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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting

Interventions

Type	Name	Description
BIOLOGICAL	Tetanus, diphtheria, and acellular pertussis vaccine	Tdap
BIOLOGICAL	Pneumococcal polysaccharide vaccine	PPSV23
BIOLOGICAL	Seasonal influenza vaccine	Seasonal influenza vaccine

Timeline

• Start date: 2021-11-11
• Primary completion: 2023-11-15
• Completion: 2023-11-15
• First posted: 2021-08-31
• Last updated: 2025-02-11
• Results posted: 2025-01-22

Locations

33 sites across 2 countries: United States, Germany

Regulatory

• FDA-regulated drug study