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Clinical trials for Autoinflammatory syndrome

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   44364   clinical trials with a EudraCT protocol, of which   7388   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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    17 result(s) found for: Autoinflammatory syndrome. Displaying page 1 of 1.
    EudraCT Number: 2015-004292-69 Sponsor Protocol Number: MEFV01 Start Date*: 2016-01-12
    Sponsor Name:UZ Leuven
    Full Title: Anakinra (Kineret®) for a hereditary autoinflammatory disease with MEFV mutation and inflammasome activation.
    Medical condition: hereditary autoinflammatory disease with MEFV mutation and inflammasome activation
    Disease:
    Population Age: Adults Gender: Male
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2015-003490-15 Sponsor Protocol Number: CACZ885D2308 Start Date*: 2016-04-14
    Sponsor Name:Novartis Pharmaceuticals
    Full Title: An Open-label, Efficacy and Safety Study of Canakinumab (Anti-interleukin-1β Monoclonal Antibody) Administered for 6 Months (24 Weeks) in Japanese Patients With the Following Cryopyrin-associated P...
    Medical condition: Cryopyrin-associated Periodic Syndromes Familial Cold Autoinflammatory Syndrome Muckle-Wells Syndrome Neonatal Onset Multisystem Inflammatory Disease
    Disease: Version SOC Term Classification Code Term Level
    19.0 10010331 - Congenital, familial and genetic disorders 10064570 Familial cold autoinflammatory syndrome PT
    19.0 10010331 - Congenital, familial and genetic disorders 10064574 NOMID LLT
    19.0 10010331 - Congenital, familial and genetic disorders 10068850 Cryopyrin associated periodic syndrome PT
    19.0 10010331 - Congenital, familial and genetic disorders 10064569 Muckle-Wells syndrome PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2010-024156-28 Sponsor Protocol Number: CACZ885DDE03T Start Date*: 2011-05-16
    Sponsor Name:Charité - University Hospital of Berlin
    Full Title: A multi-center, double-blind, placebo-controlled phase II study of the efficacy and safety of canakinumab in subjects with Schnitzler syndrome
    Medical condition: Schnitzler syndrome
    Disease: Version SOC Term Classification Code Term Level
    20.0 10040785 - Skin and subcutaneous tissue disorders 10062908 Schnitzler's syndrome PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2007-004367-22 Sponsor Protocol Number: CACZ885D2306 Start Date*: 2008-05-01
    Sponsor Name:Novartis Pharma Services AG
    Full Title: An open-label, long-term safety and efficacy study of ACZ885 (anti-interleukin-1β monoclonal antibody) administered for at least 6 months in patients with the following cryopyrin-associated periodi...
    Medical condition: The following cryopyrin-associated periodic syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Neonatal Onset Multisystem Inflammatory Disease
    Disease: Version SOC Term Classification Code Term Level
    9.1 10064569 Muckle-Wells syndrome LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) FR (Completed) ES (Completed) IT (Prematurely Ended) BE (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2019-001235-31 Sponsor Protocol Number: DEALSZ-2019-001 Start Date*: 2019-11-26
    Sponsor Name:Charité – Universitätsmedizin Berlin
    Full Title: Factor XII-associated cold autoinflammatory syndrome (FACAS) linked to kallikrein-kinin pathology: Proof of concept treatment with Lanadelumab (DX-2930)
    Medical condition: Lanadelumab in patients with Factor XII-associated cold autoinflammatory syndrome (FACAS)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021428 - Immune system disorders 10072220 Autoinflammatory disease PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-005948-33 Sponsor Protocol Number: CDFV890A12201 Start Date*: 2021-07-26
    Sponsor Name:Novartis Pharma AG
    Full Title: An open-label, single arm phase II study of DFV890 to assess the safety, tolerability and efficacy in participants with familial cold auto-inflammatory syndrome (FCAS)
    Medical condition: Familial Cold Autoinflammatory Syndrome (FCAS)
    Disease: Version SOC Term Classification Code Term Level
    25.1 10010331 - Congenital, familial and genetic disorders 10068850 Cryopyrin associated periodic syndrome PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) IT (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2006-005455-15 Sponsor Protocol Number: CACZ885D2304 Start Date*: 2007-06-13
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A three-part multicenter study, with a randomized, doubleblind, placebo controlled, withdrawal design in Part II to assess efficacy, safety, and tolerability of ACZ885 (antiinterleukin-1β monoclona...
    Medical condition: Muckle-Wells Syndrome (Autoinflammatory Disease)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10064569 Muckle-Wells syndrome LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) FR (Completed) GB (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2004-002980-26 Sponsor Protocol Number: CACZ885A2102 Start Date*: 2004-12-10
    Sponsor Name:Novartis Pharma Services AG
    Full Title: An open-label, phase II dose titration study of ACZ885 (human anti-IL-1beta monoclonal antibody) to assess the clinical efficacy, safety, pharmacokinetics and pharmacodynamics in patients with NALP...
    Medical condition: Muckle-Wells Syndrome: rare hereditary, autosomal dominant, systemic inflammatory disease, characterized by recurrent episodes of fever, arthralgia, myalgia, urticarial rash, and conjunctivitis. La...
