Trial Outcomes & Findings for 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 (NCT NCT05028634)
NCT ID: NCT05028634
Last Updated: 2025-02-11
Results Overview
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.
COMPLETED
PHASE3
63 participants
Day 28
2025-02-11
Participant Flow
As pre-specified per protocol, Cohort 1 and Cohort 2 are pooled per the following treatment groups. i. Ozanimod treatment group ii. Non-Ozanimod treatment group
Participant milestones
| Measure |
Ozanimod
Participants with relapsing forms of Multiple Sclerosis (MS) who received Oral Ozanimod were administered with regimen of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis, Adsorbed (Tdap) vaccine, Pneumococcal polysaccharide (PPSV23), and the seasonal inactivated influenza vaccine on Day 1.
|
Non-Ozanimod
Participants with relapsing forms of Multiple Sclerosis (MS) who have received either non-pegylated interferon-β (IFN-β) or no disease modifying therapy (DMT) and already received the seasonal inactivated influenza vaccine receive regimen of Tdap and PPSV23 vaccine only on Day 1.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
33
|
|
Overall Study
COMPLETED
|
30
|
32
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Ozanimod
Participants with relapsing forms of Multiple Sclerosis (MS) who received Oral Ozanimod were administered with regimen of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis, Adsorbed (Tdap) vaccine, Pneumococcal polysaccharide (PPSV23), and the seasonal inactivated influenza vaccine on Day 1.
|
Non-Ozanimod
Participants with relapsing forms of Multiple Sclerosis (MS) who have received either non-pegylated interferon-β (IFN-β) or no disease modifying therapy (DMT) and already received the seasonal inactivated influenza vaccine receive regimen of Tdap and PPSV23 vaccine only on Day 1.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
Ozanimod
n=30 Participants
Participants with relapsing forms of Multiple Sclerosis (MS) who received Oral Ozanimod were administered with regimen of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis, Adsorbed (Tdap) vaccine, Pneumococcal polysaccharide (PPSV23), and the seasonal inactivated influenza vaccine on Day 1.
|
Non-Ozanimod
n=33 Participants
Participants with relapsing forms of Multiple Sclerosis (MS) who have received either non-pegylated interferon-β (IFN-β) or no disease modifying therapy (DMT) and already received the seasonal inactivated influenza vaccine receive regimen of Tdap and PPSV23 vaccine only on Day 1.
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.1 years
STANDARD_DEVIATION 9.03 • n=5 Participants
|
46.8 years
STANDARD_DEVIATION 6.83 • n=7 Participants
|
45.0 years
STANDARD_DEVIATION 8.09 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 28Population: Modified Intent-to-Treat (mITT) Population consists of all participants who received at least one vaccination and summarized according to their initial treatment status (ozanimod vs. non-ozanimod) regardless of systemic use of corticosteroids. Participants with data available at the specified timepoint are included in the analysis.
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.
Outcome measures
| Measure |
Ozanimod
n=30 Participants
Participants with relapsing forms of Multiple Sclerosis (MS) who received Oral Ozanimod were administered with regimen of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis, Adsorbed (Tdap) vaccine, Pneumococcal polysaccharide (PPSV23), and the seasonal inactivated influenza vaccine on Day 1.
|
Non-Ozanimod
n=32 Participants
Participants with relapsing forms of Multiple Sclerosis (MS) who have received either non-pegylated interferon-β (IFN-β) or no disease modifying therapy (DMT) and already received the seasonal inactivated influenza vaccine receive regimen of Tdap and PPSV23 vaccine only on Day 1.
|
|---|---|---|
|
Percentage of Participants Meeting Immune Serological Response Criteria to Tetanus Toxoid Antigen
|
10 percentage of participants
|
53.1 percentage of participants
|
PRIMARY outcome
Timeframe: Day 28Population: Modified Intent-to-Treat (mITT) Population consists of all participants who received at least one vaccination and summarized according to their initial treatment status (ozanimod vs. non-ozanimod) regardless of systemic use of corticosteroids. Participants with data available at the specified timepoint are included in the analysis.
Participants with Serological protection to tetanus toxoid have anti-tetanus toxoid IgG concentration \>= 0.1 International Units per milliliter (IU/mL).
Outcome measures
| Measure |
Ozanimod
n=30 Participants
Participants with relapsing forms of Multiple Sclerosis (MS) who received Oral Ozanimod were administered with regimen of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis, Adsorbed (Tdap) vaccine, Pneumococcal polysaccharide (PPSV23), and the seasonal inactivated influenza vaccine on Day 1.
|
Non-Ozanimod
n=33 Participants
Participants with relapsing forms of Multiple Sclerosis (MS) who have received either non-pegylated interferon-β (IFN-β) or no disease modifying therapy (DMT) and already received the seasonal inactivated influenza vaccine receive regimen of Tdap and PPSV23 vaccine only on Day 1.
|
|---|---|---|
|
Percentage of Participants Meeting Immune Serological Protection Criteria to Tetanus Toxoid Antigen
|
100 percentage of participants
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: Day 28Population: Modified Intent-to-Treat (mITT) Population consists of all participants who received at least one vaccination and summarized according to their initial treatment status (ozanimod vs. non-ozanimod) regardless of systemic use of corticosteroids. Participants with data available at the specified timepoint are included in the analysis.
