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Clinical trials for Myositis, Inclusion Body

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
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    • 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 ).  
     
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    17 result(s) found for: Myositis, Inclusion Body. Displaying page 1 of 1.
    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: 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: (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: 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: 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)
    EudraCT Number: 2012-002859-42 Sponsor Protocol Number: CBAF312X2205 Start Date*: 2013-01-25
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A multi-centre, double-blind, placebo controlled, proof of concept study to evaluate the efficacy and tolerability of BAF312 in patients with polymyositis
    Medical condition: Polymyositis
    Disease: Version SOC Term Classification Code Term Level
    14.1 10028395 - Musculoskeletal and connective tissue disorders 10036102 Polymyositis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) CZ (Prematurely Ended) PL (Prematurely Ended) BE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2007-004359-12 Sponsor Protocol Number: IBM200702 Start Date*: 2007-04-05
    Sponsor Name:ISTITUTO NEUROLOGICO "CARLO BESTA"
    Full Title: Simvastatin treatment in inclusion body myositis (IBM)
    Medical condition: INCLUSION BODY MYOSITIS
    Disease: Version SOC Term Classification Code Term Level
    6.1 10028289 PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-003868-42 Sponsor Protocol Number: R123899 Start Date*: 2020-05-19
    Sponsor Name:University of Manchester
    Full Title: A randomised, phase IIa treatment delayed-start trial of the oral JAK 1/2 inhibitor, baricitinib, in the treatment of adult idiopathic inflammatory myopathy
    Medical condition: Idiopathic Inflammatory Myopathy (IIM)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10028395 - Musculoskeletal and connective tissue disorders 10028653 Myositis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2006-005942-35 Sponsor Protocol Number: 1413 Start Date*: 2007-03-14
    Sponsor Name:POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
    Full Title: Simvastatin therapy in IBM
    Medical condition: inclusion body myositis
    Disease: Version SOC Term Classification Code Term Level
    6.1 10028641 PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-002210-23 Sponsor Protocol Number: 1.4botox Start Date*: 2014-10-14
    Sponsor Name:Rigshospitalet
    Full Title: Can local intramuscular botulinum toxin improve dysphagia in patients with myopathic dysphagia and constriction of the cricoid muscle?
    Medical condition: Oculopharyngesl muscle dystrophy, inclusion body myositis
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004850 10019897 Hereditary progressive muscular dystrophy LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2020-004413-13 Sponsor Protocol Number: DIRECT Start Date*: 2021-05-18
    Sponsor Name:Amsterdam UMC, VU University Medical Center
    Full Title: Dual-immunotherapy and short-course medium-dose radiotherapy, followed by surgery for tumor microenvironment modification in early stage NSCLC
    Medical condition: early stage non-small cell lung cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061873 Non-small cell lung cancer PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029519 Non-small cell lung cancer stage III PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-001097-29 Sponsor Protocol Number: CA209-7T4 Start Date*: 2020-07-27
    Sponsor Name:Amsterdam UMC, VU University Medical Center
    Full Title: Rescue by radiotherapy and anti-CTLA4/PD-1 after failure of anti-PD-1 therapy in metastatic NSCLC patients, a proof-of-concept study.
    Medical condition: advanced non-small cell lung cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061873 Non-small cell lung cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-004529-22 Sponsor Protocol Number: D3465C00001 Start Date*: 2021-08-24
    Sponsor Name:AstraZeneca
    Full Title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Subcutaneous Anifrolumab in Adult Patients with Systemic Lupus Erythematosus
    Medical condition: Moderate-to-severe Systemic Lupus Erythematosus (SLE)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10028395 - Musculoskeletal and connective tissue disorders 10042945 Systemic lupus erythematosus PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Trial now transitioned) BG (Trial now transitioned) DE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2015-003277-15 Sponsor Protocol Number: 8400-211 Start Date*: 2016-09-02
    Sponsor Name:Idera Pharmaceuticals, Inc.
    Full Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial of IMO-8400 in Patients with Dermatomyositis
    Medical condition: Dermatomyositis
    Disease: Version SOC Term Classification Code Term Level
    19.1 10040785 - Skin and subcutaneous tissue disorders 10012503 Dermatomyositis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) HU (Completed) SE (Completed)
    Trial results: View results
    EudraCT Number: 2008-008135-28 Sponsor Protocol Number: 01-281108 Start Date*: 2009-04-16
    Sponsor Name:Hull and East Yorkshire NHS Hospitals Trust
    Full Title: Effect of Sildenafil on Pulmonary Artery Pressure during hypoxia and exercise in Chronic Heart Failure
    Medical condition: We will investigate the effect of sildenafil on pulmonary artery pressure in Heart failure patients (impaired heart function). Patients will be recruited from the Heart Failure clinic at Castle Hil...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10002034 Anaemia LLT
    9.1 10040756 Sinusitis NOS LLT
    9.1 10016807 Fluid retention LLT
    9.1 10022437 Insomnia LLT
    9.1 10016998 Forehead headache LLT
    9.1 10010108 Common migraine LLT
    9.1 10002855 Anxiety LLT
    9.1 10044565 Tremor LLT
    9.1 10033987 Paresthesia LLT
    9.1 10006790 Burning sensation NOS LLT
    9.1 10020937 Hypoaesthesia LLT
    9.1 10007882 Cellulitis LLT
    9.1 10022000 Influenza LLT
    9.1 10038870 Retinal hemorrhage LLT
    9.1 10047544 Visual disturbance NOS LLT
    9.1 10047513 Vision blurred LLT
    9.1 10034960 Photophobia LLT
    9.1 10008795 Chromatopsia LLT
    9.1 10051819 Cyanopsia LLT
    9.1 10015910 Eye blood shot LLT
    9.1 10015946 Eye irritation LLT
    9.1 10038189 Red eye LLT
    9.1 10047531 Visual acuity reduced LLT
    9.1 10013036 Diplopia LLT
    9.1 10000173 Abnormal sensation in eye LLT
    9.1 10047340 Vertigo LLT
    9.1 10065027 Sudden deafness LLT
    9.1 10016825 Flushing LLT
    9.1 10006461 Bronchitis NOS LLT
    9.1 10015090 Epistaxis LLT
    9.1 10039092 Rhinitis NOS LLT
    9.1 10011224 Cough LLT
    9.1 10028735 Nasal congestion LLT
    9.1 10012735 Diarrhoea LLT
    9.1 10013946 Dyspepsia LLT
    9.1 10017869 Gastritis NOS LLT
    9.1 10017888 Gastroenteritis LLT
    9.1 10017885 Gastrooesophageal reflux disease LLT
    9.1 10019022 Haemorrhoids LLT
    9.1 10000060 Abdominal distension LLT
    9.1 10013781 Dry mouth LLT
    9.1 10001760 Alopecia LLT
    9.1 10015150 Erythema LLT
    9.1 10029410 Night sweats LLT
    9.1 10040913 Skin rash LLT
    9.1 10028411 Myalgia LLT
    9.1 10003988 Back pain LLT
    9.1 10018800 Gynaecomastia LLT
    9.1 10036661 Priapism LLT
    9.1 10052791 Erection increased (excl priapism) LLT
    9.1 10037660 Pyrexia LLT
    9.1 10042438 Sudden hearing loss, unspecified LLT
    9.1 10033425 Pain in extremity LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (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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