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

Last updated: January 23, 2025
Sponsor: Celgene
Overall Status: Completed

Phase

3

Condition

Multiple Sclerosis

Memory Loss

Neurologic Disorders

Treatment

Seasonal influenza vaccine

Tetanus, diphtheria, and acellular pertussis vaccine

Pneumococcal polysaccharide vaccine

Clinical Study ID

NCT05028634
RPC-1063-MS-010
2021-001847-28
  • Ages 18-65
  • All Genders

Study 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

Inclusion Criteria:

  • Participant has a diagnosis of multiple sclerosis (MS) according to the 2017revision of the McDonald diagnostic criteria and has relapsing forms of multiplesclerosis (RMS): relapsing-remitting MS (RRMS) or secondary progressive MS withactive disease based on recent clinical relapse or MRI lesion activity.

Exclusion

Exclusion Criteria:

  • Participant has history of cancer, including solid tumors and hematological exceptfor basal cell cancer of the skin and carcinoma in situ of the cervix, which areexclusionary if they have not been excised and resolved.

  • Participant has a history of or currently active primary or secondaryimmunodeficiency.

  • Participant has severely compromised cardiac or pulmonary function for which asystemic hypersensitivity reaction to any of the vaccines would pose a significantrisk.

  • Participant has received the seasonal influenza vaccine for the 2021/2022 influenzaseason prior to Day 1, or history of influenza vaccine for the 2020/2021 influenzaseason within 6 months prior to Day 1.

  • Participant has previous treatment with one of the following medications orinterventions within the corresponding timeframe described as follows:

  • Any systemic immunosuppressive treatments with potential overlapping effectswith the baseline of this study. Corticosteroids that are by non-systemicroutes (e.g., topical, inhaled, intra-articular) are allowed.

  • History of treatment with IV immunoglobulin (IVIg) or plasmapheresis within 4 weeksprior to Day 1.

Study Design

Total Participants: 63
Treatment Group(s): 3
Primary Treatment: Seasonal influenza vaccine
Phase: 3
Study Start date:
November 11, 2021
Estimated Completion Date:
November 15, 2023

Connect with a study center

  • Local Institution - 200

    Bochum, 44791
    Germany

    Site Not Available

  • Local Institution - 201

    Dresden, 01307
    Germany

    Site Not Available

  • Universitaetsklinikum Jena

    Jena, 07747
    Germany

    Site Not Available

  • Local Institution - 206

    Mannheim, 68163
    Germany

    Site Not Available

  • Local Institution - 204

    Rostock, 18147
    Germany

    Site Not Available

  • Stanford University

    Palo Alto, California 94304
    United States

    Site Not Available

  • Colorado Springs Neurological Associates

    Colorado Springs, Colorado 80907
    United States

    Site Not Available

  • Hartford Healthcare CT

    Southington, Connecticut 06489
    United States

    Site Not Available

  • University of Florida Health

    Gainesville, Florida 32610
    United States

    Site Not Available

  • Neurostudies Inc

    Port Charlotte, Florida 33952
    United States

    Site Not Available

  • Accel Research Sites - Brain and Spine Institute of Port Orange - ERN - PPDS

    Port Orange, Florida 32127
    United States

    Site Not Available

  • University of Chicago Medicine

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Consultants In Neurology

    Northbrook, Illinois 60062
    United States

    Site Not Available

  • Local Institution - 111

    Kansas City, Kansas 66205
    United States

    Site Not Available

  • University Of Kansas Medical Center

    Kansas City, Kansas 66205
    United States

    Site Not Available

  • CPFCC Neurology Research Dept.

    Overland Park, Kansas 66212
    United States

    Site Not Available

  • Neuromedical Clinic of Central LA

    Alexandria, Louisiana 71301
    United States

    Site Not Available

  • Neurology Center of New England P.C.

    Foxboro, Massachusetts 02035
    United States

    Site Not Available

  • Michigan State University MS Clinic

    East Lansing, Michigan 48824
    United States

    Site Not Available

  • Shapiro Center for MS at the Minneapolis Clinic of Neurology

    Minneapolis, Minnesota 55422
    United States

    Site Not Available

  • Neurology Associates PC

    Lincoln, Nebraska 68506
    United States

    Site Not Available

  • Jersey Shore MS Center

    Neptune, New Jersey 07753
    United States

    Site Not Available

  • Holy Name Hospital

    Teaneck, New Jersey 07666
    United States

    Site Not Available

  • South Shore Neurology Associates, Inc

    Patchogue, New York 11772
    United States

    Site Not Available

  • Asheville Neurology Specialists PA

    Asheville, North Carolina 28806
    United States

    Site Not Available

  • Lake Norman Neurology

    Mooresville, North Carolina 28117
    United States

    Site Not Available

  • Local Institution - 105

    Canton, Ohio 44718
    United States

    Site Not Available

  • NeuroScience Research Center, LLC

    Canton, Ohio 44718
    United States

    Site Not Available

  • Velocity Clinical Research - Cleveland - ERN - PPDS

    Cleveland, Ohio 44122
    United States

    Site Not Available

  • Thomas Jefferson University - Clinical Research Institute

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Sanford Health

    Sioux Falls, South Dakota 57104
    United States

    Site Not Available

  • Hope Neurology MS Center

    Knoxville, Tennessee 37922
    United States

    Site Not Available

  • Central Texas Neurology Consultants PA

    Round Rock, Texas 78681
    United States

    Site Not Available

  • MultiCare Institute for Research and Innovation

    Tacoma, Washington 98405
    United States

    Site Not Available

  • Vaught Neurological Services, PLLC

    Crab Orchard, West Virginia 25827
    United States

    Site Not Available

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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