VBP15 ( 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12

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
1EUCTR2017-002704-27-NL
(EUCTR)
10/10/201925/02/2019A Study to Assess the efficacy and the safety of Vamorolone in Boys with Duchenne Muscular Dystrophy (DMD)A Phase IIb Randomized, Double-blind, Parallel Group, Placebo- and Active-controlled Study with Double-Blind Extension to Assess the Efficacy and Safety of Vamorolone in Ambulant Boys with Duchenne Muscular Dystrophy (DMD) - VISION DMD Duchenne muscular dystrophy (DMD)
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: Vamorolone
Product Code: VBP15
INN or Proposed INN: VAMOROLONE
Product Name: Vamorolone
Product Code: VBP15
INN or Proposed INN: VAMOROLONE
Product Name: Prednisone
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
ReveraGen BioPharma, Inc.NULLNot RecruitingFemale: no
Male: yes
120Phase 2United States;Czechia;Greece;Spain;Israel;Italy;United Kingdom;Czech Republic;Canada;Belgium;Australia;Netherlands;Germany;Sweden
2EUCTR2017-002704-27-ES
(EUCTR)
13/08/201911/06/2019A Study to Assess the efficacy and the safety of Vamorolone in Boys with Duchenne Muscular Dystrophy (DMD)A Phase IIb Randomized, Double-blind, Parallel Group, Placebo- and Active-controlled Study with Double-Blind Extension to Assess the Efficacy and Safety of Vamorolone in Ambulant Boys with Duchenne Muscular Dystrophy (DMD) - VISION DMD Duchenne muscular dystrophy (DMD)
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: Vamorolone
Product Code: VBP15
INN or Proposed INN: VAMOROLONE
Product Name: Vamorolone
Product Code: VBP15
INN or Proposed INN: VAMOROLONE
Product Name: Prednisone
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
ReveraGen BioPharma, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
120Phase 2United States;Greece;Spain;Israel;United Kingdom;Italy;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden
3EUCTR2017-002704-27-GR
(EUCTR)
01/08/201910/06/2019A Study to Assess the efficacy and the safety of Vamorolone in Boys withDuchenne Muscular Dystrophy (DMD)A Phase IIb Randomized, Double-blind, Parallel Group, Placebo- andActive-controlled Study with Double-Blind Extension to Assess the Efficacyand Safety of Vamorolone in Ambulant Boys with Duchenne MuscularDystrophy (DMD) - VISION DMD Duchenne muscular dystrophy (DMD)
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: Vamorolone
Product Code: VBP15
INN or Proposed INN: VAMOROLONE
Product Name: Vamorolone
Product Code: VBP15
INN or Proposed INN: VAMOROLONE
Product Name: Prednisone
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
ReveraGen BioPharma, IncNULLNot RecruitingFemale: no
Male: yes
120Phase 2Czech Republic;Canada;Greece;Spain;Belgium;Australia;Israel;Netherlands;Germany;United Kingdom;Italy;Sweden
4EUCTR2017-002704-27-BE
(EUCTR)
06/07/201921/02/2018A Study to Assess the efficacy and the safety of Vamorolone in Boys with Duchenne Muscular Dystrophy (DMD)A Phase IIb Randomized, Double-blind, Parallel Group, Placebo- and Active-controlled Study with Double-Blind Extension to Assess the Efficacy and Safety of Vamorolone in Ambulant Boys with Duchenne Muscular Dystrophy (DMD) - VISION DMD Duchenne muscular dystrophy (DMD)
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: Vamorolone
Product Code: VBP15
INN or Proposed INN: VAMOROLONE
Product Name: Vamorolone
Product Code: VBP15
INN or Proposed INN: VAMOROLONE
Product Name: Prednisone
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
ReveraGen BioPharma, Inc.NULLNot RecruitingFemale: no
Male: yes
120Phase 2United States;Czechia;Greece;Spain;Israel;Italy;United Kingdom;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden
5EUCTR2017-002704-27-CZ
(EUCTR)
19/06/201922/03/2019A Study to Assess the efficacy and the safety of Vamorolone in Boys with Duchenne Muscular Dystrophy (DMD)A Phase IIb Randomized, Double-blind, Parallel Group, Placebo- and Active-controlled Study with Double-Blind Extension to Assess the Efficacy and Safety of Vamorolone in Ambulant Boys with Duchenne Muscular Dystrophy (DMD) - VISION DMD Duchenne muscular dystrophy (DMD)
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: Vamorolone
Product Code: VBP15
INN or Proposed INN: VAMOROLONE
Product Name: Prednisone
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Product Name: Vamorolone
Product Code: VBP15
INN or Proposed INN: VAMOROLONE
ReveraGen BioPharma, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
120Phase 2United States;Greece;Spain;Israel;United Kingdom;Italy;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden
6NCT03863119
(ClinicalTrials.gov)
January 28, 201921/2/2019Expanded Access Protocol for Boys With Duchenne Muscular DystrophyAn Open-Label, Expanded Access Protocol for Boys With Duchenne Muscular Dystrophy Who Have Completed the Long-Term Extension (VBP15-LTE) or VBP15-004 StudiesDuchenne Muscular DystrophyDrug: VamoroloneReveraGen BioPharma, Inc.NULLAvailableN/AN/AMaleUnited States;Canada;Israel
7EUCTR2017-002704-27-GB
(EUCTR)
