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
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2015-001411-12-DK (EUCTR) | 10/11/2015 | 11/09/2015 | Extension study to evaluate the long-term efficacy, safety and tolerability of BYM338 in patients with sporadic inclusion body myositis | 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 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | France;United States;Belgium;Australia;Denmark;Netherlands;Japan;Italy;United Kingdom;Switzerland | ||
| 2 | EUCTR2015-001411-12-BE (EUCTR) | 09/11/2015 | 12/10/2015 | Extension study to evaluate the long-term efficacy, safety and tolerability of BYM338 in patients with sporadic inclusion body myositis | 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 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | France;United States;Belgium;Denmark;Australia;Netherlands;Japan;Italy;United Kingdom;Switzerland | ||
| 3 | EUCTR2015-001411-12-FR (EUCTR) | 04/11/2015 | 05/08/2015 | Extension study to evaluate the long-term efficacy, safety and tolerability of BYM338 in patients with sporadic inclusion body myositis | 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 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | United States;France;Belgium;Denmark;Australia;Netherlands;Japan;Italy;United Kingdom;Switzerland | ||
| 4 | EUCTR2015-001411-12-GB (EUCTR) | 04/11/2015 | 21/09/2015 | Extension study to evaluate the long-term efficacy, safety and tolerability of BYM338 in patients with sporadic inclusion body myositis | 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 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 AG | NULL | Not 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): no | France;United States;Belgium;Denmark;Australia;Netherlands;Japan;Italy;Switzerland;United Kingdom | ||
| 5 | NCT02573467 (ClinicalTrials.gov) | November 2, 2015 | 9/7/2015 | 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 | NULL | Completed | 36 Years | N/A | All | 211 | Phase 3 | United States;Australia;Belgium;Denmark;France;Italy;Japan;Netherlands;Switzerland;United Kingdom |
| 6 | JPRN-JapicCTI-153078 | 01/11/2015 | 25/11/2015 | 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. | NULL | 36 | BOTH | 240 | Phase 2-3 | NULL | ||
| 7 | EUCTR2015-001411-12-NL (EUCTR) | 22/10/2015 | 17/08/2015 | Extension study to evaluate the long-term efficacy, safety and tolerability of BYM338 in patients with sporadic inclusion body myositis | 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 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | France;United States;Belgium;Denmark;Australia;Netherlands;Japan;Italy;United Kingdom;Switzerland | ||
| 8 | EUCTR2015-001411-12-IT (EUCTR) | 14/10/2015 | 27/02/2018 | Extension study to evaluate the long-term efficacy, safety and tolerabilityof BYM338 in patients with sporadic inclusion body myositis | Extension 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. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | France;United States;Belgium;Denmark;Australia;Netherlands;Japan;United Kingdom;Switzerland;Italy | ||
| 9 | EUCTR2013-000705-23-DE (EUCTR) | 10/07/2014 | 16/01/2014 | Study of efficacy and safety of BYM338 in sporadic inclusion body myositis 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 - 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: BYM338 | Novartis Pharma Services AG | NULL | Not 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): no | United States;France;Belgium;Poland;Denmark;Australia;Netherlands;Germany;United Kingdom;Japan;Italy;Switzerland | ||
| 10 | EUCTR2013-000705-23-NL (EUCTR) | 01/07/2014 | 20/12/2013 | Study of efficacy and safety of BYM338 in sporadic inclusion body myositispatients | 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 - 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;France;Poland;Belgium;Denmark;Australia;Germany;Netherlands;United Kingdom;Switzerland;Japan;Italy | ||
| 11 | EUCTR2013-000705-23-GB (EUCTR) | 22/04/2014 | 31/01/2014 | Study of efficacy and safety of BYM338 in sporadic inclusion body myositispatients | 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 - 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: BYM338 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | United States;France;Belgium;Poland;Denmark;Australia;Germany;Netherlands;Japan;Italy;Switzerland;United Kingdom | ||
| 12 | EUCTR2013-000705-23-DK (EUCTR) | 21/03/2014 | 10/03/2014 | Study of efficacy and safety of BYM338 in sporadic inclusion body myositis 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 - 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 | Novartis Pharma Services AG | NULL | Not 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): no | France;United States;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Japan;Italy;United Kingdom;Switzerland | ||
| 13 | NCT02250443 (ClinicalTrials.gov) | March 11, 2014 | 20/3/2014 | 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 | NULL | Completed | 40 Years | 75 Years | All | 10 | Phase 2/Phase 3 | United States |
| 14 | EUCTR2013-000705-23-BE (EUCTR) | 24/02/2014 | 27/01/2014 | Study of efficacy and safety of BYM338 in sporadic inclusion body myositispatients | 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 - 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: BYM338 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;France;Poland;Belgium;Denmark;Australia;Netherlands;Germany;United Kingdom;Switzerland;Japan;Italy | ||
| 15 | EUCTR2013-000705-23-IT (EUCTR) | 09/02/2014 | 12/12/2013 | Study of efficacy and safety of BYM338 in sporadic inclusion body myositispatients | 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 - 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 SpA | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | Netherlands;France;United States;Belgium;Poland;Denmark;Australia;Germany;Japan;United Kingdom;Switzerland;Italy | ||
| 16 | NCT01925209 (ClinicalTrials.gov) | September 26, 2013 | 15/8/2013 | 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 | NULL | Completed | 36 Years | 85 Years | All | 251 | Phase 2/Phase 3 | United States;Australia;Belgium;Denmark;France;Italy;Japan;Netherlands;Switzerland;United Kingdom;Germany;Poland |
| 17 | JPRN-JapicCTI-132365 | 01/9/2013 | 03/12/2013 | 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. | NULL | 36 | 85 | BOTH | 240 | Phase 2-3 | NULL | |
| 18 | NCT01423110 (ClinicalTrials.gov) | August 2011 | 12/8/2011 | 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 | NULL | Completed | 40 Years | 80 Years | All | 14 | Phase 2 | United States |