1305.12: BI1015550 and nintedanib or pirfenidone in IPF

• Research type

  Research Study

• Full title

  Safety, tolerability, and pharmacokinetics of multiple rising oral doses of BI 1015550 in patients with idiopathic pulmonary fibrosis (IPF) on no background anti-fibrotic (Part 1) and safety and tolerability of BI 1015550 on top of Nintedanib and Pirfenidone (Part 2)

• IRAS ID

  239042

• Contact name

  Sophie Fletcher

• Contact email

  sophie.fletcher@uhs.nhs.uk

• Sponsor organisation

  Boehringer Ingelheim

• Eudract number

  2017-002736-16

• Duration of Study in the UK

  0 years, 7 months, 4 days

• Research summary

  The purpose of the research study is to investigate a treatment, BI 1015550, how this is taken up by the body, and how well it is tolerated. The study will also look at BI 1015550 when it is taken in addition to Nintedanib or Pirfenidone.
  There are 2 parts to this study; Part 1 will compare BI 1015550 to placebo (a dummy treatment); each patient in the study will be allocated to one or other of these in a blinded fashion (i.e neither the patient nor their doctor will know which treatment is being received). Part 2 of the study will continue to compare the above alongside your standard of care therapy, either Nintedanib or Pirfenidone. If you participate in the study you will have a 2:1 chance of receiving BI 1015550 to placebo.
  Both Nintedanib or Pirfenidone have been approved for this condition in the UK, to treat idiopathic pulmonary fibrosis (IPF).
  The participant will be invited for a screening visit to determine if they meet the criteria of the protocol to take part in the study. Once eligibility has been confirmed, they will enter the treatment phase of the trial. The duration of the treatment phases will be at least 2 weeks in Part 1 which will be extended to 12 weeks if acceptable safety and 2 weeks in Part 2 which will be extended to 4 weeks if acceptable safety. The study requires approximately 13 visits in Part 1, and 9 visits in Part 2 to the study clinic site, plus daily telephone calls between study visits up to Day 14 and weekly phone calls between study visits thereafter until end of treatment.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  18/LO/0503

• Date of REC Opinion

  10 May 2018

• REC opinion

  Further Information Favourable Opinion