Back to resultsSafety 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
Primary Purpose
Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tetanus, diphtheria, and acellular pertussis vaccine
Pneumococcal polysaccharide vaccine
Seasonal influenza vaccine
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, Ozanimod, Relapsing-remitting multiple sclerosis
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.
Sites / Locations
- Stanford University
- Colorado Springs Neurological AssociatesRecruiting
- Hartford Healthcare CT
- University of Florida HealthRecruiting
- Neurostudies IncRecruiting
- Accel Research Sites - Brain and Spine Institute of Port Orange - ERN - PPDSRecruiting
- University of Chicago MedicineRecruiting
- Consultants In Neurology
- University Of Kansas Medical Center
- CPFCC Neurology Research Dept.Recruiting
- Neuromedical Clinic of Central LARecruiting
- Neurology Center of New England P.C.Recruiting
- Michigan State University MS Clinic
- Shapiro Center for MS at the Minneapolis Clinic of Neurology
- Neurology Associates PCRecruiting
- Jersey Shore MS CenterRecruiting
- Holy Name HospitalRecruiting
- South Shore Neurology Associates, IncRecruiting
- Asheville Neurology Specialists PARecruiting
- Lake Norman NeurologyRecruiting
- NeuroScience Research Center, LLCRecruiting
- Velocity Clinical Research - Cleveland - ERN - PPDSRecruiting
- Thomas Jefferson University - Clinical Research InstituteRecruiting
- Sanford Health
- Hope Neurology MS CenterRecruiting
- Central Texas Neurology Consultants PA
- MultiCare Institute for Research and InnovationRecruiting
- Vaught Neurological Services, PLLCRecruiting
- Medical College of WisconsinRecruiting
- Local Institution - 200Recruiting
- Local Institution - 201Recruiting
- Local Institution - 206Recruiting
- Local Institution - 204Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Cohort 1 - Ozanimod
Cohort 1 - non-pegylated interferon-β or no disease modifying therapy
Cohort 2 - Ozanimod
Cohort 2 - non-pegylated interferon-β or no disease modifying therapy
Arm Description
Comprises of participants received oral ozanimod will be administered tetanus, diphtheria, and acellular pertussis vaccine (Tdap), pneumococcal polysaccharide vaccine (PPSV23), and the seasonal inactivated influenza vaccine -Enrollment is closed for this cohort
Comprises of participants received either non-pegylated interferon-β (IFN-β) or no disease modifying therapy (DMT) will be administered tetanus, diphtheria, and acellular pertussis vaccine (Tdap), Pneumococcal polysaccharide vaccine (PPSV23), and the seasonal inactivated influenza vaccine -Enrollment is closed for this cohort
Comprises of participants received oral ozanimod will be administered tetanus, diphtheria, and acellular pertussis vaccine (Tdap), and pneumococcal polysaccharide vaccine (PPSV23).
Comprises of participants received either non-pegylated interferon-β (IFN-β) or no disease modifying therapy (DMT) will be administered tetanus, diphtheria, and acellular pertussis vaccine (Tdap) and Pneumococcal polysaccharide vaccine (PPSV23).
Outcomes
Primary Outcome Measures
Proportion of participants with serologic response to tetanus toxoid
Measured by comparing the anti-tetanus toxoid immunoglobulin G (IgG) antibody titers at 4 weeks post-vaccination compared to the pre-vaccination titers. Participants with a pre-vaccination IgG antibody titer level ≤ 0.10 IU/mL will have a serologic response if post-vaccination titer levels are ≥ 0.40 IU/mL. To demonstrate a serologic response if pre-vaccination titer levels are > 0.10 IU/mL and ≤ 2.7 IU/mL, participants will have at least a 4-fold increase in post-vaccination titers. If participants have a pre-vaccination titer level > 2.7 IU/mL, they will have at least a 2-fold increase in titers to demonstrate a response.
Secondary Outcome Measures
Tetanus
Proportion of subjects with serological protection against tetanus toxoid.
Pneumococcus
Proportion of participants with serologic response to at least 5 of the following pneumococcal serotypes: 3, 6B, 9N, 11A, 14, 19A, 19F, 22F and 23F.
