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

Celgene

Status and phase: Completed; Phase 3

Conditions: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting

Treatments: Biological: Pneumococcal polysaccharide vaccine; Biological: Seasonal influenza vaccine; Biological: Tetanus, diphtheria, and acellular pertussis vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT05028634

2021-001847-28 (EudraCT Number)

RPC-1063-MS-010

Details and patient eligibility

About

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.

Enrollment: 63 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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63 participants in 4 patient groups

Cohort 1 - Ozanimod

Experimental group

Description:

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

Treatment:

Biological: Seasonal influenza vaccine

Biological: Tetanus, diphtheria, and acellular pertussis vaccine

Biological: Pneumococcal polysaccharide vaccine

Cohort 1 - non-pegylated interferon-β or no disease modifying therapy

Experimental group

Description:

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

Treatment:

Biological: Seasonal influenza vaccine

Biological: Tetanus, diphtheria, and acellular pertussis vaccine

Biological: Pneumococcal polysaccharide vaccine

Cohort 2 - Ozanimod

Experimental group

Description:

Comprises of participants received oral ozanimod will be administered tetanus, diphtheria, and acellular pertussis vaccine (Tdap), and pneumococcal polysaccharide vaccine (PPSV23).

Treatment:

Biological: Tetanus, diphtheria, and acellular pertussis vaccine

Biological: Pneumococcal polysaccharide vaccine

Cohort 2 - non-pegylated interferon-β or no disease modifying therapy

Experimental group

Description:

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).

Treatment:

Biological: Tetanus, diphtheria, and acellular pertussis vaccine

Biological: Pneumococcal polysaccharide vaccine