Pamrevlumab (FG-3019) ( DrugBank: Pamrevlumab )


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13

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
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registration
Public_titleScientific_titleConditionInterventionPrimary_
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Recruitment_
Status
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agemin
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agemax
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PhaseCountries
1EUCTR2020-000699-39-NL
(EUCTR)
28/06/202109/02/2021Evaluation of Pamrevlumab for the Treatment of Ambulatory Patients Affected by Duchenne Muscular Dystrophy and just Treated with CorticosteroidsA Phase 3, Randomized, Double-Blind, Trial of Pamrevlumab (FG-3019) or Placebo in Combination with Systemic Corticosteroids in Ambulatory Subjects with Duchenne Muscular Dystrophy (DMD) Ambulatory 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: Pamrevlumab
Product Code: FG-3019
INN or Proposed INN: PAMREVLUMAB
FibroGen, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
70Phase 3United States;France;Canada;Spain;Belgium;Austria;Australia;Netherlands;United Kingdom;Italy
2EUCTR2020-000699-39-AT
(EUCTR)
26/04/202129/01/2021Evaluation of Pamrevlumab for the Treatment of Ambulatory Patients Affected Duchenne Muscular Dystrophy and just Treated with CorticosteroidsA Phase 3, Randomized, Double-Blind, Trial of Pamrevlumab (FG-3019) or Placebo in Combination with Systemic Corticosteroids in Ambulatory Subjects with Duchenne Muscular Dystrophy (DMD) Ambulatory 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: Pamrevlumab
Product Code: FG-3019
INN or Proposed INN: PAMREVLUMAB
FibroGen, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
70Phase 3United States;France;Canada;Spain;Belgium;Australia;Austria;Netherlands;United Kingdom;Italy
3EUCTR2020-000699-39-IT
(EUCTR)
19/04/202104/06/2021Evaluation of Pamrevlumab for the Treatment of Ambulatory Patients Affected by Duchenne Muscular Dystrophy and just Treated with CorticosteroidsA Phase 3, Randomized, Double-Blind, Trial of Pamrevlumab (FG-3019) or Placebo in Combination with Systemic Corticosteroids in Ambulatory Subjects with Duchenne Muscular Dystrophy (DMD) - na Ambulatory 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: Pamrevlumab
Product Code: [FG-3019]
INN or Proposed INN: PAMREVLUMAB
FIBROGENNULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
70Phase 3France;United States;Czechia;Canada;Spain;Belgium;Austria;Australia;Netherlands;United Kingdom;Switzerland;Italy
4EUCTR2020-000698-26-AT
(EUCTR)
02/02/202117/08/2020A Phase 3, Randomized, Double-Blind, Trial of Pamrevlumab (FG-3019) or Placebo in Combination with Systemic Corticosteroids in Subjects with Non-ambulatory Duchenne Muscular Dystrophy (DMD) A Phase 3, Randomized, Double-Blind, Trial of Pamrevlumab (FG-3019) or Placebo in Combination with Systemic Corticosteroids in Subjects with Non-ambulatory Duchenne Muscular Dystrophy (DMD) Non-ambulatory 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: Pamrevlumab
Product Code: FG-3019
INN or Proposed INN: PAMREVLUMAB
FibroGen, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
96Phase 3United States;Czechia;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Netherlands
5EUCTR2020-000698-26-NL
(EUCTR)
20/01/202108/09/2020Evaluation of Pamrevlumab for the Treatment of Male Patients Affected by Non-ambulatory Duchenne Muscular Dystrophy and just Treated with CorticosteroidsA Phase 3, Randomized, Double-Blind, Trial of Pamrevlumab (FG-3019) or Placebo in Combination with Systemic Corticosteroids in Subjects with Non-ambulatory Duchenne Muscular Dystrophy (DMD) Non-ambulatory 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: Pamrevlumab
Product Code: FG-3019
INN or Proposed INN: PAMREVLUMAB
FibroGen, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
90Phase 3United States;Czechia;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Netherlands
6EUCTR2020-000698-26-IT
(EUCTR)
28/12/202006/11/2020Evaluation of Pamrevlumab for the Treatment of Male Patients Affected by Non-ambulatory Duchenne Muscular Dystrophy and just Treated with CorticosteroidsA Phase 3, Randomized, Double-Blind, Trial of Pamrevlumab (FG-3019) or Placebo in Combination with Systemic Corticosteroids in Subjects with Non-ambulatory Duchenne Muscular Dystrophy (DMD) - na Non-ambulatory 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: Pamrevlumab
Product Code: [FG-3019]
INN or Proposed INN: PAMREVLUMAB
FIBROGENNULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
90Phase 3United States;Czechia;Slovakia;Spain;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Netherlands
7EUCTR2020-000698-26-GB
(EUCTR)
16/12/202014/10/2020Evaluation of Pamrevlumab for the Treatment of Male Patients Affected by Non-ambulatory Duchenne Muscular Dystrophy and just Treated with CorticosteroidsA Phase 3, Randomized, Double-Blind, Trial of Pamrevlumab (FG-3019) or Placebo in Combination with Systemic Corticosteroids in Subjects with Non-ambulatory Duchenne Muscular Dystrophy (DMD) Non-ambulatory 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: Pamrevlumab
Product Code: FG-3019
INN or Proposed INN: PAMREVLUMAB
FibroGen, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
90Phase 3United States;Slovakia;Spain;Turkey;Austria;Israel;United Kingdom;Italy;Switzerland;France;Czech Republic;Canada;Belgium;Australia;Netherlands
8EUCTR2020-000698-26-CZ
(EUCTR)
15/12/202019/08/2020Evaluation of Pamrevlumab for the Treatment of Male Patients Affected by Non-ambulatory Duchenne Muscular Dystrophy and just Treated with CorticosteroidsA Phase 3, Randomized, Double-Blind, Trial of Pamrevlumab (FG-3019) or Placebo in Combination with Systemic Corticosteroids in Subjects with Non-ambulatory Duchenne Muscular Dystrophy (DMD) Non-ambulatory 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: Pamrevlumab
Product Code: FG-3019
INN or Proposed INN: PAMREVLUMAB
FibroGen, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
92Phase 3France;United States;Czechia;Czech Republic;Belgium;Spain;Austria;Netherlands;United Kingdom;Italy;Switzerland;China
9NCT04632940
(ClinicalTrials.gov)
December 11, 202012/11/2020Phase 3 Trial of Pamrevlumab or Placebo in Combination With Systemic Corticosteroids in Participants With Ambulatory DMDA Phase 3, Randomized, Double-Blind, Trial of Pamrevlumab (FG-3019) or Placebo in Combination With Systemic Corticosteroids in Ambulatory Subjects With Duchenne Muscular Dystrophy (DMD)Duchenne Muscular DystrophyDrug: Pamrevlumab;Drug: Placebo;Drug: CorticosteroidsFibroGenNULLActive, not recruiting6 Years11 YearsMale70Phase 3United States;Australia;Austria;Belgium;Canada;China;France;Italy;Netherlands;Spain;United Kingdom;Switzerland
10NCT04371666
(ClinicalTrials.gov)
July 30, 202029/4/2020Phase 3 Trial of Pamrevlumab or Placebo With Systemic Corticosteroids in Participants With Non-ambulatory DMDA Phase 3, Randomized, Double-Blind, Trial of Pamrevlumab (FG-3019) or Placebo in Combination With Systemic Corticosteroids in Subjects With Non-ambulatory Duchenne Muscular Dystrophy (DMD)Duchenne Muscular DystrophyDrug: Pamrevlumab;Drug: Placebo;Drug: CorticosteroidsFibroGenNULLActive, not recruiting12 YearsN/AMale92Phase 3United States;Australia;Austria;Belgium;Canada;China;Czechia;France;Israel;Italy;Netherlands;Spain;Switzerland;United Kingdom
11NCT02606136
(ClinicalTrials.gov)
November 30, 20154/11/2015Trial of Pamrevlumab (FG-3019), in Non-Ambulatory Subjects With Duchenne Muscular Dystrophy (DMD)Trial of Pamrevlumab (FG-3019), a Monoclonal Antibody to Connective Tissue Growth Factor, in Non-Ambulatory Subjects With Duchenne Muscular DystrophyDuchenne Muscular DystrophyDrug: pamrevlumab (FG-3019)FibroGenNULLActive, not recruiting12 YearsN/AMale21Phase 2United States
12EUCTR2020-000699-39-BE
(EUCTR)
28/01/2021Evaluation of Pamrevlumab for the Treatment of Ambulatory Patients Affected by Duchenne Muscular Dystrophy and just Treated with CorticosteroidsA Phase 3, Randomized, Double-Blind, Trial of Pamrevlumab (FG-3019) or Placebo in Combination with Systemic Corticosteroids in Ambulatory Subjects with Duchenne Muscular Dystrophy (DMD) Ambulatory 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: Pamrevlumab
Product Code: FG-3019
INN or Proposed INN: PAMREVLUMAB
FibroGen, Inc.NULLNAFemale: no
Male: yes
70Phase 3France;United States;Canada;Spain;Belgium;Austria;Australia;Netherlands;United Kingdom;Italy
13EUCTR2020-000698-26-BE
(EUCTR)
21/09/2020Evaluation of Pamrevlumab for the Treatment of Male Patients Affected by Non-ambulatory Duchenne Muscular Dystrophy and just Treated with CorticosteroidsA Phase 3, Randomized, Double-Blind, Trial of Pamrevlumab (FG-3019) or Placebo in Combination with Systemic Corticosteroids in Subjects with Non-ambulatory Duchenne Muscular Dystrophy (DMD) Non-ambulatory 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: Pamrevlumab
Product Code: FG-3019
INN or Proposed INN: PAMREVLUMAB
FibroGen, Inc.NULLNAFemale: no
Male: yes
96Phase 3United States;Czechia;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Netherlands