WVE-210201 ( DrugBank: - )


1 disease
IDDisease name (Link within this page)Number of trials
113Muscular dystrophy20

113. Muscular dystrophy


Clinical trials : 622 Drugs : 485 - (DrugBank : 99) / Drug target genes : 59 - Drug target pathways : 168
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;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Poland;Australia;Germany;Netherlands;Japan;Sweden
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
7EUCTR2018-000975-34-NL
(EUCTR)
06/02/201916/08/2018A Study of WVE-210201 in Patients previously enrolled in WVE-DMDX51-001A Multicenter, Open-Label Extension Study of WVE-210201 in Patients previously enrolled in WVE-DMDX51-001 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
Wave Life Sciences Ltd.NULLAuthorised-recruitment may be ongoing or finished Female: no
Male: yes
40 Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;United States;Canada;Belgium;Netherlands;Italy;United Kingdom
8EUCTR2018-000975-34-BE
(EUCTR)
13/11/201821/09/2018A Study of WVE-210201 in Patients Previously Enrolled in WVE-DMDX51-001A Multicenter, Open-Label Extension Study of WVE-210201 in Patients Previously Enrolled in WVE-DMDX51-001 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
Wave Life Sciences Ltd.NULLNot RecruitingFemale: no
Male: yes
40Phase 1France;United States;Canada;Belgium;Netherlands;Italy;United Kingdom
9EUCTR2018-000975-34-GB
(EUCTR)
25/10/201826/06/2018A Study of WVE-210201 in Patients Previously Enrolled in WVE-DMDX51-001A Multicenter, Open-Label Extension Study of WVE-210201 in Patients Previously Enrolled in WVE-DMDX51-001 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
Wave Life Sciences Ltd.NULLNot RecruitingFemale: no
Male: yes
40Phase 1France;United States;Canada;Belgium;Netherlands;Italy;United Kingdom
10EUCTR2017-002686-21-NL
(EUCTR)
26/06/201819/06/2018A study to assess the safety and tolerability of different doses of WVE-210201 in patients with Duchenne Muscular DystrophyA Multicenter, Double-blind, Placebo-controlled, Phase 1 Study of WVE-210201 Administered Intravenously to 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
Wave Life Sciences Ltd.NULLNot RecruitingFemale: no
Male: yes
32Phase 1France;United States;Czech Republic;Belgium;Spain;Ireland;Denmark;Netherlands;Italy;United Kingdom
11EUCTR2017-002686-21-BE
(EUCTR)
28/05/201812/03/2018A study to assess the safety and tolerability of different doses of WVE-210201 in patients with Duchenne Muscular DystrophyA Multicenter, Double-blind, Placebo-controlled, Phase 1 Study of WVE-210201 Administered Intravenously to 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
Wave Life Sciences Ltd.NULLNot Recruiting Female: no
Male: yes
32 Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;United States;Canada;Belgium;Netherlands;Italy;United Kingdom
12EUCTR2017-002686-21-IT
(EUCTR)
25/05/201805/11/2020A study to assess the safety and tolerability of different doses of WVE-210201 in patients with Duchenne Muscular DystrophyA Multicenter, Double-blind, Placebo-controlled, Phase 1 Study of WVE-210201 Administered Intravenously to 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
WAVE LIFE SCIENCES USA INCNULLNot RecruitingFemale: no
Male: yes
32Phase 1United States;France;Canada;Belgium;Netherlands;United Kingdom;Italy
13EUCTR2017-002686-21-GB
(EUCTR)
11/04/201827/12/2017A study to assess the safety and tolerability of different doses of WVE-210201 in patients with Duchenne Muscular DystrophyA Multicenter, Double-blind, Placebo-controlled, Phase 1 Study of WVE-210201 Administered Intravenously to 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
Wave Life Sciences Ltd.NULLAuthorised-recruitment may be ongoing or finished Female: no
Male: yes
32 Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;United States;Canada;Belgium;Netherlands;Italy;United Kingdom
14NCT03508947
(ClinicalTrials.gov)
January 24, 201816/4/2018Safety and Tolerability of WVE-210201 in Patients With Duchenne Muscular DystrophyA Multicenter, Double-blind, Placebo-controlled, Phase 1 Study of WVE-210201 Administered Intravenously to Patients With Duchenne Muscular DystrophyDuchenne Muscular DystrophyDrug: WVE-210201;Drug: PlaceboWave Life Sciences Ltd.NULLCompleted5 Years18 YearsMale36Phase 1United States;Belgium;Canada;France;Italy;Netherlands;United Kingdom
15EUCTR2017-002686-21-FR
(EUCTR)
29/01/2018A study to assess the safety and tolerability of different doses of WVE-210201 in patients with Duchenne Muscular DystrophyA Multicenter, Double-blind, Placebo-controlled, Phase 1 Study of WVE-210201 Administered Intravenously to 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
Wave Life Sciences Ltd.NULLNot RecruitingFemale: no
Male: yes
32Phase 1United States;France;Czech Republic;Belgium;Spain;Ireland;Denmark;Netherlands;Italy;United Kingdom
16EUCTR2018-004009-22-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;Ireland;Spain;United States
17EUCTR2018-000975-34-FR
(EUCTR)
28/06/2018A Study of WVE-210201 in Patients previously enrolled in WVE-DMDX51-001A Multicenter, Open-Label Extension Study of WVE-210201 in Patients previously enrolled in WVE-DMDX51-001 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
Wave Life Sciences Ltd.NULLNAFemale: no
Male: yes
40Phase 1United States;France;Canada;Belgium;Netherlands;Italy;United Kingdom
18EUCTR2018-004009-22-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): noGermany;Japan;Sweden;Netherlands;Australia;Belgium;Poland;Canada;Czech Republic;France;Italy;United Kingdom;Turkey;Ireland;Spain;United States
19EUCTR2018-004009-22-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
20EUCTR2018-004009-22-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