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

Multiple Sclerosis Clinical Trial

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

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
• 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
• 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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

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

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting