Safety, tolerability, PK/PD of C21 in patients with IPF

• Research type

  Research Study

• Full title

  A phase 2, multi-centre, randomised, double-blind, placebo-controlled, parallel-group study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of C21 in patients with Idiopathic Pulmonary Fibrosis (IPF)

• IRAS ID

  240162

• Contact name

  Jessica Bainbridge

• Contact email

  jessica.bainbridge@parexel.com

• Sponsor organisation

  Vicore Pharma AB

• Eudract number

  2017-004923-63

• Duration of Study in the UK

  1 years, 6 months, 1 days

• Research summary

  Idiopathic Pulmonary Fibrosis (IPF) is a condition in which the lung for unknown reasons increasingly creates scar tissue and consequently breathing becomes increasingly difficult.

  There's currently no cure for IPF, however the following options are available:
  - 2 medications that can help slow down the progression of IPF in some people: pirfenidone and nintedanib.
  - Oxygen treatment
  - Pulmonary rehabilitation

  The main purpose of this study is to assess how safe and tolerable C21 is in patients with IPF.
  C21 (an investigational new drug) has been tested in animal studies and in studies with healthy volunteers. In animal studies, it was shown that C21 may reduce scars in the lung but this has not yet been confirmed in human patients.

  Participants will take either C21 solution or placebo. A placebo is a solution that does not contain the active drug. Participants will be in 2 groups, selected by chance. About half of participants will receive C21 for 4 weeks and the other half will receive placebo for the same period. The study is “double blinded”, neither participant nor study team will know which kind of study drug is used.

  Participants will have 6 visits to the study centre (one of these visits will take place as a phone call). The maximum duration of the study is about 3 months.

  Before start of study treatment, there will be “screening period” (Visit 1), when the study doctor will find out participants eligibility to enter the study. If eligible for the study, participants will start taking the study medication on Day 1 of the study (Visit 2).

  Approximately 30 participants will take part at about 3 5 study centres in Europe.

  This study is being sponsored by Vicore Pharma.

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  18/LO/0111

• Date of REC Opinion

  17 Apr 2018

• REC opinion

  Further Information Favourable Opinion