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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

NCT05028634

CompletedPhase 3

Sponsor: Celgene

Conditions: Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting

Interventions: Tetanus, diphtheria, and acellular pertussis vaccine, Pneumococcal polysaccharide vaccine, Seasonal influenza vaccine

Countries: United States, Germany

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 overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (33)

Palo Alto, California, United States
Colorado Springs, Colorado, United States
Southington, Connecticut, United States
Gainesville, Florida, United States
Port Charlotte, Florida, United States
Port Orange, Florida, United States
Chicago, Illinois, United States
Northbrook, Illinois, United States
Kansas City, Kansas, United States
Overland Park, Kansas, United States
Alexandria, Louisiana, United States
Foxborough, Massachusetts, United States
East Lansing, Michigan, United States
Minneapolis, Minnesota, United States
Lincoln, Nebraska, United States
Neptune City, New Jersey, United States
Teaneck, New Jersey, United States
Patchogue, New York, United States
Asheville, North Carolina, United States
Mooresville, North Carolina, United States
Canton, Ohio, United States
Cleveland, Ohio, United States
Philadelphia, Pennsylvania, United States
Sioux Falls, South Dakota, United States
Knoxville, Tennessee, United States
Round Rock, Texas, United States
Tacoma, Washington, United States
Crab Orchard, West Virginia, United States
Milwaukee, Wisconsin, United States
Bochum, Germany
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