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 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.

Search in Page    e.g. "Phase 3", "Not recruiting", "Japan"    Synonyms (DrugBank) were also searched for.
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
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PhaseCountries
1NCT03710941February 19, 20196 May 2019Safety and Efficacy of REGN2477+REGN1033 in Patients With Sporadic Inclusion Body MyositisA Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Intravenously Administered REGN2477+REGN1033 in Patients With Sporadic Inclusion Body MyositisSporadic Inclusion Body MyositisDrug: REGN2477+REGN1033;Drug: Matching placeboRegeneron PharmaceuticalsNot recruiting45 Years75 YearsAll0Phase 2
2NCT03440034May 22, 201826 August 2019Study of Pioglitazone in Sporadic Inclusion Body MyositisAn Open-Label Pilot Study of Pioglitazone in Sporadic Inclusion Body MyositisMyositis;Inclusion Body Myositis;Muscular Diseases;Musculoskeletal Disease;Neuromuscular Diseases;Nervous System DiseasesDrug: PioglitazoneJohns Hopkins UniversityNot recruiting50 YearsN/AAll15Phase 1United States
3NCT02753530August 9, 20176 May 2019Study of Arimoclomol in Inclusion Body Myositis (IBM)Phase II Study of Arimoclomol for the Treatment of Sporadic Inclusion Body Myositis (IBM)Inclusion Body MyositisDrug: Arimoclomol;Other: PlaceboOrphazymeUniversity of Kansas Medical Center;University College, LondonNot recruiting45 YearsN/AAll150Phase 2United States;United Kingdom
4NCT02573467November 2, 201516 December 2017An 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 CBYM338B2203Extension 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 MyositisSporadic Inclusion Body MyositisDrug: Bimagrumab;Drug: PlaceboNovartis PharmaceuticalsNot recruiting36 YearsN/AAll211Phase 3United States;Australia;Belgium;Denmark;France;Italy;Japan;Netherlands;Switzerland;United Kingdom
5JPRN-JapicCTI-15307801/11/20152 April 2019Extension Study of the Long-term Efficacy and Safety of BYM338 in Patients With Sporadic Inclusion Body Myositis Who Previously Participated in the Core Study CBYM338B2203Extension 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 MyositisSporadic Inclusion Body MyositisIntervention 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.36BOTH240Phase 2-3
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
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PhaseCountries
6NCT02481453July 15, 201521 January 2019Rapamycine vs Placebo for the Treatment of Inclusion Body MyositisÉtude de l'Effet de la Rapamycine Sur la Force Musculaire et la réponse Immunitaire au Cours de la Myosite à Inclusions: étude RAPAMIInclusion Body Myositis (IBM)Drug: Rapamycin;Drug: PlaceboInstitut National de la Santé Et de la Recherche Médicale, FranceNot recruiting45 Years85 YearsAll44Phase 2/Phase 3France
7NCT02317094January 20152 November 2015Blood-flow Restricted Exercise in Inclusion Body MyositisLow-intensity Blood-flow Restricted Muscle Exercise in Patients With Sporadic Inclusion Body Myositis: a Randomised Controlled TrialSporadic Inclusion Body MyositisOther: Blood-flow restricted training;Drug: Care as usualUniversity of Southern DenmarkOdense University HospitalNot recruiting35 YearsN/ABoth22N/ADenmark
8EUCTR2014-002210-23-DK14/10/201430 April 2019Can 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-
RigshospitaletNot Recruiting Female: yes
Male: yes
15Phase 2Denmark
9NCT02250443March 11, 201415 April 2019Study of Long-term Safety, Efficacy Tolerability of BYM338 in Patients With Sporadic Inclusion Body MyositisAn Open-label, Long-term Study to Evaluate the Safety and Tolerability of BYM338 in Patients With Sporadic Inclusion Body MyositisSporadic Inclusion Body Myositis (sIBM)Drug: BYM338 (Bimagrumab)Novartis PharmaceuticalsNot recruiting40 Years75 YearsAll10Phase 2/Phase 3United States
10NCT01925209September 26, 201316 December 2017Efficacy and Safety of Bimagrumab/BYM338 at 52 Weeks on Physical Function, Muscle Strength, Mobility in sIBM PatientsA 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 MyositisSporadic Inclusion Body MyositisDrug: BYM338/bimagrumab;Drug: PlaceboNovartis PharmaceuticalsNot recruiting36 Years85 YearsAll251Phase 2/Phase 3United States;Australia;Belgium;Denmark;France;Italy;Japan;Netherlands;Switzerland;United Kingdom;Germany;Poland
