Suvodirsen ( 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10

113. 筋ジストロフィー


臨床試験数 : 646 薬物数 : 471 - (DrugBank : 105) / 標的遺伝子数 : 59 - 標的パスウェイ数 : 170
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2018-004009-22-CZ
(EUCTR)
25/09/201926/06/2019Study of WVE-210201 in Patients (able to walk independently) with Duchenne Muscular DystrophyA Randomized, Double-blind, Placebo-controlled, Efficacy and Safety Study of WVE-210201 in Ambulatory Patients 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] - Nervous System Diseases [C10]
Product Name: WVE-210201
Product Code: WVE-210201
INN or Proposed INN: WVE-210201
Other descriptive name: suvodirsen
Wave Life Sciences UK LimitedNULLNot RecruitingFemale: no
Male: yes
150Phase 2;Phase 3United States;Japan;United Kingdom;Spain;Canada;Czech Republic;Netherlands;Sweden;Turkey;Belgium;Ireland;Poland;Italy;Australia;France;Germany
2NCT03907072
(ClinicalTrials.gov)
September 4, 20195/4/2019Efficacy and Safety Study of WVE-210201 (Suvodirsen) With Open-label Extension in Ambulatory Patients With Duchenne Muscular DystrophyA Randomized, Double-blind, Placebo-controlled, Efficacy and Safety Study of WVE-210201 With Open-label Extension in Ambulatory Patients With Duchenne Muscular Dystrophy (DYSTANCE 51)Duchenne Muscular DystrophyDrug: WVE-210201 (suvodirsen);Drug: PlaceboWave Life Sciences Ltd.NULLTerminated5 Years12 YearsMale6Phase 2/Phase 3United States;Belgium;Canada;Czechia;France;Italy;Sweden;United Kingdom
3EUCTR2018-004009-22-SE
(EUCTR)
20/07/201905/04/2019Study of WVE-210201 in Patients (able to walk independently) with Duchenne Muscular DystrophyA Randomized, Double-blind, Placebo-controlled, Efficacy and Safety Study of WVE-210201 with Open-label Extension in Ambulatory Patients with Duchenne Muscular Dystrophy (DYSTANCE 51) 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] - Nervous System Diseases [C10]
Product Name: WVE-210201
Product Code: WVE-210201
INN or Proposed INN: WVE-210201
Other descriptive name: suvodirsen
Wave Life Sciences UK LimitedNULLNot Recruiting Female: no
Male: yes
150 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Australia;Netherlands;Germany;Japan;Sweden
4EUCTR2018-004009-22-IT
(EUCTR)
09/07/201905/11/2020Study of WVE-210201 in Patients (able to walk independently) with Duchenne Muscular DystrophyA Randomized, Double-blind, Placebo-controlled, Efficacy and Safety Study of WVE-210201 in Ambulatory Patients 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] - Nervous System Diseases [C10]
Product Name: WVE-210201
Product Code: [WVE-210201]
Other descriptive name: suvodirsen
Wave Life Sciences UK LimitedNULLNot RecruitingFemale: no
Male: yes
150Phase 2;Phase 3United States;Czechia;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Poland;Australia;Germany;Netherlands;Japan;Sweden
5EUCTR2018-004009-22-GB
(EUCTR)
27/06/201928/03/2019Study of WVE-210201 in Patients (able to walk independently) with Duchenne Muscular DystrophyA Randomized, Double-blind, Placebo-controlled, Efficacy and Safety Study of WVE-210201 with Open-label Extension in Ambulatory Patients with Duchenne Muscular Dystrophy (DYSTANCE 51) 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] - Nervous System Diseases [C10]
Product Name: WVE-210201
Product Code: WVE-210201
INN or Proposed INN: WVE-210201
Other descriptive name: suvodirsen
Wave Life Sciences UK LimitedNULLNot RecruitingFemale: no
Male: yes
150Phase 2;Phase 3United States;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Australia;Netherlands;Germany;Japan;Sweden
6EUCTR2018-004009-22-BE
(EUCTR)
07/06/201921/05/2019Study of WVE-210201 in Patients (able to walk independently) with Duchenne Muscular DystrophyA Randomized, Double-blind, Placebo-controlled, Efficacy and Safety Study of WVE-210201 with Open-label Extension in Ambulatory Patients with Duchenne Muscular Dystrophy (DYSTANCE 51) 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] - Nervous System Diseases [C10]
Product Name: WVE-210201
Product Code: WVE-210201
INN or Proposed INN: WVE-210201
Other descriptive name: suvodirsen
Wave Life Sciences UK LimitedNULLNot RecruitingFemale: no
Male: yes
150Phase 2;Phase 3United States;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Poland;Australia;Germany;Netherlands;Japan;Sweden
7EUCTR2018-004009-22-FR
(EUCTR)
26/03/2019Study of WVE-210201 in Patients (able to walk independently) with Duchenne Muscular DystrophyA Randomized, Double-blind, Placebo-controlled, Efficacy and Safety Study of WVE-210201 in Ambulatory Patients 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] - Nervous System Diseases [C10]
Product Name: WVE-210201
Product Code: WVE-210201
INN or Proposed INN: WVE-210201
Other descriptive name: suvodirsen
Wave Life Sciences UK LimitedNULLNAFemale: no
Male: yes
150Phase 2;Phase 3United States;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Australia;Netherlands;Germany;Japan;Sweden
8EUCTR2018-004009-22-PL
(EUCTR)
18/06/2019Study of WVE-210201 in Patients (able to walk independently) with Duchenne Muscular DystrophyA Randomized, Double-blind, Placebo-controlled, Efficacy and Safety Study of WVE-210201 in Ambulatory Patients 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] - Nervous System Diseases [C10]
Product Name: WVE-210201
Product Code: WVE-210201
INN or Proposed INN: WVE-210201
Other descriptive name: suvodirsen
Wave Life Sciences UK LimitedNULLNot RecruitingFemale: no
Male: yes
150Phase 2;Phase 3United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Australia;Germany;Netherlands;Japan;Sweden;Turkey;United States;Spain;Ireland
9EUCTR2018-004009-22-DE
(EUCTR)
21/08/2019Study of WVE-210201 in Patients (able to walk independently) with Duchenne Muscular DystrophyA Randomized, Double-blind, Placebo-controlled, Efficacy and Safety Study of WVE-210201 with Open-label Extension in Ambulatory Patients with Duchenne Muscular Dystrophy (DYSTANCE 51) 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] - Nervous System Diseases [C10]
Product Name: WVE-210201
Product Code: WVE-210201
INN or Proposed INN: WVE-210201
Other descriptive name: suvodirsen
Wave Life Sciences UK LimitedNULLNot Recruiting Female: no
Male: yes
150 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Australia;Netherlands;Germany;Japan;Sweden
10EUCTR2018-004009-22-NL
(EUCTR)
13/05/2019Study of WVE-210201 in Patients (able to walk independently) with Duchenne Muscular DystrophyA Randomized, Double-blind, Placebo-controlled, Efficacy and Safety Study of WVE-210201 in Ambulatory Patients 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] - Nervous System Diseases [C10]
Product Name: WVE-210201
Product Code: WVE-210201
INN or Proposed INN: WVE-210201
Other descriptive name: suvodirsen
Wave Life Sciences UK LimitedNULLNA Female: no
Male: yes
150 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Ireland;Turkey;Italy;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Australia;Netherlands;Germany;Japan;Sweden