Study Stopped
Trial was terminated for business reasons. There has been no change in the benefit/risk profile of ofatumumab.
A Open-label Study to Assess Response to COVID-19 Vaccine in Multiple Sclerosis Participants Treated With Ofatumumab
An Open-label Multicenter Study to Assess Response to COVID-19 Vaccine in Participants With Multiple Sclerosis Treated With Ofatumumab 20 mg Subcutaneously
1 other identifier
interventional
24
1 country
7
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jun 2021
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 3, 2021
CompletedFirst Posted
Study publicly available on registry
May 7, 2021
CompletedStudy Start
First participant enrolled
June 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 14, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 14, 2023
CompletedResults Posted
Study results publicly available
June 20, 2024
CompletedMay 16, 2025
May 1, 2025
1.8 years
May 3, 2021
March 25, 2024
May 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
An immune response is defined as a positive SARS-CoV-2 qualitative IgG antibody assay ≥14 days after full course \[2 doses\] vaccination to non live mRNA COVID-19 vaccine, Participants with a negative or borderline result were considered non-responders, as well as participants with a missing or invalid immune response assessment at 14 days post-vaccination (imputed as non-responders).
Cohorts 1 - 3: >=14 days after vaccination: Day 36 (Pfizer) or Day 43 (Moderna); Cohorts 4-6: Day 1
Secondary Outcomes (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
Percentage 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
Study Arms (6)
Cohort 1 - 2 WKs vaccine prior to OMB157
EXPERIMENTALParticipants received non-live COVID-19 mRNA vaccine at least two weeks prior to start of ofatumumab (OMB157) (20 mg subcutaneous).
Cohort 2 - vaccine 4 WKs after OMB157
EXPERIMENTALParticipants received non-live COVID-19 mRNA vaccine at least four weeks after start of ofatumumab (OMB157) (20 mg subcutaneous).
Cohort 3 - Interferon or glatiramer acetate - vaccine 4 WKs after
ACTIVE COMPARATORParticipants will receive non-live COVID-19 mRNA vaccine at least 4 weeks after start of prescribed interferon or glatiramer acetate
Cohort 4 - Fully vaccinated and on OMB457 ≥ 4 WKs
EXPERIMENTALParticipants fully vaccinated with a non-live COVID mRNA vaccine and on ofatumumab for at least 4 weeks (20 mg subcutaneous)
Cohort 5 -Fully vaccinated, on interferon or glatiramer acetate for ≥ 4 WKs ± booster
EXPERIMENTALParticipants 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.
Cohort 6 - Fully vaccinated, currently on OMB457 for ≥ 4 WKs, + booster
EXPERIMENTALParticipants fully vaccinated with a non-live COVID mRNA vaccine with a booster and on ofatumumab for at least 4 weeks (20 mg subcutaneous)
Interventions
3 loading doses followed by monthly administrations
Pfizer or Moderna mRNA Vaccine
iDMT
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Center For Neurology and Spine
Phoenix, Arizona, 85032, United States
Infinity Clinical Research LLC .
Hollywood, Florida, 33024, United States
Dragonfly Research LLC
Wellesley, Massachusetts, 02481, United States
Minnesota Center Multiple Sclerosis
Plymouth, Minnesota, 55446, United States
The MS Center for Innovation in Care
St Louis, Missouri, 63131, United States
The Neurological Institute PA
Charlotte, North Carolina, 28204, United States
Dayton Center for Neurological Disorders
Centerville, Ohio, 45459, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 3, 2021
First Posted
May 7, 2021
Study Start
June 10, 2021
Primary Completion
April 14, 2023
Study Completion
April 14, 2023
Last Updated
May 16, 2025
Results First Posted
June 20, 2024
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on https://www.clinicalstudydatarequest.com/.