secondary progressive multiple sclerosis (SPMS)
Conditions
Interventions
Trade Name: Mayzent 2 mg Filmtabletten
Product Name: Mayzent 2 mg Filmtabletten
Product Code: BAF312A
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: SIPONIMOD
CAS Number: 1234627-85-0
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Sponsors
Novartis Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed informed consent must be obtained prior to participation in the study. 2. One of the following MS treatments as part of clinical routine: a. Cohort 1: Siponimod treatment according to EU SmPC without interrupting daily dosing for the purpose of vaccination with SARS-CoV-2 modRNA b. Cohort 2: Siponimod treatment according to EU SmPC interrupting daily dosing for the purpose of vaccination with SARS-CoV-2 modRNA c. Cohort 3: Dimethylfumarate, glatirameracetate, interferon, teriflunomode as per respective EU SmPC or no current treatment with diagnosis of SPMS or with RRMS at risk to develop SPMS (at the discretion of the treating physician) 3. Planning to receive a SARS-CoV-2 modRNA vaccination as part of clinical routine 4. No change regarding DMT within 4 weeks prior to inclusion to AMA-VACC, i.e. stable on current DMT according to dosing within label, no interruption, start or withdrawal of DMT in this period of time and no planned switch of DMT within following 2 months 5. Patients willing and eligible to receive a modRNA vaccine against COVID-19 as part of clinical routine Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1. History of COVID-19 2. SARS-CoV-2 antibodies at screening 3. Patients likely not being able or willing to complete the study 4. Use of other investigational drugs within 5 half-lives of enrollment/initiation of study treatment (e.g. small molecules) or until the expected pharmacodynamic effect has returned to baseline (e.g., biologics), whichever is longer 5. Patients with any medical or psychological condition that, in the investigators opinion, renders the patient unable to understand the nature, scope, and possible consequences of the study and who are therefore not able to comply with the requirements of the study and capable of giving informed consent 6. No person directly associated with the administration of the study is allowed to participate as a study subject 7. No family member of the investigational study staff is allowed to participate in this study 8. Known or suspected clinically relevant allergy, intolerance or hypersensitivity to peanuts, soya (only cohort 1 and 2) or to any of the study treatments designated for the individual subject (DMTs or mRNA vaccines) or drugs of similar chemical classes (active substance or excipients) 9. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception while taking study treatment and for 10 days of study treatment after stopping medication. 10. For cohort 3: patients with contraindications for their current MS medication according to the respective EU SmPC
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To estimate the proportion of those achieving seroconversion (i.e. having SARS-CoV-2 serum functional antibodies) after receiving a modRNA vaccine in participants treated concomitantly with siponimod and siponimod treatment break.;Secondary Objective: • Describing SARS-CoV-2 serum functional antibody levels in participants treated concomitantly with siponimod versus siponimod treatment break versus first-line DMTs and in patients currently not on a DMT • Describing the T cell response to modRNA vaccines in participants treated concomitantly with siponimod versus siponimod treatment break versus first-line DMTs and in patients currently not on a DMT • Describing safety, incl. AEs related to discontinuation and new onset of siponimod treatment and patients developing COVID-19 ;Primary end point(s): Proportion of participants achieving seroconversion as defined by detection of SARS-CoV-2 serum functional antibodies one week after second dose of vaccine in participants treated concomitantly with siponimod and siponimod treatment break (yes/no);Timepoint(s) of evaluation of this end point: 1 week after second dose of vaccine in participants treated concomitantly with siponimod and siponimod treatment break | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • SARS-CoV-2 serum functional antibody levels one week, one month and six months after second dose of vaccine and additionally one month after an optional booster vaccination in participants treated concomitantly with siponimod versus siponimod treatment break versus first-line DMTs and in patients currently not on a DMT • SARS-CoV-2 specific T-cell levels one week, one month and six months after second dose of vaccine and additionally one month after an optional booster vaccination in participants treated concomitantly with siponimod versus siponimod treatment break versus first-line DMTs and in patients currently not on a DMT measured by e.g. enzyme-linked immunosorbent spot (ELIspot) assay from peripheral blood mononuclear cells that were stimulated with SARS-CoV-2 peptide mix • AEs, SAEs, incl. patients with clinical confirmed COVID-19, events leading to discontinuation in participants treated concomitantly with siponimod versus siponimod treatment break versus first-line DMTs and in patients currently not on a DMT ;Timepoint(s) of evaluation of this end point: 1 week, 1 month and six months after second dose of vaccine plus one month after booster vaccination | — |
Countries
Germany
Contacts
Public ContactMedizinischer Infoservice (MCC)
Novartis Pharma GmbH
Outcome results
None listed