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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04869358
Recruitment Status : Recruiting
First Posted : May 3, 2021
Last Update Posted : June 24, 2022
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Multiple Sclerosis Drug: Ofatumumab Phase 4

Detailed Description:

This is a two cohort, multicenter, open-label, prospective study of 40 (optionally up to 60) patients with relapsing multiple sclerosis (RMS) planning to undergo a SARS-CoV-2 mRNA vaccination (initial vaccinations or booster vaccines) as part of clinical routine. The maximal duration of the study for an individual patient is 22 months.

  • The first cohort will be RMS patients receiving SARS-CoV-2 mRNA vaccine (initial vaccinations or booster vaccines) as part of clinical routine prior to starting ofatumumab treatment.
  • The second cohort will be participants receiving SARS-CoV-2 mRNA vaccine (initial vaccinations or booster vaccines) as part of clinical routine while already stable on ofatumumab treatment for at least 4 weeks (since first dose).

Development of SARS-CoV-2 specific T-cells and functional anti-SARS-CoV-2 antibodies will be investigated for up to 18 months after the participants' vaccination.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : May 27, 2021
Actual Primary Completion Date : May 10, 2022
Estimated Study Completion Date : July 30, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Ofatumumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Vaccination before treatment initiation
Patients will receive SARS-CoV-2 mRNA vaccines before starting ofatumumab treatment (approx. 1 month later)
 Drug: Ofatumumab
Ofatumumab 20 mg s.c. on days 1, 7, 14, week 4 and every 4 weeks thereafter
Other Name: OMB157
Experimental: Vaccination during treatment
Patients will receive SARS-CoV-2 mRNA vaccines while already stable on ofatumumab treatment (at least 4 weeks since first dose)
 Drug: Ofatumumab
Ofatumumab 20 mg s.c. on days 1, 7, 14, week 4 and every 4 weeks thereafter
Other Name: OMB157


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of RMS patients having established SARS-CoV-2-specific T cells after receiving a modRNA vaccine [ Time Frame: at 1 month after second dose of vaccine or booster vaccine ]
    Detection of SARS-CoV-2 specific T-cells measured at the central laboratory e.g. by enzyme-linked immunosorbent spot (ELIspot) assay from peripheral blood mononuclear cells


Secondary Outcome Measures :
  1. Percentage of participants achieving seroconversion [ Time Frame: at baseline, 1 week, 1 , 6, 12 and 18 months after second dose of vaccine or 1,6 and 12 months after booster vaccine ]
    SARS-CoV-2 neutralizing antibodies measured at the central laboratory

  2. Percentage of participants maintaining SARS-CoV-2 specific T-cells [ Time Frame: at baseline, 1 week, 1 , 6, 12 and 18 months after second dose of vaccine or 1,6 and 12 months after booster vaccine ]
    Maintenance of SARS-CoV-2 specific T-cells over time measured at the central laboratory e.g. by enzyme-linked immunosorbent spot (ELIspot) assay from peripheral blood mononuclear cells

  3. Immunophenotyping of peripheral blood mononuclear cells [ Time Frame: at baseline, 1 week, 1 , 6, 12 and 18 months after second dose of vaccine or 1,6 and 12 months after booster vaccine ]
    Phenotypic description of the cellular immune response performed at the central laboratory by FACS analysis

  4. Number of treatment emergent adverse events, serious adverse events and COVID-19 infections [ Time Frame: Up to 18 months after second dose of vaccine or 12 months after booster vaccine ]
    Untoward medical occurrences (including abnormal laboratory tests, vital signs and other safety assessments) will be captured as adverse events including COVID-19 infections


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04869358


Contacts
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Contact: Novartis Pharmaceuticals +41613241111 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals

Locations
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Germany
Novartis Investigative Site Active, not recruiting
Berlin, Germany, 13353
Novartis Investigative Site Active, not recruiting
Bielefeld, Germany, D 33647
Novartis Investigative Site Active, not recruiting
Dresden, Germany, 01307
Novartis Investigative Site Active, not recruiting
Erbach, Germany, 64711
Novartis Investigative Site Withdrawn
Erlangen, Germany, 91054
Novartis Investigative Site Active, not recruiting
Siegen, Germany, 57076
Novartis Investigative Site Recruiting
Ulm, Germany, 89073
Novartis Investigative Site Active, not recruiting
Unterhaching, Germany, 82008
Sponsors and Collaborators
Novartis Pharmaceuticals
More Information
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04869358    
Other Study ID Numbers: COMB157GDE01
First Posted: May 3, 2021    Key Record Dates
Last Update Posted: June 24, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on https://www.clinicalstudydatarequest.com/.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
COVID-19
SARS-CoV-2 mRNA vaccine
immune response
Ofatumumab
 Relapsing Multiple Sclerosis
RMS
adult
MS
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
 Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Ofatumumab
Antineoplastic Agents