PAMREVLUMAB ( DrugBank: Pamrevlumab )


2 diseases
告示番号疾患名(ページ内リンク)臨床試験数
85特発性間質性肺炎11
113筋ジストロフィー13

85. 特発性間質性肺炎


臨床試験数 : 598 薬物数 : 435 - (DrugBank : 116) / 標的遺伝子数 : 100 - 標的パスウェイ数 : 210
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1JPRN-jRCT2051210169
16/01/202205/02/2022A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects with Idiopathic Pulmonary Fibrosis (IPF)A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary FibrosisPamrevlumab or placebo, 30 mg/kg, IV, Day 1 and every 3 weeks thereafter, up to Week 48, for a total of up to 17 infusions.Tracy GanskeNULLRecruiting>= 40age old<= 85age oldBoth34Phase 3United States;Argentina;Chile;Russia;Australia;Taiwan;Hong Kong;South Korea;the People's Republic of China;Japan
2EUCTR2020-000697-22-IE
(EUCTR)
04/05/202102/12/2020A study to compare the use of Pamrevlumab with Placebo in patients with Idiopathic Pulmonary Fibrosis.Zephyrus II: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects with Idiopathic Pulmonary Fibrosis (IPF). Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: Pamrevlumab
Product Code: FG-3019
INN or Proposed INN: PAMREVLUMAB
FibroGen, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
340Phase 3Serbia;Czechia;Spain;Ukraine;Ireland;Lebanon;Colombia;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Poland;Brazil;Dominican Republic;Peru;Denmark;Georgia;Netherlands;Germany
3EUCTR2020-000697-22-NL
(EUCTR)
24/12/202004/06/2020A study to compare the use of Pamrevlumab with Placebo in patients with Idiopathic Pulmonary Fibrosis.Zephyrus II: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects with Idiopathic Pulmonary Fibrosis (IPF). Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: Pamrevlumab
Product Code: FG-3019
INN or Proposed INN: PAMREVLUMAB
FibroGen, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
340Phase 3Serbia;Czechia;Spain;Ukraine;Ireland;Lebanon;Colombia;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Poland;Brazil;Dominican Republic;Peru;Denmark;Georgia;Netherlands;Germany
4EUCTR2020-000697-22-DK
(EUCTR)
13/10/202014/08/2020A study to compare the use of Pamrevlumab with Placebo in patients with Idiopathic Pulmonary Fibrosis.Zephyrus II: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects with Idiopathic Pulmonary Fibrosis (IPF). Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: Pamrevlumab
Product Code: FG-3019
INN or Proposed INN: PAMREVLUMAB
FibroGen, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
340Phase 3Serbia;Czechia;Spain;Ukraine;Ireland;Lebanon;Colombia;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Poland;Brazil;Dominican Republic;Denmark;Peru;Georgia;Netherlands;Germany
5EUCTR2020-000697-22-DE
(EUCTR)
13/10/202005/08/2020A study to compare the use of Pamrevlumab with Placebo in patients with Idiopathic Pulmonary Fibrosis.Zephyrus II: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects with Idiopathic Pulmonary Fibrosis (IPF). Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: Pamrevlumab
Product Code: FG-3019
INN or Proposed INN: PAMREVLUMAB
FibroGen, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
340Phase 3Serbia;Czechia;Spain;Ukraine;Ireland;Lebanon;Colombia;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Poland;Brazil;Dominican Republic;Peru;Denmark;Georgia;Netherlands;Germany
6NCT04419558
(ClinicalTrials.gov)
September 30, 20203/6/2020Zephyrus II: Efficacy and Safety Study of Pamrevlumab in Participants With Idiopathic Pulmonary Fibrosis (IPF)Zephyrus II: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects With Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary FibrosisDrug: Pamrevlumab;Drug: PlaceboFibroGenNULLRecruiting40 Years85 YearsAll340Phase 3United States;Brazil;Colombia;Czechia;Denmark;Dominican Republic;France;Georgia;Germany;Hungary;Ireland;Italy;Korea, Republic of;Lebanon;Mexico;Netherlands;Peru;Poland;Serbia;Spain;Switzerland;Ukraine;United Kingdom
7EUCTR2020-000697-22-IT
(EUCTR)
29/07/202021/01/2021A study to compare the use of Pamrevlumab with Placebo in patients with Idiopathic Pulmonary Fibrosis.Zephyrus II: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects with Idiopathic Pulmonary Fibrosis (IPF). - Zephyrus II Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: Pamrevlumab
Product Code: [FG-3019]
INN or Proposed INN: PAMREVLUMAB
FIBROGENNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
340Phase 3Serbia;Czechia;Spain;Ukraine;Ireland;Lebanon;Colombia;United Kingdom;Italy;India;France;Hungary;Mexico;Poland;Brazil;Belgium;Dominican Republic;Denmark;Peru;Georgia;Bulgaria;Norway;Netherlands;Germany
8EUCTR2020-000697-22-HU
(EUCTR)
08/07/202022/05/2020A study to compare the use of Pamrevlumab with Placebo in patients with Idiopathic Pulmonary Fibrosis.Zephyrus II: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects with Idiopathic Pulmonary Fibrosis (IPF). Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: Pamrevlumab
Product Code: FG-3019
INN or Proposed INN: PAMREVLUMAB
FibroGen, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
340Phase 3Serbia;Spain;Ukraine;Lebanon;Ireland;Colombia;Italy;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Poland;Belgium;Brazil;Dominican Republic;Peru;Denmark;Bulgaria;Georgia;Norway;Netherlands;Germany
9NCT03955146
(ClinicalTrials.gov)
June 27, 201916/5/2019Evaluation of Efficacy and Safety of Pamrevlumab in Patients With Idiopathic Pulmonary FibrosisA Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects With Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary FibrosisDrug: Pamrevlumab;Drug: PlaceboFibroGenNULLRecruiting40 Years85 YearsAll340Phase 3United States;Argentina;Australia;Chile;China;Hong Kong;Japan;Korea, Republic of;Russian Federation;Taiwan;Czechia;France;Germany;Hungary;Italy;Lebanon;Netherlands;Peru;Spain
10EUCTR2014-005658-20-BG
(EUCTR)
23/02/201618/12/2015FG-3019 treatment in Idiopathic Pulmonary Fibrosis (IPF) patients.A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of FG-3019 in Patients with Idiopathic Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis
MedDRA version: 19.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 19.1;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;Level: HLT;Classification code 10033979;Term: Parenchymal lung disorders NEC;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: FG-3019 10mg/mL in 10 mL vials
Product Code: FG-3019
INN or Proposed INN: Pamrevlumab
FibroGen, Inc.NULLNot RecruitingFemale: yes
Male: yes
136Phase 2United States;Canada;Australia;South Africa;Bulgaria;New Zealand;India
11NCT01890265
(ClinicalTrials.gov)
July 30, 201324/6/2013Evaluate the Safety and Efficacy of FG-3019 (Pamrevlumab) in Participants With Idiopathic Pulmonary Fibrosis (IPF)A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of FG-3019 in Patients With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: Pamrevlumab;Drug: Placebo;Drug: Sub-Study: Pirfenidone;Drug: Sub-Study: NintedanibFibroGenNULLCompleted40 Years80 YearsAll160Phase 2United States;Australia;Bulgaria;Canada;India;New Zealand;South Africa

