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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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ vaccination up to 70, 180, 270 and 360 days

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