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Clinical trials for Tezepelumab

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   43881   clinical trials with a EudraCT protocol, of which   7295   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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    18 result(s) found for: Tezepelumab. Displaying page 1 of 1.
    EudraCT Number: 2018-004588-30 Sponsor Protocol Number: D5180C00011 Start Date*: 2019-06-05
    Sponsor Name:AstraZeneca AB
    Full Title: A Multicenter, Randomized, Open-label, Parallel group, Functionality, and Performance Study of an Accessorized Pre-filled Syringe and Autoinjector with Home-administered Subcutaneous Tezepelumab i...
    Medical condition: Severe uncontrolled 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: PL (Completed)
    Trial results: View results
    EudraCT Number: 2022-001294-31 Sponsor Protocol Number: D5244C00001 Start Date*: 2022-12-06
    Sponsor Name:AstraZeneca AB
    Full Title: A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Phase 3 Efficacy and Safety Study of Tezepelumab in Patients with Eosinophilic Esophagitis (CROSSING)
    Medical condition: Eosinophilic esophagitis (EoE) is a rare, chronic inflammatory disorder triggered by an immune response to foods and aeroantigens and characterized by a combination of esophageal dysfunction and eo...
    Disease: Version SOC Term Classification Code Term Level
    20.1 10017947 - Gastrointestinal disorders 10064220 Eosinophilic esophagitis LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: NO (Ongoing) SE (Ongoing) SK (Ongoing) ES (Ongoing) CZ (Ongoing) DK (Ongoing) GR (Ongoing) FI (Ongoing) DE (Ongoing) BE (Ongoing) NL (Ongoing) IT (Ongoing) AT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-001997-52 Sponsor Protocol Number: 20170755 Start Date*: 2018-12-28
    Sponsor Name:Amgen Inc
    Full Title: A Dose-Ranging, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Tezepelumab Alone or Combined with Topical Corticosteroids in Moderate-to-Severe Atopic Dermatitis.
    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: EE (Completed) GB (GB - no longer in EU/EEA) LV (Prematurely Ended) DE (Prematurely Ended) CZ (Prematurely Ended) HU (Completed) PL (Prematurely Ended) ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2018-002069-21 Sponsor Protocol Number: D5180C00013 Start Date*: 2018-10-23
    Sponsor Name:AstraZeneca AB
    Full Title: A Phase 2, Randomized, Double-blind, Parallel Group, Placebo Controlled Study to Evaluate the Effect of Tezepelumab on Airway Inflammation in Adults with Inadequately Controlled Asthma on Inhaled C...
    Medical condition: Severe 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: DK (Completed) GB (GB - no longer in EU/EEA) DE (Completed)
    Trial results: View results
    EudraCT Number: 2017-003078-15 Sponsor Protocol Number: D5180C00007 Start Date*: 2018-07-04
    Sponsor Name:AstraZeneca AB
    Full Title: A Multicentre, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults and Adolescents with Severe Uncontrolled Asth...
    Medical condition: Severe uncontrolled 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 (GB - no longer in EU/EEA) DE (Completed) FR (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2021-006691-17 Sponsor Protocol Number: D5180C00024 Start Date*: 2022-07-13
    Sponsor Name:AstraZeneca AB
    Full Title: A Randomised, Double-Blind, Parallel-Group, Placebo-Controlled 40-week Phase 3 Efficacy and Safety Study of Tezepelumab in Reducing Oral Corticosteroid Use in Adults with Oral Corticosteroid Depend...
    Medical condition: Severe 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: CZ (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-005457-85 Sponsor Protocol Number: D5180C00037 Start Date*: 2022-07-20
    Sponsor Name:AstraZeneca AB
    Full Title: A Multicentre, Single-arm, Phase 3b Efficacy and Safety Study of Tezepelumab 210 mg Administered Subcutaneously to Reduce Oral Corticosteroid Use in Adult Participants with Severe Asthma on High-do...
    Medical condition: Severe 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: DE (Ongoing) ES (Ongoing) BE (Ongoing) PL (Ongoing) LV (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-003079-69 Sponsor Protocol Number: D5180C00009 Start Date*: 2018-04-26
    Sponsor Name:AstraZeneca AB
    Full Title: A Multicentre, Randomized, Double-Blind, Placebo Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Reducing Oral Corticosteroid Use in Adults with Oral Corticosteroid ...
    Medical condition: Severe 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: DE (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2019-001363-67 Sponsor Protocol Number: D5241C00001 Start Date*: 2019-10-22
    Sponsor Name:AstraZeneca AB
    Full Title: A Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter, Phase 2a Study to Explore the Efficacy and Safety of Tezepelumab in Patients with Moderate to Very Severe Chronic Obstru...
