BMS-986089 ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
113筋ジストロフィー9

113. 筋ジストロフィー


臨床試験数 : 622 薬物数 : 485 - (DrugBank : 99) / 標的遺伝子数 : 59 - 標的パスウェイ数 : 168
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2016-001654-18-DE
(EUCTR)
13/11/201723/06/2017Clinical Trial to Evaluate the Efficacy, Safety, and Tolerability of RO7239361 in Ambulatory Boys With Duchenne Muscular DystrophyA randomized, double blind, placebo-controlled, study to assess the efficacy, safety, and tolerability of RO7239361 in ambulatory boys with Duchenne Muscular dystrophy Duchenne Muscular Dystrophy
MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: RO7239361 Injections, 7.5 mg/Syringe (10.7 mg/mL)
Product Code: RO7239361
INN or Proposed INN: Anti-myostatin Adnectin
Other descriptive name: BMS-986089-01, anti-myostatin
Product Name: RO7239361 Injections, 15 mg/Syringe (21.4 mg/mL)
Product Code: RO7239361
INN or Proposed INN: Anti-myostatin Adnectin
Other descriptive name: BMS-986089-01, anti-myostatin
Product Name: RO7239361 Injections, 35 mg/Syringe (50 mg/mL)
Product Code: RO7239361
INN or Proposed INN: Anti-myostatin Adnectin
Other descriptive name: BMS-986089-01, anti-myostatin
Product Name: RO7239361 Injections, 50 mg/Syringe (71.4 mg/mL)
Product Code: RO7239361
INN or Proposed INN: Anti-myostatin Adnectin
Other descriptive name: BMS-986089-01, anti-myostatin
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: no
Male: yes
159Phase 3United States;Spain;United Kingdom;Italy;France;Canada;Argentina;Belgium;Australia;Germany;Netherlands;Japan;Sweden
2EUCTR2016-001654-18-BE
(EUCTR)
10/11/201726/06/2017Clinical Trial to Evaluate the Efficacy, Safety, and Tolerability of RO7239361 (BMS-986089) in Ambulatory Boys With Duchenne Muscular DystrophyA randomized, double blind, placebo-controlled, study to assess the efficacy, safety, and tolerability of RO7239361 (BMS-986089) in ambulatory boys with Duchenne Muscular dystrophy Duchenne Muscular Dystrophy
MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: BMS-986089-01 (RO7239361) Injections, 7.5 mg/Syringe (10.7 mg/mL)
Product Code: RO7239361 (BMS-986089)
INN or Proposed INN: Anti-myostatin Adnectin
Other descriptive name: BMS-986089-01 (RO7239361) , anti-myostatin
Product Name: BMS-986089-01 (RO7239361) Injections, 15 mg/Syringe (21.4 mg/mL)
Product Code: RO7239361 (BMS-986089)
INN or Proposed INN: Anti-myostatin Adnectin
Other descriptive name: BMS-986089-01 (RO7239361), anti-myostatin
Product Name: BMS-986089-01 (RO7239361) Injections, 35 mg/Syringe (50 mg/mL)
Product Code: RO7239361 (BMS-986089)
INN or Proposed INN: Anti-myostatin Adnectin
Other descriptive name: BMS-986089-01 (RO7239361), anti-myostatin
Product Name: BMS-986089-01 (RO7239361) Injections, 50 mg/Syringe (71.4 mg/mL)
Product Code: RO7239361 (BMS-986089)
INN or Proposed INN: Anti-myostati
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: no
Male: yes
159Phase 3United States;Spain;Italy;United Kingdom;France;Canada;Argentina;Belgium;Australia;Germany;Netherlands;Japan;Sweden
3EUCTR2016-001654-18-FR
(EUCTR)
10/11/201730/10/2017Clinical Trial to Evaluate the Efficacy, Safety, and Tolerability of BMS-986089 in Ambulatory Boys With Duchenne Muscular DystrophyA Randomized, Double Blind, Placebo-Controlled, Study to Assess the Efficacy, Safety, and Tolerability of BMS-986089 in Ambulatory Boys with Duchenne Muscular Dystrophy Duchenne Muscular Dystrophy
MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: BMS-986089-01 Injections, 7.5 mg/Syringe (10.7 mg/mL)
Product Code: BMS-986089
INN or Proposed INN: Anti-Myostatin Adnectin
Other descriptive name: BMS-986089-01, anti-myostatin
Product Name: BMS-986089-01 Injections, 15 mg/Syringe (21.4 mg/mL)
Product Code: BMS-986089
INN or Proposed INN: Anti-Myostatin Adnectin
Other descriptive name: BMS-986089-01, anti-myostatin
Product Name: BMS-986089-01 Injections, 35 mg/Syringe (50 mg/mL)