Pneumococcus
Proportion of participants with serological protection against the following pneumococcal serotypes: 3, 6B, 9N, 11A, 14, 19A, 19F, 22F and 23F.
Safety of concomitant vaccine administration in participants taking ozanimod
A Safety Adverse Event (SAE) or Adverse Event (AE) incidence is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening (i.e., any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05028634
Brief Title
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
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 27, 2021 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celgene
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting
Keywords
Multiple Sclerosis, Ozanimod, Relapsing-remitting multiple sclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1 - Ozanimod
Arm Type
Experimental
Arm Description
Comprises of participants received oral ozanimod will be administered tetanus, diphtheria, and acellular pertussis vaccine (Tdap), pneumococcal polysaccharide vaccine (PPSV23), and the seasonal inactivated influenza vaccine
-Enrollment is closed for this cohort
Arm Title
Cohort 1 - non-pegylated interferon-β or no disease modifying therapy
Arm Type
Experimental
Arm Description
Comprises of participants received either non-pegylated interferon-β (IFN-β) or no disease modifying therapy (DMT) will be administered tetanus, diphtheria, and acellular pertussis vaccine (Tdap), Pneumococcal polysaccharide vaccine (PPSV23), and the seasonal inactivated influenza vaccine
-Enrollment is closed for this cohort
Arm Title
Cohort 2 - Ozanimod
Arm Type
Experimental
Arm Description
Comprises of participants received oral ozanimod will be administered tetanus, diphtheria, and acellular pertussis vaccine (Tdap), and pneumococcal polysaccharide vaccine (PPSV23).
Arm Title
Cohort 2 - non-pegylated interferon-β or no disease modifying therapy
Arm Type
Experimental
Arm Description
Comprises of participants received either non-pegylated interferon-β (IFN-β) or no disease modifying therapy (DMT) will be administered tetanus, diphtheria, and acellular pertussis vaccine (Tdap) and Pneumococcal polysaccharide vaccine (PPSV23).
Intervention Type
Biological
Intervention Name(s)
Tetanus, diphtheria, and acellular pertussis vaccine
Other Intervention Name(s)
Tdap
Intervention Description
Tdap
Intervention Type
Biological
Intervention Name(s)
Pneumococcal polysaccharide vaccine
Other Intervention Name(s)
PPSV23
Intervention Description
PPSV23
Intervention Type
Biological
Intervention Name(s)
Seasonal influenza vaccine
Intervention Description
Seasonal influenza vaccine
Primary Outcome Measure Information:
Title
Proportion of participants with serologic response to tetanus toxoid
Description
Measured by comparing the anti-tetanus toxoid immunoglobulin G (IgG) antibody titers at 4 weeks post-vaccination compared to the pre-vaccination titers. Participants with a pre-vaccination IgG antibody titer level ≤ 0.10 IU/mL will have a serologic response if post-vaccination titer levels are ≥ 0.40 IU/mL. To demonstrate a serologic response if pre-vaccination titer levels are > 0.10 IU/mL and ≤ 2.7 IU/mL, participants will have at least a 4-fold increase in post-vaccination titers. If participants have a pre-vaccination titer level > 2.7 IU/mL, they will have at least a 2-fold increase in titers to demonstrate a response.
Time Frame
At Day 28
Secondary Outcome Measure Information:
Title
Tetanus
Description
Proportion of subjects with serological protection against tetanus toxoid.
Time Frame
At Day 28
Title
Pneumococcus
Description
Proportion of participants with serologic response to at least 5 of the following pneumococcal serotypes: 3, 6B, 9N, 11A, 14, 19A, 19F, 22F and 23F.
Time Frame
At Day 28
Title
Pneumococcus
Description
Proportion of participants with serological protection against the following pneumococcal serotypes: 3, 6B, 9N, 11A, 14, 19A, 19F, 22F and 23F.
Time Frame
At Day 28
Title
Safety of concomitant vaccine administration in participants taking ozanimod
Description
A Safety Adverse Event (SAE) or Adverse Event (AE) incidence is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening (i.e., any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE.
