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:

60

Study ID:

NCT05028634

Recruitment Status:

Recruiting

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 More Info
Jeffery Dunn, Site 106
Contact
Colorado Springs Neurological Associates
Colorado Springs Colorado, 80907, United States More Info
Kimberly Wagner, Site 110
Contact
Hartford Healthcare CT
Southington Connecticut, 06489, United States More Info
Derek Smith, Site 122
Contact
University of Florida Health
Gainesville Florida, 32610, United States More Info
Torge Rempe, Site 135
Contact
Neurostudies Inc
Port Charlotte Florida, 33952, United States More Info
Liliana Montoya, Site 108
Contact
Accel Research Sites - Brain and Spine Institute of Port Orange - ERN - PPDS
Port Orange Florida, 32127, United States More Info
Timothy Wierzbicki, Site 130
Contact
386-740-0770
University of Chicago Medicine
Chicago Illinois, 60637, United States More Info
Anthony Reder, Site 102
Contact
Consultants In Neurology
Northbrook Illinois, 60062, United States More Info
Daniel Wynn, Site 112
Contact
University Of Kansas Medical Center
Kansas City Kansas, 66205, United States More Info
Sharon Lynch, Site 111
Contact
816-289-2052
CPFCC Neurology Research Dept.
Overland Park Kansas, 66212, United States More Info
Jeffrey Kaplan, Site 125
Contact
913-438-0868
Neuromedical Clinic of Central LA
Alexandria Louisiana, 71301, United States More Info
Ariel Antezana, Site 113
Contact
318-730-4675
Neurology Center of New England P.C.
Foxboro Massachusetts, 02035, United States More Info
Salvatore Napoli, Site 126
Contact
781-551-5812
Michigan State University MS Clinic
East Lansing Michigan, 48824, United States More Info
Jayne Ward, Site 118
Contact
Shapiro Center for MS at the Minneapolis Clinic of Neurology
Minneapolis Minnesota, 55422, United States More Info
Jonathan Calkwood, Site 124
Contact
763-302-4199
Neurology Associates PC
Lincoln Nebraska, 68506, United States More Info
Gary Pattee, Site 120
Contact
Jersey Shore MS Center
Neptune New Jersey, 07753, United States More Info
David Duncan, Site 137
Contact
Holy Name Hospital
Teaneck New Jersey, 07666, United States More Info
Mary Ann Picone, Site 134
Contact
South Shore Neurology Associates, Inc
Patchogue New York, 11772, United States More Info
Mark Gudesblatt, Site 100
Contact
Asheville Neurology Specialists PA
Asheville North Carolina, 28806, United States More Info
James Patton, Site 127
Contact
Lake Norman Neurology
Mooresville North Carolina, 28117, United States More Info
Doug Jeffery, Site 107
Contact
NeuroScience Research Center, LLC
Canton Ohio, 44718, United States More Info
Ryan Drake, Site 105
Contact
Velocity Clinical Research - Cleveland - ERN - PPDS
Cleveland Ohio, 44122, United States More Info
Joan Rothenberg, Site 132
Contact
Thomas Jefferson University - Clinical Research Institute
Philadelphia Pennsylvania, 19107, United States More Info
Thomas Leist, Site 128
Contact
215-955-6871
Sanford Health
Sioux Falls South Dakota, 57104, United States More Info
Abdul Alchaki, Site 103
Contact
Hope Neurology MS Center
Knoxville Tennessee, 37922, United States More Info
Sibyl Wray, Site 101
Contact
865-218-6222
Central Texas Neurology Consultants PA
Round Rock Texas, 78681, United States More Info
Edward Fox, Site 116
Contact
MultiCare Institute for Research and Innovation
Tacoma Washington, 98405, United States More Info
Rinu Abraham, Site 140
Contact
Vaught Neurological Services, PLLC
Crab Orchard West Virginia, 25827, United States More Info
Barry Vaught, Site 139
Contact
Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States More Info
Ahmed Obeidat, Site 133
Contact
937-608-2712
Local Institution - 200
Bochum , 44791, Germany More Info
Site 200
Contact
Local Institution - 201
Dresden , 01307, Germany More Info
Site 201
Contact
Local Institution - 206
Mannheim , 68163, Germany More Info
Site 206
Contact
Local Institution - 204
Rostock , 18147, Germany More Info
Site 204
Contact

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

60

Study ID:

NCT05028634

Recruitment Status:

Recruiting

Sponsor:


Celgene

How clear is this clinincal trial information?

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