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

Completed · Phase 3

Conditions studied: Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting

In brief

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.

Key facts

Study ID

NCT05028634

Run by

Celgene

People needed

63

Starts

2021-11-11

Expected to finish

2023-11-15

Last updated by the study team

2025-02-11

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• Neuromedical Clinic of Central LA — Alexandria, Louisiana, United States
• Neurology Center of New England P.C. — Foxborough, Massachusetts, United States
• Michigan State University MS Clinic — East Lansing, Michigan, United States
• Shapiro Center for MS at the Minneapolis Clinic of Neurology — Minneapolis, Minnesota, United States
• Neurology Associates PC — Lincoln, Nebraska, United States
• Jersey Shore MS Center — Neptune City, New Jersey, United States
• Holy Name Hospital — Teaneck, New Jersey, United States
• South Shore Neurology Associates, Inc — Patchogue, New York, United States
• Asheville Neurology Specialists PA — Asheville, North Carolina, United States
• Lake Norman Neurology — Mooresville, North Carolina, United States
• Local Institution - 105 — Canton, Ohio, United States
• Velocity Clinical Research - Cleveland - ERN - PPDS — Cleveland, Ohio, United States
• Thomas Jefferson University - Clinical Research Institute — Philadelphia, Pennsylvania, United States
• Sanford Health — Sioux Falls, South Dakota, United States
• Hope Neurology MS Center — Knoxville, Tennessee, United States

Full record on ClinicalTrials.gov

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