Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease
characterized by the presence of bone in soft tissue where bone normally does not exist,
known as Heterotopic Ossification (HO). It is often associated with painful, recurrent
episodes of soft tissue swelling (flare-ups) that lead to abnormal stiffening and immobility
(ankyloses) of major joints with cumulative and irreversible loss of movement and disability.
This study will evaluate the efficacy of 2 dosing regimens of IPN60130 in inhibiting new HO
volume compared with placebo (a dummy treatment) in adult and paediatric participants with
FOP. It will be assessed by a scan (provides internal images of the body) called low dose
Whole Body Computed Tomography (WBCT), excluding head.
Adults and participants 5 years of age or older are also eligible for a sub study to evaluate
HO lesions assessed by another type of scan, Fluorine-18-labelled natrium fluoride Positron
Emission Tomography-Computed Tomography ([18F]NaF PET-CT ).
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.
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