15. 封入体筋炎 Inclusion body myositis Clinical trials / Disease details


臨床試験数 : 42 薬物数 : 60 - (DrugBank : 16) / 標的遺伝子数 : 12 - 標的パスウェイ数 : 123

  
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05272969
(ClinicalTrials.gov)
March 31, 202228/1/2022Pompe & Pain - Study to Assess Nociceptive Pain in Adult Patients With Pompe DiseasePompe & Pain - Observational Study to Assess Musculoskeletal Pain in Late-onset Pompe Disease (LOPD)Pompe Disease (Late-onset);Inclusion Body Myositis;Spinal Muscular Atrophy Type 3;FSHDDiagnostic Test: Beck depression inventory fast screen (Questionnaire);Diagnostic Test: Brief Pain Inventory (BPI) (Questionnaire);Diagnostic Test: German Pain Inventory (Questionnaire);Diagnostic Test: Fatigue Severity and Disability Scale (FSS) (Questionnaire);Diagnostic Test: Rotterdam Handicap Scale (RHS) (Questionnaire);Diagnostic Test: R-PAct (Questionnaire);Diagnostic Test: Quick Motor Function Test;Diagnostic Test: Handheld Dynamometry (HHD);Diagnostic Test: Six-minute walk test (6MWT);Diagnostic Test: Pressure pain threshold;Diagnostic Test: Muscle ultrasound;Diagnostic Test: Vital signs;Diagnostic Test: Borg Scale;Diagnostic Test: Laboratory assessment: Creatine kinase;Diagnostic Test: Laboratory assessment: Vitamin D Level;Diagnostic Test: Laboratory assessment: calcium;Diagnostic Test: Laboratory assessment: magnesium;Diagnostic Test: Laboratory assessment: phosphate;Genetic: Genetic test: ACE polymorphism;Genetic: Genetic test: ACTN3 polymorphism;Genetic: Blood draw for optional genetic exome sequencingLMU KlinikumNULLNot yet recruiting18 YearsN/AAll95Germany
2NCT04789070
(ClinicalTrials.gov)
January 1, 202215/2/2021Phase III Trial of Sirolimus in IBMA Double-Blind Randomised Controlled Trial (dbRCT) Phase III Trial Investigating the Effect of Sirolimus on Disease Progression in Patients With Inclusion Body Myositis (IBM) as Measured by the IBM Functional Rating Scale (IBM-FRS)Inclusion Body MyositisDrug: Sirolimus;Drug: PlaceboUniversity of Kansas Medical CenterThe Perron InstituteNot yet recruiting45 YearsN/AAll140Phase 3United States
3NCT05032131
(ClinicalTrials.gov)
September 202127/8/2021Cell Therapy for IBM by Muscle Injection of ADSVF: a Phase I TrialCell Therapy for Inclusion Body Myositis (IBM) by Muscle Injection of Autologous Uncultured Adipose-Derived Stromal Vascular Fraction (ADSVF): a Phase I TrialInclusion Body MyositisBiological: ADSVFAssistance Publique - Hôpitaux de ParisNULLNot yet recruiting45 Years80 YearsAll32Phase 1NULL
4NCT04659031
(ClinicalTrials.gov)
May 25, 202125/11/2020A Phase 1 Study of ABC008 in Adult Patients With Inclusion Body Myositis (IBM)A Phase 1, Open-Label, Ascending Dose Study of ABC008 in Adult Patients With Inclusion Body Myositis (IBM)Inclusion Body MyositisDrug: ABC008Abcuro, Inc.NULLRecruiting40 YearsN/AAll27Phase 1Australia
5NCT04421677
(ClinicalTrials.gov)
August 20, 202018/5/2020Safety and Tolerability of Phenylbutyrate in Inclusion Body MyositisSafety and Tolerability of Phenylbutyrate in Inclusion Body MyositisInclusion Body Myositis;Sporadic Inclusion Body MyositisDrug: Phenylbutyrate Oral TabletUniversity of Kansas Medical CenterNULLActive, not recruiting18 YearsN/AAll10Phase 1United States
6EUCTR2019-000749-11-GB
(EUCTR)
09/10/201920/06/2019An 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 IBM4809 trialAn 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 IBM4809 trial. Sporadic Inclusion Body Myositis (sIBM)
MedDRA version: 21.1;Level: LLT;Classification code 10075052;Term: Sporadic inclusion body myositis;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Product Name: Arimoclomol
Product Code: BRX-345
INN or Proposed INN: ARIMOCLOMOL
Other descriptive name: Arimoclomol citrate
Orphazyme A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130Phase 3United States;United Kingdom
7NCT04049097
(ClinicalTrials.gov)
May 20, 20191/4/2019Arimoclomol in Sporadic Inclusion Body Myositis - Open Label Extension TrialAn 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 IBM4809 TrialInclusion Body MyositisDrug: ArimoclomolOrphazymeUniversity of Kansas Medical Center;University College, LondonCompleted45 YearsN/AAll121Phase 3United States;United Kingdom
8NCT03710941
(ClinicalTrials.gov)
February 19, 201915/10/2018Safety 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 PharmaceuticalsNULLWithdrawn45 Years75 YearsAll0Phase 2NULL
9EUCTR2017-004903-33-GB
(EUCTR)
