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.

View Eligibility Criteria

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 is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

63

Study ID:

NCT05028634

Recruitment Status:

Completed

Sponsor:

Celgene

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There are 33 Locations for this study

See Locations Near You

Stanford University
Palo Alto California, 94304, United States
Colorado Springs Neurological Associates
Colorado Springs Colorado, 80907, United States
Hartford Healthcare CT
Southington Connecticut, 06489, United States
University of Florida Health
Gainesville Florida, 32610, United States
Neurostudies Inc
Port Charlotte Florida, 33952, United States
Accel Research Sites - Brain and Spine Institute of Port Orange - ERN - PPDS
Port Orange Florida, 32127, United States
University of Chicago Medicine
Chicago Illinois, 60637, United States
Consultants In Neurology
Northbrook Illinois, 60062, United States
University Of Kansas Medical Center
Kansas City Kansas, 66205, United States
CPFCC Neurology Research Dept.
Overland Park Kansas, 66212, United States
Neuromedical Clinic of Central LA
Alexandria Louisiana, 71301, United States
Neurology Center of New England P.C.
Foxboro Massachusetts, 02035, United States
Michigan State University MS Clinic
East Lansing Michigan, 48824, United States
Shapiro Center for MS at the Minneapolis Clinic of Neurology
Minneapolis Minnesota, 55422, United States
Neurology Associates PC
Lincoln Nebraska, 68506, United States
Jersey Shore MS Center
Neptune New Jersey, 07753, United States
Holy Name Hospital
Teaneck New Jersey, 07666, United States
South Shore Neurology Associates, Inc
Patchogue New York, 11772, United States
Asheville Neurology Specialists PA
Asheville North Carolina, 28806, United States
Lake Norman Neurology
Mooresville North Carolina, 28117, United States
NeuroScience Research Center, LLC
Canton Ohio, 44718, United States
Velocity Clinical Research - Cleveland - ERN - PPDS
Cleveland Ohio, 44122, United States
Thomas Jefferson University - Clinical Research Institute
Philadelphia Pennsylvania, 19107, United States
Sanford Health
Sioux Falls South Dakota, 57104, United States
Hope Neurology MS Center
Knoxville Tennessee, 37922, United States
Central Texas Neurology Consultants PA
Round Rock Texas, 78681, United States
MultiCare Institute for Research and Innovation
Tacoma Washington, 98405, United States
Vaught Neurological Services, PLLC
Crab Orchard West Virginia, 25827, United States
Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States
Local Institution - 200
Bochum , 44791, Germany
Local Institution - 201
Dresden , 01307, Germany
Local Institution - 206
Mannheim , 68163, Germany
Local Institution - 204
Rostock , 18147, Germany

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

63

Study ID:

NCT05028634

Recruitment Status:

Completed

Sponsor:


Celgene

How clear is this clinincal trial information?

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