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Clinical trials for Tralokinumab

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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    17 result(s) found for: Tralokinumab. Displaying page 1 of 1.
    EudraCT Number: 2013-005614-35 Sponsor Protocol Number: D2210C00007 Start Date*: 2014-10-14
    Sponsor Name:AstraZeneca AB
    Full Title: A 52-Week, Multicentre, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents with Asthma Inadequ...
    Medical condition: Asthma
    Disease: Version SOC Term Classification Code Term Level
    18.1 10038738 - Respiratory, thoracic and mediastinal disorders 10003553 Asthma PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) HU (Completed) PL (Completed) SK (Completed) BG (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2011-001360-21 Sponsor Protocol Number: CD-RI-CAT-354-1049 Start Date*: 2011-09-07
    Sponsor Name:AstraZeneca AB R&D Mölndal
    Full Title: A Phase 2b, Randomized, Double-blind Study to Evaluate the Efficacy of Tralokinumab in Adults with Uncontrolled, Severe Asthma
    Medical condition: Asthma
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10003553 Asthma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) CZ (Completed) ES (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2013-005615-27 Sponsor Protocol Number: D2210C00008 Start Date*: 2014-09-24
    Sponsor Name:AstraZeneca AB
    Full Title: A 52-Week, Multicentre, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents with Asthma Inadequ...
    Medical condition: Asthma
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10003553 Asthma PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) IT (Completed) CZ (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2011-005503-33 Sponsor Protocol Number: CD-RI-CAT-354-1054 Start Date*: 2012-06-04
    Sponsor Name:MedImmune Ltd
    Full Title: A Phase 1, Open-label Study to Evaluate the Pharmacokinetics of Tralokinumab in Adolescents with Asthma
    Medical condition: Asthma
    Disease: Version SOC Term Classification Code Term Level
    14.1 10038738 - Respiratory, thoracic and mediastinal disorders 10003553 Asthma PT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: PL (Completed)
    Trial results: View results
    EudraCT Number: 2014-003725-17 Sponsor Protocol Number: D2213C00001 Start Date*: 2015-04-15
    Sponsor Name:MedImmune
    Full Title: A Phase 2b, Randomized, Double-blinded, Placebo-controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of Tralokinumab in Adult Subjects with Moderate-to-Severe Atopic Dermatitis
    Medical condition: Atopic Dermatitis
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004858 10003639 Atopic dermatitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2017-005143-33 Sponsor Protocol Number: LP0162-1334 Start Date*: 2018-11-23
    Sponsor Name:LEO Pharma A/S
    Full Title: A randomised, double-blind, placebo-controlled, parallel-group, multi-centre trial to evaluate the efficacy, safety, and tolerability of tralokinumab monotherapy in adolescent subjects with moderat...
    Medical condition: Atopic Dermatitis
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004858 10003639 Atopic dermatitis LLT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed) PL (Completed) DE (Completed) NL (Completed) BE (Completed) GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2019-000598-22 Sponsor Protocol Number: TRA-WEI-0015-I Start Date*: 2020-07-13
    Sponsor Name:University Hospital Schleswig Holstein, Represented by the Board of Directors which is represented by the chairman
    Full Title: Effects of Tralokinumab treatment of atopic dermatitis on skin barrier function (TraSki)
    Medical condition: Patients with moderate to severe atopic dermatitis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10040785 - Skin and subcutaneous tissue disorders 10012438 Dermatitis atopic PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-004200-65 Sponsor Protocol Number: LP0162-1325 Start Date*: 2017-06-28
    Sponsor Name:LEO Pharma A/S
    Full Title: A randomised, double-blind, placebo-controlled, phase 3 trial to evaluate the efficacy and safety of tralokinumab monotherapy in subjects with moderate to severe atopic dermatitis who are candidate...
    Medical condition: Atopic Dermatitis
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004858 10003639 Atopic dermatitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2017-002065-21 Sponsor Protocol Number: LP0162-1339 Start Date*: 2018-02-14
    Sponsor Name:LEO Pharma A/S
    Full Title: A randomised, double-blind, placebo-controlled, phase 3 trial to evaluate the efficacy and safety of tralokinumab in combination with topical corticosteroids in subjects with moderate-to-severe ato...
