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Clinical trials for Dapansutrile

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   44339   clinical trials with a EudraCT protocol, of which   7369   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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    4 result(s) found for: Dapansutrile. Displaying page 1 of 1.
    EudraCT Number: 2019-002717-19 Sponsor Protocol Number: OLT1177-08 Start Date*: 2023-03-20
    Sponsor Name:Olatec Therapeutics LLC
    Full Title: A Multi-Center Phase 2/3 Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Safety and Efficacy Study of Dapansutrile Tablets in Subjects with an Acute Gout Flare
    Medical condition: Treatment of Acute Gout Flare
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004861 10064900 Gout flare LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-003282-98 Sponsor Protocol Number: OLT1177-07 Start Date*: 2018-03-07
    Sponsor Name:Olatec Therapeutics LLC
    Full Title: A Pilot, Open-Label, Phase 2, Single-Center, Repeat Dose, Proof-of-Concept Safety, Pharmacodynamics and Efficacy Study of Orally Administered Dapansutrile Capsules in Subjects with Schnitzler’s Syn...
    Medical condition: Schnitzler's 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: NL (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2020-005227-37 Sponsor Protocol Number: OLT1177-10 Start Date*: 2021-03-03
    Sponsor Name:Olatec Therapeutics LLC
    Full Title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of Orally Administered Dapansutrile Capsules for the Treatment of Moderate COVID-19 Symptoms and Evidence of ...
    Medical condition: COVID-19, cytokine release syndrome
    Disease: Version SOC Term Classification Code Term Level
    23.1 10042613 - Surgical and medical procedures 10084460 COVID-19 treatment PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-000943-14 Sponsor Protocol Number: OLT1177-05 Start Date*: 2017-02-23
    Sponsor Name:Olatec Therapeutics LLC
    Full Title: A Phase 2 Single-Center, Proof-of-Concept Safety and Efficacy Study of Orally Administered OLT1177 Capsules with Successive, Result-Dependent Dose Adaptation in Subjects with an Acute Gout Flare
    Medical condition: Acute gout flare
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004861 10018628 Gout acute LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
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    Query did not match any studies.
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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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