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)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-512732-30-00

Acronym

FIS-002-2019

Enrollment

Registered

2024-04-24

Start date

2019-12-06

Completion date

2024-11-07

Last updated

2024-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Facioscapulohumeral Muscular Dystrophy 1 (FSHD1)

Brief summary

The primary endpoint of the OLE is the safety and tolerability of long-term treatment of losmapimod based on AEs, clinical laboratory tests, ECGs, vital signs, and physical examination.

Detailed description

The secondary endpoint of the OLE is the plasma concentrations of losmapimod after long-term dosing (at every-12-week time points).

Interventions

DRUGLosmapimod

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoint of the OLE is the safety and tolerability of long-term treatment of losmapimod based on AEs, clinical laboratory tests, ECGs, vital signs, and physical examination.	—

Secondary

Measure	Time frame
The secondary endpoint of the OLE is the plasma concentrations of losmapimod after long-term dosing (at every-12-week time points).	—

Countries

France, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026