Safety Study to Evaluate Immune Response of Vaccines in Participants With Relapsing Forms of Multiple Sclerosis Who Receive Ozanimod Compared to Non-Pegylated Interferon (IFN)-β or No Disease Modifying Therapy
NCT ID: NCT05028634
Last Updated: 2025-02-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
63 participants
INTERVENTIONAL
2021-11-11
2023-11-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1 - Ozanimod
Comprises of participants received oral ozanimod will be administered tetanus, diphtheria, and acellular pertussis vaccine (Tdap), pneumococcal polysaccharide vaccine (PPSV23), and the seasonal inactivated influenza vaccine
-Enrollment is closed for this cohort
Tetanus, diphtheria, and acellular pertussis vaccine
Tdap
Pneumococcal polysaccharide vaccine
PPSV23
Seasonal influenza vaccine
Seasonal influenza vaccine
Cohort 1 - non-pegylated interferon-β or no disease modifying therapy
Comprises of participants received either non-pegylated interferon-β (IFN-β) or no disease modifying therapy (DMT) will be administered tetanus, diphtheria, and acellular pertussis vaccine (Tdap), Pneumococcal polysaccharide vaccine (PPSV23), and the seasonal inactivated influenza vaccine
-Enrollment is closed for this cohort
Tetanus, diphtheria, and acellular pertussis vaccine
Tdap
Pneumococcal polysaccharide vaccine
PPSV23
Seasonal influenza vaccine
Seasonal influenza vaccine
Cohort 2 - Ozanimod
Comprises of participants received oral ozanimod will be administered tetanus, diphtheria, and acellular pertussis vaccine (Tdap), and pneumococcal polysaccharide vaccine (PPSV23).
Tetanus, diphtheria, and acellular pertussis vaccine
Tdap
Pneumococcal polysaccharide vaccine
PPSV23
Cohort 2 - non-pegylated interferon-β or no disease modifying therapy
Comprises of participants received either non-pegylated interferon-β (IFN-β) or no disease modifying therapy (DMT) will be administered tetanus, diphtheria, and acellular pertussis vaccine (Tdap) and Pneumococcal polysaccharide vaccine (PPSV23).
Tetanus, diphtheria, and acellular pertussis vaccine
Tdap
Pneumococcal polysaccharide vaccine
PPSV23
Interventions
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Tetanus, diphtheria, and acellular pertussis vaccine
Tdap
Pneumococcal polysaccharide vaccine
PPSV23
Seasonal influenza vaccine
Seasonal influenza vaccine
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Participant has a history of or currently active primary or secondary immunodeficiency.
* Participant has severely compromised cardiac or pulmonary function for which a systemic hypersensitivity reaction to any of the vaccines would pose a significant risk.
* Participant has received the seasonal influenza vaccine for the 2021/2022 influenza season prior to Day 1, or history of influenza vaccine for the 2020/2021 influenza season within 6 months prior to Day 1.
* Participant has previous treatment with one of the following medications or interventions within the corresponding timeframe described as follows:
* Any systemic immunosuppressive treatments with potential overlapping effects with the baseline of this study. Corticosteroids that are by non-systemic routes (e.g., topical, inhaled, intra-articular) are allowed.
* History of treatment with IV immunoglobulin (IVIg) or plasmapheresis within 4 weeks prior to Day 1.
18 Years
65 Years
ALL
No
Sponsors
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Celgene
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Stanford University
Palo Alto, California, United States
Colorado Springs Neurological Associates
Colorado Springs, Colorado, United States
Hartford Healthcare CT
Southington, Connecticut, United States
University of Florida Health
Gainesville, Florida, United States
Neurostudies Inc
Port Charlotte, Florida, United States
Accel Research Sites - Brain and Spine Institute of Port Orange - ERN - PPDS
Port Orange, Florida, United States
University of Chicago Medicine
Chicago, Illinois, United States
Consultants In Neurology
Northbrook, Illinois, United States
Local Institution - 111
Kansas City, Kansas, United States
CPFCC Neurology Research Dept.
Overland Park, Kansas, United States
Neuromedical Clinic of Central LA
Alexandria, Louisiana, United States
Neurology Center of New England P.C.
Foxborough, Massachusetts, United States
Michigan State University MS Clinic
East Lansing, Michigan, United States
Shapiro Center for MS at the Minneapolis Clinic of Neurology
Minneapolis, Minnesota, United States
Neurology Associates PC
Lincoln, Nebraska, United States
Jersey Shore MS Center
Neptune City, New Jersey, United States
Holy Name Hospital
Teaneck, New Jersey, United States
South Shore Neurology Associates, Inc
Patchogue, New York, United States
Asheville Neurology Specialists PA
Asheville, North Carolina, United States
Lake Norman Neurology
Mooresville, North Carolina, United States
Local Institution - 105
Canton, Ohio, United States
Velocity Clinical Research - Cleveland - ERN - PPDS
Cleveland, Ohio, United States
Thomas Jefferson University - Clinical Research Institute
Philadelphia, Pennsylvania, United States
Sanford Health
Sioux Falls, South Dakota, United States
Hope Neurology MS Center
Knoxville, Tennessee, United States
Central Texas Neurology Consultants PA
Round Rock, Texas, United States
MultiCare Institute for Research and Innovation
Tacoma, Washington, United States
Vaught Neurological Services, PLLC
Crab Orchard, West Virginia, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Local Institution - 200
Bochum, , Germany
Local Institution - 201
Dresden, , Germany
Local Institution - 206
Mannheim, , Germany
Local Institution - 204
Rostock, , Germany
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2021-001847-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
RPC-1063-MS-010
Identifier Type: -
Identifier Source: org_study_id
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