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Clinical trials for APDS

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   43846   clinical trials with a EudraCT protocol, of which   7282   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: APDS. Displaying page 1 of 1.
    EudraCT Number: 2015-002900-10 Sponsor Protocol Number: APD001 Start Date*: 2016-01-29
    Sponsor Name:UCB Celltech, UK Registered Branch of UCB Pharma SA
    Full Title: AN OPEN-LABEL EXPLORATORY STUDY OF UCB5857 IN SUBJECTS WITH ACTIVATED PHOSPHOINOSITIDE 3 KINASE (PI3K) DELTA SYNDROME (APDS)
    Medical condition: Activated PI3K delta Syndrome (APDS)
    Disease:
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: IT (Completed) DE (Completed) ES (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2016-000468-41 Sponsor Protocol Number: CCDZ173X2201E1 Start Date*: 2016-07-19
    Sponsor Name:Pharming Technologies B.V.
    Full Title: An open-label, non-randomized extension study to evaluate the long term safety, tolerability, efficacy and pharmacokinetics of CDZ173 (leniolisib) in patients with APDS/PASLI (Activated phosphoinos...
    Medical condition: APDS/PASLI (Activated phosphoinositide 3-kinase delta syndrome/p110δ-activating mutation causing senescent T cells, lymphadenopathy and immunodeficiency)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10064859 Primary immunodeficiency syndrome PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Ongoing) NL (Ongoing) IE (Completed) GB (GB - no longer in EU/EEA) FR (Completed) DE (Ongoing) IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-003876-22 Sponsor Protocol Number: CCDZ173X2201 Start Date*: Information not available in EudraCT
    Sponsor Name:Novartis Pharma Services AG
    Full Title: An open-label, non-randomized, within-patient dose-finding study followed by a randomized, subject, investigator and sponsor-blinded placebo controlled study to assess the efficacy and safety of CD...
    Medical condition: APDS/PASLI (Activated phosphoinositide 3-kinase delta syndrome/ p110δ-activating mutation causing senescent T cells, lymphadenopathy and immunodeficiency)
    Disease:
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) CZ (Completed) NL (Completed) IE (Completed) FR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2015-004876-31 Sponsor Protocol Number: 204745 Start Date*: 2016-03-28
    Sponsor Name:GlaxoSmithKline Research & Development Ltd
    Full Title: An open-label, single arm study to investigate the safety, pharmacokinetics and pharmacodynamics of repeat doses of inhaled nemiralisib in patients with APDS/PASLI
    Medical condition: patients with APDS/PASLI
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10024970 Respiratory tract infections HLGT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2015-005541-30 Sponsor Protocol Number: APD003 Start Date*: 2016-08-23
    Sponsor Name:UCB BioPharma SPRL
    Full Title: AN OPEN-LABEL, EXPLORATORY, MULTICENTER, EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY, PHARMACOKINETICS AND EFFICACY OF UCB5857 IN SUBJECTS WITH ACTIVATED PHOSPHOINOSITIDE 3 KINAS...
    Medical condition: Activated PI3K delta Syndrome (APDS)
    Disease:
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Completed) IT (Completed) ES (Prematurely Ended) FR (Completed)
    Trial results: View results
    EudraCT Number: 2022-001624-14 Sponsor Protocol Number: LE3301 Start Date*: Information not available in EudraCT
    Sponsor Name:Pharming Technologies B.V.
    Full Title: An Open-Label, Single Arm Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Leniolisib in Pediatric Patients (Aged 4 to 11 Years) With APDS (Activated Phosphoinositide 3-Kina...
    Medical condition: Activated Phosphoinositide 3-Kinase Delta Syndrome
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10078281 Activated PI3 kinase delta syndrome PT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: FR (Ongoing)
    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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