A Rollover Study to Further Evaluate the Safety and Efficacy of Palovarotene Capsules in Male and Female Participants Aged ≥14 Years With Fibrodysplasia Ossificans Progressiva (FOP) Who Have Completed the Relevant Parent Studies. (PIVOINE)

  • End date
    Nov 11, 2024
  • participants needed
  • sponsor
Updated on 13 July 2022


The main objective of this study is to further evaluate the safety and efficacy of palovarotene in adult and paediatric participants with FOP.

The aim of the study is also to ensure treatment continuity to participants who have completed one of the parent studies (Study PVO-1A-301, Study PVO-1A-202 and Study PVO-1A-204) and who, in the investigator's judgement, may benefit from palovarotene therapy.

Condition Fibrodysplasia Ossificans Progressiva (FOP)
Treatment Palovarotene
Clinical Study IdentifierNCT05027802
Last Modified on13 July 2022


Yes No Not Sure

Inclusion Criteria

Participant has completed the EOS or End of Treatment Visit of Study PVO-1A-301 or PVO-1A-202 (PVO-1A-202 Parts C and D correspond to Study PVO-1A-204 in France) and did not previously withdraw consent from any of the parent studies to be eligible for Study CLIN-60120-452
Participant must be ≥14 years of age (aligned with the age of treated participants in the ongoing parent studies PVO-1A-301 and PVO-1A-202/PVO-1A-204) and qualify as 100% skeletally mature (if <18 years, based on assessments carried out at parent EOS Visit; if ≥18 years, automatically considered 100% skeletally mature) or have reached final adult height based on investigator's assessment, at the time the Study CLIN- 60120-452 informed consent is signed

Exclusion Criteria

History of allergy or hypersensitivity to retinoids, gelatin, lactose (note that lactose intolerance is not exclusionary) or palovarotene, or unresponsiveness to prior treatment with palovarotene
Uncontrolled cardiovascular, hepatic, pulmonary, gastrointestinal, endocrine, metabolic, ophthalmologic, immunologic, psychiatric, or other significant disease
Intercurrent known or suspected non-healed fracture at any location
Any other medical condition/clinically significant abnormalities that would expose the participant to undue risk or interfere with study assessments
Amylase or lipase >2× above the upper limit of normal (ULN) or with a history of chronic pancreatitis
Elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5× ULN
Fasting triglycerides >400 mg/dL with or without therapy
Suicidal ideation (type 4 or 5) or any suicidal behaviour at the Inclusion Visit as defined by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Current use of vitamin A or beta carotene, multivitamins containing vitamin A or beta carotene, or herbal preparations, fish oil, and unable or unwilling to discontinue use of these products during palovarotene treatment
Exposure to synthetic oral retinoids other than palovarotene within 4 weeks of the Inclusion Visit
Concurrent treatment with tetracycline or any tetracycline derivatives due to the potential increased risk of pseudotumor cerebri
Use of concomitant medications that are strong inhibitors or inducers of cytochrome P450 (CYP450) 3A4 activity; or kinase inhibitors such as imatinib
Palovarotene is commercially available in the country where the study is being conducted
Any reason that, in the opinion of the investigator, would lead to the inability of the participant and/or family to comply with the protocol
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