Time Frame
At Day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BMS Study Connect Contact Center www.BMSStudyConnect.com
Phone
855-907-3286
Email
Clinical.Trials@bms.com
First Name & Middle Initial & Last Name or Official Title & Degree
First line of the email MUST contain NCT # and Site #.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffery Dunn, Site 106
Facility Name
Colorado Springs Neurological Associates
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kimberly Wagner, Site 110
Facility Name
Hartford Healthcare CT
City
Southington
State/Province
Connecticut
ZIP/Postal Code
06489
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Derek Smith, Site 122
Facility Name
University of Florida Health
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Torge Rempe, Site 135
Facility Name
Neurostudies Inc
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liliana Montoya, Site 108
Facility Name
Accel Research Sites - Brain and Spine Institute of Port Orange - ERN - PPDS
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Timothy Wierzbicki, Site 130
Phone
386-740-0770
Facility Name
University of Chicago Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anthony Reder, Site 102
Facility Name
Consultants In Neurology
City
Northbrook
State/Province
Illinois
ZIP/Postal Code
60062
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Wynn, Site 112
Facility Name
University Of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sharon Lynch, Site 111
Phone
816-289-2052
Facility Name
CPFCC Neurology Research Dept.
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey Kaplan, Site 125
Phone
913-438-0868
Facility Name
Neuromedical Clinic of Central LA
City
Alexandria
State/Province
Louisiana
ZIP/Postal Code
71301
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ariel Antezana, Site 113
Phone
318-730-4675
Facility Name
Neurology Center of New England P.C.
City
Foxboro
State/Province
Massachusetts
ZIP/Postal Code
02035
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Salvatore Napoli, Site 126
Phone
781-551-5812
Facility Name
Michigan State University MS Clinic
City
East Lansing
State/Province
Michigan
ZIP/Postal Code
48824
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jayne Ward, Site 118
Facility Name
Shapiro Center for MS at the Minneapolis Clinic of Neurology
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55422
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Calkwood, Site 124
Phone
763-302-4199
Facility Name
Neurology Associates PC
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68506
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gary Pattee, Site 120
Facility Name
Jersey Shore MS Center
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07753
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Duncan, Site 137
Facility Name
Holy Name Hospital
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Ann Picone, Site 134
Facility Name
South Shore Neurology Associates, Inc
City
Patchogue
State/Province
New York
ZIP/Postal Code
11772
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Gudesblatt, Site 100
Facility Name
Asheville Neurology Specialists PA
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28806
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Patton, Site 127
Facility Name
Lake Norman Neurology
City
Mooresville
State/Province
North Carolina
ZIP/Postal Code
28117
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Doug Jeffery, Site 107
Facility Name
NeuroScience Research Center, LLC
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ryan Drake, Site 105
Facility Name
Velocity Clinical Research - Cleveland - ERN - PPDS
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joan Rothenberg, Site 132
Facility Name
Thomas Jefferson University - Clinical Research Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Leist, Site 128
Phone
215-955-6871
Facility Name
Sanford Health
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abdul Alchaki, Site 103
Facility Name
Hope Neurology MS Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37922
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sibyl Wray, Site 101
Phone
865-218-6222
Facility Name
Central Texas Neurology Consultants PA
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edward Fox, Site 116
Facility Name
MultiCare Institute for Research and Innovation
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rinu Abraham, Site 140
Facility Name
Vaught Neurological Services, PLLC
City
Crab Orchard
State/Province
West Virginia
ZIP/Postal Code
25827
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barry Vaught, Site 139
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Obeidat, Site 133
Phone
937-608-2712
Facility Name
Local Institution - 200
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 200
Facility Name
Local Institution - 201
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 201
Facility Name
Local Institution - 206
City
Mannheim
ZIP/Postal Code
68163
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 206
Facility Name
Local Institution - 204
City
Rostock
ZIP/Postal Code
18147
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 204
12. IPD Sharing Statement
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
http://www.BMSStudyConnect.com
Description
BMS Clinical Trial Patient Recruiting
Learn more about this trial
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
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