Learn more about trials that may be of interest to you
ClinicalTrials.gov is a web-based resource that provides patients, their family members, health care professionals, researchers and the public with easy access to information on publicly and privately supported clinical studies on a wide range of diseases and conditions. The site is maintained by the National Library of Medicine (NLM) at the National Institutes of Health (NIH) in the United States.
Information on ClinicalTrials.gov is provided and updated by the sponsor or principal investigator of the clinical study. Studies are generally submitted to the site (that is, registered) when they begin, and the information on the site is updated throughout the study.
Ipsen recently submitted two studies to ClinicalTrials.gov.
The first, PIVOINE, is a Rollover Study. This means that only patients who are currently enrolled in the MOVE Trial will be eligible to participate when the study begins enrolling patients, currently targeted for November 2021. This Rollover Study will continue to provide palovarotene to FOP patients ages 14 and over as regulatory submissions to approve and commercially distribute the drug are reviewed.
The second study, FALKON, is a phase II study to assess the efficacy and safety of 2 dosage regimens of the oral drug IPN60130. This is the drug formerly known as BLU-782 which Ipsen licensed from Blueprint Medicines in 2019. The study will be initially open to people living with FOP ages 15 and over. Entry for younger participants, 5 to 14, will occur once safety in patients 15 and older has been confirmed to the satisfaction of the FDA. Trial locations have not yet been announced. For the first 12 months, patients will be randomly assigned to take low dose, high dose or placebo. After the first 12 months, those on placebo will be randomly assigned to either the low or high-dose regimen. This trial is currently planned to begin on-site preparations in late September 2021. The enrollment date when patients are able to sign up to participate in the trial, will be announced at a later date.