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Clinical trials for dupilumab

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
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    • 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   44341   clinical trials with a EudraCT protocol, of which   7370   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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    70 result(s) found for: dupilumab. Displaying page 3 of 4.
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    EudraCT Number: 2018-001953-28 Sponsor Protocol Number: EFC15804 Start Date*: 2019-07-01
    Sponsor Name:Sanofi-aventis Recherche & Développement
    Full Title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, 52-week Pivotal Study to Assess the Efficacy, Safety, and Tolerability of Dupilumab in Patients with Moderate-to-severe Chronic Obstr...
    Medical condition: Chronic obstructive pulmonary disease
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10009033 Chronic obstructive pulmonary disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) SE (Completed) DK (Completed) FI (Completed) CZ (Completed) HU (Completed) PL (Completed) SK (Completed) BG (Completed) IT (Completed) RO (Ongoing)
    Trial results: View results
    EudraCT Number: 2019-003774-41 Sponsor Protocol Number: EFC16459 Start Date*: 2021-03-17
    Sponsor Name:Sanofi-aventis Recherche & Développement
    Full Title: A randomized, double blind, placebo-controlled, multi-center, parallel group study to evaluate the efficacy and safety of dupilumab in patients with prurigo nodularis who are inadequately controlle...
    Medical condition: Prurigo Nodularis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10040785 - Skin and subcutaneous tissue disorders 10029263 Neurodermatitis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) HU (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2020-003117-35 Sponsor Protocol Number: EFC16723 Start Date*: 2021-03-17
    Sponsor Name:Sanofi-aventis Recherche & Développement
    Full Title: A randomized, double-blind, placebo-controlled, 2-part study to evaluate the efficacy and safety of dupilumab in patients with uncontrolled, chronic rhinosinusitis without nasal polyposis (CRSsNP)
    Medical condition: Chronic rhinosinusitis without nasal polyposis
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10009137 Chronic sinusitis PT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed) PT (Completed) SE (Completed) HU (Completed) PL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2020-002601-26 Sponsor Protocol Number: EFC16823 Start Date*: 2024-02-11
    Sponsor Name:Sanofi K.K
    Full Title: A randomized, double-blind, placebo-controlled, multi-center, parallel-group study to evaluate the efficacy, safety and pharmacokinetics of dupilumab compared to placebo in Japanese patients with a...
    Medical condition: atopic dermatitis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10040785 - Skin and subcutaneous tissue disorders 10012438 Dermatitis atopic PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2014-003384-38 Sponsor Protocol Number: R668-AD-1415 Start Date*: 2015-02-18
    Sponsor Name:Regeneron Pharmaceuticals, Inc.
    Full Title: A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY INVESTIGATING THE EFFICACY AND SAFETY OF MULTIPLE DUPILUMAB DOSE REGIMENS ADMINISTERED AS MONOTHERAPY FOR MAINTAINING TREATMENT RESPONS...
    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: LT (Completed) EE (Completed) DE (Completed) FI (Completed) SE (Completed) GB (Completed) DK (Completed) ES (Completed) BG (Completed) PL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2018-001543-30 Sponsor Protocol Number: R3500-AD-1798 Start Date*: 2019-06-11
    Sponsor Name:Regeneron Pharmaceuticals, Inc.
    Full Title: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE 2A STUDY TO ASSESS THE EFFICACY AND SAFETY OF REGN3500 MONOTHERAPY AND COMBINATION OF REGN3500 PLUS DUPILUMAB IN ADULT PATIENTS WITH MODERATE-T...
    Medical condition: Moderate to Severe Atopic Dermatitis
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004858 10003639 Atopic dermatitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) BE (Completed) ES (Prematurely Ended) NL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2018-002573-21 Sponsor Protocol Number: B7451029 Start Date*: 2019-02-11
    Sponsor Name:Pfizer Inc.
    Full Title: A PHASE 3 RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY INVESTIGATING THE EFFICACY AND SAFETY OF PF-04965842 AND DUPILUMAB IN COMPARISON WITH PLACEB...
    Medical condition: Moderate to severe atopic dermatitis (AD)
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004858 10003639 Atopic dermatitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SK (Completed) BG (Completed) CZ (Completed) LV (Completed) FR (Completed) HU (Completed) AT (Completed) GB (Completed) ES (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2014-003263-37 Sponsor Protocol Number: R668-AD-1412 Start Date*: 2015-02-11
    Sponsor Name:Regeneron Pharmaceuticals, Inc.
    Full Title: A Phase 2A Study Investigating the Safety, Pharmacokinetics, Immunogenicity, and Exploratory Efficacy of Dupilumab in Patients Aged ≥6 to <18 Years With Atopic Dermatitis
    Medical condition: Atopic dermatits
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004858 10003639 Atopic dermatitis LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: HU (Completed) DE (Completed) CZ (Completed) PL (Completed) GB (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2013-001803-35 Sponsor Protocol Number: ACT12340 Start Date*: 2013-07-31
    Sponsor Name:Sanofi-aventis recherche et développement
    Full Title: A Randomized, Double-Blind, Phase 2, Placebo Controlled, 2 Arm Study To Evaluate Dupilumab In Patients With Bilateral Nasal Polyposis And Chronic Symptoms Of Sinusitis
    Medical condition: Nasal polyps
    Disease: Version SOC Term Classification Code Term Level
    16.1 10038738 - Respiratory, thoracic and mediastinal disorders 10028756 Nasal polyps PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed) SE (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2018-003456-20 Sponsor Protocol Number: ITN084AD Start Date*: 2020-02-17
    Sponsor Name:Division of Allergy, Immunology, and Transplantation; National Institute of Allergy and Infectious Disease
    Full Title: Grass Pollen Sublingual Tablet Immunotherapy plus Dupilumab for Induction of Tolerance in Adults with Moderate to Severe Seasonal Allergic Rhinitis.
