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

NCT04869358 | Completed Phase 4 Results

• 1 other identifier: COMB157GDE01
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Relapsing Multiple Sclerosis

Keywords

COVID-19; SARS-CoV-2 mRNA vaccine; immune response; Ofatumumab; Relapsing Multiple Sclerosis; RMS; adult; MS

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Having Established SARS-CoV-2-specific T Cells After Receiving a modRNA Vaccine

  Participants who established SARS-CoV-2-specific T cells as defined by detection of SARS-CoV-2 reactive T-cells, measured by e.g. ELIspot assay from T-cells that were stimulated with SARS-CoV-2 peptide mix, either 1 month after second dose of vaccine or 1 month after booster vaccine in participants who received the respective vaccine before or after starting ofatumumab treatment.

  1 month after second dose of vaccine or booster vaccine

Secondary Outcomes (4)

• Percentage of Participants Who Maintained T-cell Response After Receiving a modRNA Vaccine

  At Week 1, Months 6, 12 and 18 after second dose of vaccine or 1 Month after 1st booster, 1 Month after 2nd booster

• Increase in Specific T-cells After Receiving an modRNA Booster Vaccine

  Last value before booster to 1 month after booster

• Percentage of RMS Participants With Quantifiable Levels of SARS-CoV-2 Serum Functional Antibodies by Visits and Subcohorts (EAS)

  Baseline, Week 1 after Vacc, Month 1, 6, 12 after Vacc, 1 month after 1st booster, 1 month after 2nd booster

• SARS-CoV-2 Specific CD4+ Effector Memory T-cells

  Baseline, Months 1 ,6, 12 and 18 after vaccinationse of vaccine or 1,6 and 12 months after booster vaccine

Study Arms (4)

Cohort 1a

EXPERIMENTAL

Patients received first SARS-CoV-2 vaccination within the study prior to starting ofatumumab treatment.

Drug: Ofatumumab

Cohort 1b

EXPERIMENTAL

Patients had already completed initial vaccination cycle and received a booster vaccine within the study prior to starting ofatumumab treatment.

Drug: Ofatumumab

Cohort 2a

EXPERIMENTAL

Patients who received their first SARS-CoV-2 vaccination within the study while already stable on ofatumumab treatment for at least 4 weeks (since the first dose).

Drug: Ofatumumab

Cohort 2b

EXPERIMENTAL

Patients who had already completed their initial vaccination cycle and received a booster vaccine within the study while already stable on ofatumumab treatment for at least 4 weeks (since the first dose).

Drug: Ofatumumab

Interventions

Ofatumumab DRUG

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

Also known as: OMB157

Cohort 1a; Cohort 1b; Cohort 2a; Cohort 2b

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (6)

Novartis Investigative Site

Berlin, 13353, Germany

Location

Novartis Investigative Site

Bielefeld, D 33647, Germany

Location

Novartis Investigative Site

Dresden, 01307, Germany

Location

Novartis Investigative Site

Erbach im Odenwald, 64711, Germany

Location

Novartis Investigative Site

Siegen, 57076, Germany

Location

Novartis Investigative Site

Unterhaching, 82008, Germany

Location

Related Links

• A Plain Language Trial Summary is available on www.novctrd.com

MeSH Terms

Conditions

COVID-19

Interventions

ofatumumab

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

Immunophenotyping (outcome measure 5) was inconclusive due to low participant numbers.

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@Novartis.com

+ 1 862 778 8300

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: April 29, 2021
• First Posted: May 3, 2021
• Study Start: May 27, 2021
• Primary Completion: May 10, 2022
• Study Completion: June 13, 2023
• Last Updated: May 16, 2025
• Results First Posted: December 11, 2024

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

DE (6)