1305-0013 BI 1015550 in idiopathic pulmonary fibrosis

• Research type

  Research Study

• Full title

  A randomised, double-blind, placebo-controlled parallel group study in IPF patients over 12 weeks evaluating efficacy, safety and tolerability of BI 1015550 taken orally.

• IRAS ID

  280729

• Contact name

  Philip Molyneaux

• Contact email

  p.molyneaux@rbht.nhs.uk

• Sponsor organisation

  Boehringer Ingelheim

• Eudract number

  2019-004167-45

• Clinicaltrials.gov Identifier

  NCT04419506

• Duration of Study in the UK

  1 years, 3 months, 12 days

• Research summary

  The purpose of this trial is to demonstrate proof of concept of clinical activity of BI 1015550 on the change of Forced Vital Capacity (FVC) between baseline and 12 weeks.
  New treatments are needed that further reduce the decline in FVC, positively affect symptoms and improve quality of life in patients with Idiopathic Pulmonary Fibrosis.
  This trial will investigate BI 1015550 to be used in this patient population either as stand-alone treatment or in addition to local standard of care (SoC), which may or may not include currently approved antifibrotic treatments (nintedanib or pirfenidone). FVC change from baseline will be used to generate sufficient evidence of efficacy in the subpopulation on no background antifibrotic treatment, to inform the phase III program.

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  20/LO/0928

• Date of REC Opinion

  24 Jul 2020

• REC opinion

  Favourable Opinion