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

  • Clinicaltrials.gov identifier

    NCT03915769

  • Recruitment Status

    Recruiting

  • First Posted

    April 16, 2019

  • Last update posted

    February 8, 2022

Study Description

Brief 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.

  • Condition or Disease:Colitis, Ulcerative
  • Intervention/Treatment: Drug: Ozanimod
    Other: Placebo
  • Phase: Phase 3

Detailed Description

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.

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 195 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment
  • Official Title: To Evaluate Efficacy and Long-term Safety of Ozanimod in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis
  • Actual Study Start Date: June 2019
  • Estimated Primary Completion Date: February 2023
  • Estimated Study Completion Date: March 2025

Arms and interventions

Arm Intervention/treatment
Experimental: 0.46 mg ozanimod oral capsule once daily (QD)
It will be a 7-day dose escalation regimen in the IP consisting of 4 days of treatment with 0.23 mg ozanimod, followed by 3 days of treatment with 0.46 mg ozanimod, followed by 0.46 mg ozanimod.
Drug: Ozanimod
Ozanimod is an orally bioavailable, small molecule compound that activates the sphingosine 1-phosphate 1 receptor (S1P1) and the S1P 5 receptor (S1P5), although it is more selective towards S1P1 over S1P5
Experimental: 0.92 mg ozanimod oral capsule QD
It will be a 7-day dose escalation regimen in the IP consisting of 4 days of treatment with 0.23 mg ozanimod, followed by 3 days of treatment with 0.46 mg ozanimod, followed by 0.92 mg ozanimod.
Drug: Ozanimod
Ozanimod is an orally bioavailable, small molecule compound that activates the sphingosine 1-phosphate 1 receptor (S1P1) and the S1P 5 receptor (S1P5), although it is more selective towards S1P1 over S1P5
Placebo Comparator: Placebo oral capsule QD
It will be a 7-day dose escalation regimen in the IP consisting of 4 days of treatment with a placebo capsule, followed by 3 days of treatment with two placebo capsules, followed by two placebo capsules.
Other: Placebo
The placebo is a capsule that contains no study medication but looks exactly like the study medication capsule.