Product Code: BMS-986089
INN or Proposed INN: Anti-Myostatin Adnectin
Other descriptive name: BMS-986089-01, anti-myostatin
Product Name: BMS-986089-01 Injections, 50 mg/Syringe (71.4 mg/mL)
Product Code: BMS-986089
INN or Proposed INN: Anti-Myostatin Adnectin
Other descriptive name: BMS-986089-01, anti-myostatin
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: no
Male: yes
160Phase 3United States;Spain;Italy;United Kingdom;France;Canada;Argentina;Belgium;Australia;Germany;Netherlands;Japan;Sweden
4EUCTR2016-001654-18-GB
(EUCTR)
01/11/201727/06/2017Clinical Trial to Evaluate the Efficacy, Safety, and Tolerability of RO7239361 in Ambulatory Boys With Duchenne Muscular DystrophyA Randomized, Double Blind, Placebo-Controlled, Study to Assess the Efficacy, Safety, and Tolerability of RO7239361 in Ambulatory Boys with Duchenne Muscular Dystrophy Duchenne Muscular Dystrophy
MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: RO7239361 Injections, 7.5 mg/Syringe (10.7 mg/mL)
Product Code: RO7239361
INN or Proposed INN: Anti-Myostatin Adnectin
Other descriptive name: BMS-986089-01, Anti-myostatin
Product Name: RO7239361 Injections, 15 mg/Syringe (21.4 mg/mL)
Product Code: RO7239361
INN or Proposed INN: Anti-Myostatin Adnectin
Other descriptive name: BMS-986089-01, anti-myostatin
Product Name: RO7239361 Injections, 35 mg/Syringe (50 mg/mL)
Product Code: RO7239361
INN or Proposed INN: Anti-Myostatin Adnectin
Other descriptive name: BMS-986089-01, anti-myostatin
Product Name: RO7239361 Injections, 50 mg/Syringe (71.4 mg/mL)
Product Code: RO7239361
INN or Proposed INN: Anti-Myostatin Adnectin
Other descriptive name: BMS-986089-01, anti-myostatin
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: no
Male: yes
159Phase 3United States;Spain;United Kingdom;Italy;France;Canada;Argentina;Belgium;Australia;Germany;Netherlands;Japan;Sweden
5EUCTR2016-001654-18-NL
(EUCTR)
26/10/201712/07/2017Clinical Trial to Evaluate the Efficacy, Safety, and Tolerability of RO7239361 in Ambulatory Boys With Duchenne Muscular DystrophyA Randomized, Double Blind, Placebo-Controlled, Study to Assess the Efficacy, Safety, and Tolerability of RO7239361 in Ambulatory Boys with Duchenne Muscular Dystrophy Duchenne Muscular Dystrophy
MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: RO7239361 Injections, 7.5 mg/Syringe (10.7 mg/mL)
Product Code: RO7239361
INN or Proposed INN: Anti-Myostatin Adnectin
Other descriptive name: BMS-986089-01, Anti-myostatin
Product Name: RO7239361 Injections, 15 mg/Syringe (21.4 mg/mL)
Product Code: RO7239361
INN or Proposed INN: Anti-Myostatin Adnectin
Other descriptive name: BMS-986089-01, anti-myostatin
Product Name: RO7239361 Injections, 35 mg/Syringe (50 mg/mL)
Product Code: RO7239361
INN or Proposed INN: Anti-Myostatin Adnectin
Other descriptive name: BMS-986089-01, anti-myostatin
Product Name: RO7239361 Injections, 50 mg/Syringe (71.4 mg/mL)
Product Code: RO7239361
INN or Proposed INN: Anti-Myostatin Adnectin
Other descriptive name: BMS-986089-01, anti-myostatin
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: no
Male: yes
159Phase 3United States;Spain;Italy;United Kingdom;France;Canada;Argentina;Belgium;Australia;Netherlands;Germany;Japan;Sweden
6EUCTR2016-001654-18-IT
(EUCTR)
19/09/201707/02/2018A Randomized, Double Blind, Placebo-Controlled, Study to Assess the Efficacy, Safety, and Tolerability of BMS-986089 in Ambulatory Boys with Duchenne Muscular Dystrophy - - A Randomized, Double Blind, Placebo-Controlled, Study to Assess the Efficacy, Safety, and Tolerability of BMS-986089 in Ambulatory Boys with Duchenne Muscular Dystrophy - - Duchenne Muscular Dystrophy
MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: BMS-986089-01 Injections, 7.5 mg/Syringe (10.7 mg/mL)
Product Code: BMS-986089
INN or Proposed INN: Anti-Myostatin Adnectin
Other descriptive name: BMS-986089-01, anti-myostatin