18/06/201805/04/2018Study of Arimoclomol in patients with Inclusion Body Myositis (IBM)Phase 2/3 Study of Arimoclomol in Inclusion Body Myositis (IBM)A Randomized, Double-blind, Placebo-Controlled Trial Sporadic Inclusion Body Myositis (sIBM)
MedDRA version: 21.1;Level: LLT;Classification code 10075052;Term: Sporadic inclusion body myositis;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Product Name: Arimoclomol
Product Code: BRX-345
INN or Proposed INN: ARIMOCLOMOL
Other descriptive name: Arimoclomol citrate
Orphazyme A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 2;Phase 3United States;United Kingdom
10NCT03440034
(ClinicalTrials.gov)
May 22, 201814/11/2017Study 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 UniversityNULLCompleted50 YearsN/AAll19Phase 1United States
11NCT02753530
(ClinicalTrials.gov)
August 16, 201725/4/2016Study 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, LondonCompleted45 YearsN/AAll152Phase 2United States;United Kingdom
12EUCTR2015-001411-12-DK
(EUCTR)
10/11/201511/09/2015Extension study to evaluate the long-term efficacy, safety and tolerability of BYM338 in patients with sporadic inclusion body myositisExtension 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
MedDRA version: 18.1;Level: PT;Classification code 10066407;Term: Inclusion body myositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: BYM338
INN or Proposed INN: Bimagrumab
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
240Phase 3France;United States;Belgium;Australia;Denmark;Netherlands;Japan;Italy;United Kingdom;Switzerland
13EUCTR2015-001411-12-BE
(EUCTR)
09/11/201512/10/2015Extension study to evaluate the long-term efficacy, safety and tolerability of BYM338 in patients with sporadic inclusion body myositisExtension 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
MedDRA version: 18.0;Level: PT;Classification code 10066407;Term: Inclusion body myositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: BYM338
INN or Proposed INN: Bimagrumab
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
240Phase 3France;United States;Belgium;Denmark;Australia;Netherlands;Japan;Italy;United Kingdom;Switzerland
14EUCTR2015-001411-12-FR
(EUCTR)
04/11/201505/08/2015Extension study to evaluate the long-term efficacy, safety and tolerability of BYM338 in patients with sporadic inclusion body myositisExtension 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
MedDRA version: 18.0;Level: PT;Classification code 10066407;Term: Inclusion body myositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: BYM338
INN or Proposed INN: Bimagrumab
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;France;Belgium;Denmark;Australia;Netherlands;Japan;Italy;United Kingdom;Switzerland
15EUCTR2015-001411-12-GB
(EUCTR)
04/11/201521/09/2015Extension study to evaluate the long-term efficacy, safety and tolerability of BYM338 in patients with sporadic inclusion body myositisExtension 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
MedDRA version: 18.0;Level: PT;Classification code 10066407;Term: Inclusion body myositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: BYM338
INN or Proposed INN: Bimagrumab
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
240 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Belgium;Denmark;Australia;Netherlands;Japan;Italy;Switzerland;United Kingdom
16NCT02573467
(ClinicalTrials.gov)
November 2, 20159/7/2015An 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 PharmaceuticalsNULLCompleted36 YearsN/AAll211Phase 3United States;Australia;Belgium;Denmark;France;Italy;Japan;Netherlands;Switzerland;United Kingdom
17JPRN-JapicCTI-153078
01/11/201525/11/2015Extension 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 Myositis Sporadic 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.NULL36BOTH240Phase 2-3NULL
18EUCTR2015-001411-12-NL
(EUCTR)
22/10/201517/08/2015Extension study to evaluate the long-term efficacy, safety and tolerability of BYM338 in patients with sporadic inclusion body myositisExtension 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
MedDRA version: 19.0;Level: PT;Classification code 10066407;Term: Inclusion body myositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: BYM338
INN or Proposed INN: Bimagrumab
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
240Phase 3France;United States;Belgium;Denmark;Australia;Netherlands;Japan;Italy;United Kingdom;Switzerland
19EUCTR2015-001411-12-IT
