Flag of the European Union EU Clinical Trials Register Help

Clinical trials for Myositis

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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     
    75 result(s) found for: Myositis. Displaying page 1 of 4.
    1  2  3  4  Next»
    EudraCT Number: 2015-001411-12 Sponsor Protocol Number: CBYM338B2203E1 Start Date*: 2015-11-04
    Sponsor Name:Novartis Pharma Services AG
    Full Title: Extension of the CBYM338B2203 phase IIb/III study to evaluate the long-term efficacy, safety and tolerability of intravenous BYM338 in patients with sporadic inclusion body myositis
    Medical condition: Sporadic Inclusion Body Myositis
    Disease: Version SOC Term Classification Code Term Level
    18.0 10028395 - Musculoskeletal and connective tissue disorders 10066407 Inclusion body myositis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) NL (Completed) DK (Completed) GB (Completed) BE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2013-000705-23 Sponsor Protocol Number: CBYM338B2203 Start Date*: 2014-02-09
    Sponsor Name:Novartis Farma SpA
    Full Title: A randomized, double-blind, placebo-controlled, multicenter, parallel group, dose-finding, pivotal, phase IIb/III study to evaluate the efficacy, safety and tolerability of intravenous BYM338 at 52...
    Medical condition: Sporadic Inclusion Body Myositis
    Disease: Version SOC Term Classification Code Term Level
    14.1 10028395 - Musculoskeletal and connective tissue disorders 10066407 Inclusion body myositis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed) NL (Completed) DE (Completed) BE (Completed) GB (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2008-008208-42 Sponsor Protocol Number: 08/0168 Start Date*: 2009-06-26
    Sponsor Name:UCL - The Joint UCLH/UCL Comprehensive Biomedical Research Unit
    Full Title: A Randomised, Double-Blind Placebo-Controlled Pilot Study Assessing the Safety and Tolerability of Arimoclomol in Adult with Sporadic Inclusion Body Myositis
    Medical condition: The research project proposes to investigate Sporadic Inclusion Body Myositis (IBM). IBM is the commonest acquired disease of muscle affecting people aged 50 years and over. It is a progressive and...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10066407 Inclusion body myositis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2018-000391-15 Sponsor Protocol Number: AIFA-2016-02364869 Start Date*: 2018-06-05
    Sponsor Name:Azienda Unità Sanitaria Locale - IRCCS di Reggio Emilia
    Full Title: Multicentric, open-label, prospective study of subcutaneous tocilizumab in adult patients with refractory myositis
    Medical condition: Myositis (dermatomyositis [DM] or polymyositis [PM])
    Disease: Version SOC Term Classification Code Term Level
    20.0 10040785 - Skin and subcutaneous tissue disorders 10012503 Dermatomyositis PT
    20.0 10028395 - Musculoskeletal and connective tissue disorders 10028653 Myositis PT
    20.0 10028395 - Musculoskeletal and connective tissue disorders 10036102 Polymyositis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2021-002286-17 Sponsor Protocol Number: INCB00928-201 Start Date*: 2022-04-19
    Sponsor Name:Incyte Corporation
    Full Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of INCB000928 in Participants With Fibrodysplasia Ossificans Progressiva
    Medical condition: Fibrodysplasia ossificans progressiva
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10068715 Fibrodysplasia ossificans progressiva PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) DE (Trial now transitioned) NL (Trial now transitioned) PT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2022-000692-39 Sponsor Protocol Number: IVY Start Date*: 2023-06-19
    Sponsor Name:Amsterdam University Medical Center
    Full Title: Safety, tolerability and immunogenicity of intradermal mRNA SARS-CoV2 vaccination in patients with Fibrodysplasia Ossificans Progressiva
    Medical condition: Fibrodyplasia Ossificans Progressiva (FOP)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10068715 Fibrodysplasia ossificans progressiva PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2022-000880-40 Sponsor Protocol Number: R2477-FOP-2175 Start Date*: 2022-08-29
    Sponsor Name:Regeneron Pharmaceuticals, Inc.
