VP01: Phase II study in IPF

The phase II study in IPF (AIR) 

The phase II study with C21 in IPF has been designed in collaboration with international clinical experts in IPF and will investigate both safety and lung function. The study aims to support the decision to initiate a confirmatory phase IIb/III study. It is a multicenter study with regulatory approvals in UK, India, Ukraine and Russia. The first patient was recruited in India in November 2020. The study is estimated to read-out in Q4, 2022.

The IPF study was designed to: 

  • provide strong statistical power  
  • to detect a treatment effect  
  • make patient recruitment easier  
  • reduce the number of patients needed  

Instead of a blinded placebo controlled three-month study, which the safety package automatically allows for, Vicore will conduct a six months study and compare with well documented patient baseline values. This is feasible since the important endpoint, FVC, a measurement of lung volume, is an objective measure and because disease progression has consistently been documented to correspond to a decrease of lung volume of approximately 120 ml per six months. By doing this change, it is also possible to eliminate the risk of unintentional unblinding, since patients may realize whether or not they are on drug or placebo during the course of the study. In addition, patients will be given the opportunity to continue treatment for another three months.  

Read more about the study at clinicaltrials.gov

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