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Clinical trials for BAF312

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    9 result(s) found for: BAF312. Displaying page 1 of 1.
    EudraCT Number: 2012-003056-36 Sponsor Protocol Number: CBAF312A2304 Start Date*: 2012-10-31
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary pro...
    Medical condition: Secondary progressive multiple sclerosis
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029205 - Nervous system disorders 10063400 Secondary progressive multiple sclerosis PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: HU (Prematurely Ended) IE (Completed) DE (Prematurely Ended) CZ (Completed) SK (Completed) NL (Completed) ES (Ongoing) GB (GB - no longer in EU/EEA) AT (Completed) SE (Completed) PT (Prematurely Ended) IT (Prematurely Ended) LV (Completed) GR (Completed) LT (Completed) EE (Completed) BE (Prematurely Ended) PL (Completed) BG (Prematurely Ended) FR (Completed)
    Trial results: View results
    EudraCT Number: 2012-002859-42 Sponsor Protocol Number: CBAF312X2205 Start Date*: 2013-01-25
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A multi-centre, double-blind, placebo controlled, proof of concept study to evaluate the efficacy and tolerability of BAF312 in patients with polymyositis
    Medical condition: Polymyositis
    Disease: Version SOC Term Classification Code Term Level
    14.1 10028395 - Musculoskeletal and connective tissue disorders 10036102 Polymyositis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) CZ (Prematurely Ended) PL (Prematurely Ended) BE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-001799-39 Sponsor Protocol Number: CBAF312X2206 Start Date*: 2013-09-26
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A double blind, randomized, placebo-controlled study to evaluate, safety, tolerability, efficacy and preliminary dose-response of BAF312 in patients with active dermatomyositis.
    Medical condition: Active dermatomyositis
    Disease: Version SOC Term Classification Code Term Level
    18.0 10040785 - Skin and subcutaneous tissue disorders 10012503 Dermatomyositis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) CZ (Prematurely Ended) PL (Prematurely Ended) BE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2009-014392-51 Sponsor Protocol Number: CBAF312A2201E1 Start Date*: 2009-12-21
    Sponsor Name:Novartis Farmacéutica S.A.
    Full Title: Fase de extensión del estudio CBAF312A2201 con enmascaramiento de la dosis para evaluar la seguridad, tolerabilidad y eficacia a largo plazo de BAF312 administrado por vía oral una vez al día a pac...
    Medical condition: Esclerosis Múltiple Recurrente Remitente
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Completed) HU (Completed) DE (Prematurely Ended) PL (Completed) IT (Prematurely Ended) FI (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2008-006311-21 Sponsor Protocol Number: CBAF312A2202 Start Date*: 2009-07-28
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A multi-centre, double-blind, placebo controlled, proof of concept study to evaluate the efficacy and tolerability of BAF312 in patients with polymyositis and dermatomyositis
    Medical condition: Polymyositis and dermatomyositis
    Disease: Version SOC Term Classification Code Term Level
    9.1 10036102 Polymyositis LLT
    9.1 10012503 Dermatomyositis LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) SE (Prematurely Ended) HU (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2008-008719-25 Sponsor Protocol Number: CBAF312A2201 Start Date*: Information not available in EudraCT
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A phase II, double-blind, randomized, multi-center, adaptive dose-ranging, placebo-controlled, parallel-group study evaluating safety, tolerability and efficacy on MRI lesion parameters and determi...
    Medical condition: Relapsing-remitting multiple sclerosis
    Disease: Version SOC Term Classification Code Term Level
    9.1 10063399 Relapsing-remitting multiple sclerosis PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed) FI (Completed) ES (Completed) IT (Completed) HU (Completed)
    Trial results: View results
    EudraCT Number: 2020-002700-39 Sponsor Protocol Number: CBAF312D2301 Start Date*: 2021-09-10
    Sponsor Name:Novartis Pharma AG
    Full Title: 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 followe...
    Medical condition: Multiple Sclerosis in pediatric patients
    Disease: Version SOC Term Classification Code Term Level
    20.1 10029205 - Nervous system disorders 10028245 Multiple sclerosis PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) PT (Trial now transitioned) EE (Ongoing) FR (Trial now transitioned) BE (Trial now transitioned) LT (Prematurely Ended) AT (Trial now transitioned) SK (Trial now transitioned) ES (Ongoing) LV (Trial now transitioned) PL (Trial now transitioned) IT (Trial now transitioned) HR (Trial now transitioned) RO (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-005738-23 Sponsor Protocol Number: CBAF312X2207 Start Date*: 2018-06-15
    Sponsor Name:Novartis Pharma AG
    Full Title: A phase II, patient and investigator-blinded, randomized, placebo-controlled study to evaluate efficacy, safety and tolerability of BAF312 in patients with stroke due to intracerebral hemorrhage (ICH)
    Medical condition: Intracerebral Hemorrhage
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004852 10022754 Intracerebral hemorrhage LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2020-005752-38 Sponsor Protocol Number: CBAF312ADE03 Start Date*: 2021-03-18
    Sponsor Name:Novartis Pharma GmbH
    Full 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) (AMA-VACC)
    Medical condition: secondary progressive multiple sclerosis (SPMS)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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