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
Outcome measures
| Measure |
Ozanimod
n=29 Participants
Participants with relapsing forms of Multiple Sclerosis (MS) who received Oral Ozanimod were administered with regimen of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis, Adsorbed (Tdap) vaccine, Pneumococcal polysaccharide (PPSV23), and the seasonal inactivated influenza vaccine on Day 1.
|
Non-Ozanimod
n=32 Participants
Participants with relapsing forms of Multiple Sclerosis (MS) who have received either non-pegylated interferon-β (IFN-β) or no disease modifying therapy (DMT) and already received the seasonal inactivated influenza vaccine receive regimen of Tdap and PPSV23 vaccine only on Day 1.
|
|---|---|---|
|
Percentage of Participants With Serologic Response to Pneumococcal Polysaccharide Vaccine (PPSV23)
|
69.0 percentage of participants
|
87.5 percentage of participants
|
SECONDARY outcome
Timeframe: Day 28Population: Modified Intent-to-Treat (mITT) Population consists of all participants who received at least one vaccination and summarized according to their initial treatment status (ozanimod vs. non-ozanimod) regardless of systemic use of corticosteroids. Participants with data available at the specified timepoint are included in the analysis.
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.
Outcome measures
| Measure |
Ozanimod
n=30 Participants
Participants with relapsing forms of Multiple Sclerosis (MS) who received Oral Ozanimod were administered with regimen of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis, Adsorbed (Tdap) vaccine, Pneumococcal polysaccharide (PPSV23), and the seasonal inactivated influenza vaccine on Day 1.
|
Non-Ozanimod
n=32 Participants
Participants with relapsing forms of Multiple Sclerosis (MS) who have received either non-pegylated interferon-β (IFN-β) or no disease modifying therapy (DMT) and already received the seasonal inactivated influenza vaccine receive regimen of Tdap and PPSV23 vaccine only on Day 1.
|
|---|---|---|
|
Percentage of Participants With Serologic Protection Against Pneumococcal Polysaccharide Vaccine (PPSV23)
|
66.7 percentage of participants
|
71.9 percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 28Population: Modified Intent-to-Treat (mITT) Population consists of all participants who received at least one vaccination and summarized according to their initial treatment status (ozanimod vs. non-ozanimod) regardless of systemic use of corticosteroids.
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.
Outcome measures
| Measure |
Ozanimod
n=30 Participants
Participants with relapsing forms of Multiple Sclerosis (MS) who received Oral Ozanimod were administered with regimen of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis, Adsorbed (Tdap) vaccine, Pneumococcal polysaccharide (PPSV23), and the seasonal inactivated influenza vaccine on Day 1.
|
Non-Ozanimod
n=33 Participants
Participants with relapsing forms of Multiple Sclerosis (MS) who have received either non-pegylated interferon-β (IFN-β) or no disease modifying therapy (DMT) and already received the seasonal inactivated influenza vaccine receive regimen of Tdap and PPSV23 vaccine only on Day 1.
|
|---|---|---|
|
Number of Participants With Adverse Events
AEs
|
11 Participants
|
11 Participants
|
|
Number of Participants With Adverse Events
SAEs
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
Moderate or Severe AEs
|
2 Participants
|
4 Participants
|
|
Number of Participants With Adverse Events
AEs leading to Death
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 28Population: Modified Intent-to-Treat (mITT) Population consists of all participants who received at least one vaccination and summarized according to their initial treatment status (ozanimod vs. non-ozanimod) regardless of systemic use of corticosteroids.
Blood samples were collected to assess laboratory parameters
Outcome measures
| Measure |
Ozanimod
n=30 Participants
Participants with relapsing forms of Multiple Sclerosis (MS) who received Oral Ozanimod were administered with regimen of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis, Adsorbed (Tdap) vaccine, Pneumococcal polysaccharide (PPSV23), and the seasonal inactivated influenza vaccine on Day 1.
|
Non-Ozanimod
n=33 Participants
Participants with relapsing forms of Multiple Sclerosis (MS) who have received either non-pegylated interferon-β (IFN-β) or no disease modifying therapy (DMT) and already received the seasonal inactivated influenza vaccine receive regimen of Tdap and PPSV23 vaccine only on Day 1.
