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Vaccines Immune Response with Ozanimod for Multiple Sclerosis

Phase 3
Waitlist Available
Research Sponsored by Celgene
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at day 28
Awards & highlights

Summary

This trial will compare the safety and effectiveness of a new MS drug, ozanimod, to interferon-beta and no disease modifying therapies. The data from this study will be used to support the labels for ozanimod in MS.

Who is the study for?
This trial is for individuals with relapsing forms of multiple sclerosis (RMS) who meet the McDonald diagnostic criteria. It's not for those with a history of cancer (except certain skin cancers), immune deficiencies, severe heart or lung issues, recent flu vaccinations, or recent use of systemic immunosuppressants.Check my eligibility
What is being tested?
The study tests how well people with RMS respond to vaccines while taking Ozanimod compared to those on interferon-beta or no therapy at all. Vaccines include Tetanus, Diphtheria and Pertussis (Tdap), Seasonal Flu, and Pneumococcal Polysaccharide.See study design
What are the potential side effects?
Possible side effects from the vaccines may include soreness at injection site, fever, fatigue, headache and allergic reactions. Ozanimod can cause infections due to immune system suppression.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at day 28
This trial's timeline: 3 weeks for screening, Varies for treatment, and at day 28 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of participants with serologic response to tetanus toxoid
Secondary outcome measures
Pneumococcus
Safety of concomitant vaccine administration in participants taking ozanimod
Tetanus

Side effects data

From 2011 Phase 3 trial • 138 Patients • NCT01199861
19%
Headache
16%
Nasopharyngitis
12%
Upper respiratory tract infection
11%
Lymphopenia
7%
Cough
5%
Urinary tract infection
3%
Fatigue
3%
Diarrhoea
2%
Nausea
1%
Paraparesis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Fingolimod
Placebo

Trial Design

4Treatment groups
Experimental Treatment
Group I: Cohort 2 - non-pegylated interferon-β or no disease modifying therapyExperimental Treatment2 Interventions
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).
Group II: Cohort 2 - OzanimodExperimental Treatment2 Interventions
Comprises of participants received oral ozanimod will be administered tetanus, diphtheria, and acellular pertussis vaccine (Tdap), and pneumococcal polysaccharide vaccine (PPSV23).
Group III: Cohort 1 - non-pegylated interferon-β or no disease modifying therapyExperimental Treatment3 Interventions
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
Group IV: Cohort 1 - OzanimodExperimental Treatment3 Interventions
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
First Studied
Drug Approval Stage
How many patients have taken this drug
Tetanus, diphtheria, and acellular pertussis vaccine
2022
Completed Phase 3
~370
Seasonal influenza vaccine
2010
Completed Phase 3
~210
Pneumococcal polysaccharide vaccine
2008
Completed Phase 4
~510

Find a Location

Who is running the clinical trial?

CelgeneLead Sponsor
643 Previous Clinical Trials
130,049 Total Patients Enrolled
10 Trials studying Multiple Sclerosis
7,094 Patients Enrolled for Multiple Sclerosis
James Sheffield, MDStudy DirectorCelgene
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,536 Previous Clinical Trials
3,375,744 Total Patients Enrolled
12 Trials studying Multiple Sclerosis
17,953 Patients Enrolled for Multiple Sclerosis

Media Library

Seasonal influenza vaccine Clinical Trial Eligibility Overview. Trial Name: NCT05028634 — Phase 3
Multiple Sclerosis Research Study Groups: Cohort 1 - non-pegylated interferon-β or no disease modifying therapy, Cohort 1 - Ozanimod, Cohort 2 - Ozanimod, Cohort 2 - non-pegylated interferon-β or no disease modifying therapy
Multiple Sclerosis Clinical Trial 2023: Seasonal influenza vaccine Highlights & Side Effects. Trial Name: NCT05028634 — Phase 3
Seasonal influenza vaccine 2023 Treatment Timeline for Medical Study. Trial Name: NCT05028634 — Phase 3
Multiple Sclerosis Patient Testimony for trial: Trial Name: NCT05028634 — Phase 3
~17 spots leftby Jul 2025
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