Phase 3
N=63
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 · Multiple Sclerosis, Relapsing-Remitting
Bottom Line
View on ClinicalTrials.gov: NCT05028634 ↗Enrolled (actual)
63
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Percentage of Participants Meeting Immune Serological Response Criteria to Tetanus Toxoid Antigen — 10; 53.1 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Tetanus, diphtheria, and acellular pertussis vaccine (Biological); Pneumococcal polysaccharide vaccine (Biological); Seasonal influenza vaccine (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Celgene
- Primary completion
- Nov 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Meeting Immune Serological Response Criteria to Tetanus Toxoid Antigen |
10; 53.1 | — |
| PRIMARY Percentage of Participants Meeting Immune Serological Protection Criteria to Tetanus Toxoid Antigen |
100; 100 | — |
| SECONDARY Percentage of Participants With Serologic Response to Pneumococcal Polysaccharide Vaccine (PPSV23) |
69.0; 87.5 | — |
| SECONDARY Percentage of Participants With Serologic Protection Against Pneumococcal Polysaccharide Vaccine (PPSV23) |
66.7; 71.9 | — |
| SECONDARY Number of Participants With Adverse Events |
11; 11; 0; 0; 2; 4 | — |
| SECONDARY Number of Participants With Abnormalities in Blood Chemistry Parameters |
6; 7; 1; 1; 0; 0 | — |
| SECONDARY Number of Participants With Abnormalities in Blood Hematology Parameters |
1; 0; 0; 0; 0; 0 | — |
| SECONDARY Change From Baseline in Blood Chemistry Parameters - Sodium; Potassium; Chloride; Calcium; Magnesium; Phosphate; Blood Urea Nitrogen; Glucose |
-0.7; -0.3; -0.14; -0.08; -0.9; 0.2 | — |
| SECONDARY Change From Baseline in Blood Chemistry Parameters - Creatinine; Bilirubin; Direct Bilirubin |
-1.1; -0.6; 0.4; 0.1; 0.0; 0.0 | — |
| SECONDARY Change From Baseline in Blood Chemistry Parameters - Albumin |
-0.2; -0.8 | — |
| SECONDARY Change From Baseline in Blood Chemistry Parameters - Alkaline Phosphatase |
2.9; -1.1 | — |
| SECONDARY Change From Baseline in Blood Chemistry Parameters - Alanine Aminotransferase; Aspartate Aminotransferase; Gamma Glutamyl Transferase |
3.5; 1.4; 2.1; 0.9; 3.2; 0.6 | — |
| SECONDARY Change From Baseline in Blood Hematology Parameters - Erythrocytes |
-0.06; -0.07 | — |
| SECONDARY Change From Baseline in Blood Hematology Parameters - Leukocytes; Basophils; Eosinophils; Lymphocytes; Monocytes; Neutrophils; Platelets |
0.58; 0.33; -0.013; -0.007; 0.038; 0.013 | — |
| SECONDARY Change From Baseline in Blood Hematology Parameters - Basophils/Leukocytes; Eosinophils/Leukocytes; Lymphocytes/Leukocytes; Monocytes/Leukocytes; Neutrophils/Leukocytes |
-0.34; -0.14; 0.05; 0.05; 0.17; -1.35 | — |
| SECONDARY Change From Baseline in Blood Hematology Parameters - Hemoglobin; Erythrocytes Mean Corpuscular HGB Concentration |
-1.9; -2.9; 1.2; 0.2 | — |
| SECONDARY Change From Baseline in Blood Hematology Parameters - Erythrocytes Mean Corpuscular Volume |
-0.3; -0.5 | — |
| SECONDARY Change From Baseline in Blood Hematology Parameters - Erythrocytes Mean Corpuscular Hemoglobin |
-0.1; -0.1 | — |
| SECONDARY Change From Baseline in Blood Hematology Parameters - Hematocrit |
-0.007; -0.010 | — |
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.
Data sourced from ClinicalTrials.gov (NCT05028634). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.