We reported last year that Fulcrum Therapeutics announced that it will be starting a phase 3 clinical trial of its investigational drug, losmapimod, in people with facioscapulohumeral muscular dystrophy (FSHD).
In an exciting step for the UK FSHD community the clinical trial is now recruiting in the UK. This trial is looking into the efficacy and safety of losmapimod for treating patients with FSHD. It is called the ‘Reach’ trial.
It is a global trial and patients will be randomised to receive either losmapimod or placebo for 48 weeks. It is a double-blind trial, which means that neither the researchers, other study staff, subjects, sponsor nor the monitor will know whether a participant is taking the drug or the placebo until the end of the study.
The study will recruit people to the trial based upon strict eligibility, inclusion and exclusion criteria.
To be eligible for the study, participants must:
- Be between 18 and 65 years of age, inclusive.
- Have a genetically confirmed diagnosis of FSHD 1 or FSHD 2.
- Have a clinical severity score of 2 to 4 (Ricci Score; Range 0-5), at screening. Patients who are wheelchair-dependent or dependent on walker or wheelchair for activities are not permitted to enrol in the study.
- Meet previously defined criteria for arm-reach.
- Be able to have MRI scans.
Further information about the Fulcrum Reach trial, including eligibility, inclusion and exclusion criteria, can be found here. MDUK’s clinical trial FAQs can be accessed here.
The trial aims to recruit 230 patients with FSHD. Recruitment is across over 30 international sites. UK sites will be recruiting a small number of these participants to the trial, and sites are in Newcastle and London.
People with FSHD interested in participating in this clinical trial should discuss this with their neuromuscular consultant who will be able to provide further information and share relevant details with trial sites if appropriate.
MDUK is hopeful that more FSHD clinical trials will come to the UK within the next few years, potentially bringing more opportunities to take part in trials for the FSHD community.