A Open-label Study to Assess Response to COVID-19 Vaccine in Multiple Sclerosis Participants Treated With Ofatumumab

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-10

Study Completion Date

2023-04-14

Brief Summary

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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.

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Detailed Description

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This was a six-cohort, multicenter, prospective study planned for up to 88 relapsing multiple sclerosis (MS) participants. The study was intended to address two questions: 1) Can participants treated with ofatumumab develop an immune response if receiving a COVID-19 mRNA vaccine two weeks prior to ofatumumab start? 2) If receiving COVID-19 mRNA vaccine after introduction of ofatumumab treatment, can participants develop an immune response? Cohort 1: participants received an mRNA COVID-19 vaccine at least two weeks prior to ofatumumab start. Cohort 2: participants received an mRNA COVID-19 vaccine at least four weeks after beginning ofatumumab. Cohort 3: participants on an interferon or glatiramer acetate who received COVID-19 mRNA vaccine. Cohort 4: participants fully vaccinated with an RNA COVID-19 vaccine at least four weeks after ofatumumab start. Cohort 5: participants vaccinated with an RNA COVID-19 vaccine, with or without a booster dose, and on interferon or glatiramer acetate. Cohort 6: participants fully vaccinated with an RNA COVID-19 vaccine who received a booster dose at least four weeks after ofatumumab start. Participants obtained the COVID-19 mRNA vaccine from their HCP (private insurance) or appropriate federal, state or local program.

Participants in Cohort 1 received loading doses of ofatumumab and subsequent dosing was 20 mg s.c. administered monthly. All other cohorts continued current dosing schedule of either ofatumumab, glatiramer acetate or interferon. Participation in trial was maximum of 421 days which was dependent on the Cohort.

Conditions

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Relapsing Multiple Sclerosis (RMS)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort 1 - 2 WKs vaccine prior to OMB157

Participants received non-live COVID-19 mRNA vaccine at least two weeks prior to start of ofatumumab (OMB157) (20 mg subcutaneous).

Group Type EXPERIMENTAL

Ofatumumab

Intervention Type DRUG

3 loading doses followed by monthly administrations

mRNA COVID-19 vaccine

Intervention Type BIOLOGICAL

Pfizer or Moderna mRNA Vaccine

Cohort 2 - vaccine 4 WKs after OMB157

Participants received non-live COVID-19 mRNA vaccine at least four weeks after start of ofatumumab (OMB157) (20 mg subcutaneous).

Group Type EXPERIMENTAL

Ofatumumab

Intervention Type DRUG

3 loading doses followed by monthly administrations

mRNA COVID-19 vaccine

Intervention Type BIOLOGICAL

Pfizer or Moderna mRNA Vaccine

Cohort 3 - Interferon or glatiramer acetate - vaccine 4 WKs after

Participants will receive non-live COVID-19 mRNA vaccine at least 4 weeks after start of prescribed interferon or glatiramer acetate

Group Type ACTIVE_COMPARATOR

mRNA COVID-19 vaccine

Intervention Type BIOLOGICAL

Pfizer or Moderna mRNA Vaccine

interferon or glatiramer acetate

Intervention Type DRUG

iDMT

Cohort 4 - Fully vaccinated and on OMB457 ≥ 4 WKs

Participants fully vaccinated with a non-live COVID mRNA vaccine and on ofatumumab for at least 4 weeks (20 mg subcutaneous)

Group Type EXPERIMENTAL

Ofatumumab

Intervention Type DRUG

3 loading doses followed by monthly administrations

mRNA COVID-19 vaccine

Intervention Type BIOLOGICAL

Pfizer or Moderna mRNA Vaccine

Cohort 5 -Fully vaccinated, on interferon or glatiramer acetate for ≥ 4 WKs ± booster

Participants fully vaccinated with a non-live COVID mRNA vaccine, without or without a booster, and on interferon or glatiramer acetate for at least 4 weeks.

Group Type EXPERIMENTAL

mRNA COVID-19 vaccine

Intervention Type BIOLOGICAL

Pfizer or Moderna mRNA Vaccine

interferon or glatiramer acetate

Intervention Type DRUG

iDMT

Cohort 6 - Fully vaccinated, currently on OMB457 for ≥ 4 WKs, + booster

Participants fully vaccinated with a non-live COVID mRNA vaccine with a booster and on ofatumumab for at least 4 weeks (20 mg subcutaneous)

Group Type EXPERIMENTAL

Ofatumumab

Intervention Type DRUG

3 loading doses followed by monthly administrations

mRNA COVID-19 vaccine

Intervention Type BIOLOGICAL

Pfizer or Moderna mRNA Vaccine

Interventions

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Ofatumumab

3 loading doses followed by monthly administrations

Intervention Type DRUG

mRNA COVID-19 vaccine

Pfizer or Moderna mRNA Vaccine

Intervention Type BIOLOGICAL

interferon or glatiramer acetate

iDMT

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No