|
|---|---|---|
|
Number of Participants With Abnormalities in Blood Chemistry Parameters
Alanine Transaminase (ALT) OR Aspartate aminotransferase (AST) > 1X Upper Limit of Normal (ULN)
|
6 Participants
|
7 Participants
|
|
Number of Participants With Abnormalities in Blood Chemistry Parameters
ALT or AST > 2XULN
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormalities in Blood Chemistry Parameters
ALT OR AST > 3XULN
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Blood Chemistry Parameters
ALT OR AST > 5XULN
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Blood Chemistry Parameters
ALT OR AST > 10XULN
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Blood Chemistry Parameters
Gamma-glutamyl transferase (GGT) OR Alkaline Phosphatase (ALP) > 1XULN
|
7 Participants
|
4 Participants
|
|
Number of Participants With Abnormalities in Blood Chemistry Parameters
GGT OR ALP > 2.5XULN
|
2 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Blood Chemistry Parameters
GGT OR ALP > 5XULN
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Blood Chemistry Parameters
GGT OR ALP > 20XULN
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Blood Chemistry Parameters
TOTAL BILIRUBIN > 1XULN
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormalities in Blood Chemistry Parameters
TOTAL BILIRUBIN > 1.5XULN
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormalities in Blood Chemistry Parameters
TOTAL BILIRUBIN > 2XULN
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Blood Chemistry Parameters
TOTAL BILIRUBIN > 3XULN
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Blood Chemistry Parameters
TOTAL BILIRUBIN > 10XULN
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 28Population: Modified Intent-to-Treat (mITT) Population consists of all participants who received at least one vaccination and summarized according to their initial treatment status (ozanimod vs. non-ozanimod) regardless of systemic use of corticosteroids. Participants with data available at the specified timepoint are included in the analysis.
Blood samples were collected to assess laboratory parameters
Outcome measures
| Measure |
Ozanimod
n=29 Participants
Participants with relapsing forms of Multiple Sclerosis (MS) who received Oral Ozanimod were administered with regimen of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis, Adsorbed (Tdap) vaccine, Pneumococcal polysaccharide (PPSV23), and the seasonal inactivated influenza vaccine on Day 1.
|
Non-Ozanimod
n=33 Participants
Participants with relapsing forms of Multiple Sclerosis (MS) who have received either non-pegylated interferon-β (IFN-β) or no disease modifying therapy (DMT) and already received the seasonal inactivated influenza vaccine receive regimen of Tdap and PPSV23 vaccine only on Day 1.
|
|---|---|---|
|
Number of Participants With Abnormalities in Blood Hematology Parameters
ABSOLUTE LYMPHOCYTE COUNT (ALC) < 0.2 (x10E9/L)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Blood Hematology Parameters
ABSOLUTE NEUTROPHIL COUNT (ANC) < 0.5 (x10E9/L)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Blood Hematology Parameters
ABSOLUTE NEUTROPHIL COUNT (ANC) < 1 (x10E9/L)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Blood Hematology Parameters
TOTAL WBC > 20 (x10E9/L)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and End of Study (Day 28)Population: Modified Intent-to-Treat (mITT) Population consists of all participants who received at least one vaccination and summarized according to their initial treatment status (ozanimod vs. non-ozanimod) regardless of systemic use of corticosteroids. Participants with data available at the specified timepoint are included in the analysis.
Blood samples were collected to assess laboratory parameters.
Outcome measures
| Measure |
Ozanimod
n=30 Participants
Participants with relapsing forms of Multiple Sclerosis (MS) who received Oral Ozanimod were administered with regimen of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis, Adsorbed (Tdap) vaccine, Pneumococcal polysaccharide (PPSV23), and the seasonal inactivated influenza vaccine on Day 1.
|
Non-Ozanimod
n=31 Participants
Participants with relapsing forms of Multiple Sclerosis (MS) who have received either non-pegylated interferon-β (IFN-β) or no disease modifying therapy (DMT) and already received the seasonal inactivated influenza vaccine receive regimen of Tdap and PPSV23 vaccine only on Day 1.
|
|---|---|---|
|
Change From Baseline in Blood Chemistry Parameters - Sodium; Potassium; Chloride; Calcium; Magnesium; Phosphate; Blood Urea Nitrogen; Glucose
Sodium
|
-0.7 mmol/L
Standard Deviation 1.90
|
-0.3 mmol/L
Standard Deviation 2.56
|
|
Change From Baseline in Blood Chemistry Parameters - Sodium; Potassium; Chloride; Calcium; Magnesium; Phosphate; Blood Urea Nitrogen; Glucose
Potassium
|
-0.14 mmol/L
Standard Deviation 0.637
|
-0.08 mmol/L
Standard Deviation 0.315
|
|
Change From Baseline in Blood Chemistry Parameters - Sodium; Potassium; Chloride; Calcium; Magnesium; Phosphate; Blood Urea Nitrogen; Glucose
Chloride
|
-0.9 mmol/L
Standard Deviation 5.19
|
0.2 mmol/L
Standard Deviation 2.63
|
|
Change From Baseline in Blood Chemistry Parameters - Sodium; Potassium; Chloride; Calcium; Magnesium; Phosphate; Blood Urea Nitrogen; Glucose
Calcium
|
-0.044 mmol/L
Standard Deviation 0.0881
|
-0.015 mmol/L
Standard Deviation 0.0888
|
|
Change From Baseline in Blood Chemistry Parameters - Sodium; Potassium; Chloride; Calcium; Magnesium; Phosphate; Blood Urea Nitrogen; Glucose
Magnesium
|
-0.003 mmol/L
Standard Deviation 0.0572
|
-0.001 mmol/L
Standard Deviation 0.0549
|
|
Change From Baseline in Blood Chemistry Parameters - Sodium; Potassium; Chloride; Calcium; Magnesium; Phosphate; Blood Urea Nitrogen; Glucose
Phosphate
|
-0.011 mmol/L
Standard Deviation 0.2197
|
-0.041 mmol/L
Standard Deviation 0.1640
|
|
Change From Baseline in Blood Chemistry Parameters - Sodium; Potassium; Chloride; Calcium; Magnesium; Phosphate; Blood Urea Nitrogen; Glucose
Blood Urea Nitrogen
|
0.044 mmol/L
Standard Deviation 1.1424
|
0.165 mmol/L
Standard Deviation 1.1542
|
|
Change From Baseline in Blood Chemistry Parameters - Sodium; Potassium; Chloride; Calcium; Magnesium; Phosphate; Blood Urea Nitrogen; Glucose
Glucose
|
0.28 mmol/L
Standard Deviation 0.845
|
0.08 mmol/L
Standard Deviation 0.946
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and End of Study (Day 28)Population: Modified Intent-to-Treat (mITT) Population consists of all participants who received at least one vaccination and summarized according to their initial treatment status (ozanimod vs. non-ozanimod) regardless of systemic use of corticosteroids. Participants with data available at the specified timepoint are included in the analysis.
