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

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04878211
Collaborator
(none)
66
4
3
26.6
16.5
0.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Ofatumumab
  • Biological: mRNA COVID-19 vaccine
  • Drug: interferon or glatiramer acetate
Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
66 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jun 10, 2021
Anticipated Primary Completion Date :
Aug 30, 2023
Anticipated Study Completion Date :
Aug 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ofatumumab - vaccine 2 weeks prior

RMS participants will receive non-live COVID-19 mRNA vaccine at least two weeks prior to start of ofatumumab (20 mg subcutaneous)

Drug: Ofatumumab
3 loading doses followed by monthly administrations

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

Experimental: Ofatumumab -vaccine 4 weeks after

RMS participants will receive non-live COVID-19 mRNA vaccine at least four weeks after start of ofatumumab (20 mg subcutaneous)

Drug: Ofatumumab
3 loading doses followed by monthly administrations

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

Active Comparator: Interferon or glatiramer acetate - vaccine 4 weeks after

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
Pfizer or Moderna mRNA Vaccine

Drug: interferon or glatiramer acetate
iDMT

Outcome Measures

Primary Outcome Measures

  1. Percentage of patients achieving a SARS-CoV-2 immune response [Vaccination up to 14 days]

    An immune response is defined as achieving a positive SARS-CoV-2 qualitative IgG antibody assay 14 days after 2nd vaccination dose is received

Secondary Outcome Measures

  1. Percentage of patients with a sustained immune response to non-live mRNA COVID-19 vaccine in ofatumumab treated participants [From 14 to 45 days after vaccination]

    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.

  2. Percentage of patients achieving an immune conversion to non-live mRNA COVID-19 vaccine in ofatumumab treated participants [Vaccination up to 14 days]

    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

  3. Percentage of patients developing a neutralizing antibody [Vaccination up to 14 days]

    Neutralizing antibody development is defined as positive SARS-CoV-2 neutralization antibody assay 14 days after 2nd vaccination dose is received.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Novartis Investigative Site Phoenix Arizona United States 85032
2 Novartis Investigative Site Sunrise Florida United States 33351
3 Novartis Investigative Site Saint Louis Missouri United States 63131
4 Novartis Investigative Site Charlotte North Carolina United States 28204

Sponsors and Collaborators

  • Novartis Pharmaceuticals

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT04878211
Other Study ID Numbers:
  • COMB157GUS16
First Posted:
May 7, 2021
Last Update Posted:
Jul 21, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Novartis Pharmaceuticals
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 21, 2022