    Medical condition: Moderate to Severe Seasonal Allergic Rhinitis
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004870 10039776 Seasonal allergic rhinitis LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2015-004458-16 Sponsor Protocol Number: R668-AD-1526 Start Date*: 2018-10-28
    Sponsor Name:Regeneron Pharmaceuticals, Inc.
    Full Title: Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Dupilumab Monotherapy in Patients ≥12 to <18 Years of Age, With Moderate-to-severe Atopic Dermatitis
    Medical condition: Atopic dermatits
    Disease: Version SOC Term Classification Code Term Level
    20.0 10040785 - Skin and subcutaneous tissue disorders 10012438 Dermatitis atopic PT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2017-004458-41 Sponsor Protocol Number: D-001-01 Start Date*: 2018-10-04
    Sponsor Name:Charité - Universitätsmedizin Berlin Klinik für Dermatologie und Allergologie
    Full Title: A multicenter, randomized, double-blind, placebo-controlled, phase 2, 16-week treatment study with a 16 week follow-up period to assess the efficacy and safety of Dupilumab (anti-IL4Ra) in adult pa...
    Medical condition: chronic spontaneous urticaria despite H1-antihistamine treatment
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004858 10009159 Chronic urticaria LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2024-000164-37 Sponsor Protocol Number: LPS17250 Start Date*: 2024-04-09
    Sponsor Name:Sanofi (China) Investment Co., Ltd, Shanhai Branch
    Full Title: Open-label exploratory study to evaluate the effect of dupilumab on skin barrier function in Chinese patients with moderate to severe atopic dermatitis
    Medical condition: Atopic Dermatitis
    Disease: Version SOC Term Classification Code Term Level
    21.1 10040785 - Skin and subcutaneous tissue disorders 10003639 Atopic dermatitis LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2024-000402-15 Sponsor Protocol Number: LPS17244 Start Date*: 2024-09-05
    Sponsor Name:Sanofi (China) Investment Co., Ltd, Shanhai Branch
    Full Title: Open-label exploratory study to evaluate the effect of dupilumab on skin barrier function in Chinese pediatric patients with moderate-to-severe atopic dermatitis
    Medical condition: Atopic Dermatitis
    Disease: Version SOC Term Classification Code Term Level
    21.1 10040785 - Skin and subcutaneous tissue disorders 10003639 Atopic dermatitis LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2020-003542-36 Sponsor Protocol Number: LPS16763 Start Date*: 2021-01-19
    Sponsor Name:Sanofi-aventis Recherche & Développement
    Full Title: A multi-center, exploratory study to assess dupilumab effect on pruritus neuro-mechanisms in patients with atopic dermatitis
    Medical condition: 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: View results
    EudraCT Number: 2018-002264-57 Sponsor Protocol Number: M16-046 Start Date*: 2019-07-22
    Sponsor Name:AbbVie Deutschland GmbH & Co. KG
    Full Title: A Multicenter, Randomized, Double-Blind, Double-Dummy, Active Controlled Study Comparing the Safety and Efficacy of Upadacitinib to Dupilumab in Adult Subjects with Moderate to Severe Atopic Dermat...
    Medical condition: moderate to severe Atopic Dermatitis
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004858 10003639 Atopic dermatitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) FI (Completed) GB (GB - no longer in EU/EEA) NL (Completed) SE (Completed) FR (Completed) HU (Completed) NO (Completed) ES (Completed) HR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2015-002653-35 Sponsor Protocol Number: R668-AD-1424 Start Date*: 2016-01-14
    Sponsor Name:Regeneron Pharmaceuticals, Inc.
    Full Title: A phase 3 study investigating the efficacy, safety, and tolerability of Dupilumab administered to adult patients with severe atopic dermatitis who are not adequately controlled with or are intolera...
    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) BE (Completed) GB (Completed) NL (Completed) SK (Completed) AT (Completed) IE (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2018-004705-26 Sponsor Protocol Number: LPS15497 Start Date*: 2020-03-24
    Sponsor Name:Sanofi Aventis Groupe
    Full Title: A randomized double blind placebo controlled study evaluating the effect of dupilumab on sleep in adult patients with moderate to severe atopic dermatitis
    Medical condition: 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: GB (GB - no longer in EU/EEA) DE (Completed) FR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2019-003162-41 Sponsor Protocol Number: SGZ-2018-12012 Start Date*: 2021-02-10
    Sponsor Name:Klinikum rechts der Isar, Technische Universität München
    Full Title: An investigator-initiated, multi-center, randomized, double-blind, placebo controlled study of Dupilumab to demonstrate efficacy in subjects with nummular eczema
    Medical condition: Subjects with nummular eczema
    Disease: Version SOC Term Classification Code Term Level
    20.0 10040785 - Skin and subcutaneous tissue disorders 10012431 Dermatitis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2014-001198-15 Sponsor Protocol Number: R668-AD-1334 Start Date*: 2015-01-06
    Sponsor Name:Regeneron Pharmaceuticals, Inc.
    Full Title: A PHASE 3 CONFIRMATORY STUDY INVESTIGATING THE EFFICACY AND SAFETY OF DUPILUMAB MONOTHERAPY ADMINISTERED TO ADULT PATIENTS WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS
    Medical condition: Atopic dermatitis
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004858 10003639 Atopic dermatitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: EE (Completed) DE (Completed) ES (Completed) FI (Completed) DK (Completed) BG (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
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