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Exploring the Immune Response to SARS-CoV-2 modRNA Vaccines in Patients With Secondary Progressive Multiple Sclerosis (AMA-VACC)

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04792567
Collaborator
(none)
41
Enrollment
10
Locations
3
Arms
16.1
Anticipated Duration (Months)
4.1
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to understand whether participants can mount an immune response to SARS-CoV-2 modRNA vaccines administered either during continuous siponimod treatment or during a treatment break.

Condition or Disease Intervention/Treatment Phase
  • Drug: BAF312
  • Drug: Baseline disease modifying therapies (DMTs)
 Phase 4

Detailed Description

This is a three cohort, multicenter, open-label, prospective study of 60 (optionally up to 90) multiple sclerosis (MS) patients currently treated with siponimod or a first-line disease modifying therapy (DMT) or without MS treatment in clinical routine planning to undergo a SARS-CoV-2 modRNA vaccination as part of clinical routine. The maximal duration of the study for an individual patient is 14 months.

  • The first cohort in this study will be participants not interrupting their current siponimod therapy for the purpose of a SARS-CoV-2 modRNA vaccination.

  • The second cohort will be participants interrupting their current siponimod therapy for the purpose of a SARS-CoV-2 modRNA vaccination for approximately 2-3 months.

  • The third cohort will be participants receiving modRNA vaccine while on treatment with the following first-line DMTs (dimethylfumarate, glatirameracetate, interferons, teriflunomide) or no current treatment in clinical routine.

The study will investigate the development of functional anti-SARS-CoV-2 antibodies and T-cell titers for six months after the participants' vaccination.

Study Design

Study Type:
Interventional
Actual Enrollment :
41 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-label Multicenter Study to Assess Response to SARS-CoV-2 modRNA Vaccines in Participants With Secondary Progressive Multiple Sclerosis Treated With Mayzent (Siponimod)
Actual Study Start Date :
Apr 19, 2021
Actual Primary Completion Date :
Sep 6, 2021
Anticipated Study Completion Date :
Aug 22, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Siponimod - continuous

Continuous treatment with siponimod (oral, daily, dose depending on CYP2C9 genotype: 2mg or 1 mg) during SARS-CoV-2 mRNA vaccination

Drug: BAF312
taken orally once per day (dose depends on CYP2C9 genotype)
Other Names:
  • Siponimod

    		•
    Experimental: Siponimod- interrupted

    Siponimod (oral, daily, dose depending on CYP2C9 genotype: 2mg or 1 mg) with treatment interruption (for approx. 2-3 months) for the purpose of a SARS-CoV-2 mRNA vaccination

    Drug: BAF312
    taken orally once per day (dose depends on CYP2C9 genotype)
    Other Names:
  • Siponimod

    		•
    Active Comparator: Comparator

    Baseline DMTs or no treatment during SARS-CoV-2 mRNA vaccination

    Drug: Baseline disease modifying therapies (DMTs)
    DMTs: Dimethylfumarate, glatirameracetate, interferon, teriflunomode according to respective SmPC

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of participants achieving seroconversion after receiving a modRNA vaccine [at 1 week after second dose of vaccine]

      Seroconversion is defined by detection of SARS-CoV-2 serum functional antibodies

    Secondary Outcome Measures

    1. SARS-CoV-2 serum functional antibody levels over time [at baseline, 1 week, 1 month and 6 months after second dose of vaccine]

      SARS-CoV-2 neutralizing antibodies measured at the central laboratory

    2. T-cell response to modRNA vaccines over time [at baseline, 1 week, 1 month and 6 months after second dose of vaccine]

      SARS-CoV-2 specific T-cell levels measured at the central laboratory e.g. by enzyme-linked immunosorbent spot (ELIspot) assay from peripheral blood mononuclear cells

    3. Number of treatment emergent adverse events, serious adverse events and COVID-19 infections [Up to 12 months after second dose of vaccine]

      Untoward medical occurrences (including abnormal laboratory tests, vital signs and other safety assessments) will be captured as adverse events and COVID-19 infections will be recorded

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Secondary Progressive Multiple Sclerosis (SPMS) diagnosis or with Relapsing Remitting Multiple Sclerosis (RRMS) at risk to develop SPMS (at the discretion of the treating physician)

    • on stable MS treatment (Siponimod, dimethylfumarate, glatirameracetate, interferon, teriflunomode or no current treatment)

    • no recent treatment changes

    Exclusion Criteria:

    • prior or current COVID-19 disease

    • SARS-CoV-2 antibodies at screening Other protocol-defined inclusion/exclusion criteria may apply

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Novartis Investigative Site Mittweida Sachsen Germany 09648
    2 Novartis Investigative Site Bogen Germany 94327
    3 Novartis Investigative Site Chemnitz Germany 09117
    4 Novartis Investigative Site Dresden Germany 01307
    5 Novartis Investigative Site Düsseldorf Germany 40211
    6 Novartis Investigative Site Neuburg an der Donau Germany 86633
    7 Novartis Investigative Site Pforzheim Germany 75172
    8 Novartis Investigative Site Regensburg Germany 93059
    9 Novartis Investigative Site Ruelzheim Germany 76761
    10 Novartis Investigative Site Ulm Germany 89073

    Sponsors and Collaborators

    • Novartis Pharmaceuticals

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Novartis Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT04792567
    Other Study ID Numbers:
    • CBAF312ADE03
    • 2020-005752-38
    First Posted:
    Mar 11, 2021
    Last Update Posted:
    Aug 10, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Novartis Pharmaceuticals
    COVID-19
    SARS-CoV-2 mRNA vaccine
    Siponimod
    Secondary Progressive Multiple Sclerosis
    SPMS
    adult
    MS
    Additional relevant MeSH terms:
    Neoplasm Metastasis
    Multiple Sclerosis
    Multiple Sclerosis, Chronic Progressive
    Sclerosis
    Siponimod

    Study Results

    No Results Posted as of Aug 10, 2022