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Saracatinib Trial TO Prevent FOP — STOPFOP  

Fibrodysplasia Ossificans Progressiva Clinical Trial

Official title:
Saracatinib Trial TO Prevent FOP

Clinical Trial Summary

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 12 months. 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

  • Fibrodysplasia Ossificans Progressiva
Clinical Trial Details
NCT number NCT04307953
Study type Interventional
Source Amsterdam UMC, location VUmc
Contact Bernard J Smilde, MD
Phone +31204444444
Email b.smilde@amsterdamumc.nl
Status Recruiting
Phase Phase 2
Start date August 5, 2020
Completion date August 1, 2024
View Details
See also
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