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Clinical Trial Summary

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 15 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 ).

Clinical Trial Description


Study Design

Related Conditions & MeSH terms

  • Fibrodysplasia Ossificans Progressiva

NCT number NCT05039515
Study type Interventional
Source Ipsen
Contact Ipsen Recruitment Enquiries
Phone see email
Email [email protected]
Status Not yet recruiting
Phase Phase 2
Start date September 27, 2021
Completion date August 30, 2025

See also
  Status Clinical Trial Phase
Active, not recruiting NCT02279095 - An Open-Label Extension Study of Palovarotene Treatment in Fibrodysplasia Ossificans Progressiva (FOP) Phase 2
Active, not recruiting NCT03312634 - An Efficacy and Safety Study of Palovarotene for the Treatment of Fibrodysplasia Ossificans Progressiva. Phase 3
Active, not recruiting NCT02979769 - An Open-Label Extension Study of Palovarotene to Prevent Heterotopic Ossification in People With Fibrodysplasia Ossificans Progressiva (FOP) in France Phase 2
Completed NCT02066324 - Urine Sample Collection From FOP Patients N/A
Completed NCT02190747 - An Efficacy and Safety Study of Palovarotene to Treat Preosseous Flare-ups in FOP Subjects Phase 2
Completed NCT04829773 - Study Evaluating the Effect of Food on the Pharmacokinetics of Palovarotene and the Effect of Palovarotene on the Pharmacokinetics of the CYP3A4 Substrate Midazolam in Two Cohorts of Healthy Adult Subjects Phase 1
Completed NCT04665323 - An International Cross-sectional Survey to Evaluate the Burden of Fibrodysplasia Ossificans Progressiva (FOP) on Patients and Their Families.
Active, not recruiting NCT03188666 - A Study to Examine the Safety, Tolerability and Effects on Abnormal Bone Formation of REGN2477 in Patients With Fibrodysplasia Ossificans Progressiva Phase 2
Terminated NCT02521792 - In-Home Evaluation of Episodic Administration of Palovarotene in Fibrodysplasia Ossificans Progressiva (FOP) Subjects Phase 2
Completed NCT02322255 - A Natural History Study of Fibrodysplasia Ossificans Progressiva (FOP)
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