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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
  • 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   44393   clinical trials with a EudraCT protocol, of which   7405   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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    72 result(s) found for: dupilumab. Displaying page 2 of 4.
    EudraCT Number: 2013-003254-24 Sponsor Protocol Number: R668-AD-1224 Start Date*: 2015-03-12
    Sponsor Name:Regeneron Pharmaceuticals, Inc.
    Full Title: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO DEMONSTRATE THE EFFICACY AND LONG-TERM SAFETY OF DUPILUMAB IN ADULT PATIENTS WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS
    Medical condition: Moderate to severe atopic dermatitis (AD).
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004858 10003639 Atopic dermatitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) CZ (Completed) IT (Completed) HU (Completed) NL (Completed) LV (Prematurely Ended) BE (Completed) PL (Completed) ES (Completed) RO (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2019-003520-20 Sponsor Protocol Number: R668-BP-1902 Start Date*: 2020-05-19
    Sponsor Name:Regeneron Pharmaceuticals, Inc.
    Full Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Dupilumab in Adult Patients with Bullous Pemphigoid
    Medical condition: Bullous pemphigoid (BP)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10040785 - Skin and subcutaneous tissue disorders 10034277 Pemphigoid PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) DE (Trial now transitioned) PL (Trial now transitioned) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-003101-42 Sponsor Protocol Number: EFC14146 Start Date*: 2016-11-18
    Sponsor Name:SANOFI-AVENTIS RECHERCHE ET DEVELOPPEMENT
    Full Title: A Randomized, 24-Week Treatment, Double-blind, Placebo-controlled Efficacy and Safety Study of Dupilumab Every Other Week, in Patients with Bilateral Nasal Polyposis on a Background Therapy with In...
    Medical condition: nasal polyps
    Disease: Version SOC Term Classification Code Term Level
    19.0 10038738 - Respiratory, thoracic and mediastinal disorders 10028756 Nasal polyps PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) HU (Completed) DE (Completed) NL (Completed) CZ (Completed) FR (Completed) PL (Completed) BG (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2019-003088-22 Sponsor Protocol Number: R668-AD-1924 Start Date*: 2021-01-07
    Sponsor Name:Regeneron Pharmaceuticals, Inc.
    Full Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel- Group Study to Evaluate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients with Moderate-to-Severe Atopic H...
    Medical condition: Atopic hand and foot dermatitis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10040785 - Skin and subcutaneous tissue disorders 10012431 Dermatitis PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2019-003775-19 Sponsor Protocol Number: EFC16461 Start Date*: 2020-09-23
    Sponsor Name:Sanofi-Aventis Recherche & Développement
    Full Title: Master protocol of three randomized, double-blind, placebo-controlled, multi center, parallel-group studies of dupilumab in patients with chronic spontaneous urticaria (CSU) who remain symptomatic ...
    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: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) FR (Completed) HU (Completed) GB (GB - no longer in EU/EEA) ES (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2018-001954-91 Sponsor Protocol Number: EFC15805 Start Date*: 2020-06-04
    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 (Prematurely Ended) LV (Completed) NL (Completed) LT (Completed) BG (Completed) GB (GB - no longer in EU/EEA) FR (Prematurely Ended) PT (Completed) PL (Prematurely Ended) ES (Prematurely Ended) GR (Completed) BE (Completed) HU (Prematurely Ended) CZ (Completed) SK (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2019-003078-24 Sponsor Protocol Number: R668-EE-1877 Start Date*: 2020-09-01
    Sponsor Name:Regeneron Pharmaceuticals
    Full Title: A Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Dupilumab in Pediatric Patients With Active Eosinophilic Esophagitis
    Medical condition: Eosinophilic Esophagitis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10017947 - Gastrointestinal disorders 10017947 Gastrointestinal disorders SOC
    20.1 10017947 - Gastrointestinal disorders 10064212 Eosinophilic oesophagitis PT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2019-003801-90 Sponsor Protocol Number: EFC16460 Start Date*: 2020-02-11
    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) GB (GB - no longer in EU/EEA) PT (Completed) HU (Completed) ES (Ongoing) IT (Completed)
    Trial results: View results
    EudraCT Number: 2019-002742-20 Sponsor Protocol Number: R668-AS-1903 Start Date*: 2020-06-08
    Sponsor Name:Regeneron Pharmaceuticals Inc.
    Full Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Effect of Dupilumab on Exercise Capacity in Patients with Moderate-to-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 Gender: Male, Female
    Trial protocol: DE (Completed) GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2019-001561-32 Sponsor Protocol Number: 201900237 Start Date*: 2020-04-28
    Sponsor Name:University Medical Center Groningen
    Full Title: Dupilumab in adults with severe chronic hand eczema with an inadequate response or intolerance to alitretinoin: a randomized, double-blind, placebo-controlled proof of concept efficacy study
    Medical condition: Hand eczema
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004858 10066695 Chronic hand dermatitis LLT
    20.0 100000004858 10036145 Pompholyx eczema LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-004997-16 Sponsor Protocol Number: R668-AD-1652 Start Date*: 2018-02-09
    Sponsor Name:Regeneron Pharmaceuticals, Inc.
