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)

This study is looking for adult participants, meaning you must be 18 years old or older. There is no upper age limit, so older adults can also take part if they meet other health requirements.

The study is open to both men and women. Your gender does not affect whether you can join this research.

Crucially, this particular study is an 'Open-Label Extension'. This means that to be eligible, you would usually have already participated in the earlier part of this Losmapimod study (the 'Phase 2' trial). The details you were given when you joined the first part of the study would explain if you could continue into this extension phase.

If you are eligible and choose to take part in this study, you would primarily be continuing treatment with Losmapimod, as this is an extension phase of a previous study. You would attend regular appointments at a clinic, likely every 12 weeks, for about a year (48 weeks).

During these visits, healthcare professionals would carry out several assessments to monitor your health and the medicine's effects. These would include physical examinations, taking your vital signs (such as blood pressure and heart rate), blood tests, and possibly urine tests. You would also have electrocardiograms (ECGs) to check your heart health.

Throughout the study, you would continue to take the study medicine, Losmapimod, as directed. You would need to report any new or worsening health problems or side effects to the study team. Regular follow-up ensures your safety is prioritised while gathering important data about the long-term effects of the medication. The total duration of this specific extension study is 48 weeks.