KYRIOS
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- Ofatumumab
B-lymphocyte antigen CD20 binding agent
- COVID-19 mRNA vaccine (nucleoside-modified)
- COVID-19 mRNA Vaccine (nucleoside modified)
Results by group
Percentage of Participants Having Established SARS-CoV-2-specific T Cells After Receiving a modRNA Vaccine
1 month after second dose of vaccine or booster vaccine
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Cohort 1a | 80.0 percentage of participants | 28.4–99.5 | 5 |
| Cohort 1b | 87.5 percentage of participants | 47.3–99.7 | 8 |
| Cohort 2a | 100.0 percentage of participants | 39.8–100 | 4 |
| Cohort 2b | 46.7 percentage of participants | 21.3–73.4 | 15 |
| Total | 68.8 percentage of participants | 50–83.9 | 32 |
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Cohort 1a | 6 | 0 (0.0%) | 0 |
| Cohort 1b | 8 | 0 (0.0%) | 0 |
| Cohort 2a | 5 | 1 (20.0%) | 0 |
| Cohort 2b | 15 | 1 (6.7%) | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Percentage of Participants Having Established SARS-CoV-2-specific T Cells After Receiving a modRNA Vaccine
1 month after second dose of vaccine or booster vaccine
Proportion of RMS patients having established SARS-CoV-2-specific T cells as defined by detection of SARS-CoV-2 reactive T-cells, measured by e.g. enzyme-linked immunosorbent spot (ELIspot) assay from T-cells that were stimulated with SARS-CoV-2 peptide mix, either one month after second dose of vaccine or one month after booster vaccine in participants who received the respective vaccine before o
Other measures (5)
Percentage of Participants Who Maintained T-cell Response After Receiving a modRNA Vaccine
At Week 1, Months 6, 12 and 18 after second dose of vaccine or 1 Month after 1st booster, 1 Month after 2nd booster
Increase in Specific T-cells After Receiving an modRNA Booster Vaccine
Last value before booster to 1 month after booster
Percentage of RMS Participants With Quantifiable Levels of SARS-CoV-2 Serum Functional Antibodies by Visits and Subcohorts (EAS)
Baseline, Week 1 after Vacc, Month 1, 6, 12 after Vacc, 1 month after 1st booster, 1 month after 2nd booster
Immune responseSARS-CoV-2 Specific CD4+ Effector Memory T-cells
Baseline, Months 1 ,6, 12 and 18 after vaccinationse of vaccine or 1,6 and 12 months after booster vaccine
Thinking and memoryImmune response• Proportion of RMS patients with detectable SARS-CoV-2 reactive T-cells one week, 6, 12 and 18 months after second dose of vaccine or 6 and 12 months after booster vaccine in participants who received the vaccine before or after starting ofatumumab treatment (yes/no)
Who could take part
Relapsing MS · 18 to 100
Inclusion Criteria: * Relapsing Multiple Sclerosis (RMS) diagnosis * eligible for ofatumumab treatment * willing and eligible to receive SARS-CoV-2 mRNA vaccine Exclusion Criteria: * known prior or current COVID-19 infection * previous treatment with BTK inhibitor or anti-CD20 therapy other than ofatumumab * no previous vaccination with a non-modRNA SARS-CoV-2 vaccine. Other protocol-defined inclusion/exclusion criteria may apply
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
This study aimed to understand whether patients with relapsing multiple sclerosis (RMS) can mount an immune response to SARS-CoV-2 mRNA vaccines (initial vaccinations or booster vaccines) when vaccinated either before initiation of ofatumumab treatment or at least 4 weeks after commencing ofatumumab treatment.
Papers
Loading reviews and guidelines…
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History
Started
May 2021
Main results due
May 2022
Finished
Jun 2023
Results posted
Dec 2024
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