Losmapimod
Sponsors
Fulcrum Therapeutics Inc., GlaxoSmithKline, Cambridge University Hospitals NHS Foundation Trust, Fulcrum Therapeutics
Conditions
Acute Coronary SyndromeCardiovascular DiseaseChronic Obstructive Pulmonary DiseaseFacioscapulohumeral Muscular Dystrophy (FSHD)Facioscapulohumeral Muscular Dystrophy 1Facioscapulohumeral Muscular Dystrophy 1 (FSHD1)Glomerulosclerosis, Focal SegmentalPulmonary Disease, Chronic Obstructive
Phase 1
Phase 2
Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-centre, Dose Ranging Study to Evaluate the Efficacy and Safety of Losmapimod Tablets Administered Twice Daily Compared With Placebo for 24 Weeks in Adult Subjects With Chronic Obstructive Pulmonary Disease (COPD).
CompletedNCT01218126
Start: 2010-11-04End: 2011-12-21Updated: 2018-02-06
Losmapimod in Chronic Obstructive Pulmonary Disease Patients Stratified by Fibrinogen.
CompletedNCT01541852
Start: 2012-06-30End: 2014-02-28Updated: 2015-03-17
A Phase II, Repeat Dose, Proof of Mechanism Study of Losmapimod to Reduce Proteinuria in Patients With Focal Segmental Glomerulosclerosis (FSGS)
CompletedNCT02000440
Start: 2014-07-01End: 2016-05-11Updated: 2017-06-12
Evaluation of Safety, Tolerability, and Changes in Biomarker and Clinical Outcome Assessments of Losmapimod for FSHD1 With Extension
TerminatedNCT04004000
Start: 2019-08-23End: 2024-10-31Updated: 2025-12-02
Efficacy and Safety of Losmapimod in Treating Subjects With Facioscapulohumeral Muscular Dystrophy (FSHD) With Open-Label Extension (OLE)
TerminatedNCT04264442
Start: 2020-02-13End: 2024-11-07Updated: 2025-09-30
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)
CompletedCTIS2024-512732-30-00
Start: 2019-12-06End: 2024-11-07Target: 11Updated: 2024-04-30
An 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 Extension
CompletedCTIS2024-512736-29-00
Start: 2019-08-23End: 2024-10-31Target: 14Updated: 2024-06-11
Phase 3
Efficacy and Safety of Losmapimod in Treating Participants With Facioscapulohumeral Muscular Dystrophy (FSHD) (REACH)
TerminatedNCT05397470
Start: 2022-06-16End: 2024-11-19Updated: 2025-11-07
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)
CompletedCTIS2024-512737-33-00
Start: 2022-09-30End: 2024-10-28Target: 144Updated: 2024-08-13