A Open-label Study to Assess Response to COVID-19 Vaccine in Multiple Sclerosis Participants Treated With Ofatumumab
What it found
The trial was stopped early for safety reasons.
Reason given: Trial was terminated for business reasons. There has been no change in the benefit/risk profile of ofatumumab.
What was tested
Treatment tested
- Ofatumumab
B-lymphocyte antigen CD20 binding agent
- mRNA COVID-19 vaccine
- Interferon
Results by group
Percentage of Participants With Response by SARS-CoV-2 Qualitative IgG Antibody Assay at 14 Days Post-vaccination by Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set)
Cohorts 1 - 3: >=14 days after vaccination: Day 36 (Pfizer) or Day 43 (Moderna); Cohorts 4-6: Day 1
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| C1: VN - Plan to Start OMB157 | 100.0 Percentage of participants | 47.8–100 | 5 |
| C2: VN - on OMB157 >=4 WKs | 100.0 Percentage of participants | 15.8–100 | 2 |
| C4: FV - OMB157 >=4 WKs | 0.0 Percentage of participants | 0–97.5 | 1 |
| C5: FV - INFy or GA >=4 WKs | 100.0 Percentage of participants | 69.2–100 | 11 |
| C6: FV - on OMB157 >=4 WKs + Booster | 50.0 Percentage of participants | 6.8–93.2 | 5 |
| Overall | 86.4 Percentage of participants | 65.1–97.1 | 24 |
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 1 | 5 | 0 (0.0%) | 0 |
| Cohort 2 | 2 | 0 (0.0%) | 0 |
| Cohort 3 | 0 | 0 | 0 |
| Cohort 4 | 1 | 0 (0.0%) | 0 |
| Cohort 5 | 11 | 1 (9.1%) | 0 |
| Cohort 6 | 5 | 1 (20.0%) | 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 With Response by SARS-CoV-2 Qualitative IgG Antibody Assay at 14 Days Post-vaccination by Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set)
Cohorts 1 - 3: >=14 days after vaccination: Day 36 (Pfizer) or Day 43 (Moderna); Cohorts 4-6: Day 1
Immune responseSafety
Other measures (2)
Percentage of Patients With an Immune Response by SARS-CoV-2 Qualitative IgG Antibody Assay by Time Point, Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set)
Vaccination up to 70, 180, 270 and 360 days
Immune responseSafetyPercentage of Participants Achieving Immune Conversion by Individual Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set)
Cohorts 1 - 3: >=14 days after vaccination: Day 36 (Pfizer) or Day 43 (Moderna); Cohorts 4-5: Day 1
Immune responseSafety
Who could take part
Relapsing MS · 18 to 55
Inclusion Criteria: * Signed informed consent must be obtained prior to participation in the study * Diagnosis of relapsing MS by 2017 revised McDonald criteria * Were willing to comply with the study schedule * Cohort 1: Were receiving an mRNA COVID-19 vaccine (Pfizer or Moderna vaccine) at least two weeks prior to starting ofatumumab * Cohort 2: Were receiving an mRNA COVID-19 vaccine (Pfizer or Moderna vaccine) and on ofatumumab for at least 4 weeks * Cohort 3: Were receiving an mRNA COVID-19 vaccine (Pfizer or Moderna vaccine) and on interferon or glatiramer acetate for at least 4 weeks * Cohort 4: Fully vaccinated with a non-live COVID mRNA vaccine (Pfizer or Moderna vaccine) and on ofatumumab for at least 4 weeks * Cohort 5: Fully vaccinated with a non-live COVID mRNA vaccine (Pfizer or Moderna vaccine), with or without a booster, and on interferon or glatiramer acetate for at least 4 weeks * Cohort 6: Fully vaccinated with a non-live COVID mRNA vaccine, (Pfizer or Moderna vaccine), with a booster, and on ofatumumab for at least 4 weeks Exclusion Criteria: * Received the J\&J vaccine. * Had a contraindication to receiving an mRNA COVID-19 vaccine * Had an immediate allergic reaction to past vaccine or injection * Experienced a major episode of infection requiring hospitalization or treatment with intravenous antibiotics within 2 weeks prior to the screening visit
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
This study evaluated if relapsing multiple sclerosis (MS) participants treated with ofatumumab 20 mg subcutaneous (s.c.) administered once monthly could develop an adequate immune response to the COVID-19 mRNA vaccine compared to participants on an interferon or glatiramer acetate.
Papers
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History
Started
Jun 2021
Main results due
Apr 2023
Finished
Apr 2023
Results posted
Jun 2024
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