CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 41 enrolled
Drug / intervention
BAF312 +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04792567
NCT04792567Phase 4Completed

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)

Novartis Pharmaceuticals·interventional·Posted Mar 11, 2021·Updated Jun 20, 2024

In Brief

A Phase 4 clinical trial evaluating BAF312, Baseline disease modifying therapies (DMTs), and 2 other interventions for Secondary Progressive Multiple Sclerosis. Completed, enrolled 41 participants across 10 sites.

Detailed Summary

The purpose of this study was to understand whether participants could mount an immune response to SARS-CoV-2 modRNA vaccines administered either during continuous siponimod treatment or during a treatment break versus while on treatment with first-line DMTS or no current MS treatment..

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany
Collaborators--

Timeline

Phase 4CompletedFinished
20222023202420252026
First PostedMar 11, 2021
Enrollment StartApr 19, 2021
Primary CompletionSep 6, 2021
Study CompletionAug 15, 2022
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 5.3 years ago

Interventions

BAF312drug

taken orally once per day (dose depends on CYP2C9 genotype)

Baseline disease modifying therapies (DMTs)drug

DMTs: Dimethylfumarate, glatirameracetate, interferon, teriflunomode according to respective SmPC

BNT162biological

Administerd according to the respective EU SmPC at the discretion of the treating physician independent of AMA-VACC. If suggested by local regulations and performed as part of clinical routine any type of booster/refresher vaccination (e.g. mRNA, vector, peptide) was allowed in this study.

mRNA-1273biological

Administerd according to the respective EU SmPC at the discretion of the treating physician independent of AMA-VACC. If suggested by local regulations and performed as part of clinical routine any type of booster/refresher vaccination (e.g. mRNA, vector, peptide) was allowed in this study