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) ES (Completed) FR (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2011-005154-57 Sponsor Protocol Number: CACZ885D2307E1 Start Date*: 2012-01-03
    Sponsor Name:Novartis Pharma Services AG
    Full Title: An open-label extension study to assess efficacy, safety and tolerability of canakinumab and the efficacy and safety of childhood vaccinations in patients with Cryopyrin Associated Periodic Syndrom...
    Medical condition: Cryopyrin Associated Periodic Syndromes (CAPS)
    Disease: Version SOC Term Classification Code Term Level
    14.0 10010331 - Congenital, familial and genetic disorders 10068850 Cryopyrin associated periodic syndrome PT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed) FR (Completed) ES (Completed) DE (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2010-021166-30 Sponsor Protocol Number: 2010-SS-Canakinumab Start Date*: 2010-11-25
    Sponsor Name:Radboud University Nijmegen Medical Centre
    Full Title: Efficacy and safety of canakinumab in Schnitzler syndrome
    Medical condition: Schnitzler syndrome is an acquired autoinflammatory syndrome characterized by urticaria and monoclonal gammopathy, accompanied by intermittent fever, arthralgia or arthritis, bone pain and lymphade...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2015-003491-69 Sponsor Protocol Number: CACZ885DCA01 Start Date*: 2016-04-14
    Sponsor Name:Novartis Pharmaceuticals
    Full Title: An Open Label Study to Assess the Safety, Tolerability and Efficacy of Canakinumab (ACZ885) in Patients Aged 4 Years or Older Diagnosed With Cryopyrin-associated Periodic Syndromes (CAPS) in Canada
    Medical condition: Cryopyrin Associated Periodic Syndrome
    Disease: Version SOC Term Classification Code Term Level
    19.0 10010331 - Congenital, familial and genetic disorders 10068850 Cryopyrin associated periodic syndrome PT
    Population Age: Children, Under 18, Adults Gender: Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-003828-23 Sponsor Protocol Number: ML39310 Start Date*: 2017-04-11
    Sponsor Name:Charité - Universitätsmedizin Berlin; Dpt. of Dermatology and Allergy
    Full Title: A pilot open-label study to assess the efficacy and safety of tocilizumab (TCZ) in patients with active Schnitzler’s syndrome (SchS)
    Medical condition: Schnitzler’s syndrome (SchS)
    Disease: Version SOC Term Classification Code Term Level
    19.1 10040785 - Skin and subcutaneous tissue disorders 10062908 Schnitzler's syndrome PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2013-001849-13 Sponsor Protocol Number: 2013/cardio3 Start Date*: 2013-07-09
    Sponsor Name:ASLTO2-Maria Vittoria Hospital Cardiology
    Full Title: AnakInRa Treatment of Recurrent Idiopathic Pericarditis
    Medical condition: idiopathic recurrent pericarditis
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-003424-31 Sponsor Protocol Number: I4V-MC-JAGA Start Date*: Information not available in EudraCT
    Sponsor Name:Eli Lilly and Company
    Full Title: Treatment of Conditions Expected to Benefit from JAK 1/2 Inhibition: CANDLE, CANDLE-Related Conditions, SAVI, and Severe Juvenile Dermatomyositis
    Medical condition: CANDLE, CANDLE-Related Conditions, SAVI, and Severe Juvenile Dermatomyositis, Aicardi-Goutieres Syndrome
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2025-000001-16 Sponsor Protocol Number: I4V-JE-JAJE Start Date*: 2025-02-19
    Sponsor Name:Eli Lilly and Company
    Full Title: A Phase 2/3, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Baricitinib in Adult and Pediatric Japanese Patients with NNS/CANDLE, SAVI, and AGS
    Medical condition: Nakajo-Nishimura Syndrome, Chronic Atypical Neutrophilic Dermatosis with Lipodystrophy and Elevated Temperature Syndrome, STING-Associated Vasculopathy with Onset in Infancy, Aicardi Goutieres Sy...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10073960 CANDLE syndrome PT
    21.1 10047065 - Vascular disorders 10047115 Vasculitis PT
    27.1 10010331 - Congenital, familial and genetic disorders 10054935 Aicardi's syndrome PT
    Population Age: Children, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2020-000489-40 Sponsor Protocol Number: IZD174-002 Start Date*: 2020-09-22
    Sponsor Name:Inflazome (Australia) Pty Ltd.
    Full Title: A Multi-Centre, Randomised, Open-Label, Phase IIb Study to Evaluate the Safety, Tolerability and Efficacy of IZD174 in Patients with Cryopyrin Associated Periodic Syndromes
    Medical condition: Cryopyrin-associated periodic syndrome (CAPS)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10068850 Cryopyrin associated periodic syndrome PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2009-016859-22 Sponsor Protocol Number: CACZ885D2307 Start Date*: 2013-02-04
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A one-year open-label, multicenter trial to assess efficacy, safety and tolerability of canakinumab (ACZ885) and the efficacy and safety of childhood vaccinations in patients aged 4 years or younge...
    Medical condition: Cryopyrin Associated Periodic Syndromes (CAPS)
    Disease: Version SOC Term Classification Code Term Level
    12.1 10068850 Cryopyrin associated periodic syndrome LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed) DE (Completed) ES (Completed) GB (Completed) BE (Completed) Outside EU/EEA IE (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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