Outcome Measures

  • Primary Outcome Measures: 1. Proportion of subjects with clinical response [ Time Frame: At Week 12 ]
    Defined as a reduction from Baseline in the complete Mayo score of ≥ 3 points and ≥ 30%, and a reduction from Baseline in the rectal bleeding subscore of ≥ 1 point or an absolute rectal bleeding subscore of ≤ 1 point
  • Secondary Outcome Measures: 1. Proportion of subjects with clinical remission [ Time Frame: At Week 12 and Week 52 ]
    Defined as: Definition 1. Complete Mayo score of ≤ 2 points with no individual subscore of > 1 point, Definition 2. Rectal bleeding subscore = 0 and stool frequency subscore ≤ 1 (and a decrease of ≥ 1 point from the Baseline stool frequency subscore) and endoscopy subscore ≤ 1
  • 2. Proportion of subjects in clinical remission measured at week 12- Rectal Bleeding [ Time Frame: Up to week 12 ]
    Defined as Rectal bleeding subscore = 0 and stool frequency subscore ≤ 1 (and a decrease of ≥ 1 point from the Baseline stool frequency subscore) and endoscopy subscore ≤ 1
  • 3. Proportion of subjects with endoscopic improvement [ Time Frame: At Week 12 and Week 52 ]
    Defined as an endoscopy subscore of ≤ 1 point
  • 4. Proportion of subjects with mucosal healing [ Time Frame: At Week 12 and Week 52 ]
    Defined as an endoscopy subscore of ≤ 1 point and a Geboes index score < 2.0
  • 5. Proportion of subjects with a clinical response [ Time Frame: At Week 9 ]
    Defined as a reduction from Baseline in the partial Mayo score of ≥ 2 points and ≥ 30%, and a reduction from Baseline in the rectal bleeding subscore of ≥ 1 point or an absolute rectal bleeding subscore of ≤ 1 point
  • 6. Change in the EuroQol-5 Dimension (EQ-5D) from baseline [ Time Frame: At Week 12 ]
    Is a quality of life questionnaires and will be collected from all subjects at visits
  • 7. Proportion of subjects in clinical remission measured at week 52 - Mayo Score [ Time Frame: Up to week 52 ]
    Complete Mayo score of ≤ 2 points with no individual subscore of > 1 point
  • 8. Proportion of subject with clinical response [ Time Frame: At week 52 ]
    Defined as a reduction from Baseline in the complete Mayo score of ≥ 3 points and ≥ 30%, and a reduction from Baseline in the rectal bleeding subscore of ≥ 1 point or an absolute rectal bleeding subscore of ≤ 1 point
  • 9. Proportion of subjects in remission while off corticosteroids for any length of time [ Time Frame: Up to week 52 ]
    Proportion of subjects in remission while off corticosteroids for any length of time
  • 10. Change in partial Mayo score from Baseline [ Time Frame: Up to week 64 ]
    Change in partial Mayo score from Baseline
  • 11. Adverse Event (AE) [ Time Frame: From enrollment until at least 75 days after completion of study treatment ]
    Number of participants with adverse event.
  • 12. Proportion of subjects in clinical remission measured at week 52- Rectal Bleeding [ Time Frame: Up to week 52 ]
    Defined as an endoscopy subscore of ≤ 1 point
  • 13. Proportion of subject with clinical response at week 52 [ Time Frame: Up to week 52 ]
    Defined as a reduction from Baseline in the complete Mayo score of ≥ 3 points and ≥ 30%, and a reduction from Baseline in the rectal bleeding subscore of ≥ 1 point or an absolute rectal bleeding subscore of ≤ 1 point
  • 14. Proportion of subjects with endoscopic improvement [ Time Frame: Up to week 52 ]
    Defined as an endoscopy subscore of ≤ 1 point
  • 15. Proportion of subjects with mucosal healing [ Time Frame: Up to week 52 ]
    Defined as an endoscopy subscore of ≤ 1 point and a Geboes index score < 2.0

Eligibility Criteria

  • Ages Eligible for Study: 18 to 75 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

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 of signing the informed consent form (ICF) at Screening. 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. Subject has evidence of UC extending ≥ 15 cm from the anal verge as determined by Baseline endoscopy (flexible sigmoidoscopy or colonoscopy). 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 Subject has severe extensive colitis 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. 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

Contacts and Locations

Contacts

Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com

Contact: First line of the email MUST contain the NCT# and Site #.

