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NCT05028634CompletedPhase 3

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

A Phase 3b, Multicenter, Open-label Study to Evaluate the Immune Response to, and the Safety of, Vaccines in Participants With Relapsing Forms of Multiple Sclerosis Who Receive Oral Ozanimod Compared to Non-pegylated Interferon (IFN)-β or No Disease Modifying Therapy

Source: ClinicalTrials.gov · Last updated 11 Feb 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
63 (actual)
First submitted
25 Aug 2021
Start date
11 Nov 2021
Primary completion date
15 Nov 2023
Lead sponsor
Celgene
NCT number
NCT05028634
EudraCT number
2021-001847-28

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 63
  • From 11 Nov 2021 to the primary completion date, 15 Nov 2023
  • 33 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (33)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Local Institution - 200
Coordinator of this site? Confirm its status
BochumGermanyUnknown status
Local Institution - 201
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DresdenGermanyUnknown status
Local Institution - 206
Coordinator of this site? Confirm its status
MannheimGermanyUnknown status
Local Institution - 204
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RostockGermanyUnknown status
Neuromedical Clinic of Central LA
Coordinator of this site? Confirm its status
AlexandriaUnited StatesUnknown status
Asheville Neurology Specialists PA
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AshevilleUnited StatesUnknown status
Local Institution - 105
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CantonUnited StatesUnknown status
University of Chicago Medicine
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ChicagoUnited StatesUnknown status
Velocity Clinical Research - Cleveland - ERN - PPDS
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ClevelandUnited StatesUnknown status
Colorado Springs Neurological Associates
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Colorado SpringsUnited StatesUnknown status
Vaught Neurological Services, PLLC
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Crab OrchardUnited StatesUnknown status
Michigan State University MS Clinic
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East LansingUnited StatesUnknown status
Neurology Center of New England P.C.
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FoxboroughUnited StatesUnknown status
University of Florida Health
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GainesvilleUnited StatesUnknown status
Local Institution - 111
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Kansas CityUnited StatesUnknown status
Hope Neurology MS Center
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KnoxvilleUnited StatesUnknown status
Neurology Associates PC
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LincolnUnited StatesUnknown status
Medical College of Wisconsin
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MilwaukeeUnited StatesUnknown status
Shapiro Center for MS at the Minneapolis Clinic of Neurology
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MinneapolisUnited StatesUnknown status
Lake Norman Neurology
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MooresvilleUnited StatesUnknown status
Jersey Shore MS Center
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Neptune CityUnited StatesUnknown status
Consultants in Neurology
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NorthbrookUnited StatesUnknown status
CPFCC Neurology Research Dept.
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Overland ParkUnited StatesUnknown status
Stanford University
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Palo AltoUnited StatesUnknown status
South Shore Neurology Associates, Inc
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PatchogueUnited StatesUnknown status
Thomas Jefferson University - Clinical Research Institute
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PhiladelphiaUnited StatesUnknown status
Neurostudies Inc.
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Port CharlotteUnited StatesUnknown status
Accel Research Sites - Brain and Spine Institute of Port Orange - ERN - PPDS
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Port OrangeUnited StatesUnknown status
Central Texas Neurology Consultants, PA
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Round RockUnited StatesUnknown status
Sanford Health
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Sioux FallsUnited StatesUnknown status
Hartford Healthcare CT
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SouthingtonUnited StatesUnknown status
MultiCare Institute for Research and Innovation
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TacomaUnited StatesUnknown status
Holy Name Hospital
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TeaneckUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.