Clinical trial NCT05028634: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Keywords: Multiple Sclerosis
Ozanimod
Relapsing-remitting multiple sclerosis
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2021-08-31
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Percentage of Participants Meeting Immune Serological Response Criteria to Tetanus Toxoid Antigen
timeFrame: Day 28
measure: Percentage of Participants Meeting Immune Serological Protection Criteria to Tetanus Toxoid Antigen
timeFrame: Day 28
Secondary outcomes:
measure: Percentage of Participants With Serologic Response to Pneumococcal Polysaccharide Vaccine (PPSV23)
timeFrame: Day 28
measure: Percentage of Participants With Serologic Protection Against Pneumococcal Polysaccharide Vaccine (PPSV23)
timeFrame: Day 28
measure: Number of Participants With Adverse Events
timeFrame: Day 1 to Day 28
measure: Number of Participants With Abnormalities in Blood Chemistry Parameters
timeFrame: Day 1 to Day 28
measure: Number of Participants With Abnormalities in Blood Hematology Parameters
timeFrame: Day 1 to Day 28
measure: Change From Baseline in Blood Chemistry Parameters - Sodium; Potassium; Chloride; Calcium; Magnesium; Phosphate; Blood Urea Nitrogen; Glucose
timeFrame: Baseline (Day 1) and End of Study (Day 28)
measure: Change From Baseline in Blood Chemistry Parameters - Creatinine; Bilirubin; Direct Bilirubin
timeFrame: Baseline (Day 1) and End of Study (Day 28)
measure: Change From Baseline in Blood Chemistry Parameters - Albumin
timeFrame: Baseline (Day 1) and End of Study (Day 28)
measure: Change From Baseline in Blood Chemistry Parameters - Alkaline Phosphatase
timeFrame: Baseline (Day 1) and End of Study (Day 28)
measure: Change From Baseline in Blood Chemistry Parameters - Alanine Aminotransferase; Aspartate Aminotransferase; Gamma Glutamyl Transferase
timeFrame: Baseline (Day 1) and End of Study (Day 28)
measure: Change From Baseline in Blood Hematology Parameters - Erythrocytes
timeFrame: Baseline (Day 1) and End of Study (Day 28)
measure: Change From Baseline in Blood Hematology Parameters - Leukocytes; Basophils; Eosinophils; Lymphocytes; Monocytes; Neutrophils; Platelets
timeFrame: Baseline (Day 1) and End of Study (Day 28)
measure: Change From Baseline in Blood Hematology Parameters - Basophils/Leukocytes; Eosinophils/Leukocytes; Lymphocytes/Leukocytes; Monocytes/Leukocytes; Neutrophils/Leukocytes
timeFrame: Baseline (Day 1) and End of Study (Day 28)
measure: Change From Baseline in Blood Hematology Parameters - Hemoglobin; Erythrocytes Mean Corpuscular HGB Concentration
timeFrame: Baseline (Day 1) and End of Study (Day 28)
measure: Change From Baseline in Blood Hematology Parameters - Erythrocytes Mean Corpuscular Volume
timeFrame: Baseline (Day 1) and End of Study (Day 28)
measure: Change From Baseline in Blood Hematology Parameters - Erythrocytes Mean Corpuscular Hemoglobin
timeFrame: Baseline (Day 1) and End of Study (Day 28)
measure: Change From Baseline in Blood Hematology Parameters - Hematocrit
timeFrame: Baseline (Day 1) and End of Study (Day 28)
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: Colorado Springs
country: United States
facility: Colorado Springs Neurological Associates
state: Colorado
city: Southington
country: United States
facility: Hartford Healthcare CT
state: Connecticut
city: Gainesville
country: United States
facility: University of Florida Health
state: Florida
city: Port Charlotte
country: United States
facility: Neurostudies Inc
state: Florida
city: Port Orange
country: United States
facility: Accel Research Sites - Brain and Spine Institute of Port Orange - ERN - PPDS
state: Florida
city: Chicago
country: United States
facility: University of Chicago Medicine
state: Illinois
city: Northbrook
country: United States
facility: Consultants In Neurology
state: Illinois
city: Kansas City
country: United States
facility: Local Institution - 111
state: Kansas
city: Overland Park
country: United States
facility: CPFCC Neurology Research Dept.
state: Kansas
city: Alexandria
country: United States
facility: Neuromedical Clinic of Central LA
state: Louisiana
city: Foxboro
country: United States
facility: Neurology Center of New England P.C.
state: Massachusetts
city: East Lansing
country: United States
facility: Michigan State University MS Clinic
state: Michigan
city: Minneapolis
country: United States
facility: Shapiro Center for MS at the Minneapolis Clinic of Neurology
state: Minnesota
city: Lincoln
country: United States
facility: Neurology Associates PC
state: Nebraska
city: Neptune
country: United States
facility: Jersey Shore MS Center
state: New Jersey
city: Teaneck
country: United States
facility: Holy Name Hospital
state: New Jersey
city: Patchogue
country: United States
facility: South Shore Neurology Associates, Inc
state: New York
city: Asheville
country: United States
facility: Asheville Neurology Specialists PA
state: North Carolina
city: Mooresville
country: United States
facility: Lake Norman Neurology
state: North Carolina
city: Canton
country: United States
facility: Local Institution - 105
state: Ohio
city: Cleveland
country: United States
facility: Velocity Clinical Research - Cleveland - ERN - PPDS
state: Ohio
city: Philadelphia
country: United States
facility: Thomas Jefferson University - Clinical Research Institute
state: Pennsylvania
city: Sioux Falls
country: United States
facility: Sanford Health
state: South Dakota
city: Knoxville
country: United States
facility: Hope Neurology MS Center
state: Tennessee
city: Round Rock
country: United States
facility: Central Texas Neurology Consultants PA
state: Texas
city: Tacoma
country: United States
facility: MultiCare Institute for Research and Innovation
state: Washington
city: Crab Orchard
country: United States
facility: Vaught Neurological Services, PLLC
state: West Virginia
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Bochum
country: Germany
facility: Local Institution - 200
city: Dresden
country: Germany
facility: Local Institution - 201
city: Mannheim
country: Germany
facility: Local Institution - 206
city: Rostock
country: Germany
facility: Local Institution - 204
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: