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Clinical trials for Brodalumab

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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    17 result(s) found for: Brodalumab. Displaying page 1 of 1.
    EudraCT Number: 2018-001021-10 Sponsor Protocol Number: SAHL1011 Start Date*: 2018-08-06
    Sponsor Name:Sahlgrenska University Hospital
    Full Title: Brodalumab in a randomised, open, phase IV study evaluating clinical efficacy in psoriasis patients switching from TNF-alpha inhibitor treatment
    Medical condition: Moderate to severe plaque psoriasis
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004858 10071117 Plaque psoriasis LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: SE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-000667-24 Sponsor Protocol Number: 20120104 Start Date*: 2012-06-26
    Sponsor Name:Amgen Inc.
    Full Title: A Phase 3 Study to Evaluate the Efficacy and Safety of Induction and Maintenance Regimens of Brodalumab Compared With Placebo and Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis: A...
    Medical condition: Moderate to severe plaque psoriasis
    Disease: Version SOC Term Classification Code Term Level
    18.0 10040785 - Skin and subcutaneous tissue disorders 10037153 Psoriasis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PL (Prematurely Ended) BE (Completed) HU (Completed) GR (Prematurely Ended) LV (Prematurely Ended) IT (Completed)
    Trial results: View results
    EudraCT Number: 2017-004998-13 Sponsor Protocol Number: LP0160-1329 Start Date*: 2020-06-02
    Sponsor Name:LEO Pharma A/S
    Full Title: Adjustable brodalumab dosage regimen compared with standard brodalumab treatment for 52 weeks in subjects with moderate-to-severe plaque psoriasis and ≥120 kg body weight
    Medical condition: moderate-to-severe plaque psoriasis and a body weight ≥120 kg.
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004858 10071117 Plaque psoriasis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) DE (Trial now transitioned) DK (Prematurely Ended) GB (GB - no longer in EU/EEA) BE (Trial now transitioned) IT (Trial now transitioned) HU (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2012-000656-34 Sponsor Protocol Number: 20120103 Start Date*: 2012-07-18
    Sponsor Name:Amgen Inc.
    Full Title: A Phase 3 Study to Evaluate the Efficacy and Safety of Induction and Maintenance Regimens of Brodalumab Compared With Placebo and Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis: A...
    Medical condition: Moderate to severe plaque psoriasis
    Disease: Version SOC Term Classification Code Term Level
    17.1 10040785 - Skin and subcutaneous tissue disorders 10037153 Psoriasis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PL (Prematurely Ended) CZ (Prematurely Ended) PT (Prematurely Ended) AT (Prematurely Ended) HU (Completed) NL (Prematurely Ended) ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2014-003701-15 Sponsor Protocol Number: 20101228 Start Date*: 2015-05-01
    Sponsor Name:Amgen Inc.
    Full Title: A Randomized, Double-blind, Placebo-controlled Study With an Open Label Extension to Evaluate the Safety and Efficacy of Brodalumab in Subjects With Axial Spondyloarthritis
    Medical condition: Axial Spondyloarthritis
    Disease: Version SOC Term Classification Code Term Level
    18.0 10028395 - Musculoskeletal and connective tissue disorders 10051265 Spondyloarthropathy PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2012-000651-13 Sponsor Protocol Number: 20120102 Start Date*: 2012-06-27
    Sponsor Name:Amgen Inc.
    Full Title: A Phase 3 Study to Evaluate the Efficacy, Safety, and Effect of Withdrawal and Retreatment With Brodalumab in Subjects With Moderate to Severe Plaque Psoriasis: AMAGINE-1
    Medical condition: Moderate to severe plaque psoriasis
    Disease: Version SOC Term Classification Code Term Level
    18.0 10040785 - Skin and subcutaneous tissue disorders 10037153 Psoriasis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PL (Prematurely Ended) DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2019-001868-30 Sponsor Protocol Number: LP0160-1396 Start Date*: 2020-08-04
    Sponsor Name:LEO Pharma A/S
    Full Title: A phase 3, randomised, double-blind, multi-centre trial to evaluate the efficacy, safety, and tolerability of brodalumab treatment compared to placebo (blinded) and ustekinumab (open-label) in adol...
    Medical condition: Moderate-to-severe plaque psoriasis in adolescents from 12 to 17 years of age
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004858 10071117 Plaque psoriasis LLT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed) DE (Prematurely Ended) GB (GB - no longer in EU/EEA) NL (Completed) BE (Completed) IT (Prematurely Ended) HU (Prematurely Ended) PL (Completed)
    Trial results: View results
    EudraCT Number: 2013-003554-25 Sponsor Protocol Number: 20090406 Start Date*: 2014-01-14
    Sponsor Name:Amgen Inc.
    Full Title: A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy, Safety and Effect on Radiographic Progression of Brodalumab in Subjects with Psoriatic Arthritis: AMVISION-1
    Medical condition: Psoriatic Arthritis
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004859 10037160 Psoriatic arthritis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GR (Prematurely Ended) CZ (Prematurely Ended) BE (Completed) HU (Prematurely Ended) IT (Completed) GB (Prematurely Ended) ES (Prematurely Ended) SK (Prematurely Ended) EE (Prematurely Ended) BG (Prematurely Ended) FR (Completed)
    Trial results: View results
    EudraCT Number: 2019-004099-20 Sponsor Protocol Number: LP0160-1510 Start Date*: 2020-11-25
    Sponsor Name:LEO Pharma A/S
    Full Title: Efficacy and safety comparison of brodalumab versus guselkumab in adult subjects with moderate-to-severe plaque psoriasis and inadequate response to ustekinumab.
    Medical condition: adult subjects with moderate-to-severe plaque psoriasis
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004858 10071117 Plaque psoriasis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (GB - no longer in EU/EEA) BE (Completed) AT (Prematurely Ended) FR (Prematurely Ended) NL (Prematurely Ended) GR (Prematurely Ended) DK (Completed) CZ (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-003553-16 Sponsor Protocol Number: 20110144 Start Date*: 2014-01-14
    Sponsor Name:Amgen Inc.
    Full Title: A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of Brodalumab in Subjects with Psoriatic Arthritis: AMVISION-2
    Medical condition: Psoriatic Arthritis
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004859 10037160 Psoriatic arthritis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GR (Prematurely Ended) DE (Prematurely Ended) HU (Completed) LV (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-003867-21 Sponsor Protocol Number: LP0160-1327 Start Date*: 2017-10-30
    Sponsor Name:LEO Pharma A/S
    Full Title: A phase 4 trial comparing the efficacy of subcutaneous injections of brodalumab to oral administrations of fumaric acid esters in adults with moderate to severe plaque psoriasis
    Medical condition: moderate to severe plaque psoriasis
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004858 10050576 Psoriasis vulgaris LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2012-003351-11 Sponsor Protocol Number: 20120141 Start Date*: 2013-03-08
    Sponsor Name:Amgen Inc.
    Full Title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Brodalumab in Subjects With Inadequately Controlled Asthma and High Bronchodilator Reversibility
    Medical condition: Asthma
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004855 10003561 Asthma, unspecified LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) IE (Prematurely Ended) IT (Completed) GR (Prematurely Ended) PL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2018-000097-30 Sponsor Protocol Number: 2018-PSO-IL17R Start Date*: 2018-04-18
    Sponsor Name:Herlev and Gentofte Hospital
    Full Title: Efficacy of brodalumab in patients with psoriasis with failure of other anti-IL-17 treatments
    Medical condition: Psoriasis
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004858 10050576 Psoriasis vulgaris LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2021-003785-13 Sponsor Protocol Number: KTDIIS02 Start Date*: 2021-11-19
    Sponsor Name:Karolinska Universitetssjukhuset
    Full Title: An investigator-initiated, open label trial to investigate efficacy of brodalumab in eczematized psoriasis (BRodalumab in Eczematized PSOriasis)
    Medical condition: eczematized psoriasis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-003697-14 Sponsor Protocol Number: PsoPET2 Start Date*: 2017-12-18
    Sponsor Name:Aarhus University Hospital
    Full Title: A randomised, double-blind, placebo-controlled, trial to evaluate the efficacy of brodalumab monotherapy on vascular and systemic inflammation by 18F-FDG-PET/CT in subjects with moderate-to-sever...
    Medical condition: Moderate-to-severe psoriasis. Vascular and systemic (splenic) inflammation in psoriasis subjects.
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004858 10050576 Psoriasis vulgaris LLT
    20.0 100000004866 10003605 Atherosclerosis of aorta LLT
    20.0 100000004851 10041634 Spleen disorder NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2019-004230-42 Sponsor Protocol Number: 18562 Start Date*: 2020-07-31
    Sponsor Name:Radboudumc
    Full Title: Dose reduction of the new generation biologics (IL17 and IL23 inhibitors) in psoriasis: A pragmatic, multicentre, randomized, controlled, non-inferiority study - BeNeBio study
    Medical condition: psoriasis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10040785 - Skin and subcutaneous tissue disorders 10037153 Psoriasis PT
    20.0 10040785 - Skin and subcutaneous tissue disorders 10037155 Psoriasis and similar disorders LLT
    20.0 10040785 - Skin and subcutaneous tissue disorders 10050576 Psoriasis vulgaris LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2009-016163-12 Sponsor Protocol Number: 20090403 Start Date*: 2010-07-02
    Sponsor Name:Amgen Inc
    Full Title: A Long-term Assessment of the Safety and Efficacy of AMG 827 Subcutaneous Treatment in Subjects with Psoriasis.
    Medical condition: Moderate to severe plaque psoriasis
    Disease: Version SOC Term Classification Code Term Level
    17.0 10040785 - Skin and subcutaneous tissue disorders 10037153 Psoriasis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (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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