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Clinical trials for ap1189

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   44366   clinical trials with a EudraCT protocol, of which   7389   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: ap1189. Displaying page 1 of 1.
    EudraCT Number: 2022-002605-26 Sponsor Protocol Number: SynAct-CS006 Start Date*: 2022-12-22
    Sponsor Name:SynAct Pharma ApS
    Full Title: A two-part, randomized, double-blind, multi-center, placebo-controlled study of the dose-range, safety and efficacy of 4 and 12 weeks of treatment with AP1189 in adult rheumatoid arthritis (RA) pat...
    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: BG (Completed)
    Trial results: (No results available)
    EudraCT Number: 2022-001828-15 Sponsor Protocol Number: SynAct-CS007 Start Date*: 2022-09-14
    Sponsor Name:SynAct Pharma ApS
    Full Title: A double-blind, multi-center, randomized, placebo-controlled study of the safety and efficacy of 12 weeks extended treatment with AP1189 in early rheumatoid arthritis (RA) patients naïve to DMARD t...
    Medical condition:
    Disease: Version SOC Term Classification Code Term Level
    23.1 100000004859 10003268 Arthritis rheumatoid LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-001185-15 Sponsor Protocol Number: SynAct-CS002 Start Date*: 2019-06-06
    Sponsor Name:SynAct Pharma ApS
    Full Title: A double-blind, multi-center, two-part, randomized, placebo-controlled study of the safety, tolerability, and efficacy of 4 weeks of treatment with AP1189 in early rheumatoid arthritis (RA) patient...
    Medical condition: rheumatoid arthritis
    Disease: Version SOC Term Classification Code Term Level
    23.1 10028395 - Musculoskeletal and connective tissue disorders 10039073 Rheumatoid arthritis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed) SE (Completed) NO (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2020-000971-18 Sponsor Protocol Number: SynAct-CS003 Start Date*: 2020-05-28
    Sponsor Name:SynAct Pharma ApS
    Full Title: An exploratory, randomized, double-blind, multicenter, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, and efficacy of AP1189 daily doses versus placebo administered ...
    Medical condition: Idiopathic membranous nephropathy and severe proteinuria
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038359 - Renal and urinary disorders 10027170 Membranous nephropathy LLT
    21.1 10038359 - Renal and urinary disorders 10029164 Nephrotic syndrome PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Trial now transitioned) NO (Completed)
    Trial results: (No results available)
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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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