- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04792567
Exploring the Immune Response to SARS-CoV-2 modRNA Vaccines in Patients With Secondary Progressive Multiple Sclerosis (AMA-VACC) (AMA-VACC)
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)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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-
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Bogen, Germany, 94327
- Novartis Investigative Site
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Chemnitz, Germany, 09117
- Novartis Investigative Site
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Dresden, Germany, 01307
- Novartis Investigative Site
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Düsseldorf, Germany, 40211
- Novartis Investigative Site
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Neuburg an der Donau, Germany, 86633
- Novartis Investigative Site
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Pforzheim, Germany, 75172
- Novartis Investigative Site
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Regensburg, Germany, 93059
- Novartis Investigative Site
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Ruelzheim, Germany, 76761
- Novartis Investigative Site
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Ulm, Germany, 89073
- Novartis Investigative Site
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Sachsen
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Mittweida, Sachsen, Germany, 09648
- Novartis Investigative Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
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taken orally once per day (dose depends on CYP2C9 genotype)
Other Names:
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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
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taken orally once per day (dose depends on CYP2C9 genotype)
Other Names:
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Active Comparator: Comparator
Baseline DMTs or no treatment during SARS-CoV-2 mRNA vaccination
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DMTs: Dimethylfumarate, glatirameracetate, interferon, teriflunomode according to respective SmPC
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of participants achieving seroconversion after receiving a modRNA vaccine
Time Frame: at 1 week after second dose of vaccine
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Seroconversion is defined by detection of SARS-CoV-2 serum functional antibodies
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at 1 week after second dose of vaccine
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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SARS-CoV-2 neutralizing antibodies measured at the central laboratory
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at baseline, 1 week, 1 month and 6 months after second dose of vaccine
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T-cell response to modRNA vaccines over time
Time Frame: at baseline, 1 week, 1 month and 6 months after second dose of vaccine
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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
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at baseline, 1 week, 1 month and 6 months after second dose of vaccine
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Number of treatment emergent adverse events, serious adverse events and COVID-19 infections
Time Frame: Up to 12 months after second dose of vaccine
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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
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Up to 12 months after second dose of vaccine
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Immune System Diseases
- Neoplasms
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Neoplastic Processes
- Multiple Sclerosis
- Multiple Sclerosis, Chronic Progressive
- Sclerosis
- Neoplasm Metastasis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Immunosuppressive Agents
- Immunologic Factors
- Sphingosine 1 Phosphate Receptor Modulators
- Siponimod
Other Study ID Numbers
- CBAF312ADE03
- 2020-005752-38 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD 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/.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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