Blood samples were collected to assess laboratory parameters.
Outcome measures
| Measure |
Ozanimod
n=30 Participants
Participants with relapsing forms of Multiple Sclerosis (MS) who received Oral Ozanimod were administered with regimen of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis, Adsorbed (Tdap) vaccine, Pneumococcal polysaccharide (PPSV23), and the seasonal inactivated influenza vaccine on Day 1.
|
Non-Ozanimod
n=31 Participants
Participants with relapsing forms of Multiple Sclerosis (MS) who have received either non-pegylated interferon-β (IFN-β) or no disease modifying therapy (DMT) and already received the seasonal inactivated influenza vaccine receive regimen of Tdap and PPSV23 vaccine only on Day 1.
|
|---|---|---|
|
Change From Baseline in Blood Chemistry Parameters - Creatinine; Bilirubin; Direct Bilirubin
Creatinine
|
-1.1 umol/L
Standard Deviation 9.64
|
-0.6 umol/L
Standard Deviation 9.77
|
|
Change From Baseline in Blood Chemistry Parameters - Creatinine; Bilirubin; Direct Bilirubin
Bilirubin
|
0.4 umol/L
Standard Deviation 2.81
|
0.1 umol/L
Standard Deviation 3.09
|
|
Change From Baseline in Blood Chemistry Parameters - Creatinine; Bilirubin; Direct Bilirubin
Direct Bilirubin
|
0.0 umol/L
Standard Deviation 0.20
|
0.0 umol/L
Standard Deviation 0.18
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and End of Study (Day 28)Population: Modified Intent-to-Treat (mITT) Population consists of all participants who received at least one vaccination and summarized according to their initial treatment status (ozanimod vs. non-ozanimod) regardless of systemic use of corticosteroids. Participants with data available at the specified timepoint are included in the analysis.
Blood samples were collected to assess laboratory parameters.
Outcome measures
| Measure |
Ozanimod
n=30 Participants
Participants with relapsing forms of Multiple Sclerosis (MS) who received Oral Ozanimod were administered with regimen of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis, Adsorbed (Tdap) vaccine, Pneumococcal polysaccharide (PPSV23), and the seasonal inactivated influenza vaccine on Day 1.
|
Non-Ozanimod
n=31 Participants
Participants with relapsing forms of Multiple Sclerosis (MS) who have received either non-pegylated interferon-β (IFN-β) or no disease modifying therapy (DMT) and already received the seasonal inactivated influenza vaccine receive regimen of Tdap and PPSV23 vaccine only on Day 1.
|
|---|---|---|
|
Change From Baseline in Blood Chemistry Parameters - Albumin
|
-0.2 g/L
Standard Deviation 2.67
|
-0.8 g/L
Standard Deviation 2.91
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and End of Study (Day 28)Population: Modified Intent-to-Treat (mITT) Population consists of all participants who received at least one vaccination and summarized according to their initial treatment status (ozanimod vs. non-ozanimod) regardless of systemic use of corticosteroids. Participants with data available at the specified timepoint are included in the analysis.
Blood samples were collected to assess laboratory parameters.