21/09/201825/06/2019A Study to Assess the efficacy and the safety of Vamorolone in comparison to Prednisone in Boys with Duchenne Muscular Dystrophy (DMD)A Phase IIb Randomized, Double-blind, Parallel Group, Placebo- and Active-controlled Study with Double-Blind Extension to Assess the Efficacy and Safety of Vamorolone in Ambulant Boys with Duchenne Muscular Dystrophy (DMD) - VISION DMD Duchenne muscular dystrophy (DMD)
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: Vamorolone
Product Code: VBP15
INN or Proposed INN: VAMOROLONE
Product Name: Vamorolone
Product Code: VBP15
INN or Proposed INN: VAMOROLONE
Product Name: Prednisone
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
ReveraGen BioPharma, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
120Phase 2United States;Greece;Spain;Israel;United Kingdom;Italy;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden
8EUCTR2017-002704-27-SE
(EUCTR)
15/08/201812/03/2018A Study to Assess the efficacy and the safety of Vamorolone in Boys with Duchenne Muscular Dystrophy (DMD)A Phase IIb Randomized, Double-blind, Parallel Group, Placebo- and Active-controlled Study with Double-Blind Extension to Assess the Efficacy and Safety of Vamorolone in Ambulant Boys with Duchenne Muscular Dystrophy (DMD) - VISION DMD Duchenne muscular dystrophy (DMD)
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: Vamorolone
Product Code: VBP15
INN or Proposed INN: VAMOROLONE
Product Name: Vamorolone
Product Code: VBP15
INN or Proposed INN: VAMOROLONE
Product Name: Prednisone
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
ReveraGen BioPharma, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
120Phase 2United States;Czechia;Greece;Spain;Israel;Italy;United Kingdom;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden
9EUCTR2017-003568-10-GB
(EUCTR)
05/01/201817/05/2018An Extension Study to Assess the Long-term Safety and Efficacy ofVamorolone in Boys With Duchenne Muscular Dystrophy(DMD)A 24-month Phase II Open-label, Multicenter Long-term Extension Study toAssess the Long-term Safety and Efficacy of Vamorolone in Boys withDuchenne Muscular Dystrophy (DMD) - VBP15-LTE Duchenne Muscular Dystrophy (DMD)
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: Vamorolone
INN or Proposed INN: Vamorolone
Other descriptive name: EV substance code: SUB188638
Product Name: Vamorolone
INN or Proposed INN: Vamorolone
Other descriptive name: EV substance code: SUB188638
Product Name: Vamorolone
INN or Proposed INN: Vamorolone
Other descriptive name: EV substance code: SUB188638
Product Name: Vamorolone
INN or Proposed INN: Vamorolone
Other descriptive name: EV substance code: SUB188638
ReveraGen BioPharma Inc.NULLNot RecruitingFemale: no
Male: yes
48Phase 2United States;Canada;Australia;Israel;United Kingdom;Sweden
10EUCTR2016-004262-26-GB
(EUCTR)
16/02/201721/12/2020A Study to Assess Vamorolone in Boys With Duchenne Muscular Dystrophy(DMD)VBP15-002 A Phase IIa Open-Label, Multiple Ascending Dose Study to Assess the Safety, Tolerability,Pharmacokinetics, Pharmacodynamics, and Exploratory Efficacy of Vamorolone in Boys with Duchenne MuscularDystrophy (DMD) Duchenne muscular dystrophy (DMD)
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: Vamarolone
Product Code: VBP15
INN or Proposed INN: vamorolone
Product Name: Vamorolone
Product Code: VBP15
INN or Proposed INN: vamorolone
Product Name: Vamorolone
Product Code: VBP15
INN or Proposed INN: vamorolone
Product Name: Vamorolone
Product Code: VBP15
INN or Proposed INN: vamorolone
ReveraGen BioPharma, Inc.NULLNot RecruitingFemale: no
Male: yes
48Phase 2United States;Canada;Australia;Israel;United Kingdom;Sweden
11EUCTR2016-004462-26-GB
(EUCTR)
16/02/201723/12/2016 A Study to Assess Vamorolone in Boys With Duchenne Muscular Dystrophy (DMD) VBP15-002 A Phase IIa Open-Label, Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Exploratory Efficacy of Vamorolone in Boys with Duchenne Muscular Dystrophy (DMD) Duchenne muscular dystrophy (DMD)
MedDRA version: 19.0;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: Vamarolone
Product Code: VBP15
INN or Proposed INN: vamorolone
Product Name: Vamorolone
Product Code: VBP15
INN or Proposed INN: vamorolone
Product Name: Vamorolone
Product Code: VBP15
INN or Proposed INN: vamorolone
Product Name: Vamorolone
Product Code: VBP15
INN or Proposed INN: vamorolone
ReveraGen BioPharma, Inc.NULLNot Recruiting Female: no
Male: yes
48 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Canada;Australia;Israel;United Kingdom
12EUCTR2016-004263-38-GB
(EUCTR)
10/02/201708/02/2019 An Extension Study to Assess the Long-term Safety and Efficacy of Vamorolone in Boys With Duchenne Muscular Dystrophy (DMD) A Phase II Open-label, Multicenter Extension Study to Assess the Longterm Safety and Efficacy of Vamorolone in Boys with Duchenne Muscular Dystrophy (DMD) Duchenne muscular dystrophy (DMD)
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: Vamarolone
Product Code: VBP15
INN or Proposed INN: vamorolone
Product Name: Vamorolone
Product Code: VBP15
INN or Proposed INN: vamorolone
Product Name: Vamorolone
Product Code: VBP15
INN or Proposed INN: vamorolone
Product Name: Vamorolone
Product Code: VBP15
INN or Proposed INN: vamorolone
ReveraGen BioPharma, Inc.NULLNot Recruiting Female: no
Male: yes
48 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Canada;Australia;Israel;United Kingdom;Sweden