- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03915769
To Evaluate Efficacy and Long-term Safety of Ozanimod in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis
January 3, 2024 updated by: Celgene
A Phase 2/3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of Oral Ozanimod to Evaluate Efficacy and Long-term Safety in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Estimated)
195
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Abiko, Japan, 270-1168
- Local Institution - 139
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Aki-gun, Japan, 735-8585
- Local Institution - 152
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Chikushino, Japan, 818-8502
- Local Institution - 122
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Fujiidera, Japan, 538-0027
- Local Institution - 150
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Fukui, Japan, 910-8526
- Local Institution - 114
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Fukui, Japan, 918-8503
- Local Institution - 124
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Fukuoka, Japan, 810-0001
- Local Institution - 161
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Fukuoka, Japan, 812-0033
- Local Institution - 164
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Fukuoka, Japan, 815-8555
- Local Institution - 155
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Gifu, Japan, 500-8717
- Local Institution - 140
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Hakodate, Japan, 040-8611
- Local Institution - 151
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Hirosaki, Japan, 036-8203
- Local Institution - 133
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Hiroshima, Japan, 734-8530
- Local Institution - 160
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Hiroshima, Japan, 734-8551
- Local Institution - 106
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Hitachi, Ibaraki, Japan, 317-0077
- Local Institution - 126
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Iizuka, Japan, 820-8505
- Local Institution - 162
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Isehara City, Kanagawa, Japan, 259-1193
- Local Institution - 134
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Kahoku-gun, Japan, 920-0293
- Local Institution - 120
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Kannonji, Japan, 769-1695
- Local Institution - 135
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Kashihara, Japan, 634-8522
- Local Institution - 101
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Kashiwa, Japan, 277-0871
- Local Institution - 158
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Kawagoe, Japan, 350-8550
- Local Institution - 157
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Kobe, Japan, 650-0015
- Local Institution - 163
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Kobe, Japan, 650-0017
- Local Institution - 130
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Komatsu, Japan, 923-8560
- Local Institution - 121
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Koriyama, Japan, 963-8501
- Local Institution - 144
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Kurume, Japan, 830-8543
- Local Institution - 142
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Kurume, Japan, 839-0809
- Local Institution - 165
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Kurume, Fukuoka, Japan, 830-0011
- Local Institution - 111
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Kyoto-city, Japan, 602-8566
- Local Institution - 141
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Matsuyama, Japan, 790-0024
- Local Institution - 118
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Minato-ku, Japan, 105-8471
- Local Institution - 108
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Minato-ku, Japan, 108-8642
- Local Institution - 107
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Mitaka, Japan, 181-8611
- Local Institution - 109
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Morioka, Japan, 020-8505
- Local Institution - 110
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Nagaoka, Japan, 940-8653
- Local Institution - 125
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Nagoya-shi, Japan, 466-8560
- Local Institution - 167
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Ogaki, Japan, 503-8502
- Local Institution - 119
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Oita, Japan, 870-0823
- Local Institution - 159
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Okayama, Japan, 700-0013
- Local Institution - 136
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Osaki-shi, Japan, 989-6183
- Local Institution - 127
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Otsu, Japan, 520-2192
- Local Institution - 113
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Saga, Japan, 849-8501
- Local Institution - 154
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Saitama, Japan, 336-0963
- Local Institution - 116
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Sakai, Japan, 591-8025
- Local Institution - 145
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Sakura, Japan, 285-8741
- Local Institution - 102
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Sapporo, Japan, 060-0033
- Local Institution - 103
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Sapporo, Japan, 062-8618
- Local Institution - 147
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Sendai, Japan, 980-0021
- Local Institution - 146
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Shinagawa-ku, Tokyo, Japan, 141-8625
- Local Institution - 128
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Shinju-ku, Japan, 169-0073
- Local Institution - 117
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Shizuoka-shi, Japan, 420-8630
- Local Institution - 137
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Sunto-gun, Japan, 411-8611
- Local Institution - 149
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Takamatsu, Japan, 760-8557
- Local Institution - 112
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Takatsuki, Japan, 569-0086
- Local Institution - 115
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Takatsuki, Japan, 569-1096
- Local Institution - 143
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Toshima-ku, Japan, 171-0021
- Local Institution - 166
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Toyama, Japan, 939-8511
- Local Institution - 129
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Tsu, Japan, 514-8507
- Local Institution - 123
