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

Study Overview
=================
Brief Summary
-----------------
This study will evaluate if participants treated with ofatumumab 20 mg subcutaneous (s.c.) administered once monthly can develop an adequate immune response to the COVID-19 mRNA vaccine compared to participants on an interferon or glatiramer acetate.

Detailed Description
-----------------
This is a three-cohort, multicenter, prospective study of up to 66 relapsing MS participants. The first cohort will be participants receiving an mRNA COVID-19 vaccine at least two weeks prior to ofatumumab start. The second cohort will be participants receiving an mRNA COVID-19 vaccine at least four weeks after beginning ofatumumab. The third cohort will be participants currently on an interferon or glatiramer acetate planning to receive COVID-19 mRNA vaccine. Participants will obtain the COVID-19 mRNA vaccine from their HCP (private insurance) or appropriate federal, state or local program.

Official Title
-----------------
An Open-label Multicenter Study to Assess Response to COVID-19 Vaccine in Participants With Multiple Sclerosis Treated With Ofatumumab 20 mg Subcutaneously

Conditions
-----------------
Relapsing Multiple Sclerosis (RMS)

Intervention / Treatment
-----------------
* Drug: Ofatumumab
* Biological: mRNA COVID-19 vaccine
* Drug: interferon or glatiramer acetate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent must be obtained prior to participation in the study Diagnosis of relapsing MS by 2017 revised McDonald criteria Willing to comply with the study schedule Will be receiving an mRNA COVID-19 vaccine (Pfizer or Moderna vaccine) at least two weeks prior to starting ofatumumab Eligible to receive and plan to be started on ofatumumab OR currently on prescribed ofatumumab for ≥ 4 weeks OR currently on commercially prescribed interferon or glatiramer acetate for ≥ 4 weeks Exclusion Criteria: Already has received Pfizer, Moderna or Johnson & Johnson vaccine Known diagnosis of COVID-19 prior to screening Has a contraindication to receiving an mRNA COVID-19 vaccine Has an immediate allergic reaction to past vaccine or injection Any major episode of infection requiring hospitalization or treatment with intravenous antibiotics within 2 weeks prior to the screening visit

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ofatumumab - vaccine 2 weeks prior<br>RMS participants will receive non-live COVID-19 mRNA vaccine at least two weeks prior to start of ofatumumab (20 mg subcutaneous) | Drug: Ofatumumab<br>* 3 loading doses followed by monthly administrations<br>Biological: mRNA COVID-19 vaccine<br>* Pfizer or Moderna mRNA Vaccine<br>|
| Experimental: Ofatumumab -vaccine 4 weeks after<br>RMS participants will receive non-live COVID-19 mRNA vaccine at least four weeks after start of ofatumumab (20 mg subcutaneous) | Drug: Ofatumumab<br>* 3 loading doses followed by monthly administrations<br>Biological: mRNA COVID-19 vaccine<br>* Pfizer or Moderna mRNA Vaccine<br>|
| Active Comparator: Interferon or glatiramer acetate - vaccine 4 weeks after<br>RMS participants will receive non-live COVID-19 mRNA vaccine at least 4 weeks after start of prescribed interferon or glatiramer acetate | Biological: mRNA COVID-19 vaccine<br>* Pfizer or Moderna mRNA Vaccine<br>Drug: interferon or glatiramer acetate<br>* iDMT<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients achieving a SARS-CoV-2 immune response | An immune response is defined as achieving a positive SARS-CoV-2 qualitative IgG antibody assay 14 days after 2nd vaccination dose is received | Vaccination up to 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with a sustained immune response to non-live mRNA COVID-19 vaccine in ofatumumab treated participants | A sustained immune response to non-mRNA COVID vaccine is defined as achieving a positive SARS-CoV-2 qualitative IgG antibody after more than 14 days up to approximately one year after 2nd vaccination dose is received. | From 14 to 45 days after vaccination | 
| Percentage of patients achieving an immune conversion to non-live mRNA COVID-19 vaccine in ofatumumab treated participants | Immune conversion to non-live mRNA COVID-19 vaccine is defined as either: Baseline absence of SARS-CoV-2 spike IgG with post-vaccination SARS-CoV-2 positive qualitative antibody assay 14 days after 2nd vaccination dose is received OR Baseline serum presence of SARS-CoV-2 quantitative IgG antibody with post-vaccination ≥ 4-fold increase in SARS-CoV-2 quantitative antibody titer as determined by dilution assay 14 days after 2nd vaccination dose is received | Vaccination up to 14 days | 
| Percentage of patients developing a neutralizing antibody | Neutralizing antibody development is defined as positive SARS-CoV-2 neutralization antibody assay 14 days after 2nd vaccination dose is received. | Vaccination up to 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiple Sclerosis, Relapsing Multiple Sclerosis, COVID, COVID-19, Vaccine, Coronavirus, adult, OMB157