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Clinical trials for Eye Diseases AND Graves Disease AND teprotumumab

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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    4 result(s) found for: Eye Diseases AND Graves Disease AND teprotumumab. Displaying page 1 of 1.
    EudraCT Number: 2017-002763-18 Sponsor Protocol Number: HZNP-TEP-301 Start Date*: 2018-02-22
    Sponsor Name:Horizon Therapeutics USA, Inc.
    Full Title: A Phase 3, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group, Multicenter Study Evaluating Teprotumumab (HZN-001) Treatment in Subjects with Active Thyroid Eye Disease (OPTIC Trial)
    Medical condition: Active Thyroid Eye Disease (TED)
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004853 10057889 Graves' ophthalmopathy LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2017-002713-58 Sponsor Protocol Number: HZNP-TEP-302 Start Date*: 2018-08-13
    Sponsor Name:Horizon Therapeutics USA, Inc.
    Full Title: Multicenter, Safety and Efficacy, Open-Label Extension Study Evaluating Teprotumumab (HZN.001) Treatment in Subjects with Thyroid Eye Disease
    Medical condition: Thyroid Eye Disease (TED)
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004853 10057889 Graves' ophthalmopathy LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2020-005999-36 Sponsor Protocol Number: HZNP-TEP-402 Start Date*: 2022-05-24
    Sponsor Name:Horizon Therapeutics U.S.A., Inc.
    Full Title: A Phase 3b/4, Double-masked, Randomized, International, Parallel-assignment, Multicenter Trial in Patients with Thyroid Eye Disease to Evaluate the Safety and Tolerability of Different Dosing Durat...
    Medical condition: Thyroid Eye Disease (TED)
    Disease: Version SOC Term Classification Code Term Level
    20.1 10015919 - Eye disorders 10057889 Graves' ophthalmopathy LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) IT (Trial now transitioned) FR (Trial now transitioned) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-000113-31 Sponsor Protocol Number: TED01RV Start Date*: 2014-07-14
    Sponsor Name:River Vision Development Corporation
    Full Title: A randomized, double-masked, placebo-controlled, efficacy and safety study of RV 001, an insulin-like growth factor-1 receptor (IGF-1R) antagonist antibody (fully human), administered every 3 weeks...
    Medical condition: Thyroid-Associated Ophthalmopathy / Graves' Ophthalmopathy
    Disease: Version SOC Term Classification Code Term Level
    18.1 10015919 - Eye disorders 10015919 Eye disorders SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) IT (Completed) GB (Completed) NL (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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