Outcome measures
| Measure |
Ozanimod
n=28 Participants
Participants with relapsing forms of Multiple Sclerosis (MS) who received Oral Ozanimod were administered with regimen of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis, Adsorbed (Tdap) vaccine, Pneumococcal polysaccharide (PPSV23), and the seasonal inactivated influenza vaccine on Day 1.
|
Non-Ozanimod
n=31 Participants
Participants with relapsing forms of Multiple Sclerosis (MS) who have received either non-pegylated interferon-β (IFN-β) or no disease modifying therapy (DMT) and already received the seasonal inactivated influenza vaccine receive regimen of Tdap and PPSV23 vaccine only on Day 1.
|
|---|---|---|
|
Change From Baseline in Blood Chemistry Parameters - Alkaline Phosphatase
|
2.9 IU/L
Standard Deviation 14.48
|
-1.1 IU/L
Standard Deviation 8.73
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and End of Study (Day 28)Population: Modified Intent-to-Treat (mITT) Population consists of all participants who received at least one vaccination and summarized according to their initial treatment status (ozanimod vs. non-ozanimod) regardless of systemic use of corticosteroids. Participants with data available at the specified timepoint are included in the analysis.
Blood samples were collected to assess laboratory parameters.
Outcome measures
| Measure |
Ozanimod
n=28 Participants
Participants with relapsing forms of Multiple Sclerosis (MS) who received Oral Ozanimod were administered with regimen of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis, Adsorbed (Tdap) vaccine, Pneumococcal polysaccharide (PPSV23), and the seasonal inactivated influenza vaccine on Day 1.
|
Non-Ozanimod
n=33 Participants
Participants with relapsing forms of Multiple Sclerosis (MS) who have received either non-pegylated interferon-β (IFN-β) or no disease modifying therapy (DMT) and already received the seasonal inactivated influenza vaccine receive regimen of Tdap and PPSV23 vaccine only on Day 1.
|
|---|---|---|
|
Change From Baseline in Blood Chemistry Parameters - Alanine Aminotransferase; Aspartate Aminotransferase; Gamma Glutamyl Transferase
Alanine Aminotransferase
|
3.5 U/L
Standard Deviation 8.88
|
1.4 U/L
Standard Deviation 5.08
|
|
Change From Baseline in Blood Chemistry Parameters - Alanine Aminotransferase; Aspartate Aminotransferase; Gamma Glutamyl Transferase
Aspartate Aminotransferase
|
2.1 U/L
Standard Deviation 3.77
|
0.9 U/L
Standard Deviation 5.64
|
|
Change From Baseline in Blood Chemistry Parameters - Alanine Aminotransferase; Aspartate Aminotransferase; Gamma Glutamyl Transferase
Gamma Glutamyl Transferase
|
3.2 U/L
Standard Deviation 23.09
|
0.6 U/L
Standard Deviation 8.39
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and End of Study (Day 28)Population: Modified Intent-to-Treat (mITT) Population consists of all participants who received at least one vaccination and summarized according to their initial treatment status (ozanimod vs. non-ozanimod) regardless of systemic use of corticosteroids. Participants with data available at the specified timepoint are included in the analysis.
Blood samples were collected to assess laboratory parameters.
Outcome measures
| Measure |
Ozanimod
n=24 Participants
Participants with relapsing forms of Multiple Sclerosis (MS) who received Oral Ozanimod were administered with regimen of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis, Adsorbed (Tdap) vaccine, Pneumococcal polysaccharide (PPSV23), and the seasonal inactivated influenza vaccine on Day 1.
|
Non-Ozanimod
n=31 Participants
Participants with relapsing forms of Multiple Sclerosis (MS) who have received either non-pegylated interferon-β (IFN-β) or no disease modifying therapy (DMT) and already received the seasonal inactivated influenza vaccine receive regimen of Tdap and PPSV23 vaccine only on Day 1.
|
|---|---|---|
|
Change From Baseline in Blood Hematology Parameters - Erythrocytes
|
-0.06 10^12 cells per liter
Standard Deviation 0.191
|
-0.07 10^12 cells per liter
Standard Deviation 0.265
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and End of Study (Day 28)Population: Modified Intent-to-Treat (mITT) Population consists of all participants who received at least one vaccination and summarized according to their initial treatment status (ozanimod vs. non-ozanimod) regardless of systemic use of corticosteroids. Participants with data available at the specified timepoint are included in the analysis.
Blood samples were collected to assess laboratory parameters.
Outcome measures
| Measure |
Ozanimod
n=24 Participants
Participants with relapsing forms of Multiple Sclerosis (MS) who received Oral Ozanimod were administered with regimen of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis, Adsorbed (Tdap) vaccine, Pneumococcal polysaccharide (PPSV23), and the seasonal inactivated influenza vaccine on Day 1.
|
Non-Ozanimod
n=31 Participants
Participants with relapsing forms of Multiple Sclerosis (MS) who have received either non-pegylated interferon-β (IFN-β) or no disease modifying therapy (DMT) and already received the seasonal inactivated influenza vaccine receive regimen of Tdap and PPSV23 vaccine only on Day 1.
