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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
Study 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 weeks3 visits
Treatment ~ Varies
Follow Up ~ at day 28
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at day 28
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 • NCT0119986119%
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
636 Previous Clinical Trials
128,908 Total Patients Enrolled
9 Trials studying Multiple Sclerosis
6,900 Patients Enrolled for Multiple Sclerosis
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,506 Previous Clinical Trials
3,369,467 Total Patients Enrolled
10 Trials studying Multiple Sclerosis
17,675 Patients Enrolled for Multiple Sclerosis
James Sheffield, MDStudy DirectorCelgene
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of weak immune system.You have a serious heart or lung condition that could make a bad reaction to the vaccine risky for you.You got the flu shot for the 2021/2022 season before the study starts, or you got the flu shot for the 2020/2021 season within 6 months before the study starts.You have a history of any type of cancer except for certain types of skin and cervical cancers that have been removed and resolved.You have received strong immune-suppressing treatments that could interfere with the study's goals, but certain types of corticosteroids are allowed.You have been diagnosed with multiple sclerosis based on specific diagnostic criteria from 2017.You have a type of multiple sclerosis that is getting worse or showing recent activity on MRI scans or clinical exams.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1 - non-pegylated interferon-β or no disease modifying therapy
- Group 2: Cohort 1 - Ozanimod
- Group 3: Cohort 2 - Ozanimod
- Group 4: Cohort 2 - non-pegylated interferon-β or no disease modifying therapy
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Multiple Sclerosis Patient Testimony for trial: Trial Name: NCT05028634 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you please tell me the percentage of people who have had adverse reactions to the Seasonal influenza vaccine?
"There is some efficacy data and multiple rounds of safety data, so the team at Power gave it a score of 3."
Answered by AI
How many people can join this research project?
"Yes, as indicated by the clinicaltrials.gov listing, this study is still recruiting patients. This trial was first posted on October 27th, 2021 and was last updated on November 15th, 2022. Sixty participants are needed at 31 different sites."
Answered by AI
Does this research on the influenza vaccine build off of other similar investigations?
"Currently, there are 8 clinical trials underway for Seasonal influenza vaccine. One of these studies is in Phase 3. Halifax, Nova Scotia hosts many of the research centres conducting these studies; however, there are a total 75 locations running investigations into this treatment across North America."
Answered by AI
At how many facilities is this research project currently being conducted?
"The trial is being conducted out of University Of Kansas Medical Center, Thomas Jefferson University - Clinical Research Institute, and Jersey Shore MS Center as well as 31 other locations."
Answered by AI
Is this research only looking for test subjects that are over the age of seventy?
"The age bracket for individuals eligible to enroll in this clinical trial is between 18 and 55 years old."
Answered by AI
Is it possible to join this experiment currently?
"According to the listing on clinicaltrials.gov, this study is still looking for patients. The original posting date was October 27th, 2021 and the most recent update was November 15th, 2022."
Answered by AI
How can I get involved in this research?
"Eligible candidates for this study must be between 18-55 years old, have a diagnosis of multiple sclerosis, and be in an acute relapsing state. This trial has the capacity to enroll 60 individuals."
Answered by AI
Who else is applying?
What state do they live in?
Tennessee
What site did they apply to?
Asheville Neurology Specialists PA
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
Additional help with protection from flu or pneumonia type symptoms while taking immunosuppressant.
PatientReceived 1 prior treatment
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