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


臨床試験数 : 42 薬物数 : 33 - (DrugBank : 11) / 標的遺伝子数 : 12 - 標的パスウェイ数 : 123

  
18 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2015-001411-12-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
2EUCTR2015-001411-12-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
3EUCTR2015-001411-12-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
4EUCTR2015-001411-12-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
5NCT02573467
(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
6JPRN-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
7EUCTR2015-001411-12-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
8EUCTR2015-001411-12-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
9EUCTR2013-000705-23-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
10EUCTR2013-000705-23-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
11EUCTR2013-000705-23-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
12EUCTR2013-000705-23-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
13NCT02250443
(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
14EUCTR2013-000705-23-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
15EUCTR2013-000705-23-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
16NCT01925209
(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
17JPRN-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
18NCT01423110
(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