|
|---|---|---|
|
Change From Baseline in Blood Hematology Parameters - Leukocytes; Basophils; Eosinophils; Lymphocytes; Monocytes; Neutrophils; Platelets
Lymphocytes
|
0.046 10^9 cells per liter
Standard Deviation 0.1806
|
0.021 10^9 cells per liter
Standard Deviation 0.3580
|
|
Change From Baseline in Blood Hematology Parameters - Leukocytes; Basophils; Eosinophils; Lymphocytes; Monocytes; Neutrophils; Platelets
Leukocytes
|
0.58 10^9 cells per liter
Standard Deviation 1.271
|
0.33 10^9 cells per liter
Standard Deviation 1.298
|
|
Change From Baseline in Blood Hematology Parameters - Leukocytes; Basophils; Eosinophils; Lymphocytes; Monocytes; Neutrophils; Platelets
Basophils
|
-0.013 10^9 cells per liter
Standard Deviation 0.0320
|
-0.007 10^9 cells per liter
Standard Deviation 0.0253
|
|
Change From Baseline in Blood Hematology Parameters - Leukocytes; Basophils; Eosinophils; Lymphocytes; Monocytes; Neutrophils; Platelets
Eosinophils
|
0.038 10^9 cells per liter
Standard Deviation 0.2872
|
0.013 10^9 cells per liter
Standard Deviation 0.1531
|
|
Change From Baseline in Blood Hematology Parameters - Leukocytes; Basophils; Eosinophils; Lymphocytes; Monocytes; Neutrophils; Platelets
Monocytes
|
-0.021 10^9 cells per liter
Standard Deviation 0.1734
|
0.025 10^9 cells per liter
Standard Deviation 0.1506
|
|
Change From Baseline in Blood Hematology Parameters - Leukocytes; Basophils; Eosinophils; Lymphocytes; Monocytes; Neutrophils; Platelets
Neutrophils
|
0.480 10^9 cells per liter
Standard Deviation 1.1208
|
0.218 10^9 cells per liter
Standard Deviation 1.2622
|
|
Change From Baseline in Blood Hematology Parameters - Leukocytes; Basophils; Eosinophils; Lymphocytes; Monocytes; Neutrophils; Platelets
Platelets
|
-5.3 10^9 cells per liter
Standard Deviation 37.08
|
1.4 10^9 cells per liter
Standard Deviation 36.33
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and End of Study (Day 28)Population: Modified Intent-to-Treat (mITT) Population consists of all participants who received at least one vaccination and summarized according to their initial treatment status (ozanimod vs. non-ozanimod) regardless of systemic use of corticosteroids. Participants with data available at the specified timepoint are included in the analysis.
Blood samples were collected to assess laboratory parameters.
Outcome measures
| Measure |
Ozanimod
n=21 Participants
Participants with relapsing forms of Multiple Sclerosis (MS) who received Oral Ozanimod were administered with regimen of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis, Adsorbed (Tdap) vaccine, Pneumococcal polysaccharide (PPSV23), and the seasonal inactivated influenza vaccine on Day 1.
|
Non-Ozanimod
n=31 Participants
Participants with relapsing forms of Multiple Sclerosis (MS) who have received either non-pegylated interferon-β (IFN-β) or no disease modifying therapy (DMT) and already received the seasonal inactivated influenza vaccine receive regimen of Tdap and PPSV23 vaccine only on Day 1.
|
|---|---|---|
|
Change From Baseline in Blood Hematology Parameters - Basophils/Leukocytes; Eosinophils/Leukocytes; Lymphocytes/Leukocytes; Monocytes/Leukocytes; Neutrophils/Leukocytes
Basophils/Leukocytes
|
-0.34 percentage
Standard Deviation 0.528
|
-0.14 percentage
Standard Deviation 0.442
|
|
Change From Baseline in Blood Hematology Parameters - Basophils/Leukocytes; Eosinophils/Leukocytes; Lymphocytes/Leukocytes; Monocytes/Leukocytes; Neutrophils/Leukocytes
Eosinophils/Leukocytes
|
0.05 percentage
Standard Deviation 3.919
|
0.05 percentage
Standard Deviation 1.950
|
|
Change From Baseline in Blood Hematology Parameters - Basophils/Leukocytes; Eosinophils/Leukocytes; Lymphocytes/Leukocytes; Monocytes/Leukocytes; Neutrophils/Leukocytes
Lymphocytes/Leukocytes
|
0.17 percentage
Standard Deviation 3.675
|
-1.35 percentage
Standard Deviation 6.883
|
|
Change From Baseline in Blood Hematology Parameters - Basophils/Leukocytes; Eosinophils/Leukocytes; Lymphocytes/Leukocytes; Monocytes/Leukocytes; Neutrophils/Leukocytes
Monocytes/Leukocytes
|
-0.97 percentage
Standard Deviation 3.135
|
0.03 percentage
Standard Deviation 2.192
|
|
Change From Baseline in Blood Hematology Parameters - Basophils/Leukocytes; Eosinophils/Leukocytes; Lymphocytes/Leukocytes; Monocytes/Leukocytes; Neutrophils/Leukocytes
Neutrophils/Leukocytes
|
1.09 percentage
Standard Deviation 6.750
|
1.40 percentage
Standard Deviation 7.177
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and End of Study (Day 28)Population: Modified Intent-to-Treat (mITT) Population consists of all participants who received at least one vaccination and summarized according to their initial treatment status (ozanimod vs. non-ozanimod) regardless of systemic use of corticosteroids. Participants with data available at the specified timepoint are included in the analysis.
