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

Sponsor

Celgene (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05028634

Collaborator

(none)

Enrollment

Locations

Arms

17.1

Anticipated Duration (Months)

1.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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

Study Design

Study Type:

Interventional

Anticipated 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 :

Oct 27, 2021

Anticipated Primary Completion Date :

Mar 31, 2023

Anticipated Study Completion Date :

Mar 31, 2023

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 Other Names: Tdap Biological: Pneumococcal polysaccharide vaccine PPSV23 Other Names: 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 Other Names: Tdap Biological: Pneumococcal polysaccharide vaccine PPSV23 Other Names: 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 Other Names: Tdap Biological: Pneumococcal polysaccharide vaccine PPSV23 Other Names: 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 Other Names: Tdap Biological: Pneumococcal polysaccharide vaccine PPSV23 Other Names: PPSV23

Outcome Measures

Primary Outcome Measures

Proportion of participants with serologic response to tetanus toxoid [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

Tetanus [At Day 28]
Proportion of subjects with serological protection against tetanus toxoid.
Pneumococcus [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.
Pneumococcus [At Day 28]
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 [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

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Stanford University	Palo Alto	California	United States	94304
2	Colorado Springs Neurological Associates	Colorado Springs	Colorado	United States	80907
3	Hartford Healthcare CT	Southington	Connecticut	United States	06489
4	University of Florida Health	Gainesville	Florida	United States	32610
5	University of Florida Health	Gainesville	Florida	United States	32610
6	Neurostudies Inc	Port Charlotte	Florida	United States	33952
7	Neurostudies Inc	Port Charlotte	Florida	United States	33952
8	Accel Research Sites - Brain and Spine Institute of Port Orange - ERN - PPDS	Port Orange	Florida	United States	32127
9	Accel Research Sites - Brain and Spine Institute of Port Orange - ERN - PPDS	Port Orange	Florida	United States	32127
10	University of Chicago Medicine	Chicago	Illinois	United States	60637
11	University of Chicago Medicine	Chicago	Illinois	United States	60637
12	Consultants In Neurology	Northbrook	Illinois	United States	60062
13	University of Kansas Medical Center	Kansas City	Kansas	United States	66205
14	CPFCC Neurology Research Dept.	Overland Park	Kansas	United States	66212
15	Neuromedical Clinic of Central LA	Alexandria	Louisiana	United States	71301
16	Neuromedical Clinic of Central LA	Alexandria	Louisiana	United States	71301
17	Neurology Center of New England P.C.	Foxboro	Massachusetts	United States	02035
18	Neurology Center of New England P.C.	Foxboro	Massachusetts	United States	02035
19	Michigan State University MS Clinic	East Lansing	Michigan	United States	48824
20	Shapiro Center for MS at the Minneapolis Clinic of Neurology	Minneapolis	Minnesota	United States	55422
21	Neurology Associates PC	Lincoln	Nebraska	United States	68506
22	Jersey Shore MS Center	Neptune	New Jersey	United States	07753
23	Jersey Shore MS Center	Neptune	New Jersey	United States	07753
24	Holy Name Hospital	Teaneck	New Jersey	United States	07666
25	South Shore Neurology Associates, Inc	Patchogue	New York	United States	11772
26	South Shore Neurology Associates, Inc	Patchogue	New York	United States	11772
27	Asheville Neurology Specialists PA	Asheville	North Carolina	United States	28806
28	Asheville Neurology Specialists PA	Asheville	North Carolina	United States	28806
29	Lake Norman Neurology	Mooresville	North Carolina	United States	28117
30	NeuroScience Research Center, LLC	Canton	Ohio	United States	44718
31	Velocity Clinical Research - Cleveland - ERN - PPDS	Cleveland	Ohio	United States	44122
32	Thomas Jefferson University	Philadelphia	Pennsylvania	United States	19107
33	Thomas Jefferson University	Philadelphia	Pennsylvania	United States	19107
34	Sanford Health	Sioux Falls	South Dakota	United States	57104
35	Hope Neurology MS Center	Knoxville	Tennessee	United States	37922
36	Hope Neurology MS Center	Knoxville	Tennessee	United States	37922
37	Central Texas Neurology Consultants PA	Round Rock	Texas	United States	78681
38	MultiCare Institute for Research and Innovation	Tacoma	Washington	United States	98405
39	MultiCare Institute for Research and Innovation	Tacoma	Washington	United States	98405
40	Vaught Neurological Services, PLLC	Crab Orchard	West Virginia	United States	25827
41	Vaught Neurological Services, PLLC	Crab Orchard	West Virginia	United States	25827
42	Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226
43	Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226
44	St. Josef Hospital	Bochum		Germany	44791
45	Dresden University Clinic	Dresden		Germany	01307
46	Local Institution - 206	Mannheim		Germany	68163
47	Nervenärztliche Gemeinschaftspraxis Neuroplus	Mannheim		Germany	68163
48	Universitätsklinik Rostock	Rostock		Germany	18147