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

Relapsing Multiple Sclerosis (RMS) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04878211
• Other study ID #: COMB157GUS16
• Status: Completed
• Phase: Phase 4
• Start date: June 10, 2021
• Est. completion date: April 14, 2023

Study information

• Verified date: February 2024
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is a six-cohort, multicenter, prospective study of up to 88 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. The fourth cohort will be participants fully vaccinated with an RNA COVID-19 vaccine at least four weeks after ofatumumab start. The fifth cohort will be participants fully vaccinated with an RNA COVID-19 vaccine, with or without a booster dose, and currently on interferon or glatiramer acetate. The sixth cohort will be participants fully vaccinated with an RNA COVID-19 vaccine and received a booster dose at least four weeks after ofatumumab start. Participants will obtain the COVID-19 mRNA vaccine from their HCP (private insurance) or appropriate federal, state or local program.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 14, 2023
• Est. primary completion date: April 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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
• Cohort 1: Will be receiving an mRNA COVID-19 vaccine (Pfizer or Moderna vaccine) at least two weeks prior to starting ofatumumab
• Cohort 2: Will be receiving an mRNA COVID-19 vaccine (Pfizer or Moderna vaccine) and on ofatumumab for at least 4 weeks
• Cohort 3: Will be 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:

• 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

Related Conditions & MeSH terms

• COVID-19
• Multiple Sclerosis
• Relapsing Multiple Sclerosis (RMS)
• Sclerosis

Intervention

Drug:
• Ofatumumab
3 loading doses followed by monthly administrations

Biological:
• mRNA COVID-19 vaccine
Pfizer or Moderna mRNA Vaccine

Drug:
• interferon or glatiramer acetate
iDMT

Locations

Country	Name	City	State
United States	Dayton Center for Neurological Disorders	Centerville	Ohio
United States	The Neurological Institute PA	Charlotte	North Carolina
United States	Center For Neurology and Spine	Phoenix	Arizona
United States	Minnesota Center Multiple Sclerosis	Plymouth	Minnesota
United States	The MS Center for Innovation in Care	Saint Louis	Missouri
United States	Infinity Clinical Research LLC .	Sunrise	Florida
United States	Dragonfly Research LLC	Wellesley	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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