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 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: RPC-1063-MS-0102021-001847-28
• Study Type: interventional
• Target: 63
• Locations: 2 countries
• Sites: 33

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.

Conditions

Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting

Keywords

Multiple Sclerosis; Ozanimod; Relapsing-remitting multiple sclerosis

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants Meeting Immune Serological Response Criteria to Tetanus Toxoid Antigen

  Serologic response to tetanus toxoid criteria are as follows - if pre vaccination antibody titer is ≤0.10 IU/mL, post-vaccination level ≥0.40 IU/mL; if pre-vaccination antibody titer is \>0.10 IU/mL and ≤2.7 IU/mL, at least a 4-fold increase in titer; if pre-vaccination antibody titer is\>2.7 IU/mL, at least a 2-fold increase in titer.

  Day 28

• Percentage of Participants Meeting Immune Serological Protection Criteria to Tetanus Toxoid Antigen

  Participants with Serological protection to tetanus toxoid have anti-tetanus toxoid IgG concentration \>= 0.1 International Units per milliliter (IU/mL).

  Day 28

Secondary Outcomes (17)

• Percentage of Participants With Serologic Response to Pneumococcal Polysaccharide Vaccine (PPSV23)

  Day 28

• Percentage of Participants With Serologic Protection Against Pneumococcal Polysaccharide Vaccine (PPSV23)

  Day 28

• Number of Participants With Adverse Events

  Day 1 to Day 28

• Number of Participants With Abnormalities in Blood Chemistry Parameters

  Day 1 to Day 28

• Number of Participants With Abnormalities in Blood Hematology Parameters

  Day 1 to Day 28

Study Arms (4)

Cohort 1 - Ozanimod

EXPERIMENTAL

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

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

Cohort 1 - non-pegylated interferon-β or no disease modifying therapy

EXPERIMENTAL

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

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

Cohort 2 - Ozanimod

EXPERIMENTAL

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; Biological: Pneumococcal polysaccharide vaccine

Cohort 2 - non-pegylated interferon-β or no disease modifying therapy

EXPERIMENTAL

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; Biological: Pneumococcal polysaccharide vaccine

Interventions

Tetanus, diphtheria, and acellular pertussis vaccine BIOLOGICAL

Tdap

Also known as: Tdap

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

Pneumococcal polysaccharide vaccine BIOLOGICAL

PPSV23

Also known as: PPSV23

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

Seasonal influenza vaccine BIOLOGICAL

Seasonal influenza vaccine

Cohort 1 - Ozanimod; Cohort 1 - non-pegylated interferon-β or no disease modifying therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Celgene: lead

Study Sites (33)

Stanford University

Palo Alto, California, 94304, United States

Location

Colorado Springs Neurological Associates

Colorado Springs, Colorado, 80907, United States

Location

Hartford Healthcare CT

Southington, Connecticut, 06489, United States

Location

University of Florida Health

Gainesville, Florida, 32610, United States

Location

Neurostudies Inc

Port Charlotte, Florida, 33952, United States

Location

Accel Research Sites - Brain and Spine Institute of Port Orange - ERN - PPDS

Port Orange, Florida, 32127, United States

Location

University of Chicago Medicine

Chicago, Illinois, 60637, United States

Location

Consultants In Neurology

Northbrook, Illinois, 60062, United States

Location

Local Institution - 111

Kansas City, Kansas, 66205, United States

Location

CPFCC Neurology Research Dept.

Overland Park, Kansas, 66212, United States

Location

Neuromedical Clinic of Central LA

Alexandria, Louisiana, 71301, United States

Location

Neurology Center of New England P.C.

Foxborough, Massachusetts, 02035, United States

Location

Michigan State University MS Clinic

East Lansing, Michigan, 48824, United States

Location

Shapiro Center for MS at the Minneapolis Clinic of Neurology

Minneapolis, Minnesota, 55422, United States

Location

Neurology Associates PC

Lincoln, Nebraska, 68506, United States

Location

Jersey Shore MS Center

Neptune City, New Jersey, 07753, United States

Location

Holy Name Hospital

Teaneck, New Jersey, 07666, United States

Location

South Shore Neurology Associates, Inc

Patchogue, New York, 11772, United States

Location

Asheville Neurology Specialists PA

Asheville, North Carolina, 28806, United States

Location

Lake Norman Neurology

Mooresville, North Carolina, 28117, United States

Location

Local Institution - 105

Canton, Ohio, 44718, United States

Location

Velocity Clinical Research - Cleveland - ERN - PPDS

Cleveland, Ohio, 44122, United States

Location

Thomas Jefferson University - Clinical Research Institute

Philadelphia, Pennsylvania, 19107, United States

Location

Sanford Health

Sioux Falls, South Dakota, 57104, United States

Location

Hope Neurology MS Center

Knoxville, Tennessee, 37922, United States

Location

Central Texas Neurology Consultants PA

Round Rock, Texas, 78681, United States

Location

MultiCare Institute for Research and Innovation

Tacoma, Washington, 98405, United States

Location

Vaught Neurological Services, PLLC

Crab Orchard, West Virginia, 25827, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Local Institution - 200

Bochum, 44791, Germany

Location

Local Institution - 201

Dresden, 01307, Germany

Location

Local Institution - 206

Mannheim, 68163, Germany

Location

Local Institution - 204

Rostock, 18147, Germany

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting

Interventions

Diphtheria-Tetanus-acellular Pertussis Vaccines; Pneumococcal Vaccines; 23-valent pneumococcal capsular polysaccharide vaccine

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pertussis Vaccine; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Diphtheria Toxoid; Toxoids; Tetanus Toxoid; Vaccines, Combined; Vaccines, Acellular; Vaccines, Subunit; Streptococcal Vaccines

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please email

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2021
• First Posted: August 31, 2021
• Study Start: November 11, 2021
• Primary Completion: November 15, 2023
• Study Completion: November 15, 2023
• Last Updated: February 11, 2025
• Results First Posted: January 22, 2025

Record last verified: 2025-01

Locations

US (29); DE (4)