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

Tracking the Immune Response to SARS-CoV-2 modRNA Vaccines in an Open-label Multicenter Study in Participants With Relapsing Multiple Sclerosis Treated With Ofatumumab s.c. (KYRIOS)

ClinicalTrials.gov Identifier: NCT04869358

Novartis Reference Number: COMB157GDE01

Last Update: Nov 18, 2021

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

This study aims to understand whether patients with MS 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.

Condition

Multiple Sclerosis

Phase

Phase 4

Overall status

Recruiting

Start date

May 27, 2021

Completion date

May 31, 2023

Gender

All

Age(s)

18 Years - 100 Years (Adult, Older Adult)

Interventions

Drug

Ofatumumab

Ofatumumab 20 mg s.c. on days 1, 7, 14, week 4 and every 4 weeks thereafter

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

Other protocol-defined inclusion/exclusion criteria may apply