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Clinical trials for Lanadelumab

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   44336   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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    12 result(s) found for: Lanadelumab. Displaying page 1 of 1.
    EudraCT Number: 2020-002472-12 Sponsor Protocol Number: UMCN-AKF20.04 Start Date*: 2020-06-11
    Sponsor Name:Radboud University Medical Center
    Full Title: Lanadelumab for treatment of COVID-19 disease
    Medical condition: COVID-19
    Disease: Version SOC Term Classification Code Term Level
    23.0 10021881 - Infections and infestations 10084268 COVID-19 PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-002093-42 Sponsor Protocol Number: SHP643-301 Start Date*: 2020-02-04
    Sponsor Name:Shire (Shire is now part of Takeda)
    Full Title: SPRING STUDY: An Open-Label, Multicenter, Phase 3 Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Lanadelumab for Prevention Against Acute Attacks of Hereditary Angioedema (...
    Medical condition: Hereditary Angioedema (HAE)
    Disease: Version SOC Term Classification Code Term Level
    23.1 10010331 - Congenital, familial and genetic disorders 10019860 Hereditary angioedema PT
    23.1 10010331 - Congenital, familial and genetic disorders 10075280 Hereditary angioedema attack LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) HU (Completed) ES (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2023-001105-31 Sponsor Protocol Number: SHP643-304 Start Date*: 2024-04-26
    Sponsor Name:Takeda
    Full Title: A Multi-center, Open-label Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Lanadelumab (SHP643) in Chinese Subjects with Hereditary Angioedema
    Medical condition: Hereditary Angioedema (HAE)
    Disease:
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2022-002621-98 Sponsor Protocol Number: SHP643-302 Start Date*: 2022-08-19
    Sponsor Name:Takeda
    Full Title: A Phase 3 Multi-center, Open-label Study to Evaluate the Efficacy and Safety of Lanadelumab (SHP643) in Japanese Subjects with Hereditary Angioedema
    Medical condition: Hereditary Angioedema (HAE)
    Disease: Version SOC Term Classification Code Term Level
    23.1 10010331 - Congenital, familial and genetic disorders 10075280 Hereditary angioedema attack LLT
    23.1 10010331 - Congenital, familial and genetic disorders 10019860 Hereditary angioedema PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2018-004136-30 Sponsor Protocol Number: DEALSZ-2018-001 Start Date*: 2019-07-02
    Sponsor Name:Charité - Universitätsmedizin Berlin Klinik für Dermatologie und Allergologie
    Full Title: An Open-Label, Pilot Study to assess the effect of Lanadelumab on the clinical signs and symptoms of Hereditary angioedema with normal C1-inhibitor
    Medical condition: Lanadelumab in patients with Hereditary angioedema
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10019860 Hereditary angioedema PT
    20.0 10010331 - Congenital, familial and genetic disorders 10074782 Hereditary angioedema breakthrough attack LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    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: 2019-004823-20 Sponsor Protocol Number: TAK-743-3001 Start Date*: 2021-07-22
    Sponsor Name:Takeda Development Center Americas (TDCA)
    Full Title: An Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Lanadelumab for Prevention Against Acute Attacks of Non-histaminergic Angioedema with Normal C1-Inhibitor (C1-INH)
    Medical condition: non-histaminergic angioedema with normal C1-INH
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004858 10002425 Angioedemas HLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) HU (Completed) PL (Completed) NL (Completed) IT (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2019-001703-20 Sponsor Protocol Number: SHP643-303 Start Date*: 2020-08-28
    Sponsor Name:Dyax Corporation, a Takeda company
    Full Title: A Phase 3, Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy and Safety of Lanadelumab for Prevention Against Acute Attacks of Non-histaminergic Angioedema wi...
    Medical condition: non-histaminergic angioedema with normal C1-INH and acquired angioedema due to C1-INH deficiency
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004858 10002425 Angioedemas HLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Completed) HU (Completed) PL (Completed) IT (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2015-005255-27 Sponsor Protocol Number: DX-2930-04 Start Date*: 2016-11-30
    Sponsor Name:Dyax Corp. (an indirect, wholly-owned subsidiary of Shire plc.)
    Full Title: HELP Study ExtensionTM: An Open-Label Study to Evaluate the Long-Term Safety and Efficacy of DX-2930 for Prevention Against Acute Attacks of Hereditary Angioedema (HAE)
    Medical condition: Type I and Type II Hareditary Angioedema (HAE)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10075280 Hereditary angioedema attack LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2015-003943-20 Sponsor Protocol Number: DX-2930-03 Start Date*: 2016-03-31
    Sponsor Name:Dyax Corp., an indirect, wholly-owned subsidiary of Shire plc.
    Full Title: HELP Study™: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study to Evaluate DX 2930 For Long-Term Prophylaxis Against Acute Attacks of Hereditary Angioedema (HAE)
    Medical condition: Hereditary angioedema (HAE)
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004850 10075280 Hereditary angioedema attack LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2022-000757-93 Sponsor Protocol Number: ISIS721744-CS7 Start Date*: 2022-09-05
    Sponsor Name:IONIS PHARMACEUTICALS, INC.
    Full Title: An Open-Label, Long Term Safety and Efficacy Study of Donidalorsen in the Prophylactic Treatment of Hereditary Angioedema (HAE)
    Medical condition: Hereditary Angioedema (HAE)
    Disease: Version SOC Term Classification Code Term Level
    23.1 10010331 - Congenital, familial and genetic disorders 10019860 Hereditary angioedema PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) ES (Ongoing) BE (Trial now transitioned) IT (Trial now transitioned) DE (Trial now transitioned) NL (Ongoing) DK (Completed) PL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-001226-21 Sponsor Protocol Number: KVD900-301 Start Date*: 2022-12-01
    Sponsor Name:KalVista Pharmaceuticals Ltd
    Full Title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3, Three-way Crossover Trial to Evaluate the Efficacy and Safety of Two Dose Levels of KVD900, an Oral Plasma Kallikrein Inhibitor, for On-Dema...
    Medical condition: Hereditary Angioedema Type I or II
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004850 10080956 Hereditary angioedema type I LLT
    26.0 100000004850 10080960 Hereditary angioedema type II LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) HU (Completed) GR (Completed) IT (Completed) ES (Ongoing) NL (Completed) BG (Completed) PL (Completed) PT (Completed) SK (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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