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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

  • Clinicaltrials.gov identifier

    NCT05028634

  • Recruitment Status

    Recruiting

  • First Posted

    August 31, 2021

  • Last update posted

    December 20, 2021

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.

  • Condition or Disease:Multiple Sclerosis
    Multiple Sclerosis, Relapsing-Remitting
  • Intervention/Treatment: Biological: Tetanus, diphtheria, and acellular pertussis vaccine
    Biological: Pneumococcal polysaccharide vaccine
    Biological: Seasonal influenza vaccine
  • Phase: Phase 3

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 60 participants
  • Allocation: Non-Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • 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
  • Actual Study Start Date: October 2021
  • Estimated Primary Completion Date: April 2022
  • Estimated Study Completion Date: May 2022

Arms and interventions

Arm Intervention/treatment
Experimental: Cohort 1 - Ozanimod
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.
Biological: Tetanus, diphtheria, and acellular pertussis vaccine
Tdap

Biological: Pneumococcal polysaccharide vaccine
PPSV23

Biological: Seasonal influenza vaccine
Seasonal influenza vaccine
Experimental: Cohort 1 - non-pegylated interferon-β or no disease modifying therapy
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.
Biological: Tetanus, diphtheria, and acellular pertussis vaccine
Tdap

Biological: Pneumococcal polysaccharide vaccine
PPSV23

Biological: Seasonal influenza vaccine
Seasonal influenza vaccine
Experimental: Cohort 2 - Ozanimod
Comprises of participants received oral ozanimod will be administered tetanus, diphtheria, and acellular pertussis vaccine (Tdap), and pneumococcal polysaccharide vaccine (PPSV23).
Biological: Tetanus, diphtheria, and acellular pertussis vaccine
Tdap

Biological: Pneumococcal polysaccharide vaccine
PPSV23
Experimental: Cohort 2 - non-pegylated interferon-β or no disease modifying therapy
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).
Biological: Tetanus, diphtheria, and acellular pertussis vaccine
Tdap

Biological: Pneumococcal polysaccharide vaccine
PPSV23

Outcome Measures

  • Primary Outcome Measures: 1. Proportion of participants with serologic response to tetanus toxoid [ Time Frame: At Day 28 ]
    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: 1. Tetanus [ Time Frame: At Day 28 ]
    Proportion of subjects with serological protection against tetanus toxoid.
  • 2. Pneumococcus [ Time Frame: At Day 28 ]
    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.
  • 3. Pneumococcus [ Time Frame: At Day 28 ]
    Proportion of participants with serological protection against the following pneumococcal serotypes: 3, 6B, 9N, 11A, 14, 19A, 19F, 22F and 23F.
  • 4. Safety of concomitant vaccine administration in participants taking ozanimod [ Time Frame: At Day 28 ]
    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.

Eligibility Criteria

  • Ages Eligible for Study: 18 to 55 Years (Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com

Contact: First line of the email MUST contain NCT # and Site #.

Locations

United States, California
Stanford University
Palo Alto

United States, Colorado
Colorado Springs Neurological Associates
Colorado Springs

United States, Connecticut
Hartford Healthcare CT
Southington

United States, Florida
University of Florida Health
Gainesville

United States, Florida
Neurostudies Inc
Port Charlotte

United States, Florida
Accel Research Sites - Brain and Spine Institute of Port Orange - ERN - PPDS
Port Orange

United States, Illinois
University of Chicago Medicine
Chicago

United States, Illinois
Consultants In Neurology
Northbrook

United States, Kansas
University of Kansas Medical Center
Kansas City

United States, Kansas
CPFCC Neurology Research Dept.
Overland Park

United States, Louisiana
Neuromedical Clinic of Central LA
Alexandria

United States, Massachusetts
Neurology Center of New England P.C.
Foxboro

United States, Michigan
Michigan State University MS Clinic
East Lansing

United States, Minnesota
Shapiro Center for MS at the Minneapolis Clinic of Neurology
Minneapolis

United States, Nebraska
Neurology Associates PC
Lincoln

United States, New Jersey
Jersey Shore MS Center
Neptune

United States, New Jersey
Holy Name Hospital
Teaneck

United States, New York
South Shore Neurology Associates, Inc
Patchogue

United States, North Carolina
Asheville Neurology Specialists PA
Asheville

United States, North Carolina
Lake Norman Neurology
Mooresville

United States, Ohio
NeuroScience Research Center, LLC
Canton

United States, Ohio
Velocity Clinical Research - Cleveland - ERN - PPDS
Cleveland

United States, Pennsylvania
Thomas Jefferson University
Philadelphia

United States, South Dakota
Sanford Health
Sioux Falls

United States, Tennessee
Hope Neurology MS Center
Knoxville

United States, Texas
Central Texas Neurology Consultants PA
Round Rock

United States, Washington
MultiCare Institute for Research and Innovation
Tacoma

United States, West Virginia
Vaught Neurological Services, PLLC
Crab Orchard

United States, Wisconsin
Medical College of Wisconsin
Milwaukee

Germany
St. Josef Hospital
Bochum

Germany
Dresden University Clinic
Dresden

Germany
Universitaetsklinikum Jena
Jena

Germany
Nervenärztliche Gemeinschaftspraxis Neuroplus
Mannheim

Germany
Universitätsklinik Rostock
Rostock

Sponsors and Collaborators

Celgene

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Celgene
  • ClinicalTrials.gov Identifier: NCT05028634 History of Changes
  • Other Study ID Numbers: RPC-1063-MS-010, 2021-001847-28
  • First Posted: August 31, 2021 Key Record Dates
  • Last Update Posted: December 20, 2021
  • Last Verified: December 2021
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Celgene: Multiple Sclerosis
    Ozanimod
    Relapsing-remitting multiple sclerosis
  • Additional relevant MeSH terms: Multiple Sclerosis
    Multiple Sclerosis, Relapsing-Remitting
    Sclerosis
    Pathologic Processes
    Demyelinating Autoimmune Diseases, CNS
    Autoimmune Diseases of the Nervous System
    Nervous System Diseases
    Demyelinating Diseases
    Autoimmune Diseases
    Immune System Diseases