Fulcrum Therapeutics has posted on clinicaltrials.gov the protocol for its upcoming clinical trial of losmapimod. The trial is NOT YET RECRUITING volunteers. As trial sites open up for volunteer enrollment, the FSH Society will be sending alerts to patients who reside in the geographic area of a trial site.
How can you make sure you will receive our alerts? If you are currently getting US postal mailings AND emails regularly from the FSH Society, you are all set. However, if you have received no communications the Society or only USPS but not email (or vice versa), we may not have your complete contact information. In that case, please email us with your complete contact information (full name, physical address, email, and telephone number).
Please also make sure that all interested family members with FSHD have provided their individual contact information to us. We know that many families have one member who has signed up with the FSH Society and rely on that person to forward news to them, but this system won’t work for clinical trial alerts. If your family member lives near a trial site, but you do not, you will not be notified about the trial and so your family member won’t be able to learn about it from you. They must sign up with the FSH Society and provide both their email address and geographic location.
This study is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group, multicenter study designed to evaluate the efficacy and safety of losmapimod in treating individuals with FSHD over 24 weeks. Patients will participate in this study for approximately 29 weeks. This will include a 4-week screening period, a 24-week, placebo-controlled treatment period and a 7 day safety follow-up period.
Patients must have a confirmed diagnosis of FSHD1 and be between the ages of 18 and 65. The study takes 24 weeks and requires that volunteers have an MRI and muscle biopsy.
For additional details and updates on trial sites, please visit: https://clinicaltrials.gov/ct2/show/NCT04003974