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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05028634
Other study ID # RPC-1063-MS-010
Secondary ID 2021-001847-28
Status Completed
Phase Phase 3
First received
Last updated
Start date October 27, 2021
Est. completion date November 15, 2023

Study information

Verified date January 2024
Source Celgene
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 63
Est. completion date November 15, 2023
Est. primary completion date November 15, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Tetanus, diphtheria, and acellular pertussis vaccine
Tdap
Pneumococcal polysaccharide vaccine
PPSV23
Seasonal influenza vaccine
Seasonal influenza vaccine

Locations

Country Name City State
Germany Local Institution - 200 Bochum
Germany Local Institution - 201 Dresden
Germany Local Institution - 206 Mannheim
Germany Local Institution - 204 Rostock
United States Neuromedical Clinic of Central LA Alexandria Louisiana
United States Asheville Neurology Specialists PA Asheville North Carolina
United States NeuroScience Research Center, LLC Canton Ohio
United States University of Chicago Medicine Chicago Illinois
United States Velocity Clinical Research - Cleveland - ERN - PPDS Cleveland Ohio
United States Colorado Springs Neurological Associates Colorado Springs Colorado
United States Vaught Neurological Services, PLLC Crab Orchard West Virginia
United States Michigan State University MS Clinic East Lansing Michigan
United States Neurology Center of New England P.C. Foxboro Massachusetts
United States University of Florida Health Gainesville Florida
United States University Of Kansas Medical Center Kansas City Kansas
United States Hope Neurology MS Center Knoxville Tennessee
United States Neurology Associates PC Lincoln Nebraska
United States Medical College of Wisconsin Milwaukee Wisconsin
United States Shapiro Center for MS at the Minneapolis Clinic of Neurology Minneapolis Minnesota
United States Lake Norman Neurology Mooresville North Carolina
United States Jersey Shore MS Center Neptune New Jersey
United States Consultants In Neurology Northbrook Illinois
United States CPFCC Neurology Research Dept. Overland Park Kansas
United States Stanford University Palo Alto California
United States South Shore Neurology Associates, Inc Patchogue New York
United States Thomas Jefferson University - Clinical Research Institute Philadelphia Pennsylvania
United States Neurostudies Inc Port Charlotte Florida
United States Accel Research Sites - Brain and Spine Institute of Port Orange - ERN - PPDS Port Orange Florida
United States Central Texas Neurology Consultants PA Round Rock Texas
United States Sanford Health Sioux Falls South Dakota
United States Hartford Healthcare CT Southington Connecticut
United States MultiCare Institute for Research and Innovation Tacoma Washington
United States Holy Name Hospital Teaneck New Jersey

Sponsors (1)

Lead Sponsor Collaborator
Celgene

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. At Day 28
Secondary Tetanus Proportion of subjects with serological protection against tetanus toxoid. At Day 28
Secondary 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. At Day 28
Secondary Pneumococcus Proportion of participants with serological protection against the following pneumococcal serotypes: 3, 6B, 9N, 11A, 14, 19A, 19F, 22F and 23F. At Day 28
Secondary 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. At Day 28
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