(EUCTR)
14/10/201527/02/2018Extension study to evaluate the long-term efficacy, safety and tolerabilityof BYM338 in patients with sporadic inclusion body myositisExtension of the CBYM338B2203 phase IIb/III study to evaluate the longtermefficacy, safety and tolerability of intravenous BYM338 in patientswith sporadic inclusion body myositis - Extension study to evaluate the long-term efficacy, safety and tolerability Sporadic Inclusion Body Myositis
MedDRA version: 20.0;Level: PT;Classification code 10066407;Term: Inclusion body myositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Bimagrumab
Product Code: BYM338
NOVARTIS FARMA S.P.A.NULLNot RecruitingFemale: yes
Male: yes
240Phase 3France;United States;Belgium;Denmark;Australia;Netherlands;Japan;United Kingdom;Switzerland;Italy
20NCT02481453
(ClinicalTrials.gov)
July 15, 201513/5/2015Rapamycine 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, FranceNULLCompleted45 Years85 YearsAll44Phase 2/Phase 3France
21NCT02317094
(ClinicalTrials.gov)
January 201510/12/2014Blood-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 HospitalCompleted35 YearsN/ABoth22N/ADenmark
22EUCTR2014-002210-23-DK
(EUCTR)
14/10/201402/06/2014Can 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
Other descriptive name: BOTULINUM TOXIN TYPE A
RigshospitaletNULLNot Recruiting Female: yes
Male: yes
15 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noDenmark
23EUCTR2013-000705-23-DE
(EUCTR)
10/07/201416/01/2014 Study of efficacy and safety of BYM338 in sporadic inclusion body myositis 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 myositis - RESILIENT Sporadic Inclusion Body Myositis
MedDRA version: 16.1;Level: PT;Classification code 10066407;Term: Inclusion body myositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: BYM338Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
240 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;France;Belgium;Poland;Denmark;Australia;Netherlands;Germany;United Kingdom;Japan;Italy;Switzerland
24EUCTR2013-000705-23-NL
(EUCTR)
01/07/201420/12/2013Study of efficacy and safety of BYM338 in sporadic inclusion body myositispatientsA 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 - RESILIENT Sporadic Inclusion Body Myositis
MedDRA version: 18.1;Level: PT;Classification code 10066407;Term: Inclusion body myositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: BYM338
INN or Proposed INN: na
Other descriptive name: na
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
240Phase 2United States;France;Poland;Belgium;Denmark;Australia;Germany;Netherlands;United Kingdom;Switzerland;Japan;Italy
25EUCTR2013-000705-23-GB
(EUCTR)
22/04/201431/01/2014Study of efficacy and safety of BYM338 in sporadic inclusion body myositispatientsA 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 - RESILIENT Sporadic Inclusion Body Myositis
MedDRA version: 16.1;Level: PT;Classification code 10066407;Term: Inclusion body myositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: BYM338Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;France;Belgium;Poland;Denmark;Australia;Germany;Netherlands;Japan;Italy;Switzerland;United Kingdom
26EUCTR2013-000705-23-DK
(EUCTR)
21/03/201410/03/2014Study of efficacy and safety of BYM338 in sporadic inclusion body myositis 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 myositis - RESILIENT Sporadic Inclusion Body Myositis
MedDRA version: 18.1;Level: PT;Classification code 10066407;Term: Inclusion body myositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: BYM338Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
240 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Japan;Italy;United Kingdom;Switzerland
27NCT02250443
(ClinicalTrials.gov)
March 11, 201420/3/2014Study 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 PharmaceuticalsNULLCompleted40 Years75 YearsAll10Phase 2/Phase 3United States
28EUCTR2013-000705-23-BE
(EUCTR)
24/02/201427/01/2014Study of efficacy and safety of BYM338 in sporadic inclusion body myositispatientsA 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 - RESILIENT Sporadic Inclusion Body Myositis
MedDRA version: 18.0;Level: PT;Classification code 10066407;Term: Inclusion body myositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: BYM338Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
240Phase 2United States;France;Poland;Belgium;Denmark;Australia;Netherlands;Germany;United Kingdom;Switzerland;Japan;Italy
