Safety Study to Evaluate Immune Response of Vaccines in Participants W
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
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- Tetanus, diphtheria, and acellular pertussis vaccine
- Pneumococcal polysaccharide vaccine
- Seasonal influenza vaccine
Results by group
Percentage of Participants Meeting Immune Serological Response Criteria to Tetanus Toxoid Antigen
Day 28
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Ozanimod | 10 percentage of participants | 30 | |
| Non-Ozanimod | 53.1 percentage of participants | 32 |
Ozanimod
Non-Ozanimod
Percentage of Participants Meeting Immune Serological Protection Criteria to Tetanus Toxoid Antigen
Day 28
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Ozanimod | 100 percentage of participants | 30 | |
| Non-Ozanimod | 100 percentage of participants | 33 |
Ozanimod
Non-Ozanimod
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Ozanimod | 30 | 0 (0.0%) | 0 |
| Non-Ozanimod | 33 | 0 (0.0%) | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Percentage of Participants Meeting Immune Serological Response Criteria to Tetanus Toxoid Antigen
Day 28
Immune responsePercentage of Participants Meeting Immune Serological Protection Criteria to Tetanus Toxoid Antigen
Day 28
Other measures (17)
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
SafetyNumber 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 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)
Who could take part
Relapsing and progressive · 18 to 65
Show the full 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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Loading reviews and guidelines…
History
Started
Nov 2021
Main results due
Nov 2023
Finished
Nov 2023
Results posted
Jan 2025