    Medical condition: Atopic Dermatitis
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004858 10003639 Atopic dermatitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) NL (Completed) ES (Completed) BE (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2014-001391-54 Sponsor Protocol Number: D2210C00013 Start Date*: 2015-01-23
    Sponsor Name:AstraZeneca AB
    Full Title: A Multicentre, Randomized, Double-blind, Parallel Group, Placebo Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Reducing Oral Corticosteroid Use in Adults and Adol...
    Medical condition: Asthma
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10003553 Asthma PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) NL (Completed) BE (Completed) FR (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2011-004812-40 Sponsor Protocol Number: D2211C00001 Start Date*: 2012-01-26
    Sponsor Name:AstraZeneca AB
    Full Title: A phase IIa, randomised, double-blind, placebo-controlled, parallel-arm, multicenter study to evaluate the efficacy and safety of tralokinumab (CAT-354), a recombinant human monoclonal antibody dir...
    Medical condition: Ulcerative Colitis
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004856 10045365 Ulcerative colitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) NL (Prematurely Ended) CZ (Completed) IT (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2016-004201-13 Sponsor Protocol Number: LP0162-1326 Start Date*: 2017-06-30
    Sponsor Name:LEO Pharma A/S
    Full Title: A randomised, double-blind, placebo-controlled, phase 3 trial to evaluate the efficacy and safety of tralokinumab monotherapy in subjects with moderate to severe atopic dermatitis who are candidate...
    Medical condition: Atopic Dermatitis
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004858 10003639 Atopic dermatitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed) GB (Completed) PL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2018-000747-76 Sponsor Protocol Number: LP0162-1346 Start Date*: 2018-11-20
    Sponsor Name:LEO Pharma A/S
    Full Title: A randomised, double-blind, placebo-controlled, parallel-group, multi-centre, phase 3 trial investigating the efficacy, safety, and tolerability of tralokinumab administered in combination with top...
    Medical condition: Atopic Dermatitis
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004858 10003639 Atopic dermatitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) DE (Completed) BE (Completed) GB (Completed) ES (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2015-000857-19 Sponsor Protocol Number: D2210C00014 Start Date*: 2015-08-06
    Sponsor Name:AstraZeneca AB
    Full Title: A Multicentre, Randomized, Double-blind, Parallel Group, Placebo Controlled, 12-Week, Phase 2 Study to Evaluate the Effect of Tralokinumab on Airway Inflammation in Adults with Asthma Inadequately ...
    Medical condition: Asthma
    Disease: Version SOC Term Classification Code Term Level
    18.1 10038738 - Respiratory, thoracic and mediastinal disorders 10003553 Asthma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2020-005976-36 Sponsor Protocol Number: KTDIIS01 Start Date*: 2021-05-07
    Sponsor Name:Karolinska Universitetssjukhuset
    Full Title: An investigator-initiated, open label trial to correlate efficacy of tralokinumab in subjects with atopic dermatitis to molecular signatures (PRECision in TRAlokinumab therapy)
    Medical condition: Atopic Dermatitis
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: SE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-005573-12 Sponsor Protocol Number: LP0162-1335 Start Date*: 2022-10-05
    Sponsor Name:LEO Pharma A/S
    Full Title: A single (assessor) blinded, randomised, parallel-group, monotherapy trial to evaluate the pharmacokinetic and safety of tralokinumab in children (age 2 to <12 years) with moderate-to-severe atopic...
    Medical condition: Atopic dermatitis
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004858 10003639 Atopic dermatitis LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) CZ (Trial now transitioned) NL (Trial now transitioned) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-000746-19 Sponsor Protocol Number: LP0162-1337 Start Date*: 2018-11-06
    Sponsor Name:LEO Pharma A/S
    Full Title: An open-label, single-arm, multi-centre, long-term extension trial to evaluate the safety and efficacy of tralokinumab in subjects with atopic dermatitis who participated in previous tralokinumab c...
    Medical condition: Atopic Dermatitis
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004858 10003639 Atopic dermatitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) GB (GB - no longer in EU/EEA) DE (Completed) PL (Completed) BE (Completed) CZ (Completed) IT (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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