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Clinical trials for batoclimab

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   44410   clinical trials with a EudraCT protocol, of which   7419   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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    7 result(s) found for: batoclimab. Displaying page 1 of 1.
    EudraCT Number: 2022-002839-66 Sponsor Protocol Number: IMVT-1401-3203 Start Date*: 2023-09-07
    Sponsor Name:Immunovant Sciences, GmbH
    Full Title: An Open-label Extension Study for Participants who Completed Study IMVT-1401-3201 or Study IMVT-1401-3202 to Assess the Efficacy and Safety of Batoclimab for the Treatment of Thyroid Eye Disease (TED)
    Medical condition: Thyroid Eye Disease (TED)
    Disease: Version SOC Term Classification Code Term Level
    23.1 100000004853 10084358 Thyroid eye disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Not Authorised) LV (Trial now transitioned) BE (Trial now transitioned) HU (Trial now transitioned) SK (Trial now transitioned) IT (Trial now transitioned) ES (Ongoing) PL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2022-002787-68 Sponsor Protocol Number: IMVT-1401-3201 Start Date*: Information not available in EudraCT
    Sponsor Name:Immunovant Sciences, GmbH
    Full Title: A Phase 3, Multi-center, Randomized, Quadruple-masked, Placebo-controlled Study of Batoclimab for the Treatment of Participants with Active Thyroid Eye Disease (TED)
    Medical condition: Thyroid Eye Disease (TED)
    Disease: Version SOC Term Classification Code Term Level
    23.1 100000004853 10084358 Thyroid eye disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) IT (Trial now transitioned) PL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2022-002788-30 Sponsor Protocol Number: IMVT-1401-3202 Start Date*: 2023-07-13
    Sponsor Name:Immunovant Sciences, GmbH
    Full Title: A Phase 3, Multi-center, Randomized, Quadruple-masked, Placebo-controlled Study of Batoclimab for the Treatment of Participants with Active Thyroid Eye Disease (TED)
    Medical condition: Thyroid Eye Disease (TED)
    Disease: Version SOC Term Classification Code Term Level
    23.1 10015919 - Eye disorders 10084358 Thyroid eye disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) BE (Trial now transitioned) LV (Trial now transitioned) HU (Trial now transitioned) SK (Trial now transitioned) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2022-002718-17 Sponsor Protocol Number: IMVT-1401-2401 Start Date*: 2023-06-19
    Sponsor Name:Immunovant Sciences, GmbH
    Full Title: A Phase 2b, Multi-center, Randomized, Quadruple-blind, Placebo-controlled Study of Batoclimab Treatment in Adult Participants with Active Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
    Medical condition: Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10077384 Chronic inflammatory demyelinating polyneuropathy LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) NO (Trial now transitioned) BE (Trial now transitioned) FI (Trial now transitioned) SE (Trial now transitioned) DK (Trial now transitioned) SK (Trial now transitioned) PT (Trial now transitioned) BG (Trial now transitioned) ES (Ongoing) RO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-000249-42 Sponsor Protocol Number: IMVT-1401-3101 Start Date*: 2022-10-12
    Sponsor Name:Immunovant Sciences GmbH
    Full Title: A Phase 3, Multi-center, Randomized, Quadruple-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants with Genera...
    Medical condition: Generalized Myasthenia Gravis (gMG)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029205 - Nervous system disorders 10028417 Myasthenia gravis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Trial now transitioned) ES (Ongoing) PL (Trial now transitioned) HU (Trial now transitioned) RO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2022-002894-27 Sponsor Protocol Number: IMVT-1401-2501 Start Date*: 2023-04-03
    Sponsor Name:Immunovant Sciences GmbH
    Full Title: A Proof-of-Concept, Open-label Study to Assess the Safety and Efficacy of Batoclimab in Participants with Graves’ Disease (GD)
    Medical condition: Graves` disease
    Disease: Version SOC Term Classification Code Term Level
    26.0 10014698 - Endocrine disorders 10018706 Graves' disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2018-004676-35 Sponsor Protocol Number: RVT-1401-2001 Start Date*: 2019-10-23
    Sponsor Name:Immunovant Sciences GmbH
    Full Title: ASCEND GO2: A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled Study of RVT-1401 for the Treatment of Patients with Active, Moderate to Severe Graves’ Ophthalmopathy
    Medical condition: Graves´Ophthalmopathy
    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 (Prematurely Ended) ES (Prematurely Ended) IT (Prematurely Ended)
    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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