BAF312

DRUG11 trials

Sponsors

Novartis Pharma AG, Azienda Ospedaliera Universitaria Integrata Verona, Novartis Pharmaceuticals

Conditions

Active DermatomyositisActive progressive multiple sclerosis course after an initial relapse clinical courseDermatomyositisHepatic ImpairmentMultiple Sclerosis in pediatric patientsPolymyositisRelapsing Remitting Multiple SclerosisRelapsing-remitting Multiple Sclerosis

Phase 1

Pharmacokinetics of BAF312 in Patients With Hepatic Impairment

CompletedNCT01565902

Novartis PharmaceuticalsHepatic Impairment

Start: 2012-10-31End: 2014-03-31Updated: 2020-12-29

A Single-dose, Open-label, Parallel-group Study to Assess the Pharmacokinetics of BAF312 in Subjects With Renal Impairment Compared to Subjects With Normal Renal Function

CompletedNCT01904214

Novartis PharmaceuticalsRenal Impairment

Start: 2013-07-31End: 2014-11-30Updated: 2020-12-08

Phase 2

Safety, Tolerability, Efficacy and Optimal Dose Finding Study of BAF312 in Patients With Relapsing-remitting Multiple Sclerosis

CompletedNCT00879658

Novartis PharmaceuticalsRelapsing-remitting Multiple Sclerosis

Start: 2009-03-30End: 2011-05-04Updated: 2020-01-13

Efficacy and Tolerability of BAF312 in Patients With Polymyositis and Dermatomyositis

TerminatedNCT01148810

Novartis PharmaceuticalsDermatomyositis, Polymyositis

Start: 2010-06-15End: 2012-06-13Updated: 2019-04-25

Long-term Safety, Tolerability and Efficacy of BAF312 Given Orally in Patients With Relapsing-remitting Multiple Sclerosis

CompletedNCT01185821

Novartis PharmaceuticalsRelapsing Remitting Multiple Sclerosis

Start: 2010-08-30End: 2016-10-10Updated: 2018-03-27

Efficacy and Tolerability of BAF312 in Patients With Polymyositis

TerminatedNCT01801917

Novartis PharmaceuticalsPolymyositis

Start: 2013-04-24End: 2016-08-05Updated: 2021-01-05

Safety and Efficacy of BAF312 in Dermatomyositis

TerminatedNCT02029274

Novartis PharmaceuticalsActive Dermatomyositis

Start: 2013-08-25End: 2016-02-17Updated: 2021-01-05

Phase 3

Exploring the Efficacy and Safety of Siponimod in Patients With Secondary Progressive Multiple Sclerosis (EXPAND)

CompletedNCT01665144

Novartis PharmaceuticalsSecondary Progressive Multiple Sclerosis

Start: 2012-12-20End: 2023-03-31Updated: 2024-06-05

A 2-year randomized, 3-arm, double-blind, non-inferiority study comparing the efficacy and safety of ofatumumab and siponimod versus fingolimod in pediatric patients with multiple sclerosis followed by an open-label extension

RecruitingCTIS2024-511686-11-00

Novartis Pharma AGMultiple Sclerosis in pediatric patients

Start: 2021-10-05Target: 64Updated: 2025-11-27

Phase 4

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

CompletedNCT04792567

Novartis PharmaceuticalsSecondary Progressive Multiple Sclerosis

Start: 2021-04-19End: 2022-08-15Updated: 2024-06-20

Effect of siponimod on relevant imaging and immunological hallmarks of progressive multiple sclerosis

RecruitingCTIS2024-518374-13-00

Azienda Ospedaliera Universitaria Integrata VeronaActive progressive multiple sclerosis course after an initial relapse clinical course

Start: 2022-02-28Target: 60Updated: 2024-11-05

Related Papers

Composite Confirmed Disability Worsening/Progression Is a Useful Clinical Endpoint for Multiple Sclerosis Clinical Trials

Neurology2025-04-214 citations

Siponimod Stabilizes Physical Disability Scores in People Living With Secondary Progressive Multiple Sclerosis After 2 Years of Treatment: Analysis From the Novartis Global Managed Access Program (P8-3.010)

Neurology2023-04-25

Siponimod vs placebo in active secondary progressive multiple sclerosis: a post hoc analysis from the phase 3 EXPAND study.

2022-05-3110 citations

Long-term efficacy and safety of siponimod in patients with secondary progressive multiple sclerosis: Analysis of EXPAND core and extension data up to >5 years

Multiple Sclerosis Journal2022-04-0544 citations

Blood Neurofilament Light in Progressive Multiple Sclerosis

Neurology2022-04-0447 citations

How do patients with secondary progressive multiple sclerosis enrolled in the EXPAND randomized controlled trial compare with those seen in German clinical practice in the NeuroTransData multiple sclerosis registry?

Journal of Central Nervous System Disease2022-04-013 citations

Effect of siponimod on magnetic resonance imaging measures of neurodegeneration and myelination in secondary progressive multiple sclerosis: Gray matter atrophy and magnetization transfer ratio analyses from the EXPAND phase 3 trial

Multiple Sclerosis Journal2022-03-0932 citations

Assessing the immune response to SARS-CoV-2 mRNA vaccines in siponimod-treated patients: a nonrandomized controlled clinical trial (AMA-VACC)

Therapeutic Advances in Neurological Disorders2022-01-017 citations

Cost Effectiveness and Budget Impact of Siponimod Compared to Interferon Beta-1a in the Treatment of Adult Patients with Secondary Progressive Multiple Sclerosis with Active Disease in Switzerland

PharmacoEconomics2021-04-0117 citations

Siponimod and Cognition in Secondary Progressive Multiple Sclerosis: EXPAND Secondary Analyses.

2020-12-1650 citations

Siponimod versus placebo in secondary progressive multiple sclerosis (EXPAND): a double-blind, randomised, phase 3 study.

2018-03-23609 citations

Safety and Efficacy of Siponimod (BAF312) in Patients With Relapsing-Remitting Multiple Sclerosis

JAMA Neurology2016-07-05103 citations

Novel approaches for the development of peripheral nerve regenerative therapies

Neural Regeneration Research2015-01-013 citations

Siponimod for patients with relapsing-remitting multiple sclerosis (BOLD): an adaptive, dose-ranging, randomised, phase 2 study.

2013-06-11175 citations