CompletedPhase 3Other
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
Sponsored by Celgene
NCT ID
NCT05028634
Target Enrollment
63 participants
Start Date
2021-11-11
Est. Completion
2023-11-15
About This Study
This study is designed to provide data on the immune response and safety of administering vaccines to relapsing multiple sclerosis (RMS) participants taking ozanimod compared to controls taking interferon-beta's or receiving no disease modifying therapies (DMTs). The data of this study will support the labels for ozanimod in multiple sclerosis (MS) because the effect of ozanimod on the vaccination response of MS participants is of interest to participants and prescribers.
Conditions Studied
Interventions
- •Tetanus, diphtheria, and acellular pertussis vaccine
- •Pneumococcal polysaccharide vaccine
- •Seasonal influenza vaccine
Eligibility
Age:18 Years - 65 Years
Healthy Volunteers:No
View full eligibility criteria
Inclusion Criteria: * Participant has a diagnosis of multiple sclerosis (MS) according to the 2017 revision of the McDonald diagnostic criteria and has relapsing forms of multiple sclerosis (RMS): relapsing-remitting MS (RRMS) or secondary progressive MS with active disease based on recent clinical relapse or MRI lesion activity. Exclusion Criteria: * Participant has history of cancer, including solid tumors and hematological except for basal cell cancer of the skin and carcinoma in situ of the cervix, which are exclusionary if they have not been excised and resolved. * 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.
Study Locations (33)
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
+23 more locations