This is a phase 2 study, designed as a European multicentre 6-month double blind random-ized
controlled trial (RCT) of AZD0530 versus matched placebo, followed by a 12 month trial
comparing open-label extended AZD0530 treatment with historical control data.
Study population: Male and female adult patients aged 18 years and older with a diagnosis of
FOP who meet the inclusion (active disease) and exclusion criteria will be eligible for
participation in this study. The total number of enrolled patients will be 20.
Intervention: Patients will be randomized to receive either AZD0530 100mg once daily or
matched placebo, taken orally for the first 6 months, immediately followed by an open-label
extension in which all patients will receive AZD0530 100mg once daily oral dose for a further
Endpoints: Endpoints include objective change in heterotopic bone volume measured by low-dose
whole-body computer tomography (CT) , [18F] NaF Positron Emission Tomography (PET) activity
and patient reported outcome measures.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.