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Completed

NCT Number: 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

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis, Relapsing-Remitting Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Local Institution - 200, Bochum, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tetanus, diphtheria, and acellular pertussis vaccine

Biological

Tdap

Other names: Tdap

Pneumococcal polysaccharide vaccine

Biological

PPSV23

Other names: PPSV23

Seasonal Influenza Vaccine

Biological

Seasonal influenza vaccine

Primary outcomes

  1. Percentage of Participants Meeting Immune Serological Response Criteria to Tetanus Toxoid Antigen

    Time frame: Day 28

    Serologic response to tetanus toxoid criteria are as follows - if pre vaccination antibody titer is ≤0.10 IU/mL, post-vaccination level ≥0.40 IU/mL; if pre-vaccination antibody titer is >0.10 IU/mL and ≤2.7 IU/mL, at least a 4-fold increase in titer; if pre-vaccination antibody titer is>2.7 IU/mL, at least a 2-fold increase in titer.

  2. Percentage of Participants Meeting Immune Serological Protection Criteria to Tetanus Toxoid Antigen

    Time frame: Day 28

    Participants with Serological protection to tetanus toxoid have anti-tetanus toxoid IgG concentration >= 0.1 International Units per milliliter (IU/mL).

Secondary outcomes

  1. Percentage of Participants With Serologic Response to Pneumococcal Polysaccharide Vaccine (PPSV23)

    Time frame: Day 28

    Serological response to PPSV23 was defined as the percentage of participants with a ≥2-fold increase in anti-pneumococcal polysaccharide vaccine titer in >5 of the indicated serotypes - 3, 6B, 9N, 11A, 14, 19A, 19F, 22F and 23F

  2. Percentage of Participants With Serologic Protection Against Pneumococcal Polysaccharide Vaccine (PPSV23)

    Time frame: Day 28

    Serological protection against PPSV23 was defined as the percentage of participants with Anti-pneumococcal polysaccharide IgG concentration >= 1.3 μg/mL in the indicated serotypes - 3, 6B, 9N, 11A, 14, 19A, 19F, 22F and 23F associated with increased risk of invasive and/or severe disease, including death.

  3. Number of Participants With Adverse Events

    Time frame: Day 1 to Day 28

    Adverse events include events with onset date on or after the study medication first dose date until end of study visit after the vaccine administration. Serious AEs was defined as is any AE occurring at any dose of vaccination from Day 1 to the end of the study that results in death, Is life-threatening (ie, in the opinion of the Investigator, the subject is at immediate risk of death from the AE), Requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or constitutes an important medical event.

  4. Number of Participants With Abnormalities in Blood Chemistry Parameters

    Time frame: Day 1 to Day 28

    Blood samples were collected to assess laboratory parameters

  5. Number of Participants With Abnormalities in Blood Hematology Parameters

    Time frame: Day 1 to Day 28

    Blood samples were collected to assess laboratory parameters

  6. Change From Baseline in Blood Chemistry Parameters - Sodium; Potassium; Chloride; Calcium; Magnesium; Phosphate; Blood Urea Nitrogen; Glucose

    Time frame: Baseline (Day 1) and End of Study (Day 28)

    Blood samples were collected to assess laboratory parameters.

  7. Change From Baseline in Blood Chemistry Parameters - Creatinine; Bilirubin; Direct Bilirubin

    Time frame: Baseline (Day 1) and End of Study (Day 28)

    Blood samples were collected to assess laboratory parameters.

  8. Change From Baseline in Blood Chemistry Parameters - Albumin

    Time frame: Baseline (Day 1) and End of Study (Day 28)

    Blood samples were collected to assess laboratory parameters.

  9. Change From Baseline in Blood Chemistry Parameters - Alkaline Phosphatase

    Time frame: Baseline (Day 1) and End of Study (Day 28)

    Blood samples were collected to assess laboratory parameters.

  10. Change From Baseline in Blood Chemistry Parameters - Alanine Aminotransferase; Aspartate Aminotransferase; Gamma Glutamyl Transferase

    Time frame: Baseline (Day 1) and End of Study (Day 28)

    Blood samples were collected to assess laboratory parameters.

  11. Change From Baseline in Blood Hematology Parameters - Erythrocytes

    Time frame: Baseline (Day 1) and End of Study (Day 28)

    Blood samples were collected to assess laboratory parameters.

  12. Change From Baseline in Blood Hematology Parameters - Leukocytes; Basophils; Eosinophils; Lymphocytes; Monocytes; Neutrophils; Platelets

    Time frame: Baseline (Day 1) and End of Study (Day 28)

    Blood samples were collected to assess laboratory parameters.

  13. Change From Baseline in Blood Hematology Parameters - Basophils/Leukocytes; Eosinophils/Leukocytes; Lymphocytes/Leukocytes; Monocytes/Leukocytes; Neutrophils/Leukocytes

    Time frame: Baseline (Day 1) and End of Study (Day 28)

    Blood samples were collected to assess laboratory parameters.

  14. Change From Baseline in Blood Hematology Parameters - Hemoglobin; Erythrocytes Mean Corpuscular HGB Concentration

    Time frame: Baseline (Day 1) and End of Study (Day 28)

    Blood samples were collected to assess laboratory parameters.

  15. Change From Baseline in Blood Hematology Parameters - Erythrocytes Mean Corpuscular Volume

    Time frame: Baseline (Day 1) and End of Study (Day 28)

    Blood samples were collected to assess laboratory parameters.

  16. Change From Baseline in Blood Hematology Parameters - Erythrocytes Mean Corpuscular Hemoglobin

    Time frame: Baseline (Day 1) and End of Study (Day 28)

    Blood samples were collected to assess laboratory parameters.

  17. Change From Baseline in Blood Hematology Parameters - Hematocrit

    Time frame: Baseline (Day 1) and End of Study (Day 28)

    Blood samples were collected to assess laboratory parameters. Participants with baseline and post-baseline data available at the specified timepoint are included in the analysis.

Sponsors and collaborators

Lead sponsor

Celgene

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 31, 2021
Registry last updated
Feb 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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