    Full Title: Phase 3 Randomized, Placebo-Controlled Study to Assess Safety, Tolerability, and Efficacy of Garetosmab in Patients with Fibrodysplasia Ossificans Progressiva
    Medical condition: Fibrodysplasia Ossificans Progressiva
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10068715 Fibrodysplasia ossificans progressiva PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Ongoing) FI (Trial now transitioned) IT (Trial now transitioned) NL (Ongoing) FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2014-002496-28 Sponsor Protocol Number: PVO-1A-202 Start Date*: 2015-11-13
    Sponsor Name:Clementia Pharmaceuticals Inc.
    Full Title: A Phase 2, Open-Label Extension, Efficacy and Safety Study of a RARγ-Specific Agonist (Palovarotene) in the Treatment of Preosseous Flare-ups in Subjects with Fibrodysplasia Ossificans Progressiva ...
    Medical condition: Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease characterized by painful, recurrent episodes of soft tissue swelling (flare-ups) and abnormal heterotopic ossificat...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10068715 Fibrodysplasia ossificans progressiva PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2014-001453-17 Sponsor Protocol Number: PVO-1A-201 Start Date*: 2015-07-07
    Sponsor Name:Clementia Pharmaceuticals Inc.
    Full Title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of a RARγ-Specific Agonist (Palovarotene) in the Treatment of Preosseous Flare-ups in Subjects with Fibrodysplasia O...
    Medical condition: Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease characterized by painful, recurrent episodes of soft tissue swelling (flare-ups) and abnormal heterotopic ossificat...
    Disease: Version SOC Term Classification Code Term Level
    18.0 10010331 - Congenital, familial and genetic disorders 10068715 Fibrodysplasia ossificans progressiva PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2019-003324-20 Sponsor Protocol Number: STOPFOP1 Start Date*: 2020-01-08
    Sponsor Name:VU University Medical Center
    Full Title: Saracatinib trial TO Prevent FOP
    Medical condition: Fibrodyplasia Ossificans Progressiva (FOP)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10068715 Fibrodysplasia ossificans progressiva PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-002244-70 Sponsor Protocol Number: CLIN-60120-452 Start Date*: Information not available in EudraCT
    Sponsor Name:Ipsen Pharma SAS
    Full Title: Rollover Study; Multicentre, Phase III, Open-label Study to Further Evaluate the Safety and Efficacy of Palovarotene Capsules in Male and Female Participants Aged ≥14 Years with Fibrodysplasia Ossi...
    Medical condition: Fibrodysplasia Ossificans Progressiva (FOP)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10068715 Fibrodysplasia ossificans progressiva PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) FR (Completed) IT (Completed) ES (Ongoing)
    Trial results: View results
    EudraCT Number: 2017-002541-29 Sponsor Protocol Number: PVO-1A-301 Start Date*: 2017-12-14
    Sponsor Name:Clementia Pharmaceuticals Inc
    Full Title: A Phase 3, Efficacy and Safety Study of Oral Palovarotene for the Treatment of Fibrodysplasia Ossificans Progressiva (FOP)
    Medical condition: Fibrodysplasia Ossificans Progressiva (FOP)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10068715 Fibrodysplasia ossificans progressiva PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) SE (Completed) ES (Ongoing) DE (Completed) FR (Completed) NL (Ongoing) IT (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-002269-77 Sponsor Protocol Number: IM101611 Start Date*: 2017-08-07
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: A Phase 3, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC with Standard Treatment Compared to Standard Treatment Alone in Improving Disease Activity in ...
    Medical condition: Idiopathic Inflammatory Myopathy (IIM; eg, Dermatomyositis [DM], Polymyositis [PM], autoimmune necrotizing myopathy)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004859 10042753 Symptomatic inflammatory myopathy LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) CZ (Prematurely Ended) SE (Completed) FR (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-002526-36 Sponsor Protocol Number: PVO-1A-204 Start Date*: 2022-07-05
    Sponsor Name:Clementia Pharmaceuticals Inc.
