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Clinical trials for Emapalumab

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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    6 result(s) found for: Emapalumab. Displaying page 1 of 1.
    EudraCT Number: 2017-003114-10 Sponsor Protocol Number: NI-0501-09 Start Date*: 2018-09-06
    Sponsor Name:Swedish Orphan Biovitrum AG
    Full Title: An Open-label, Single Arm, Multicenter Study to Broaden Access to Emapalumab, an Anti-Interferon Gamma (Anti-IFNγ) Monoclonal Antibody, and to Assess its Efficacy, Safety, Impact on Quality of Life...
    Medical condition: Primary Hemophagocytic Lymphohistiocytosis (pHLH)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10021428 - Immune system disorders 10071583 Haemophagocytic lymphohistiocytosis PT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) GB (GB - no longer in EU/EEA) IT (Completed) SE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2021-001577-24 Sponsor Protocol Number: NI-0501-14 Start Date*: 2021-12-15
    Sponsor Name:Swedish Orphan Biovitrum AG (Sobi AG)
    Full Title: A two-cohort, open-label, single arm, multicenter study to evaluate efficacy, safety and tolerability, pharmacokinetics and pharmacodynamics, of emapalumab in children and adults with macrophage ac...
    Medical condition: Macrophage activation syndrome (MAS) in the context of Systemic juvenile inflammatory arthritis (sJIA) and Adult onset Still’s disease (AOSD). MAS in the context of pediatric and adult Systemic lup...
    Disease: Version SOC Term Classification Code Term Level
    21.1 10021428 - Immune system disorders 10071583 Haemophagocytic lymphohistiocytosis PT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) FR (Completed) IT (Trial now transitioned) PL (Completed) DE (Completed) CZ (Trial now transitioned) BE (Completed) SE (Completed) NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-001167-93 Sponsor Protocol Number: Sobi.IMMUNO-101 Start Date*: 2020-03-27
    Sponsor Name:SWEDISH ORPHAN BIOVITRUM AB (PUBL)
    Full Title: A phase 2/3, randomized, open-label, parallel group, 3-arm, multicenter study investigating the efficacy and safety of intravenous administrations of emapalumab, an anti-interferon gamma (anti-IFN¿...
    Medical condition: SARS-CoV-2 infection
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10021881 Infections and infestations SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-004223-23 Sponsor Protocol Number: NI-0501-06 Start Date*: 2017-04-14
    Sponsor Name:Novimmune SA
    Full Title: A pilot, open-label, single arm, multicenter study to evaluate safety, tolerability, pharmacokinetics and efficacy of intravenous administrations of NI-0501, an anti-interferon gamma (anti-IFNγ) mo...
    Medical condition: Macrophage activation syndrome / Secondary hemophagocytic lymphohistiocytosis (MAS/sHLH) in patients with Systemic Juvenile Idiopathic Arthritis (sJIA)
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004851 10053867 Macrophage activation syndrome LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: IT (Completed) FR (Completed) GB (GB - no longer in EU/EEA) ES (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2012-005753-23 Sponsor Protocol Number: NI-0501-05 Start Date*: 2013-06-19
    Sponsor Name:NovImmune SA
    Full Title: A multicentre study for the long-term follow-up of HLH patients who received treatment with NI-0501, an anti-interferon gamma monoclonal antibody.
    Medical condition: haemophagocytic lymphohistiocytosis
    Disease: Version SOC Term Classification Code Term Level
    17.1 10010331 - Congenital, familial and genetic disorders 10010331 Congenital, familial and genetic disorders SOC
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: IT (Completed) CZ (Completed) DE (Completed) ES (Completed) AT (Completed) SE (Completed) GB (GB - no longer in EU/EEA) FR (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2012-003632-23 Sponsor Protocol Number: NI-0501-04 Start Date*: 2016-02-24
    Sponsor Name:NovImmune SA
    Full Title: A Phase 2/3, Open-label, Single Arm, Multicentre Study to Assess Safety, Tolerability, Pharmacokinetics and Efficacy of Intravenous Multiple Administrations of NI-0501, an Anti-interferon Gamma (An...
    Medical condition: Haemophagocytic lymphohistiocytosis
    Disease: Version SOC Term Classification Code Term Level
    19.0 10010331 - Congenital, familial and genetic disorders 10010331 Congenital, familial and genetic disorders SOC
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed) IT (Completed) AT (Completed) CZ (Completed) DE (Completed) ES (Prematurely Ended) SE (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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