Multiple Sclerosis Clinical Trial
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
Summary
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.
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.
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There are 33 Locations for this study
Palo Alto California, 94304, United States
Colorado Springs Colorado, 80907, United States
Southington Connecticut, 06489, United States
Gainesville Florida, 32610, United States
Port Charlotte Florida, 33952, United States
Port Orange Florida, 32127, United States
Chicago Illinois, 60637, United States
Northbrook Illinois, 60062, United States
Kansas City Kansas, 66205, United States
Overland Park Kansas, 66212, United States
Alexandria Louisiana, 71301, United States
Foxboro Massachusetts, 02035, United States
East Lansing Michigan, 48824, United States
Minneapolis Minnesota, 55422, United States
Lincoln Nebraska, 68506, United States
Neptune New Jersey, 07753, United States
Teaneck New Jersey, 07666, United States
Patchogue New York, 11772, United States
Asheville North Carolina, 28806, United States
Mooresville North Carolina, 28117, United States
Canton Ohio, 44718, United States
Cleveland Ohio, 44122, United States
Philadelphia Pennsylvania, 19107, United States
Sioux Falls South Dakota, 57104, United States
Knoxville Tennessee, 37922, United States
Round Rock Texas, 78681, United States
Tacoma Washington, 98405, United States
Crab Orchard West Virginia, 25827, United States
Milwaukee Wisconsin, 53226, United States
Bochum , 44791, Germany
Dresden , 01307, Germany
Mannheim , 68163, Germany
Rostock , 18147, Germany
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