15. 封入体筋炎 ［臨床試験数：21，薬物数：23（DrugBank：10），標的遺伝子数：11，標的パスウェイ数：112］
Searched query = "Inclusion body myositis"
The queries were searched in Public_title, Scientific_title, and Condition of the data. Export date: 11/20/2019, 11/21/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT03710941 | February 19, 2019 | 6 May 2019 | Safety and Efficacy of REGN2477+REGN1033 in Patients With Sporadic Inclusion Body Myositis | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Intravenously Administered REGN2477+REGN1033 in Patients With Sporadic Inclusion Body Myositis | Sporadic Inclusion Body Myositis | Drug: REGN2477+REGN1033;Drug: Matching placebo | Regeneron Pharmaceuticals | Not recruiting | 45 Years | 75 Years | All | 0 | Phase 2 | ||
| 2 | NCT03440034 | May 22, 2018 | 26 August 2019 | Study of Pioglitazone in Sporadic Inclusion Body Myositis | An Open-Label Pilot Study of Pioglitazone in Sporadic Inclusion Body Myositis | Myositis;Inclusion Body Myositis;Muscular Diseases;Musculoskeletal Disease;Neuromuscular Diseases;Nervous System Diseases | Drug: Pioglitazone | Johns Hopkins University | Not recruiting | 50 Years | N/A | All | 15 | Phase 1 | United States | |
| 3 | NCT02753530 | August 9, 2017 | 6 May 2019 | Study of Arimoclomol in Inclusion Body Myositis (IBM) | Phase II Study of Arimoclomol for the Treatment of Sporadic Inclusion Body Myositis (IBM) | Inclusion Body Myositis | Drug: Arimoclomol;Other: Placebo | Orphazyme | University of Kansas Medical Center;University College, London | Not recruiting | 45 Years | N/A | All | 150 | Phase 2 | United States;United Kingdom |
| 4 | NCT02573467 | November 2, 2015 | 16 December 2017 | An Extension Study of the Efficacy, Safety and Tolerability of BYM338 (Bimagrumab) in Patients With Sporadic Inclusion Body Myositis Who Previously Participated in the Core Study CBYM338B2203 | 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 | Sporadic Inclusion Body Myositis | Drug: Bimagrumab;Drug: Placebo | Novartis Pharmaceuticals | Not recruiting | 36 Years | N/A | All | 211 | Phase 3 | United States;Australia;Belgium;Denmark;France;Italy;Japan;Netherlands;Switzerland;United Kingdom | |
| 5 | JPRN-JapicCTI-153078 | 01/11/2015 | 2 April 2019 | Extension Study of the Long-term Efficacy and Safety of BYM338 in Patients With Sporadic Inclusion Body Myositis Who Previously Participated in the Core Study CBYM338B2203 | 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 | Sporadic Inclusion Body Myositis | Intervention name : BYM338 INN of the intervention : Bimagrumab Dosage And administration of the intervention : BYM338 (High dose, Mid dose, Low dose or Placebo) will be continuously administered via intravenous infusion to randomized patients. Once the dose with the best benefit-risk profile is selected, all ongoing subjects will be switched to open-label treatment with BYM338 at the selected dose. Control intervention name : null | Novartis Pharma K.K. | 36 | BOTH | 240 | Phase 2-3 | ||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | NCT02481453 | July 15, 2015 | 21 January 2019 | Rapamycine vs Placebo for the Treatment of Inclusion Body Myositis | Étude de l'Effet de la Rapamycine Sur la Force Musculaire et la réponse Immunitaire au Cours de la Myosite à Inclusions: étude RAPAMI | Inclusion Body Myositis (IBM) | Drug: Rapamycin;Drug: Placebo | Institut National de la Santé Et de la Recherche Médicale, France | Not recruiting | 45 Years | 85 Years | All | 44 | Phase 2/Phase 3 | France | |
| 7 | NCT02317094 | January 2015 | 2 November 2015 | Blood-flow Restricted Exercise in Inclusion Body Myositis | Low-intensity Blood-flow Restricted Muscle Exercise in Patients With Sporadic Inclusion Body Myositis: a Randomised Controlled Trial | Sporadic Inclusion Body Myositis | Other: Blood-flow restricted training;Drug: Care as usual | University of Southern Denmark | Odense University Hospital | Not recruiting | 35 Years | N/A | Both | 22 | N/A | Denmark |