Product Name: BMS-986089-01 Injections, 15 mg/Syringe (21.4 mg/mL)
Product Code: BMS-986089
INN or Proposed INN: Anti-Myostatin Adnectin
Other descriptive name: BMS-986089-01, anti-myostatin
Product Name: BMS-986089-01 Injections, 35 mg/Syringe (50 mg/mL)
Product Code: BMS-986089
INN or Proposed INN: Anti-Myostatin Adnectin
Other descriptive name: BMS-986089-01, anti-myostatin
Product Name: BMS-986089-01 Injections, 50 mg/Syringe (71.4 mg/mL)
Product Code: BMS-986089
INN or Proposed INN: Anti-Myostatin Adnectin
Other descriptive name: BMS-986089-01, anti-myostatin
BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIONNULLNot RecruitingFemale: no
Male: yes
160Phase 3United States;Spain;Italy;United Kingdom;France;Canada;Argentina;Belgium;Australia;Germany;Netherlands;Japan;Sweden
7EUCTR2016-001654-18-ES
(EUCTR)
04/09/201704/07/2017Clinical Trial to Evaluate the Efficacy, Safety, and Tolerability of BMS-986089 in Ambulatory Boys With Duchenne Muscular DystrophyA Randomized, Double Blind, Placebo-Controlled, Study to Assess the Efficacy, Safety, and Tolerability of BMS-986089 in Ambulatory Boys with Duchenne Muscular Dystrophy Duchenne Muscular Dystrophy
MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: BMS-986089-01 Injections, 7.5 mg/Syringe (10.7 mg/mL)
Product Code: BMS-986089
INN or Proposed INN: Anti-Myostatin Adnectin
Other descriptive name: BMS-986089-01, anti-myostatin
Product Name: BMS-986089-01 Injections, 15 mg/Syringe (21.4 mg/mL)
Product Code: BMS-986089
INN or Proposed INN: Anti-Myostatin Adnectin
Other descriptive name: BMS-986089-01, anti-myostatin
Product Name: BMS-986089-01 Injections, 35 mg/Syringe (50 mg/mL)
Product Code: BMS-986089
INN or Proposed INN: Anti-Myostatin Adnectin
Other descriptive name: BMS-986089-01, anti-myostatin
Bristol-Myers Squibb International CorporationNULLNot Recruiting Female: no
Male: yes
160 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;United Kingdom;Italy;France;Canada;Argentina;Belgium;Australia;Germany;Netherlands;Japan;Sweden
8EUCTR2016-001654-18-SE
(EUCTR)
12/08/201715/06/2017Clinical Trial to Evaluate the Efficacy, Safety, and Tolerability of RO7239361 in Ambulatory Boys With Duchenne Muscular DystrophyA randomized, double blind, placebo-controlled, study to assess the efficacy, safety, and tolerability of RO7239361 in ambulatory boys with Duchenne Muscular dystrophy Duchenne Muscular Dystrophy
MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: RO7239361 Injections, 7.5 mg/Syringe (10.7 mg/mL)
Product Code: RO7239361
INN or Proposed INN: Anti-myostatin Adnectin
Other descriptive name: BMS-986089-01, Anti-myostatin
Product Name: RO7239361 Injections, 15 mg/Syringe (21.4 mg/mL)
Product Code: RO7239361
INN or Proposed INN: Anti-myostatin Adnectin
Other descriptive name: BMS-986089-01, anti-myostatin
Product Name: RO7239361 Injections, 35 mg/Syringe (50 mg/mL)
Product Code: RO7239361
INN or Proposed INN: Anti-myostatin Adnectin
Other descriptive name: BMS-986089-01, anti-myostatin
Product Name: RO7239361 Injections, 50 mg/Syringe (71.4 mg/mL)
Product Code: RO7239361
INN or Proposed INN: Anti-myostatin Adnectin
Other descriptive name: BMS-986089-01, anti-myostatin
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: no
Male: yes
159Phase 3United States;Spain;Italy;United Kingdom;France;Canada;Argentina;Belgium;Australia;Germany;Netherlands;Japan;Sweden
9NCT02515669
(ClinicalTrials.gov)
December 2, 201529/7/2015Study of an Investigational Drug, RO7239361 (BMS-986089), in Ambulatory Boys With DMDA Multi-Site, Randomized, Placebo-Controlled, Double-Blind, Multiple Ascending Subcutaneous Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of RO7239361 (BMS-986089) in Ambulatory Boys With Duchenne Muscular DystrophyMuscular Dystrophy (DMD)Drug: RO7239361;Drug: PlaceboHoffmann-La RocheNULLTerminated5 Years10 YearsMale43Phase 1/Phase 2United States;Canada