Blood samples were collected to assess laboratory parameters.
Outcome measures
| Measure |
Ozanimod
n=24 Participants
Participants with relapsing forms of Multiple Sclerosis (MS) who received Oral Ozanimod were administered with regimen of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis, Adsorbed (Tdap) vaccine, Pneumococcal polysaccharide (PPSV23), and the seasonal inactivated influenza vaccine on Day 1.
|
Non-Ozanimod
n=31 Participants
Participants with relapsing forms of Multiple Sclerosis (MS) who have received either non-pegylated interferon-β (IFN-β) or no disease modifying therapy (DMT) and already received the seasonal inactivated influenza vaccine receive regimen of Tdap and PPSV23 vaccine only on Day 1.
|
|---|---|---|
|
Change From Baseline in Blood Hematology Parameters - Hemoglobin; Erythrocytes Mean Corpuscular HGB Concentration
Hemoglobin
|
-1.9 g/L
Standard Deviation 5.67
|
-2.9 g/L
Standard Deviation 7.14
|
|
Change From Baseline in Blood Hematology Parameters - Hemoglobin; Erythrocytes Mean Corpuscular HGB Concentration
Erythrocytes Mean Corpuscular HGB Concentration
|
1.2 g/L
Standard Deviation 9.81
|
0.2 g/L
Standard Deviation 9.16
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and End of Study (Day 28)Population: Modified Intent-to-Treat (mITT) Population consists of all participants who received at least one vaccination and summarized according to their initial treatment status (ozanimod vs. non-ozanimod) regardless of systemic use of corticosteroids. Participants with data available at the specified timepoint are included in the analysis.
Blood samples were collected to assess laboratory parameters.
Outcome measures
| Measure |
Ozanimod
n=23 Participants
Participants with relapsing forms of Multiple Sclerosis (MS) who received Oral Ozanimod were administered with regimen of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis, Adsorbed (Tdap) vaccine, Pneumococcal polysaccharide (PPSV23), and the seasonal inactivated influenza vaccine on Day 1.
|
Non-Ozanimod
n=31 Participants
Participants with relapsing forms of Multiple Sclerosis (MS) who have received either non-pegylated interferon-β (IFN-β) or no disease modifying therapy (DMT) and already received the seasonal inactivated influenza vaccine receive regimen of Tdap and PPSV23 vaccine only on Day 1.
|
|---|---|---|
|
Change From Baseline in Blood Hematology Parameters - Erythrocytes Mean Corpuscular Volume
|
-0.3 fL
Standard Deviation 2.25
|
-0.5 fL
Standard Deviation 1.95
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and End of Study (Day 28)Population: Modified Intent-to-Treat (mITT) Population consists of all participants who received at least one vaccination and summarized according to their initial treatment status (ozanimod vs. non-ozanimod) regardless of systemic use of corticosteroids. Participants with data available at the specified timepoint are included in the analysis.
Blood samples were collected to assess laboratory parameters.
Outcome measures
| Measure |
Ozanimod
n=24 Participants
Participants with relapsing forms of Multiple Sclerosis (MS) who received Oral Ozanimod were administered with regimen of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis, Adsorbed (Tdap) vaccine, Pneumococcal polysaccharide (PPSV23), and the seasonal inactivated influenza vaccine on Day 1.
|
Non-Ozanimod
n=31 Participants
Participants with relapsing forms of Multiple Sclerosis (MS) who have received either non-pegylated interferon-β (IFN-β) or no disease modifying therapy (DMT) and already received the seasonal inactivated influenza vaccine receive regimen of Tdap and PPSV23 vaccine only on Day 1.
|
|---|---|---|
|
Change From Baseline in Blood Hematology Parameters - Erythrocytes Mean Corpuscular Hemoglobin
|
-0.1 pg/cell
Standard Deviation 0.65
|
-0.1 pg/cell
Standard Deviation 0.72
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and End of Study (Day 28)Population: Modified Intent-to-Treat (mITT) Population consists of all participants who received at least one vaccination and summarized according to their initial treatment status (ozanimod vs. non-ozanimod) regardless of systemic use of corticosteroids.
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.
Outcome measures
| Measure |
Ozanimod
n=23 Participants
Participants with relapsing forms of Multiple Sclerosis (MS) who received Oral Ozanimod were administered with regimen of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis, Adsorbed (Tdap) vaccine, Pneumococcal polysaccharide (PPSV23), and the seasonal inactivated influenza vaccine on Day 1.
|
Non-Ozanimod
n=31 Participants
Participants with relapsing forms of Multiple Sclerosis (MS) who have received either non-pegylated interferon-β (IFN-β) or no disease modifying therapy (DMT) and already received the seasonal inactivated influenza vaccine receive regimen of Tdap and PPSV23 vaccine only on Day 1.
