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Trial record 13 of 14 for:    BAF312

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

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ClinicalTrials.gov Identifier: NCT04792567
Recruitment Status : Recruiting
First Posted : March 11, 2021
Last Update Posted : June 1, 2021
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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
Secondary Progressive Multiple Sclerosis 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 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 : April 19, 2021
Estimated Primary Completion Date : January 17, 2022
Estimated Study Completion Date : April 2, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Siponimod

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 Name: 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 Name: 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




Primary Outcome Measures :
  1. Percentage of participants achieving seroconversion after receiving a modRNA vaccine [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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



Information from the National Library of Medicine

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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:

  • 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

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): NCT04792567


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 Recruiting
Mittweida, Sachsen, Germany, 09648
Novartis Investigative Site Recruiting
Bogen, Germany, 94327
Novartis Investigative Site Recruiting
Chemnitz, Germany, 09117
Novartis Investigative Site Recruiting
Dresden, Germany, 01307
Novartis Investigative Site Recruiting
Düsseldorf, Germany, 40211
Novartis Investigative Site Recruiting
Neuburg an der Donau, Germany, 86633
Novartis Investigative Site Recruiting
Pforzheim, Germany, 75172
Novartis Investigative Site Recruiting
Regensburg, Germany, 93059
Novartis Investigative Site Recruiting
Ruelzheim, Germany, 76761
Novartis Investigative Site Recruiting
Ulm, Germany, 89073
Sponsors and Collaborators
Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04792567    
Other Study ID Numbers: CBAF312ADE03
2020-005752-38 ( EudraCT Number )
First Posted: March 11, 2021    Key Record Dates
Last Update Posted: June 1, 2021
Last Verified: May 2021
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
Siponimod
Secondary Progressive Multiple Sclerosis
SPMS
adult
MS
Additional relevant MeSH terms:
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Neoplasm Metastasis
Multiple Sclerosis
Multiple Sclerosis, Chronic Progressive
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Neoplastic Processes
Neoplasms
Siponimod
Sphingosine 1 Phosphate Receptor Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs