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Monoclonal Antibodies

Ofatumumab for Multiple Sclerosis

Phase 4
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up vaccination up to 70, 180, 270 and 360 days
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial tests if MS patients on ofatumumab can develop an immune response to the COVID-19 vaccine. Ofatumumab is given as a regular injection and works by reducing specific immune cells. The study includes different groups based on when they receive the vaccine relative to starting ofatumumab.

Eligible Conditions
  • Multiple Sclerosis (MS)

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~vaccination up to 70, 180, 270 and 360 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and vaccination up to 70, 180, 270 and 360 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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)
Secondary study objectives
Percentage of Participants Achieving Immune Conversion by Individual Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set)
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)

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

6Treatment groups
Experimental Treatment
Active Control
Group I: Cohort 6 - Fully vaccinated, currently on OMB457 for ≥ 4 WKs, + boosterExperimental Treatment2 Interventions
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 II: Cohort 5 -Fully vaccinated, on interferon or glatiramer acetate for ≥ 4 WKs ± boosterExperimental Treatment2 Interventions
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 III: Cohort 4 - Fully vaccinated and on OMB457 ≥ 4 WKsExperimental Treatment2 Interventions
Participants fully vaccinated with a non-live COVID mRNA vaccine and on ofatumumab for at least 4 weeks (20 mg subcutaneous)
Group IV: Cohort 2 - vaccine 4 WKs after OMB157Experimental Treatment2 Interventions
Participants received non-live COVID-19 mRNA vaccine at least four weeks after start of ofatumumab (OMB157) (20 mg subcutaneous).
Group V: Cohort 1 - 2 WKs vaccine prior to OMB157Experimental Treatment2 Interventions
Participants received non-live COVID-19 mRNA vaccine at least two weeks prior to start of ofatumumab (OMB157) (20 mg subcutaneous).
Group VI: Cohort 3 - Interferon or glatiramer acetate - vaccine 4 WKs afterActive Control2 Interventions
Participants will receive non-live COVID-19 mRNA vaccine at least 4 weeks after start of prescribed interferon or glatiramer acetate
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ofatumumab
2013
Completed Phase 3
~1480

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,896 Previous Clinical Trials
4,201,502 Total Patients Enrolled
105 Trials studying Multiple Sclerosis
51,636 Patients Enrolled for Multiple Sclerosis

Media Library

Ofatumumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04878211 — Phase 4
Multiple Sclerosis Research Study Groups: Cohort 1 - 2 WKs vaccine prior to OMB157, Cohort 2 - vaccine 4 WKs after OMB157, Cohort 3 - Interferon or glatiramer acetate - vaccine 4 WKs after, Cohort 4 - Fully vaccinated and on OMB457 ≥ 4 WKs, Cohort 5 -Fully vaccinated, on interferon or glatiramer acetate for ≥ 4 WKs ± booster, Cohort 6 - Fully vaccinated, currently on OMB457 for ≥ 4 WKs, + booster
Multiple Sclerosis Clinical Trial 2023: Ofatumumab Highlights & Side Effects. Trial Name: NCT04878211 — Phase 4
Ofatumumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04878211 — Phase 4
~6 spots leftby Oct 2025