    Full Title: A randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of dupilumab administered concomitantly with topical corticosteroids in patients, ≥6 years to <12 years o...
    Medical condition: Atopic Dermatitis
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004858 10003639 Atopic dermatitis LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: CZ (Completed) DE (Completed) GB (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2022-002375-11 Sponsor Protocol Number: EFC13995 Start Date*: 2022-07-20
    Sponsor Name:Sanofi-aventis recherche & développement
    Full Title: A Randomized, Double Blind, Placebo-controlled, Parallel-group Phase 3 Study to Evaluate the Efficacy and Safety of Dupilumab in Patients with Persistent 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: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2020-003756-33 Sponsor Protocol Number: EFC16720 Start Date*: 2021-03-25
    Sponsor Name:Sanofi-aventis recherche et développement
    Full Title: A randomized, double-blind, placebo-controlled, multi-center, parallel-group study of dupilumab in patients with chronic inducible cold urticaria who remain symptomatic despite the use of H1-antihi...
    Medical condition: Cold Urticaria
    Disease: Version SOC Term Classification Code Term Level
    20.0 10040785 - Skin and subcutaneous tissue disorders 10009869 Cold urticaria PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2019-002036-90 Sponsor Protocol Number: Uni-Koeln-3815 Start Date*: 2019-12-02
    Sponsor Name:University of Cologne
    Full Title: A randomized, placebo-controlled phase IIa clinical trial to evaluate the efficacy and safety of subcutaneous Dupilumab in localized scleroderma
    Medical condition: Localized scleroderma
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004859 10009206 Circumscribed scleroderma LLT
    21.0 100000004859 10018124 Generalized scleroderma LLT
    20.0 100000004859 10027979 Morphea LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2019-004013-13 Sponsor Protocol Number: B7451050 Start Date*: 2020-08-26
    Sponsor Name:Pfizer Inc.
    Full Title: A PHASE 3B RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE CONTROLLED MULTI-CENTER STUDY ASSESSING THE EFFICACY AND SAFETY OF ABROCITINIB COMPARED WITH DUPILUMAB IN ADULT PARTICIPANTS ON BACKGROUND...
    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: GB (GB - no longer in EU/EEA) LV (Completed) SK (Completed) BE (Completed) HU (Completed) CZ (Completed) DK (Prematurely Ended) FI (Completed) BG (Completed) FR (Prematurely Ended) IT (Completed)
    Trial results: View results
    EudraCT Number: 2015-001572-22 Sponsor Protocol Number: PDY14192 Start Date*: 2015-12-01
    Sponsor Name:SANOFI-AVENTIS RECHERCHE ET DEVELOPPEMENT
    Full Title: An exploratory, randomized, double-blind, placebo-controlled study of the effects of dupilumab on airway inflammation of adults with persistent asthma
    Medical condition: Asthma
    Disease: Version SOC Term Classification Code Term Level
    18.0 10038738 - Respiratory, thoracic and mediastinal disorders 10003553 Asthma PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed) SE (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2017-001262-25 Sponsor Protocol Number: D-001-02 Start Date*: 2018-11-21
    Sponsor Name:Charité - Universitätsmedizin Berlin
    Full Title: A randomized, double-blind, placebo-controlled, proof-of-concept, multicenter, 16-week treatment study with a 16 week follow-up period to assess the exploratory efficacy and safety of Dupilumab (an...
    Medical condition: Cholinergic urticaria despite H1-antihistamine treatment
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2019-001220-35 Sponsor Protocol Number: RC31-19-0045 Start Date*: 2019-10-08
    Sponsor Name:CHU de Toulouse
    Full Title: A randomized double-blinded pilot study of the efficacy and safety of dupilumab versus placebo in patients with Netherton syndrome
    Medical condition: Netherton syndrome
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10062909 Netherton's syndrome PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-001573-40 Sponsor Protocol Number: EFC13691 Start Date*: 2015-11-04
    Sponsor Name:SANOFI-AVENTIS RECHERCHE ET DEVELOPPEMENT
    Full Title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Dupilumab in Patients with Severe Steroid Dependent Asthma
    Medical condition: Asthma
    Disease: Version SOC Term Classification Code Term Level
    19.1 10038738 - Respiratory, thoracic and mediastinal disorders 10003553 Asthma PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) ES (Completed) BE (Completed) PL (Completed) HU (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2022-003303-14 Sponsor Protocol Number: DETACT Start Date*: 2023-02-16
    Sponsor Name:Medical University of Vienna
    Full Title: Effect of Dupilumab on mucus plugs and inflammatory patterns in sEvere asThmatiC paTients (DETACT)
    Medical condition: Severe asthma is a chronic inflammatory condition of the airways, characterized with wheezing, breathlessness, chest tightness and coughing. T2-high asthma is promoted by differentiated T helper c...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Trial now transitioned)
    Trial results: (No results available)
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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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