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
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Celgene
- Enrollment
- 63
- Locations
- 33
- Primary Endpoint
- Percentage of Participants Meeting Immune Serological Response Criteria to Tetanus Toxoid Antigen
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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.
Arms & Interventions
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
-Enrollment is closed for this cohort
Intervention: Tetanus, diphtheria, and acellular pertussis vaccine (Biological)
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
-Enrollment is closed for this cohort
Intervention: Pneumococcal polysaccharide vaccine (Biological)
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
-Enrollment is closed for this cohort
Intervention: Seasonal influenza vaccine (Biological)
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
-Enrollment is closed for this cohort
Intervention: Tetanus, diphtheria, and acellular pertussis vaccine (Biological)
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
-Enrollment is closed for this cohort
Intervention: Pneumococcal polysaccharide vaccine (Biological)
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
-Enrollment is closed for this cohort
Intervention: Seasonal influenza vaccine (Biological)
Cohort 2 - Ozanimod
Comprises of participants received oral ozanimod will be administered tetanus, diphtheria, and acellular pertussis vaccine (Tdap), and pneumococcal polysaccharide vaccine (PPSV23).
Intervention: Tetanus, diphtheria, and acellular pertussis vaccine (Biological)
Cohort 2 - Ozanimod
Comprises of participants received oral ozanimod will be administered tetanus, diphtheria, and acellular pertussis vaccine (Tdap), and pneumococcal polysaccharide vaccine (PPSV23).
Intervention: Pneumococcal polysaccharide vaccine (Biological)
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).
Intervention: Tetanus, diphtheria, and acellular pertussis vaccine (Biological)
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).
Intervention: Pneumococcal polysaccharide vaccine (Biological)
Outcomes
Primary Outcomes
Percentage of Participants Meeting Immune Serological Response Criteria to Tetanus Toxoid Antigen
Time Frame: Day 28
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.
Percentage of Participants Meeting Immune Serological Protection Criteria to Tetanus Toxoid Antigen
Time Frame: Day 28
Participants with Serological protection to tetanus toxoid have anti-tetanus toxoid IgG concentration \>= 0.1 International Units per milliliter (IU/mL).
Secondary Outcomes
- 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)
- Change From Baseline in Blood Chemistry Parameters - Sodium; Potassium; Chloride; Calcium; Magnesium; Phosphate; Blood Urea Nitrogen; Glucose(Baseline (Day 1) and End of Study (Day 28))
- Change From Baseline in Blood Chemistry Parameters - Creatinine; Bilirubin; Direct Bilirubin(Baseline (Day 1) and End of Study (Day 28))
- Change From Baseline in Blood Hematology Parameters - Hemoglobin; Erythrocytes Mean Corpuscular HGB Concentration(Baseline (Day 1) and End of Study (Day 28))
- Change From Baseline in Blood Chemistry Parameters - Albumin(Baseline (Day 1) and End of Study (Day 28))
- Change From Baseline in Blood Chemistry Parameters - Alkaline Phosphatase(Baseline (Day 1) and End of Study (Day 28))
- Change From Baseline in Blood Chemistry Parameters - Alanine Aminotransferase; Aspartate Aminotransferase; Gamma Glutamyl Transferase(Baseline (Day 1) and End of Study (Day 28))
- Change From Baseline in Blood Hematology Parameters - Erythrocytes(Baseline (Day 1) and End of Study (Day 28))
- Change From Baseline in Blood Hematology Parameters - Leukocytes; Basophils; Eosinophils; Lymphocytes; Monocytes; Neutrophils; Platelets(Baseline (Day 1) and End of Study (Day 28))
- Change From Baseline in Blood Hematology Parameters - Basophils/Leukocytes; Eosinophils/Leukocytes; Lymphocytes/Leukocytes; Monocytes/Leukocytes; Neutrophils/Leukocytes(Baseline (Day 1) and End of Study (Day 28))
- Change From Baseline in Blood Hematology Parameters - Erythrocytes Mean Corpuscular Volume(Baseline (Day 1) and End of Study (Day 28))
- Change From Baseline in Blood Hematology Parameters - Erythrocytes Mean Corpuscular Hemoglobin(Baseline (Day 1) and End of Study (Day 28))
- Change From Baseline in Blood Hematology Parameters - Hematocrit(Baseline (Day 1) and End of Study (Day 28))