Phase 4 N=34 Treatment

Exploring the Immune Response to SARS-CoV-2 COVID-19 Vaccines in Patients With Relapsing Multiple Sclerosis (RMS) Treated With Ofatumumab

Relapsing Multiple Sclerosis

Bottom Line

View on ClinicalTrials.gov: NCT04869358 ↗

Enrolled (actual)

Serious AEs

5.9%

Results posted

Dec 2024

Primary outcome: Primary: Percentage of Participants Having Established SARS-CoV-2-specific T Cells After Receiving a modRNA Vaccine — 80.0; 87.5; 100.0; 46.7 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Ofatumumab (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Novartis Pharmaceuticals
Primary completion: May 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants Having Established SARS-CoV-2-specific T Cells After Receiving a modRNA Vaccine	80.0; 87.5; 100.0; 46.7; 68.8	—
SECONDARY Percentage of Participants Who Maintained T-cell Response After Receiving a modRNA Vaccine	100.0; 100.0; 100.0; 100; 62.5; 60.0	—
SECONDARY Increase in Specific T-cells After Receiving an modRNA Booster Vaccine	0.8; 12.6; 2.0; 3.6; 5.3	—
SECONDARY Percentage of RMS Participants With Quantifiable Levels of SARS-CoV-2 Serum Functional Antibodies by Visits and Subcohorts (EAS)	0; 100.0; 0; 71.4; 100.0; 40.0	—
SECONDARY SARS-CoV-2 Specific CD4+ Effector Memory T-cells	2.458; 0.262; 2.583; 0.264; 0.555; 0.03	—

Summary

This study aimed to understand whether patients with relapsing multiple sclerosis (RMS) can mount an immune response to SARS-CoV-2 mRNA vaccines (initial vaccinations or booster vaccines) when vaccinated either before initiation of ofatumumab treatment or at least 4 weeks after commencing ofatumumab treatment.

Eligibility Criteria

Inclusion Criteria

Relapsing Multiple Sclerosis (RMS) diagnosis
eligible for ofatumumab treatment
willing and eligible to receive SARS-CoV-2 mRNA vaccine

Exclusion Criteria

known prior or current COVID-19 infection
previous treatment with BTK inhibitor or anti-CD20 therapy other than ofatumumab
no previous vaccination with a non-modRNA SARS-CoV-2 vaccine.

Other protocol-defined inclusion/exclusion criteria may apply

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04869358). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.