    Full Title: A Phase 2, Open-Label, Efficacy and Safety Study of an RARγ-Specific Agonist (Palovarotene) to Prevent Heterotopic Ossification in Subjects with Fibrodysplasia Ossificans Progressiva (FOP)
    Medical condition: Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease characterized by painful, recurrent episodes of soft tissue swelling (flare-ups) and abnormal heterotopic ossificat...
    Disease: Version SOC Term Classification Code Term Level
    19.0 10010331 - Congenital, familial and genetic disorders 10068715 Fibrodysplasia ossificans progressiva PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2006-000078-65 Sponsor Protocol Number: Rituximab Start Date*: 2007-01-17
    Sponsor Name:Karolinska University Hospital
    Full Title: Rituximab in the Treatment of Refractory Adult and Juvenile Dermatomyositis (DM) and Adult Polymyositis (PM)
    Medical condition: Adult polymyositis or adult dermatomyositis or juvenile dermatomyositis
    Disease: Version SOC Term Classification Code Term Level
    8.1 10036102 Polymyositis LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) CZ (Completed) GB (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-000749-11 Sponsor Protocol Number: IBM-OLE Start Date*: 2019-10-09
    Sponsor Name:Orphazyme A/S
    Full Title: An open-label, non-randomized trial to investigate the efficacy and safety of early versus delayed start of arimoclomol in patients with sporadic inclusion body myositis who have completed the IBM4...
    Medical condition: Sporadic Inclusion Body Myositis (sIBM)
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004859 10075052 Sporadic inclusion body myositis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2016-005035-33 Sponsor Protocol Number: R2477-FOP-1623 Start Date*: 2017-08-15
    Sponsor Name:Regeneron Pharmaceuticals, Inc.
    Full Title: A randomized, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, and effects on heterotopic bone formation of REGN2477 in patients with Fibrodysplasia Ossificans Progres...
    Medical condition: Fibrodysplasia Ossificans Progressiva (FOP)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10068715 Fibrodysplasia ossificans progressiva PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) NL (Completed) IT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2007-004410-13 Sponsor Protocol Number: 3401 Start Date*: 2008-03-12
    Sponsor Name:Institute od Rheumatology Prague
    Full Title: A PROSPECTIVE, RANDOMISED, ASSESSOR-BLIND, MULTICENTER STUDY OF EFFICACY AND SAFETY OF COMBINED TREATMENT OF METHOTREXATE + GLUCOCORTICOIDS VERSUS GLUCOCORTICOIDS ALONE IN PATIENTS WITH POLYMYOSITI...
    Medical condition: active polymyositis, dermatomyositis
    Disease: Version SOC Term Classification Code Term Level
    9.1 10012503 Dermatomyositis LLT
    9.1 10036102 Polymyositis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) SE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-001710-37 Sponsor Protocol Number: NL73727 Start Date*: 2021-05-26
    Sponsor Name:Academisch Medisch Centrum
    Full Title: Intravenous immunoglobulin and prednisone vs. prednisone in newly diagnosed myositis: a double blind randomized clinical trial.
    Medical condition: idiopathic inflammatory myopathies
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-004903-33 Sponsor Protocol Number: IBM4809 Start Date*: 2018-06-18
    Sponsor Name:Orphazyme A/S
    Full Title: Phase 2/3 Study of Arimoclomol in Inclusion Body Myositis (IBM) A Randomized, Double-blind, Placebo-Controlled Trial
    Medical condition: Sporadic Inclusion Body Myositis (sIBM)
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004859 10075052 Sporadic inclusion body myositis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
    1  2  3  4  Next»
    Query did not match any studies.
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Fri Jul 04 19:18:44 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA