Study to assess oral IPN60130 for the treatment of Fibrodysplasia Ossificans Progressiva (FOP) in male and female participants 5 years of age and older

Brief description of study

The purpose of this study is to investigate the safety and efficacy of an investigational drug called IPN60130 in the treatment of FOP. IPN60130 is considered “investigational” because it has not been approved by the United States Food and Drug Administration (U.S. FDA) for the treatment of FOP.

Detailed description of study

There are two parts of this study, Part A and Part B. In Part A, you could receive a high or low dose of IPN60130 or placebo as 1-4 capsules based on your weight. The placebo will look like IPN60130 but will not contain any active ingredients. After completing Part A, all participants will continue into Part B and receive IPN60130. If you were receiving IPN60130 in Part A you will continue with the same dose. If you were receiving placebo in Part A you will be assigned to receive one of the 2 doses of IPN60130. You will not know which treatment you will be receiving nor the study doctor. This is called being blinded to the treatment. Your overall participation in this study (both Part A and Part B) will last up to 26 months. Your participation will involve visits to the study site and may also involve visits at your home by a home care nurse.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

Conditions:
Medical Research, Fibrodysplasia Ossificans Progressiva, FOP
Age: Between 5 Years - 99 Years
Gender: All

Diagnosed with Fibrodysplasia Ossificans Progressiva (FOP)

Updated on 09 Mar 2024. Study ID: 844711

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