Losmapimod ( DrugBank: Losmapimod )


2 diseases
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7
222一次性ネフローゼ症候群1

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
1EUCTR2022-000389-16-ES
(EUCTR)
14/07/202215/07/2022A Phase 3 study to determine the Efficacy and Safety of Losmapimod inTreating Patients with Facioscapulohumeral Muscular DystrophyA Phase 3 Global, Randomized, Double-Blind, Placebo-Controlled, 48-Week, Parallel-Group Study of the Efficacy and Safety of Losmapimod in Treating Patients with Facioscapulohumeral Muscular Dystrophy Facioscapulohumeral Muscular Dystrophy
MedDRA version: 20.0;Level: PT;Classification code 10064087;Term: Facioscapulohumeral muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Losmapimod
Product Code: FTX-1821
INN or Proposed INN: Losmapimod
Fulcrum TherapeuticsNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
230Phase 3France;United States;Canada;Spain;Denmark;Germany;Netherlands;United Kingdom;Italy
2NCT05397470
(ClinicalTrials.gov)
June 16, 20224/5/2022Efficacy and Safety of Losmapimod in Treating Patients With Facioscapulohumeral Muscular Dystrophy (FSHD) (Reach)A Phase 3 Global, Randomized, Double-Blind, Placebo-Controlled, 48-Week, Parallel-Group Study of the Efficacy and Safety of Losmapimod in Treating Patients With Facioscapulohumeral Muscular Dystrophy (FSHD) (Reach)Facioscapulohumeral Muscular Dystrophy (FSHD)Drug: Losmapimod;Drug: Placebo oral tabletFulcrum TherapeuticsNULLRecruiting18 Years65 YearsAll230Phase 3United States;Canada;Denmark;France;Germany;Italy;Netherlands;Spain;United Kingdom
3NCT04264442
(ClinicalTrials.gov)
February 13, 202030/1/2020Efficacy and Safety of Losmapimod in Treating Subjects With Facioscapulohumeral Muscular Dystrophy (FSHD) With Open-Label Extension (OLE)A Phase 2, Randomized, Double-Blind, Placebo-Controlled, 48-Week, Parallel-Group Study of the Efficacy and Safety of Losmapimod in Treating Subjects With Facioscapulohumeral Muscular Dystrophy (FSHD) With Open-Label Extension (OLE)Facioscapulohumeral Muscular Dystrophy (FSHD)Drug: LosmapimodFulcrum TherapeuticsNULLActive, not recruiting18 Years65 YearsAll76Phase 2United States;Canada;France;Spain;Germany
4EUCTR2019-001181-15-ES
(EUCTR)
29/10/201929/10/2019Safety and Efficacy of Losmapimod in Patients with FSHDA Phase 2, Randomized, Double-Blind, Placebo-Controlled, 24-Week, Parallel-Group Study of the Efficacy and Safety of Losmapimod in Treating Subjects with Facioscapulohumeral Muscular Dystrophy (FSHD) Facioscapulohumeral Muscular Dystrophy
MedDRA version: 20.0;Level: PT;Classification code 10064087;Term: Facioscapulohumeral muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Losmapimod
Product Code: FTX-1821
INN or Proposed INN: LOSMAPIMOD
Fulcrum Therapeutics, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
66 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;United States;Spain;Germany
5EUCTR2019-001181-15-FR
(EUCTR)
17/09/201929/05/2019Safety and Efficacy of Losmapimod in Patients with FSHDA Phase 2, Randomized, Double-Blind, Placebo-Controlled, 24-Week, Parallel-Group Study of the Efficacy and Safety of Losmapimod in Treating Subjects with Facioscapulohumeral Muscular Dystrophy (FSHD) Facioscapulohumeral Muscular Dystrophy
MedDRA version: 20.0;Level: PT;Classification code 10064087;Term: Facioscapulohumeral muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Losmapimod
Product Code: FTX-1821
INN or Proposed INN: LOSMAPIMOD
Fulcrum Therapeutics, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
66 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;France;Spain;Germany
6NCT04004000
(ClinicalTrials.gov)
August 23, 201925/6/2019Evaluation of Safety, Tolerability, and Changes in Biomarker and Clinical Outcome Assessments of Losmapimod for FSHD1 With ExtensionAn Open-Label Pilot Study of Losmapimod to Evaluate the Safety, Tolerability, and Changes in Biomarker and Clinical Outcome Assessments in Subjects With Facioscapulohumeral Muscular Dystrophy 1 (FSHD1) With ExtensionFacioscapulohumeral Muscular Dystrophy 1Drug: LosmapimodFulcrum TherapeuticsNULLActive, not recruiting18 Years65 YearsAll14Phase 2Netherlands
7NCT04003974
(ClinicalTrials.gov)
August 9, 201925/6/2019Efficacy and Safety of Losmapimod in Subjects With Facioscapulohumeral Muscular Dystrophy (FSHD)A Phase 2, Randomized, Double-Blind, Placebo-Controlled, 48-Week, Parallel-Group Study of the Efficacy and Safety of Losmapimod in Treating Subjects With Facioscapulohumeral Muscular Dystrophy (FSHD)Facioscapulohumeral Muscular Dystrophy (FSHD)Drug: Losmapimod;Drug: Placebo oral tabletFulcrum TherapeuticsNULLCompleted18 Years65 YearsAll80Phase 2United States;Canada;France;Spain;Germany

222. 一次性ネフローゼ症候群


臨床試験数 : 310 薬物数 : 295 - (DrugBank : 117) / 標的遺伝子数 : 63 - 標的パスウェイ数 : 194
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02000440
(ClinicalTrials.gov)
July 1, 201427/11/2013A Phase II, Repeat Dose, Proof of Mechanism Study of Losmapimod to Reduce Proteinuria in Patients With Focal Segmental Glomerulosclerosis (FSGS)Study of Losmapimod to Reduce Proteinuria in Idiopathic Focal Segmental Glomerulosclerosis (FSGS)Glomerulosclerosis, Focal SegmentalDrug: LosmapimodGlaxoSmithKlineNULLCompleted18 Years70 YearsAll17Phase 2United States;Canada