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Clinical trials for Inebilizumab

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   44347   clinical trials with a EudraCT protocol, of which   7375   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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    4 result(s) found for: Inebilizumab. Displaying page 1 of 1.
    EudraCT Number: 2020-000949-14 Sponsor Protocol Number: VIB0551.P3.S1 Start Date*: 2020-11-16
    Sponsor Name:Viela Bio, Inc.
    Full Title: A RANDOMIZED, DOUBLE-BLIND, MULTICENTER, PLACEBO-CONTROLLED PHASE 3 STUDY WITH OPEN-LABEL PERIOD TO EVALUATE THE EFFICACY AND SAFETY OF INEBILIZUMAB IN ADULTS WITH MYASTHENIA GRAVIS
    Medical condition: Myasthenia Gravis which is either due to acetylcholine receptor antibodies (AChR) or muscle specific kinase antibodies (MuSK).
    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: FR (Trial now transitioned) DK (Prematurely Ended) DE (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-003528-33 Sponsor Protocol Number: VIB0551.P2.S2.NMO Start Date*: 2022-04-13
    Sponsor Name:Horizon Therapeutics Ireland DAC
    Full Title: An Open-label Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Inebilizumab in Pediatric Subjects with Neuromyelitis Optica Spectrum Disorder
    Medical condition: Neuromyelitis optica spectrum disorder (NMOSD; also known as Devic's syndrome and previously known as neuromyelitis optica [NMO])
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029205 - Nervous system disorders 10077875 Neuromyelitis optica spectrum disorder PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: PL (Trial now transitioned) SE (Trial now transitioned) NL (Trial now transitioned) FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-000417-33 Sponsor Protocol Number: VIB0551.P3.S2 Start Date*: 2020-09-30
    Sponsor Name:Viela Bio, Inc./Horizon Therapeutics Ireland DAC
    Full Title: A Phase 3, Randomized, Double-blind, Multicenter, Placebo-Controlled Study of Inebilizumab Efficacy and Safety in IgG4 Related Disease
    Medical condition: Immunoglobulin G4-related disease (IgG4-RD)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10028395 - Musculoskeletal and connective tissue disorders 10077271 Immunoglobulin G4 related disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) PL (Trial now transitioned) FR (Trial now transitioned) HU (Completed) NL (Trial now transitioned) IT (Trial now transitioned) SE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-000253-36 Sponsor Protocol Number: CD-IA-MEDI-551-1155 Start Date*: 2014-12-08
    Sponsor Name:MedImmune LLC
    Full Title: A Double-masked, Placebo-controlled Study with Open-label Period to Evaluate the Efficacy and Safety of MEDI-551 in Adult Subjects with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disord...
    Medical condition: Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders (NMO/NMOSD)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004852 10029322 Neuromyelitis optica LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Prematurely Ended) DE (Prematurely Ended) EE (Prematurely Ended) BG (Completed) PL (Prematurely Ended) ES (Prematurely Ended) HU (Prematurely Ended) GR (Completed) NL (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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