| 8 | EUCTR2014-002210-23-DK | 14/10/2014 | 30 April 2019 | Can local botulinum toxin improve swallowing difficulties in persons with msucle disease? | Can local intramuscular botulinum toxin improve dysphagia in patients with myopathic dysphagia and constriction of the cricoid muscle? | Oculopharyngesl muscle dystrophy, inclusion body myositis MedDRA version: 18.1 Level: LLT Classification code 10019897 Term: Hereditary progressive muscular dystrophy System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Xeomin Product Name: Xeomin Pharmaceutical Form: Concentrate and solvent for solution for injection CAS Number: 93384-43-1 Other descriptive name: BOTULINUM TOXIN TYPE A Concentration unit: U/ml unit(s)/millilitre Concentration type: equal Concentration number: 100- | Rigshospitalet | Not Recruiting | Female: yes Male: yes | 15 | Phase 2 | Denmark | |||
| 9 | NCT02250443 | March 11, 2014 | 15 April 2019 | Study of Long-term Safety, Efficacy Tolerability of BYM338 in Patients With Sporadic Inclusion Body Myositis | An Open-label, Long-term Study to Evaluate the Safety and Tolerability of BYM338 in Patients With Sporadic Inclusion Body Myositis | Sporadic Inclusion Body Myositis (sIBM) | Drug: BYM338 (Bimagrumab) | Novartis Pharmaceuticals | Not recruiting | 40 Years | 75 Years | All | 10 | Phase 2/Phase 3 | United States | |
| 10 | NCT01925209 | September 26, 2013 | 16 December 2017 | Efficacy and Safety of Bimagrumab/BYM338 at 52 Weeks on Physical Function, Muscle Strength, Mobility in sIBM Patients | A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group, Dose-finding, Pivotal, Phase 2b/3 Study to Evaluate the Efficacy, Safety, and Tolerability of Intravenous BYM338 at 52 Weeks on Physical Function, Muscle Strength, and Mobility and Additional Long Term Safety up to 2 Years in Patients With Sporadic Inclusion Body Myositis | Sporadic Inclusion Body Myositis | Drug: BYM338/bimagrumab;Drug: Placebo | Novartis Pharmaceuticals | Not recruiting | 36 Years | 85 Years | All | 251 | Phase 2/Phase 3 | United States;Australia;Belgium;Denmark;France;Italy;Japan;Netherlands;Switzerland;United Kingdom;Germany;Poland | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 11 | JPRN-JapicCTI-132365 | 01/9/2013 | 2 April 2019 | Efficacy and Safety of Bimagrumab/BYM338 at 52 Weeks on Physical Function, Muscle Strength, Mobility in sIBM Patients | 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 weeks on physical function, muscle strength, and mobility and additional long-term safety up to 2 years in patients with sporadic inclusion body myositis | Sporadic Inclusion Body Myositis | Intervention name : BYM338 INN of the intervention : Bimagrumab Dosage And administration of the intervention : BYM338 (High dose, Mid dose, Low dose or Placebo) will be administered via intravenous infusion to randomized patients beginning on Day 1 through Week 52, and up to Week 104. Control intervention name : null | Novartis Pharma K.K. | 36 | 85 | BOTH | 240 | Phase 2-3 | |||
| 12 | NCT02483845 | May 2013 | 16 December 2017 | Natalizumab in Inclusion Body Myositis (IBM) | Pilot Study of Natalizumab in the Treatment of Patients With Inclusion Body Myositis | Inclusion Body Myositis (IBM) | Drug: Natalizumab | Phoenix Neurological Associates, LTD | Not recruiting | 21 Years | 85 Years | All | 6 | Phase 1 | United States | |
| 13 | NCT01519349 | January 2012 | 16 December 2017 | Follistatin Gene Transfer to Patients With Becker Muscular Dystrophy and Sporadic Inclusion Body Myositis | Phase I Clinical Intramuscular Gene Transfer of rAAV1.CMV.huFollistatin344 Trial to Patients With Becker Muscular Dystrophy and Sporadic Inclusion Body Myositis. | Becker Muscular Dystrophy;Sporadic Inclusion Body Myositis | Biological: rAAV1.CMV.huFollistatin344 | Nationwide Children's Hospital | Parent Project Muscular Dystrophy;The Myositis Association (Grant Sponsor) | Not recruiting | 18 Years | N/A | All | 15 | Phase 1 | United States |
| 14 | NCT01423110 | August 2011 | 16 December 2017 | Efficacy, Safety and Tolerability of BYM338 in Patients With Sporadic Inclusion Body Myositis | A Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of BYM338 in Patients With Sporadic Inclusion Body Myositis | Sporadic Inclusion Body Myositis | Biological: BYM338;Biological: Placebo | Novartis Pharmaceuticals | Not recruiting | 40 Years | 80 Years | All | 14 | Phase 2 | United States | |
| 15 | NCT00769860 | September 2008 | 19 October 2017 | Arimoclomol in Sporadic Inclusion Body Myositis | Safety and Tolerability Trial of Arimoclomol for Sporadic Inclusion Body Myositis | Inclusion Body Myositis | Drug: Arimoclomol;Other: Placebo | Richard Barohn, MD | Not recruiting | 50 Years | N/A | All | 24 | Phase 2/Phase 3 | United States;United Kingdom | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 16 | EUCTR2007-004359-12-IT | 05/04/2007 | 19 March 2012 | Simvastatin treatment in inclusion body myositis (IBM) - ND | Simvastatin treatment in inclusion body myositis (IBM) - ND | INCLUSION BODY MYOSITIS MedDRA version: 6.1 Level: PT Classification code 10028289 | Trade Name: SIVASTIN Pharmaceutical Form: Tablet INN or Proposed INN: Simvastatin Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- Pharmaceutical Form: Powder and solvent for solution for infusion INN or Proposed INN: Immunoglobulins, normal human, for intravascular adm. Concentration unit: g gram(s) Concentration type: equal Concentration number: 1000- | ISTITUTO NEUROLOGICO CARLO BESTA | Not Recruiting | Female: yes Male: yes | Italy | |||||
| 17 | EUCTR2006-005942-35-IT | 14/03/2007 | 19 March 2012 | Simvastatin therapy in IBM - ND | Simvastatin therapy in IBM - ND | inclusion body myositis MedDRA version: 6.1 Level: PT Classification code 10028641 | Trade Name: SIVASTIN Pharmaceutical Form: Coated tablet INN or Proposed INN: Simvastatin Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40- Trade Name: FLEBOGAMMA 5% Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: Immunoglobulins, normal human, for intravascular adm. Concentration unit: g gram(s) Concentration type: equal Concentration number: 2- | POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI | Not Recruiting | Female: yes Male: yes | Italy | |||||
| 18 | NCT00802815 | April 2005 | 19 February 2015 | Double-blind, Randomized, Placebo-controlled Trial of Etanercept for 12 Months in Subjects With Inclusion Body Myositis | Double-blind, Randomized, Placebo-controlled Trial of Etanercept for 12 Months in Subjects With Inclusion Body Myositis | Inclusion Body Myositis | Drug: Etanercept | Washington University School of Medicine | Amgen | Not recruiting | 18 Years | 80 Years | Both | 20 | Phase 0 | United States |
| 19 | NCT00079768 | March 2004 | 19 February 2015 | Alemtuzumab to Treat Sporadic Inclusion Body Myositis | Effects of a T Cell-Depleting Monoclonal Antibody, Alemtuzumab, in Patients With Inclusion Body Myositis: A Pilot Clinicopathological Study | Myositis, Inclusion Body | Drug: Alemtuzumab (Campath) | National Institute of Neurological Disorders and Stroke (NINDS) | Not recruiting | 25 Years | 80 Years | Both | 20 | Phase 2 | United States | |
| 20 | NCT01165008 | September 2003 | 19 February 2015 | Anakinra in Myositis | Anakinra in Patients With Refractory Idiopathic Inflammatory Myopathies | Polymyositis;Dermatomyositis;Inclusion Body Myositis | Drug: Anakinra | Karolinska Institutet | Not recruiting | 18 Years | 80 Years | Both | Phase 2/Phase 3 | Sweden | ||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 21 | NCT00001261 | May 1990 | 19 February 2015 | Intravenousimmunoglobulin (IVIg) for the Treatment of Inflammatory Myopathies | The Efficacy of High-Dose Intravenous Immunoglobulin in Patients With Inflammatory Myopathies: A Three Month Randomized Trial With Option for Cross-Over | Dermatomyositis;Inclusion Body Myositis;Polymyositis | Drug: Gamma Globulin | National Institute of Neurological Disorders and Stroke (NINDS) | Not recruiting | N/A | N/A | Both | 120 | Phase 2 | United States |