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
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
8NCT04632940
(ClinicalTrials.gov)
December 11, 202012/11/2020A Phase 3 Trial of Pamrevlumab (FG-3019) or Placebo in Combination With Systemic Corticosteroids, in Ambulatory Subjects With Duchenne Muscular Dystrophy (DMD)A 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: PlaceboFibroGenNULLRecruiting6 Years11 YearsMale70Phase 3United States;Australia;Austria;Belgium;Canada;China;France;Italy;Netherlands;Spain;United Kingdom;Switzerland
9NCT04371666
(ClinicalTrials.gov)
July 30, 202029/4/2020A Phase 3 Trial of Pamrevlumab 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)Duchenne Muscular DystrophyDrug: Pamrevlumab;Drug: PlaceboFibroGenNULLActive, not recruiting12 YearsN/AMale90Phase 3United States;Australia;Austria;Belgium;Canada;China;Czechia;France;Israel;Italy;Netherlands;Spain;Switzerland;United Kingdom
10NCT02606136
(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
11EUCTR2020-000698-26-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
12EUCTR2020-000698-26-CZ
(EUCTR)
19/08/2020Evaluation 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.NULLNAFemale: no
Male: yes
90Phase 3United States;Czechia;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Netherlands
13EUCTR2020-000699-39-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