Locations

Japan
Kokikai Tokatsu-Tsujinaka Hospital
Abiko

Japan
Mazda Hospital of Mazda Motor Corporation
Aki-gun

Japan
Tokyo Medical and Dental University Hospital
Bunkyo-ku

Japan
Fukuoka University Chikushi Hospital
Chikushino

Japan
Sai Clinic
Fujiidera

Japan
Fukui Prefectural Hospital
Fukui

Japan
Fukui-ken Saiseikai Hospital
Fukui

Japan
Saiseikai Fukuoka General Hospital
Fukuoka

Japan
Harasanshin Hospital
Fukuoka

Japan
Japanese Red Cross Fukuoka Hospital
Fukuoka

Japan
Gifu Prefectural General Medical Center
Gifu

Japan
Hakodate Goryokaku Hospital
Hakodate

Japan
Hirosaki University Hospital
Hirosaki

Japan
Hiroshima Prefectural Hospital
Hiroshima

Japan
Hiroshima University Hospital
Hiroshima

Japan
Hitachi General Hospital
Hitachi, Ibaraki

Japan
Aso Iizuka Hospital
Iizuka

Japan
Saitama Medical University Hospital
Iruma-gun

Japan
Tokai University Hospital
Isehara City, Kanagawa

Japan
Kanazawa Medical University Hospital
Kahoku-gun

Japan
Mitoyo General Hospital
Kannonji

Japan
Nara Medical University Hospital
Kashihara

Japan
Tsujinaka Hospital Kashiwanoha
Kashiwa

Japan
Saitama Medical Center
Kawagoe

Japan
Medical Corporation Aoyama Clinic
Kobe

Japan
Kobe University Hospital
Kobe

Japan
Komatsu Municipal Hospital
Komatsu

Japan
Hoshi General Hospital
Koriyama

Japan
Kurume University Hospital
Kurume, Fukuoka

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

Japan
Hidaka Coloproctology Clinic
Kurume

Japan
University Hospital, Kyoto Prefectural University of Medicine
Kyoto-city

Japan
Ehime Prefectural Central Hospital
Matsuyama

Japan
Jikei University Hospital
Minato-ku

Japan
Kitasato University Kitasato Institute Hospital
Minato-ku

Japan
Kyorin University Hospital
Mitaka

Japan
Iwate Medical University Uchimaru Medical Center
Morioka

Japan
Nagaoka Chuo General Hospital
Nagaoka

Japan
Nagoya University Hospital
Nagoya-shi

Japan
Hyogo College of Medicine Hospital
Nishinomiya

Japan
Ogaki Municipal Hospital
Ogaki

Japan
Ishida Clinic of IBD and Gastroenterology
Oita

Japan
Okayama Saiseikai Outpatient Center Hospital
Okayama

Japan
Okayama University Hospital
Okayama

Japan
Iseikai Hospital
Osaka

Japan
Osaka City University Hospital
Osaka

Japan
Osaki Citizen Hospital
Osaki-shi

Japan
Shiga University of Medical Science Hospital
Otsu

Japan
Saga University Hospital
Saga

Japan
Tokitokai Tokito Clinic
Saitama

Japan
Osaka Rosai Hospital
Sakai

Japan
Toho University Medical Center Sakura Hospital
Sakura

Japan
Sapporo Medical University Hospital
Sapporo, Hokkaidô

Japan
JA Sapporo Kosei General Hospital
Sapporo

Japan
Japan Community Health care Organization Hokkaido Hospital
Sapporo

Japan
IMS Meirikai Sendai General Hospital
Sendai

Japan
NTT Medical Center Tokyo
Shinagawa-ku, Tokyo

Japan
Tokyo Yamate Medical Center
Shinju-ku

Japan
Shizuoka City Shizuoka Hospital
Shizuoka-shi

Japan
National Hospital Organization Shizuoka Medical Center
Sunto-gun

Japan
Kagawa Prefectural Central Hospital
Takamatsu

Japan
Medical Corporation Shoyu-Kai Fujita Gastroenterology Hospital
Takatsuki

Japan
Takatsuki Red Cross Hospital
Takatsuki

Japan
Hiratsuka Gastroenterological hospital
Toshima-ku

Japan
Toyama City Hospital
Toyama

Japan
Mie University hospital
Tsu

Japan
Kanke Gastrointestinal Clinic
Utsunomiya

Sponsors and Collaborators

Celgene

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Celgene
  • ClinicalTrials.gov Identifier: NCT03915769 History of Changes
  • Other Study ID Numbers: RPC01-3103, U1111-1230-3228
  • First Posted: April 16, 2019 Key Record Dates
  • Last Update Posted: February 8, 2022
  • Last Verified: February 2022
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • Plan to Share IPD: Yes
  • Plan Description: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
  • Supporting Materials: Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF), Clinical Study Report (CSR), Analytic Code
  • Time Frame: See Plan Description
  • Access Criteria: See Plan Description
  • URL: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Product Manufactured in and Exported from the U.S.: Yes
  • Keywords provided by Celgene: Ulcerative colitis
    Ozanimod
    colitis
    Ulcerative
  • Additional relevant MeSH terms: Colitis
    Colitis, Ulcerative
    Ulcer
    Gastroenteritis
    Gastrointestinal Diseases
    Digestive System Diseases
    Colonic Diseases
    Intestinal Diseases
    Pathologic Processes
    Inflammatory Bowel Diseases