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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

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 of signing the informed consent form (ICF) at Screening. 2. Subject has had Ulcerative Colitis (UC) diagnosed at least 3 months prior to first investigational product administration. The diagnosis should be confirmed by clinical and endoscopic evidence and corroborated by a histopathology report. 3. Subject has evidence of UC extending ≥ 15 cm from the anal verge as determined by Baseline endoscopy (flexible sigmoidoscopy or colonoscopy). 4. Subject has active UC defined as Mayo score of 6 to 12 inclusive, with endoscopic subscore 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. Subject must have completed through the Week 12 Visit in the Induction Period (IP) AND either:
  • - Completed participation through the last study treatment visit at Week 64 and maintained clinical response in the Maintenance Period (MP), OR - Experiencing disease relapse eligible for Open-label Extension (OLE).

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 or history of a fistula consistent with Crohn's disease or microscopic colitis or radiation 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) at Screening.4. Subject is pregnant or breastfeeding 5. Subject has clinically relevant cardiovascular conditions

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03915769
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Celgene
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Ben Hatano, MD, PhD
Principal Investigator Affiliation Celgene
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Japan
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Colitis, Ulcerative
Additional Details

Following the 4-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 52-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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Kanke Gastrointestinal Clinic, Utsunomiya, Japan

Status

Not yet recruiting

Address

Kanke Gastrointestinal Clinic

Utsunomiya, , 320-0003

Mie University hospital, Tsu, Japan

Status

Not yet recruiting

Address

Mie University hospital

Tsu, , 514-8507

Toyama City Hospital, Toyama, Japan

Status

Recruiting

Address

Toyama City Hospital

Toyama, , 939-8511

Takatsuki Red Cross Hospital, Takatsuki, Japan

Status

Recruiting

Address

Takatsuki Red Cross Hospital

Takatsuki, , 569-1096

Takatsuki, Japan

Status

Not yet recruiting

Address

Medical Corporation Shoyu-Kai Fujita Gastroenterology Hospital

Takatsuki, , 569-0086

Kagawa Prefectural Central Hospital, Takamatsu, Japan

Status

Recruiting

Address

Kagawa Prefectural Central Hospital

Takamatsu, , 760-8557

Sunto-gun, Japan

Status

Not yet recruiting

Address

National Hospital Organization Shizuoka Medical Center

Sunto-gun, , 411-8611

Shizuoka City Shizuoka Hospital, Shizuoka-shi, Japan

Status

Recruiting

Address

Shizuoka City Shizuoka Hospital

Shizuoka-shi, , 420-8630

Tokyo Yamate Medical Center, Shinju-ku, Japan

Status

Not yet recruiting

Address

Tokyo Yamate Medical Center

Shinju-ku, , 169-0073

NTT Medical Center Tokyo, Shinagawa-ku, Tokyo, Japan

Status

Not yet recruiting

Address

NTT Medical Center Tokyo

Shinagawa-ku, Tokyo, , 141-8625

IMS Meirikai Sendai General Hospital, Sendai, Japan

Status

Recruiting

Address

IMS Meirikai Sendai General Hospital

Sendai, , 980-0021

Sapporo, Japan

Status

Recruiting

Address

Japan Community Health care Organization Hokkaido Hospital

Sapporo, , 062-8618

JA Sapporo Kosei General Hospital, Sapporo, Japan

Status

Recruiting

Address

JA Sapporo Kosei General Hospital

Sapporo, , 060-0033

Sapporo Medical University Hospital, Sapporo, Hokkaidô, Japan

Status

Not yet recruiting

Address

Sapporo Medical University Hospital

Sapporo, Hokkaidô, , 060-8543

Sakura, Japan

Status

Recruiting

Address

Toho University Medical Center Sakura Hospital

Sakura, , 285-8741

Osaka Rosai Hospital, Sakai, Japan

Status

Not yet recruiting

Address

Osaka Rosai Hospital

Sakai, , 591-8025

Tokitokai Tokito Clinic, Saitama, Japan

Status

Recruiting

Address

Tokitokai Tokito Clinic

Saitama, , 336-0963

Otsu, Japan

Status

Not yet recruiting

Address

Shiga University of Medical Science Hospital

Otsu, , 520-2192

Osaki Citizen Hospital, Osaki-shi, Japan

Status

Recruiting