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Utsunomiya, Japan, 320-0003
- Local Institution - 148
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Hokkaido
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Sapporo, Hokkaido, Japan, 060-8543
- Local Institution - 104
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Hyogo
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Nishinomiya, Hyogo, Japan, 663-8501
- Local Institution - 105
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Okayama
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Okayama-shi, Okayama, Japan, 700-8558
- Local Institution - 156
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Osaka
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Osaka-shi, Osaka, Japan, 530-0052
- Local Institution - 153
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Osaka-shi
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Osaka, Osaka-shi, Japan, 545-8586
- Local Institution - 132
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Saitama
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Iruma-gun, Saitama, Japan, 3500495
- Local Institution - 131
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Tokyo
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Bunkyo-ku, Tokyo, Japan, 113-8519
- Local Institution - 138
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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:
- 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 last study treatment visit at Week 52 with maintaining clinical response, OR experiences disease relapse during the MP
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / 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.
|
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.
|
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
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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.
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The placebo is a capsule that contains no study medication but looks exactly like the study medication capsule.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of subjects with clinical response
Time Frame: At Week 12
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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
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At Week 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of subjects with clinical remission
Time Frame: At Week 12 and Week 52
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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
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At Week 12 and Week 52
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Proportion of subjects with endoscopic improvement
Time Frame: At Week 12 and Week 52
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Defined as an endoscopy subscore of ≤ 1 point
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At Week 12 and Week 52
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Proportion of subjects with mucosal healing
Time Frame: At Week 12 and Week 52
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Defined as an endoscopy subscore of ≤ 1 point and a Geboes index score < 2.0
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At Week 12 and Week 52
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Proportion of subjects with a clinical response
Time Frame: At Week 9
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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
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At Week 9
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Change in the EuroQol-5 Dimension (EQ-5D) from baseline
Time Frame: At Week 12
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Is a quality of life questionnaires and will be collected from all subjects at visits
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At Week 12
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Proportion of subject with clinical response
Time Frame: At week 52
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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
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At week 52
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Proportion of subjects in remission while off corticosteroids for any length of time
Time Frame: Up to week 52
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Proportion of subjects in remission while off corticosteroids for any length of time
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Up to week 52
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Adverse Event (AE)
Time Frame: From enrollment until at least 75 days after completion of study treatment
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Number of participants with adverse event.
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From enrollment until at least 75 days after completion of study treatment
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Proportion of subjects with a clinical response
Time Frame: At Week 12 and Week 52
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Defined as a reduction from Baseline in the 9-point Mayo score of ≥ 2 points and ≥ 35%, and a reduction from Baseline in the rectal bleeding subscore of ≥ 1 point or an absolute rectal bleeding subscore of ≤ 1 point
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At Week 12 and Week 52
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 3, 2019
Primary Completion (Estimated)
March 13, 2025
Study Completion (Estimated)
March 13, 2025
Study Registration Dates
First Submitted
April 12, 2019
First Submitted That Met QC Criteria
April 12, 2019
First Posted (Actual)
April 16, 2019
Study Record Updates
Last Update Posted (Actual)
January 5, 2024
Last Update Submitted That Met QC Criteria
January 3, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Gastrointestinal Diseases
- Gastroenteritis
- Colonic Diseases
- Intestinal Diseases
- Inflammatory Bowel Diseases
- Ulcer
- Colitis
- Colitis, Ulcerative
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Immunosuppressive Agents
- Immunologic Factors
- Sphingosine 1 Phosphate Receptor Modulators
- Ozanimod
Other Study ID Numbers
- RPC01-3103
- U1111-1230-3228 (Registry Identifier: WHO)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
IPD Sharing Time Frame
See Plan Description
IPD Sharing Access Criteria
See Plan Description
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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