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Clinical trials for ABX464

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: ABX464. Displaying page 1 of 1.
    EudraCT Number: 2021-004398-30 Sponsor Protocol Number: ABX464-108 Start Date*: 2021-11-29
    Sponsor Name:Abivax
    Full Title: A follow-up Phase II open-label study to evaluate the long-term safety and efficacy profile of ABX464 given at 25 mg once daily in subjects with Moderate to Severe Active Ulcerative Colitis
    Medical condition: Moderate to Severe Ulcerative Colitis
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10066678 Acute ulcerative colitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Trial now transitioned) HU (Trial now transitioned) SK (Trial now transitioned) BE (Trial now transitioned) AT (Trial now transitioned) SI (Trial now transitioned) FR (Trial now transitioned) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-003558-26 Sponsor Protocol Number: ABX464-103 Start Date*: 2019-12-10
    Sponsor Name:ABIVAX
    Full Title: A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with...
    Medical condition: Moderate to Severe Ulcerative Colitis
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10066678 Acute ulcerative colitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) SI (Completed) CZ (Completed) DE (Completed) SK (Completed) HU (Completed) PL (Completed) BE (Completed) GB (GB - no longer in EU/EEA) IT (Completed)
    Trial results: View results
    EudraCT Number: 2018-004677-27 Sponsor Protocol Number: ABX464-301 Start Date*: 2019-09-16
    Sponsor Name:Abivax
    Full Title: Phase IIa randomized, double blind, placebo controlled, parallel group, multiple dose study on ABX464 in combination with methotrexate (MTX), in patients with moderate to severe active Rheumatoid A...
    Medical condition: Rheumatoid Arthritis
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004859 10003268 Arthritis rheumatoid LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed) HU (Completed)
    Trial results: View results
    EudraCT Number: 2019-001578-27 Sponsor Protocol Number: ABX464-302 Start Date*: 2019-10-15
    Sponsor Name:Abivax
    Full Title: A follow-up Phase 2a open-label study to evaluate the long-term safety and efficacy profile of ABX464 in patients with moderate to severe active Rheumatoid Arthritis.
    Medical condition: Rheumatoid Arthritis
    Disease: Version SOC Term Classification Code Term Level
    23.1 100000004859 10003268 Arthritis rheumatoid LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-003284-35 Sponsor Protocol Number: ABX464-102 Start Date*: 2017-12-19
    Sponsor Name:ABIVAX
    Full Title: A follow-up Phase IIa study to evaluate the long-term safety and efficacy profile of ABX464 given at 50 mg once daily in subjects with Moderate to Severe Active Ulcerative Colitis.
    Medical condition: Moderate to severe Ulcerative Colitis.
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10066678 Acute ulcerative colitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) HU (Completed) PL (Completed) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-004195-30 Sponsor Protocol Number: ABX464-004 Start Date*: 2016-05-24
    Sponsor Name:Abivax
    Full Title: A multi-center, randomized, double-blind, placebo-controlled Phase IIa trial to compare the safety of ABX464 given at a fixed dose to placebo in fully controlled HIV infected patients treated with ...
    Medical condition: Human Immunodeficiency Virus (HIV)
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004862 10020443 Human immunodeficiency virus syndrome LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed) ES (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2017-000937-30 Sponsor Protocol Number: ABX464-101 Start Date*: 2017-09-29
    Sponsor Name:ABIVAX
    Full Title: A Phase IIa study to evaluate the safety and efficacy of ABX464 50 mg once daily versus Placebo in subjects with Moderate to Severe Active Ulcerative Colitis who have failed or are intolerant to im...
    Medical condition: Moderate to severe Ulcerative Colitis.
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10066678 Acute ulcerative colitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) HU (Completed) FR (Completed) DE (Completed) PL (Completed) ES (Prematurely Ended) AT (Completed)
    Trial results: View results
    EudraCT Number: 2019-000733-39 Sponsor Protocol Number: ABX464-104 Start Date*: 2019-11-21
    Sponsor Name:ABIVAX
    Full Title: A phase 2b, open-label, efficacy and safety study of ABX464 as maintenance therapy in patients with moderate to severe Ulcerative Colitis.
    Medical condition: Moderate to Severe Ulcerative Colitis
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10066678 Acute ulcerative colitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SK (Completed) PL (Completed) AT (Completed) SI (Completed) BE (Completed) CZ (Completed) ES (Ongoing) HU (Completed) GB (GB - no longer in EU/EEA) FR (Completed) DE (Completed) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-001673-75 Sponsor Protocol Number: ABX464-401 Start Date*: 2020-05-06
    Sponsor Name:ABIVAX
    Full Title: A phase 2/3, randomized, double blind, placebo-controlled study to evaluate the efficacy and the safety of ABX464 in treating inflammation and preventing COVID-19 associated acute respiratory failu...
    Medical condition: COVID-19 infection (infection with SARS-CoV-2 virus)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Prematurely Ended) DE (Completed) GB (GB - no longer in EU/EEA) ES (Prematurely Ended) BE (Prematurely Ended) IT (Prematurely Ended)
    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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