1305-0031: Extension trial of the long-term safety and efficacy of BI 1015550

• Research type

  Research Study

• Full title

  An open-label extension trial of the long-term safety and efficacy of BI 1015550 taken orally in patients with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF) (FIBRONEER™-ON)

• IRAS ID

  1009187

• Contact name

  Medical Information

• Contact email

  medinfo.bra@boehringer-ingelheim.com

• Sponsor organisation

  Boehringer Ingelheim Ltd.

• Clinicaltrials.gov Identifier

  NCT06238622

• Research summary

  Lay Title
  A follow-up study to test long-term treatment with nerandomilast in people with pulmonary
  fibrosis who took part in a previous study with nerandomilast

  Brief Summary
  This study is open to people with idiopathic pulmonary fibrosis (IPF) or progressive
  pulmonary fibrosis (PPF). They can only take part if they have completed treatment in a
  previous study with a medicine called nerandomilast or BI 1015550.
  The goal of this study is to find out how well people with pulmonary fibrosis tolerate longterm treatment with nerandomilast. The study also tests whether nerandomilast improves
  lung function and prolongs the time until symptoms get worse, participants need to go to
  the hospital, or die.
  Every participant takes nerandomilast as tablets for up to 1 year and 10 months. The
  participants may also continue their regular treatment for pulmonary fibrosis during the
  study.
  Participants visit their doctors regularly. During these visits, the doctors collect information
  on any health problems of the participants. Participants also regularly do lung function tests

• REC name

  East of England - Cambridge South Research Ethics Committee

• REC reference

  24/EE/0046

• Date of REC Opinion

  12 Apr 2024

• REC opinion

  Further Information Favourable Opinion