29EUCTR2013-000705-23-IT
(EUCTR)
09/02/201412/12/2013Study of efficacy and safety of BYM338 in sporadic inclusion body myositispatientsA 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 - RESILIENT Sporadic Inclusion Body Myositis
MedDRA version: 14.1;Level: PT;Classification code 10066407;Term: Inclusion body myositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: BYM338
Product Code: BYM338
INN or Proposed INN: Bimagrumab
Novartis Farma SpANULLNot RecruitingFemale: yes
Male: yes
240Phase 3Netherlands;France;United States;Belgium;Poland;Denmark;Australia;Germany;Japan;United Kingdom;Switzerland;Italy
30NCT01925209
(ClinicalTrials.gov)
September 26, 201315/8/2013Efficacy 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 PharmaceuticalsNULLCompleted36 Years85 YearsAll251Phase 2/Phase 3United States;Australia;Belgium;Denmark;France;Italy;Japan;Netherlands;Switzerland;United Kingdom;Germany;Poland
31JPRN-JapicCTI-132365
01/9/201303/12/2013Efficacy 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 myositis Sporadic 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.NULL3685BOTH240Phase 2-3NULL
32NCT02483845
(ClinicalTrials.gov)
May 201331/5/2013Natalizumab 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, LTDNULLActive, not recruiting21 Years85 YearsAll6Phase 1United States
33NCT01519349
(ClinicalTrials.gov)
January 201223/1/2012Follistatin 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)Completed18 YearsN/AAll15Phase 1United States
34NCT01423110
(ClinicalTrials.gov)
August 201112/8/2011Efficacy, 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 PharmaceuticalsNULLCompleted40 Years80 YearsAll14Phase 2United States
35EUCTR2008-008208-42-GB
(EUCTR)
26/06/200929/05/2009A Randomised, Double-Blind Placebo-Controlled Pilot Study Assessing the Safety and Tolerability of Arimoclomol in Adult with Sporadic Inclusion Body Myositis - Arimoclomol for Inclusion Body MyositisA Randomised, Double-Blind Placebo-Controlled Pilot Study Assessing the Safety and Tolerability of Arimoclomol in Adult with Sporadic Inclusion Body Myositis - Arimoclomol for Inclusion Body Myositis 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 debilitating disease which causes both muscle weakness and wasting, characteristically of the quadriceps and finger flexors. Over time it can lead to severe disability, falls and swallowing impairment. IBM is currently without a clinically proven, effective pharmacological treatment.
MedDRA version: 9.1;Level: LLT;Classification code 10066407;Term: Inclusion body myositis
Product Name: Arimoclomol
Product Code: BRX-345
INN or Proposed INN: Arimoclomol
Other descriptive name: Arimoclomol
UCL - The Joint UCLH/UCL Comprehensive Biomedical Research UnitNULLNot Recruiting Female: yes
Male: yes
24 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited Kingdom
36NCT00769860
(ClinicalTrials.gov)
September 20088/10/2008Arimoclomol in Sporadic Inclusion Body MyositisSafety and Tolerability Trial of Arimoclomol for Sporadic Inclusion Body MyositisInclusion Body MyositisDrug: Arimoclomol;Other: PlaceboRichard Barohn, MDNULLCompleted50 YearsN/AAll24Phase 2/Phase 3United States;United Kingdom
37EUCTR2007-004359-12-IT
(EUCTR)
05/04/200721/11/2007Simvastatin treatment in inclusion body myositis (IBM) - NDSimvastatin treatment in inclusion body myositis (IBM) - ND INCLUSION BODY MYOSITIS
MedDRA version: 6.1;Level: PT;Classification code 10028289
Trade Name: SIVASTIN
INN or Proposed INN: Simvastatin
INN or Proposed INN: Immunoglobulins, normal human, for intravascular adm.
ISTITUTO NEUROLOGICO CARLO BESTANULLNot RecruitingFemale: yes
Male: yes
Italy
38EUCTR2006-005942-35-IT
(EUCTR)
14/03/200704/06/2007Simvastatin therapy in IBM - NDSimvastatin therapy in IBM - ND inclusion body myositis
MedDRA version: 6.1;Level: PT;Classification code 10028641
Trade Name: SIVASTIN
INN or Proposed INN: Simvastatin
Trade Name: FLEBOGAMMA 5%
INN or Proposed INN: Immunoglobulins, normal human, for intravascular adm.
POLICLINICO UNIVERSITARIO AGOSTINO GEMELLINULLNot RecruitingFemale: yes
Male: yes
Italy
39NCT00802815
(ClinicalTrials.gov)
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(ClinicalTrials.gov)
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41NCT01165008
(ClinicalTrials.gov)
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42NCT00001261
(ClinicalTrials.gov)
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