Address

Osaki Citizen Hospital

Osaki-shi, , 989-6183

Osaka City University Hospital, Osaka, Japan

Status

Recruiting

Address

Osaka City University Hospital

Osaka, , 545-8586

Okayama, Japan

Status

Not yet recruiting

Address

Okayama Saiseikai Outpatient Center Hospital

Okayama, , 700-0013

Ogaki Municipal Hospital, Ogaki, Japan

Status

Recruiting

Address

Ogaki Municipal Hospital

Ogaki, , 503-8502

Hyogo College of Medicine Hospital, Nishinomiya, Japan

Status

Not yet recruiting

Address

Hyogo College of Medicine Hospital

Nishinomiya, , 663-8501

Nagaoka Chuo General Hospital, Nagaoka, Japan

Status

Recruiting

Address

Nagaoka Chuo General Hospital

Nagaoka, , 940-8653

Iwate Medical University Hospital, Morioka, Japan

Status

Not yet recruiting

Address

Iwate Medical University Hospital

Morioka, , 020-8505

Kyorin University Hospital, Mitaka, Japan

Status

Not yet recruiting

Address

Kyorin University Hospital

Mitaka, , 181-8611

Minato-ku, Japan

Status

Not yet recruiting

Address

Kitasato University Kitasato Institute Hospital

Minato-ku, , 108-8642

Jikei University Hospital, Minato-ku, Japan

Status

Not yet recruiting

Address

Jikei University Hospital

Minato-ku, , 105-8471

Ehime Prefectural Central Hospital, Matsuyama, Japan

Status

Recruiting

Address

Ehime Prefectural Central Hospital

Matsuyama, , 790-0024

Kyoto-city, Japan

Status

Recruiting

Address

University Hospital, Kyoto Prefectural University of Medicine

Kyoto-city, , 602-8566

Kurume, Japan

Status

Recruiting

Address

Our Lady of the Snow Social Medical Corporation St. Mary's Hospital

Kurume, , 830-8543

Kurume University Hospital, Kurume, Fukuoka, Japan

Status

Recruiting

Address

Kurume University Hospital

Kurume, Fukuoka, , 830-0011

Hoshi General Hospital, Koriyama, Japan

Status

Not yet recruiting

Address

Hoshi General Hospital

Koriyama, , 963-8501

Komatsu Municipal Hospital, Komatsu, Japan

Status

Recruiting

Address

Komatsu Municipal Hospital

Komatsu, , 923-8560

Kobe University Hospital, Kobe, Japan

Status

Not yet recruiting

Address

Kobe University Hospital

Kobe, , 650-0017

Nara Medical University Hospital, Kashihara, Japan

Status

Not yet recruiting

Address

Nara Medical University Hospital

Kashihara, , 634-8522

Mitoyo General Hospital, Kannonji, Japan

Status

Recruiting

Address

Mitoyo General Hospital

Kannonji, , 769-1695

Kanazawa Medical University Hospital, Kahoku-gun, Japan

Status

Recruiting

Address

Kanazawa Medical University Hospital

Kahoku-gun, , 920-0293

Tokai University Hospital, Isehara City, Kanagawa, Japan

Status

Recruiting

Address

Tokai University Hospital

Isehara City, Kanagawa, , 259-1193

Saitama Medical University Hospital, Iruma-gun, Japan

Status

Not yet recruiting

Address

Saitama Medical University Hospital

Iruma-gun, , 350-0495

Hitachi General Hospital, Hitachi, Ibaraki, Japan

Status

Recruiting

Address

Hitachi General Hospital

Hitachi, Ibaraki, , 317-0077

Hiroshima University Hospital, Hiroshima, Japan

Status

Not yet recruiting

Address

Hiroshima University Hospital

Hiroshima, , 734-8551

Hirosaki University Hospital, Hirosaki, Japan

Status

Not yet recruiting

Address

Hirosaki University Hospital

Hirosaki, , 036-8203

Hakodate Goryokaku Hospital, Hakodate, Japan

Status

Not yet recruiting

Address

Hakodate Goryokaku Hospital

Hakodate, , 040-8611

Gifu Prefectural General Medical Center, Gifu, Japan

Status

Recruiting

Address

Gifu Prefectural General Medical Center

Gifu, , 500-8717

Fukui-ken Saiseikai Hospital, Fukui, Japan

Status

Not yet recruiting

Address

Fukui-ken Saiseikai Hospital

Fukui, , 918-8503

Fukui Prefectural Hospital, Fukui, Japan

Status

Recruiting

Address

Fukui Prefectural Hospital

Fukui, , 910-8526

Sai Clinic, Fujiidera, Japan

Status

Not yet recruiting

Address

Sai Clinic

Fujiidera, , 538-0027

Fukuoka University Chikushi Hospital, Chikushino, Japan

Status

Not yet recruiting

Address

Fukuoka University Chikushi Hospital

Chikushino, , 818-8502

Bunkyo-ku, Tokyo, Japan

Status

Not yet recruiting

Address

Medical Hospital of Tokyo Medical and Dental University

Bunkyo-ku, Tokyo, , 113-8519

Kokikai Tokatsu-Tsujinaka Hospital, Abiko, Japan

Status

Recruiting

Address

Kokikai Tokatsu-Tsujinaka Hospital

Abiko, , 270-1168

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