    Medical condition: Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004855 10010952 COPD LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed) NL (Completed) FR (Completed) DE (Completed) ES (Ongoing) GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2018-002501-53 Sponsor Protocol Number: D5180C00018 Start Date*: 2019-05-29
    Sponsor Name:AstraZeneca AB
    Full Title: A Multicentre, Double-blind, Randomized, Placebo Controlled, Parallel Group, Phase 3, Safety Extension Study to Evaluate the Safety and Tolerability of Tezepelumab in Adults and Adolescents with Se...
    Medical condition: Severe Uncontrolled 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) FR (Ongoing) AT (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2022-003286-37 Sponsor Protocol Number: D5180C00031 Start Date*: 2022-12-22
    Sponsor Name:AstraZeneca
    Full Title: A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase 3b Study to Evaluate the Potential Effect of tezepelumab on the Humoral Immune Response to Seasonal Quadrivalent I...
    Medical condition: Moderate to Severe 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 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2020-003062-39 Sponsor Protocol Number: D5242C00001 Start Date*: 2021-03-18
    Sponsor Name:AstraZeneca AB
    Full Title: A Multicentre, Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Phase 3 Efficacy and Safety Study of Tezepelumab in Participants with Severe Chronic Rhinosinusitis with Nasal Polyposis...
    Medical condition: Severe Chronic Rhinosinusitis with Nasal Polyposis
    Disease: Version SOC Term Classification Code Term Level
    27.0 10038738 - Respiratory, thoracic and mediastinal disorders 10080060 Chronic rhinosinusitis with nasal polyps PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Ongoing) DK (Ongoing) HU (Ongoing) PL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-000554-97 Sponsor Protocol Number: D5180C00025 Start Date*: 2020-10-21
    Sponsor Name:AstraZeneca AB
    Full Title: A Phase I, Open-label Study to Evaluate the Pharmacokinetics of Tezepelumab in Children ≥ 5 to 11 Years of Age with Mild, Moderate, or Severe Asthma
    Medical condition: Mild, moderate or severe asthma
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10003553 Asthma PT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) HU (Completed)
    Trial results: View results
    EudraCT Number: 2020-002759-39 Sponsor Protocol Number: 20190194 Start Date*: 2021-04-01
    Sponsor Name:Amgen Inc.
    Full Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Ranging, Phase 2b Study to Evaluate Efficacy and Safety of Tezepelumab for the Treatment of Chronic Spontaneous Urticaria
    Medical condition: Chronic Spontaneous Urticaria
    Disease: Version SOC Term Classification Code Term Level
    20.0 10040785 - Skin and subcutaneous tissue disorders 10072757 Chronic spontaneous urticaria PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GR (Ongoing) IT (Ongoing) ES (Ongoing) PL (Completed)
    Trial results: View results
    EudraCT Number: 2022-003584-18 Sponsor Protocol Number: KKS-307 Start Date*: 2023-06-26
    Sponsor Name:Philipps University Marburg
    Full Title: Tezepelumab (Anti-TSLP-mab) in progressive pulmonary fibrosis interstitial lung disease with evidence of eosinophilia
    Medical condition: Progressive pulmonary fibrosis interstitial lung disease with evidence of eosinophilia
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10021240 Idiopathic pulmonary fibrosis PT
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10022619 Interstitial pulmonary fibrosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2022-002891-35 Sponsor Protocol Number: RECHMPL22_0123 Start Date*: 2023-01-04
    Sponsor Name:University Hospital of Montpellier
    Full Title: REVErsing airway Remodelling with Tezepelumab (REVERT): a protocol for a double-blind randomized controlled trial for patients with asthma
    Medical condition: exacerbating 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: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2022-000179-38 Sponsor Protocol Number: ESR-21-21168 Start Date*: 2022-04-28
    Sponsor Name:Bispebjerg Hospital
    Full Title: Effects of blocking TSLP on airway inflammation and the epithelial immune-response to exacerbation triggers in patients with COPD A randomized double-blind, placebo-controlled trial of tezepelumab
    Medical condition: Chronic Obstructive Pulmonary Disease (COPD)
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004855 10009032 Chronic obstructive lung disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2015-005542-56 Sponsor Protocol Number: ESR-15-10870 Start Date*: 2016-04-29
    Sponsor Name:Copenhagen University Hospital Bispebjerg
    Full Title: Effects of anti-TSLP on airway hyperresponsiveness and mast cell phenotype in asthma - A randomized double-blind, placebo-controlled trial of MEDI9929 The UPSTREAM study
    Medical condition: Asthma
    Disease: Version SOC Term Classification Code Term Level
    19.0 10038738 - Respiratory, thoracic and mediastinal disorders 10003553 Asthma PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DK (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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