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

Last updated: April 21, 2025
Sponsor: Celgene
Overall Status: Active - Not Recruiting

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: 195
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
June 03, 2019
Estimated Completion Date:
October 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 - 105

    Nishinomiya, Hyogo 663-8501
    Japan

    Site Not Available

  • Local Institution - 156

    Okayama-shi, Okayama 700-8558
    Japan

    Site Not Available

  • Local Institution - 153

    Osaka-shi, Osaka 530-0052
    Japan

    Site Not Available

  • Local Institution - 132

    Osaka, Osaka-shi 545-8586
    Japan

    Site Not Available

  • Local Institution - 131

    Iruma-gun, Saitama 3500495
    Japan

    Site Not Available

  • Local Institution - 138

    Bunkyo-ku, Tokyo 1138519
    Japan

    Site Not Available

  • Local Institution - 139

    Abiko, 270-1168
    Japan

    Site Not Available

  • Local Institution - 152

    Aki-gun, 735-8585
    Japan

    Site Not Available

  • Medical Hospital of Tokyo Medical and Dental University

    Bunkyo-ku, Tokyo, 113-8519
    Japan

    Site Not Available

  • Local Institution - 122

    Chikushino, 818-8502
    Japan

    Site Not Available

  • Local Institution - 150

    Fujiidera, 538-0027
    Japan

    Site Not Available

  • Local Institution - 114

    Fukui, 910-8526
    Japan

    Site Not Available

  • Local Institution - 124

    Fukui, 918-8503
    Japan

    Site Not Available

  • Local Institution - 155

    Fukuoka, 815-8555
    Japan

    Site Not Available

  • Local Institution - 161

    Fukuoka, 810-0001
    Japan

    Site Not Available

  • Local Institution - 164

    Fukuoka, 812-0033
    Japan

    Site Not Available

  • Local Institution - 140

    Gifu, 500-8717
    Japan

    Site Not Available

  • Local Institution - 151

    Hakodate, 040-8611
    Japan

    Site Not Available

  • Hirosaki University Hospital

    Hirosaki, 036-8203
    Japan

    Site Not Available

  • Local Institution - 133

    Hirosaki, 036-8203
    Japan

    Site Not Available

  • Local Institution - 106

    Hiroshima, 734-8551
    Japan

    Site Not Available

  • Local Institution - 160

    Hiroshima, 734-8530
    Japan

    Site Not Available

  • Local Institution - 126

    Hitachi, Ibaraki, 317-0077
    Japan

    Site Not Available

  • Aso Iizuka Hospital

    Iizuka, 820-8505
    Japan

    Site Not Available

  • Local Institution - 162

    Iizuka, 820-8505
    Japan

    Site Not Available

  • Local Institution - 134

    Isehara City, Kanagawa, 259-1193
    Japan

    Site Not Available

  • Local Institution - 120

    Kahoku-gun, 920-0293
    Japan

    Site Not Available

  • Local Institution - 135

    Kannonji, 769-1695
    Japan

    Site Not Available

  • Local Institution - 101

    Kashihara, 634-8522
    Japan

    Site Not Available

  • Local Institution - 158

    Kashiwa, 277-0871
    Japan

    Site Not Available

  • Local Institution - 157

    Kawagoe, 350-8550
    Japan

    Site Not Available

  • Local Institution - 130

    Kobe, 650-0017
    Japan

    Site Not Available

  • Local Institution - 163

    Kobe, 650-0015
    Japan

    Site Not Available

  • Local Institution - 121

    Komatsu, 923-8560
    Japan

    Site Not Available

  • Local Institution - 144

    Koriyama, 963-8501
    Japan

    Site Not Available

  • Local Institution - 142

    Kurume, 830-8543
    Japan

    Site Not Available

  • Local Institution - 165

    Kurume, 839-0809
    Japan

    Site Not Available

  • Local Institution - 111

    Kurume, Fukuoka, 830-0011
    Japan

    Site Not Available

  • Local Institution - 141

    Kyoto-city, 602-8566
    Japan

    Site Not Available

  • Local Institution - 118

    Matsuyama, 790-0024
    Japan

    Site Not Available

  • Local Institution - 107

    Minato-ku, 108-8642
    Japan

    Site Not Available

  • Local Institution - 108

    Minato-ku, 105-8471
    Japan

    Site Not Available

  • Local Institution - 109

    Mitaka, 181-8611
    Japan

    Site Not Available

  • Local Institution - 110

    Morioka, 020-8505
    Japan

    Site Not Available

  • Local Institution - 125

    Nagaoka, 940-8653
    Japan

    Site Not Available

  • Local Institution - 167

    Nagoya-shi, 466-8560
    Japan

    Site Not Available

  • Local Institution - 119

    Ogaki, 503-8502
    Japan

    Site Not Available

  • Local Institution - 159

    Oita, 870-0823
    Japan

    Site Not Available

  • Local Institution - 136

    Okayama, 700-0013
    Japan

    Site Not Available

  • Local Institution - 153

    Osaka, 533-0022
    Japan

    Site Not Available

  • Local Institution - 127

    Osaki-shi, 989-6183
    Japan

    Site Not Available

  • Osaki Citizen Hospital

    Osaki-shi, 989-6183
    Japan

    Site Not Available

  • Local Institution - 113

    Otsu, 520-2192
    Japan

    Site Not Available

  • Local Institution - 154

    Saga, 849-8501
    Japan

    Site Not Available

  • Local Institution - 116

    Saitama, 336-0963
    Japan

    Site Not Available

  • Local Institution - 145

    Sakai, 591-8025
    Japan

    Site Not Available

  • Local Institution - 102

    Sakura, 285-8741
    Japan

    Site Not Available

  • Local Institution - 103

    Sapporo, 060-0033
    Japan

    Site Not Available

  • Local Institution - 147

    Sapporo, 062-8618
    Japan

    Site Not Available

  • Local Institution - 104

    Sapporo, Hokkaidô, 060-8543
    Japan

    Site Not Available

  • IMS Meirikai Sendai General Hospital

    Sendai, 980-0021
    Japan

    Site Not Available

  • Local Institution - 146

    Sendai, 980-0021
    Japan

    Site Not Available

  • Local Institution - 128

    Shinagawa-ku, Tokyo, 141-8625
    Japan

    Site Not Available

  • Local Institution - 117

    Shinju-ku, 169-0073
    Japan

    Site Not Available

  • Local Institution - 137

    Shizuoka-shi, 420-8630
    Japan

    Site Not Available

  • Local Institution - 149

    Sunto-gun, 411-8611
    Japan

    Site Not Available

  • Local Institution - 112

    Takamatsu, 760-8557
    Japan

    Site Not Available

  • Local Institution - 115

    Takatsuki, 569-0086
    Japan

    Site Not Available

  • Local Institution - 143

    Takatsuki, 569-1096
    Japan

    Site Not Available

  • Local Institution - 166

    Toshima-ku, 171-0021
    Japan

    Site Not Available

  • Local Institution - 129

    Toyama, 939-8511
    Japan

    Site Not Available

  • Local Institution - 123

    Tsu, 514-8507
    Japan

    Site Not Available

  • Local Institution - 148

    Utsunomiya, 320-0003
    Japan

    Site Not Available

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