drugset / 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
Non-randomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2021-11-11
- Primary completion
- 2023-11-15
- Completion
- 2023-11-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pneumovax 23 | Vaccine | — | — |
| Subject | Quadrivalent influenza vaccine | Vaccine | — | — |
| Subject | Tetanus, diphtheria, and acellular pertussis vaccine | Vaccine | — | — |