|
|---|---|---|
|
Change From Baseline in Blood Hematology Parameters - Hematocrit
|
-0.007 Proportion of red blood cells in blood
Standard Deviation 0.0226
|
-0.010 Proportion of red blood cells in blood
Standard Deviation 0.0270
|
Adverse Events
Ozanimod
Non-Ozanimod
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ozanimod
n=30 participants at risk
Participants with relapsing forms of Multiple Sclerosis (MS) who received Oral Ozanimod were administered with regimen of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis, Adsorbed (Tdap) vaccine, Pneumococcal polysaccharide (PPSV23), and the seasonal inactivated influenza vaccine on Day 1.
|
Non-Ozanimod
n=33 participants at risk
Participants with relapsing forms of Multiple Sclerosis (MS) who have received either non-pegylated interferon-β (IFN-β) or no disease modifying therapy (DMT) and already received the seasonal inactivated influenza vaccine receive regimen of Tdap and PPSV23 vaccine only on Day 1.
|
|---|---|---|
|
General disorders
Fatigue
|
6.7%
2/30 • All cause mortality and Non Serious and Serious adverse events were collected from first dose (Day 1) until end of study visit (Day 28).
As pre-specified per protocol, Cohort 1 and Cohort 2 are pooled per the following treatment groups. i. Ozanimod treatment group ii. Non-Ozanimod treatment group Modified Intent-to-Treat (mITT) Population consists of all participants who received at least one vaccination and summarized according to their initial treatment status (ozanimod vs. non-ozanimod) regardless of systemic use of corticosteroids.
|
3.0%
1/33 • All cause mortality and Non Serious and Serious adverse events were collected from first dose (Day 1) until end of study visit (Day 28).
As pre-specified per protocol, Cohort 1 and Cohort 2 are pooled per the following treatment groups. i. Ozanimod treatment group ii. Non-Ozanimod treatment group Modified Intent-to-Treat (mITT) Population consists of all participants who received at least one vaccination and summarized according to their initial treatment status (ozanimod vs. non-ozanimod) regardless of systemic use of corticosteroids.
|
|
General disorders
Injection site pain
|
3.3%
1/30 • All cause mortality and Non Serious and Serious adverse events were collected from first dose (Day 1) until end of study visit (Day 28).
As pre-specified per protocol, Cohort 1 and Cohort 2 are pooled per the following treatment groups. i. Ozanimod treatment group ii. Non-Ozanimod treatment group Modified Intent-to-Treat (mITT) Population consists of all participants who received at least one vaccination and summarized according to their initial treatment status (ozanimod vs. non-ozanimod) regardless of systemic use of corticosteroids.
|
12.1%
4/33 • All cause mortality and Non Serious and Serious adverse events were collected from first dose (Day 1) until end of study visit (Day 28).
As pre-specified per protocol, Cohort 1 and Cohort 2 are pooled per the following treatment groups. i. Ozanimod treatment group ii. Non-Ozanimod treatment group Modified Intent-to-Treat (mITT) Population consists of all participants who received at least one vaccination and summarized according to their initial treatment status (ozanimod vs. non-ozanimod) regardless of systemic use of corticosteroids.
|
|
Infections and infestations
COVID-19
|
0.00%
0/30 • All cause mortality and Non Serious and Serious adverse events were collected from first dose (Day 1) until end of study visit (Day 28).
As pre-specified per protocol, Cohort 1 and Cohort 2 are pooled per the following treatment groups. i. Ozanimod treatment group ii. Non-Ozanimod treatment group Modified Intent-to-Treat (mITT) Population consists of all participants who received at least one vaccination and summarized according to their initial treatment status (ozanimod vs. non-ozanimod) regardless of systemic use of corticosteroids.
|
6.1%
2/33 • All cause mortality and Non Serious and Serious adverse events were collected from first dose (Day 1) until end of study visit (Day 28).
As pre-specified per protocol, Cohort 1 and Cohort 2 are pooled per the following treatment groups. i. Ozanimod treatment group ii. Non-Ozanimod treatment group Modified Intent-to-Treat (mITT) Population consists of all participants who received at least one vaccination and summarized according to their initial treatment status (ozanimod vs. non-ozanimod) regardless of systemic use of corticosteroids.
|
|
Infections and infestations
Urinary tract infection
|
6.7%
2/30 • All cause mortality and Non Serious and Serious adverse events were collected from first dose (Day 1) until end of study visit (Day 28).
As pre-specified per protocol, Cohort 1 and Cohort 2 are pooled per the following treatment groups. i. Ozanimod treatment group ii. Non-Ozanimod treatment group Modified Intent-to-Treat (mITT) Population consists of all participants who received at least one vaccination and summarized according to their initial treatment status (ozanimod vs. non-ozanimod) regardless of systemic use of corticosteroids.
|
0.00%
0/33 • All cause mortality and Non Serious and Serious adverse events were collected from first dose (Day 1) until end of study visit (Day 28).
As pre-specified per protocol, Cohort 1 and Cohort 2 are pooled per the following treatment groups. i. Ozanimod treatment group ii. Non-Ozanimod treatment group Modified Intent-to-Treat (mITT) Population consists of all participants who received at least one vaccination and summarized according to their initial treatment status (ozanimod vs. non-ozanimod) regardless of systemic use of corticosteroids.
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER