

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    Sakura 2111220, 285-8741
    Japan

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    Sapporo, 060-0033
    Japan

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  • Local Institution - 147

    Sapporo, 062-8618
    Japan

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  • Local Institution - 103

    Sapporo 2128295, 060-0033
    Japan

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  • Local Institution - 147

    Sapporo 2128295, 062-8618
    Japan

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  • Local Institution - 104

    Sapporo, Hokkaidô, 060-8543
    Japan

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  • IMS Meirikai Sendai General Hospital

    Sendai, 980-0021
    Japan

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  • Local Institution - 146

    Sendai, 980-0021
    Japan

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    Sendai 2111149, 980-0021
    Japan

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    Shinagawa-ku, Tokyo, 141-8625
    Japan

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    Shinagawa-ku, Tokyo 1850147, 141-8625
    Japan

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    Shinju-ku, 169-0073
    Japan

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    Shinjuku 11790353, 169-0073
    Japan

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    Shizuoka 1851717, 420-8630
    Japan

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    Shizuoka-shi, 420-8630
    Japan

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    Sunto-gun, 411-8611
    Japan

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    Takamatsu, 760-8557
    Japan

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    Takamatsu 1851100, 760-8557
    Japan

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    Takatsuki, 569-0086
    Japan

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    Takatsuki, 569-1096
    Japan

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    Takatsuki 1850910, 569-0086
    Japan

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    Takatsuki 1850910, 569-1096
    Japan

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    Toshima-ku, 171-0021
    Japan

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    Toyama, 939-8511
    Japan

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    Toyama 1849876, 939-8511
    Japan

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    Tsu, 514-8507
    Japan

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    Tsu 1849796, 514-8507
    Japan

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  • Local Institution - 148

    Utsunomiya, 320-0003
    Japan

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    Utsunomiya 1849053, 320-0003
    Japan

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    Ōgaki 1854703, 503-8502
    Japan

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  • Local Institution - 159

    Ōita 1854487, 870-0823
    Japan

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  • Local Institution - 113

    Ōtsu 1853574, 520-2192
    Japan

    Site Not Available

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