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
- Diseases
- Multiple sclerosis
- 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
Sites (33)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Local Institution - 200 Coordinator of this site? Confirm its status | Bochum | Germany | Unknown status |
| Local Institution - 201 Coordinator of this site? Confirm its status | Dresden | Germany | Unknown status |
| Local Institution - 206 Coordinator of this site? Confirm its status | Mannheim | Germany | Unknown status |
| Local Institution - 204 Coordinator of this site? Confirm its status | Rostock | Germany | Unknown status |
| Neuromedical Clinic of Central LA Coordinator of this site? Confirm its status | Alexandria | United States | Unknown status |
| Asheville Neurology Specialists PA Coordinator of this site? Confirm its status | Asheville | United States | Unknown status |
| Local Institution - 105 Coordinator of this site? Confirm its status | Canton | United States | Unknown status |
| University of Chicago Medicine Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Velocity Clinical Research - Cleveland - ERN - PPDS Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Colorado Springs Neurological Associates Coordinator of this site? Confirm its status | Colorado Springs | United States | Unknown status |
| Vaught Neurological Services, PLLC Coordinator of this site? Confirm its status | Crab Orchard | United States | Unknown status |
| Michigan State University MS Clinic Coordinator of this site? Confirm its status | East Lansing | United States | Unknown status |
| Neurology Center of New England P.C. Coordinator of this site? Confirm its status | Foxborough | United States | Unknown status |
| University of Florida Health Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
| Local Institution - 111 Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| Hope Neurology MS Center Coordinator of this site? Confirm its status | Knoxville | United States | Unknown status |
| Neurology Associates PC Coordinator of this site? Confirm its status | Lincoln | United States | Unknown status |
| Medical College of Wisconsin Coordinator of this site? Confirm its status | Milwaukee | United States | Unknown status |
| Shapiro Center for MS at the Minneapolis Clinic of Neurology Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| Lake Norman Neurology Coordinator of this site? Confirm its status | Mooresville | United States | Unknown status |
| Jersey Shore MS Center Coordinator of this site? Confirm its status | Neptune City | United States | Unknown status |
| Consultants in Neurology Coordinator of this site? Confirm its status | Northbrook | United States | Unknown status |
| CPFCC Neurology Research Dept. Coordinator of this site? Confirm its status | Overland Park | United States | Unknown status |
| Stanford University Coordinator of this site? Confirm its status | Palo Alto | United States | Unknown status |
| South Shore Neurology Associates, Inc Coordinator of this site? Confirm its status | Patchogue | United States | Unknown status |
| Thomas Jefferson University - Clinical Research Institute Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Neurostudies Inc. Coordinator of this site? Confirm its status | Port Charlotte | United States | Unknown status |
| Accel Research Sites - Brain and Spine Institute of Port Orange - ERN - PPDS Coordinator of this site? Confirm its status | Port Orange | United States | Unknown status |
| Central Texas Neurology Consultants, PA Coordinator of this site? Confirm its status | Round Rock | United States | Unknown status |
| Sanford Health Coordinator of this site? Confirm its status | Sioux Falls | United States | Unknown status |
| Hartford Healthcare CT Coordinator of this site? Confirm its status | Southington | United States | Unknown status |
| MultiCare Institute for Research and Innovation Coordinator of this site? Confirm its status | Tacoma | United States | Unknown status |
| Holy Name Hospital Coordinator of this site? Confirm its status | Teaneck | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.