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11JPRN-JapicCTI-13236501/9/20132 April 2019Efficacy and Safety of Bimagrumab/BYM338 at 52 Weeks on Physical Function, Muscle Strength, Mobility in sIBM PatientsA 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 myositisSporadic Inclusion Body MyositisIntervention 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.3685BOTH240Phase 2-3
12NCT02483845May 201316 December 2017Natalizumab in Inclusion Body Myositis (IBM)Pilot Study of Natalizumab in the Treatment of Patients With Inclusion Body MyositisInclusion Body Myositis (IBM)Drug: NatalizumabPhoenix Neurological Associates, LTDNot recruiting21 Years85 YearsAll6Phase 1United States
13NCT01519349January 201216 December 2017Follistatin Gene Transfer to Patients With Becker Muscular Dystrophy and Sporadic Inclusion Body MyositisPhase 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 MyositisBiological: rAAV1.CMV.huFollistatin344Nationwide Children's HospitalParent Project Muscular Dystrophy;The Myositis Association (Grant Sponsor)Not recruiting18 YearsN/AAll15Phase 1United States
14NCT01423110August 201116 December 2017Efficacy, Safety and Tolerability of BYM338 in Patients With Sporadic Inclusion Body MyositisA Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of BYM338 in Patients With Sporadic Inclusion Body MyositisSporadic Inclusion Body MyositisBiological: BYM338;Biological: PlaceboNovartis PharmaceuticalsNot recruiting40 Years80 YearsAll14Phase 2United States
15NCT00769860September 200819 October 2017Arimoclomol in Sporadic Inclusion Body MyositisSafety and Tolerability Trial of Arimoclomol for Sporadic Inclusion Body MyositisInclusion Body MyositisDrug: Arimoclomol;Other: PlaceboRichard Barohn, MDNot recruiting50 YearsN/AAll24Phase 2/Phase 3United States;United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2007-004359-12-IT05/04/200719 March 2012Simvastatin treatment in inclusion body myositis (IBM) - NDSimvastatin treatment in inclusion body myositis (IBM) - NDINCLUSION 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 BESTANot RecruitingFemale: yes
Male: yes
Italy
17EUCTR2006-005942-35-IT14/03/200719 March 2012Simvastatin therapy in IBM - NDSimvastatin therapy in IBM - NDinclusion 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 GEMELLINot RecruitingFemale: yes
Male: yes
Italy
18NCT00802815April 200519 February 2015Double-blind, Randomized, Placebo-controlled Trial of Etanercept for 12 Months in Subjects With Inclusion Body MyositisDouble-blind, Randomized, Placebo-controlled Trial of Etanercept for 12 Months in Subjects With Inclusion Body MyositisInclusion Body MyositisDrug: EtanerceptWashington University School of MedicineAmgenNot recruiting18 Years80 YearsBoth20Phase 0United States
19NCT00079768March 200419 February 2015Alemtuzumab to Treat Sporadic Inclusion Body MyositisEffects of a T Cell-Depleting Monoclonal Antibody, Alemtuzumab, in Patients With Inclusion Body Myositis: A Pilot Clinicopathological StudyMyositis, Inclusion BodyDrug: Alemtuzumab (Campath)National Institute of Neurological Disorders and Stroke (NINDS)Not recruiting25 Years80 YearsBoth20Phase 2United States
20NCT01165008September 200319 February 2015Anakinra in MyositisAnakinra in Patients With Refractory Idiopathic Inflammatory MyopathiesPolymyositis;Dermatomyositis;Inclusion Body MyositisDrug: AnakinraKarolinska InstitutetNot recruiting18 Years80 YearsBothPhase 2/Phase 3Sweden
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21NCT00001261May 199019 February 2015Intravenousimmunoglobulin (IVIg) for the Treatment of Inflammatory MyopathiesThe Efficacy of High-Dose Intravenous Immunoglobulin in Patients With Inflammatory Myopathies: A Three Month Randomized Trial With Option for Cross-OverDermatomyositis;Inclusion Body Myositis;PolymyositisDrug: Gamma GlobulinNational Institute of Neurological Disorders and Stroke (NINDS)Not recruitingN/AN/ABoth120Phase 2United States

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