BI 1493-0002 – Boehringer Ingelheim (Idiopathic Pulmonary Fibrosis)

A double-blind, randomised, placebo-controlled, parallel group, Phase IIa trial to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of BI 765423 administered intravenously with or without standard of care in patients with idiopathic pulmonary fibrosis

1493-0002

Who can take part?

You may be able to take part if you have idiopathic pulmonary fibrosis (IPF), a condition where the lungs become scarred over time, making it harder to breathe.

You may be eligible if you:

• Are 40 years of age or older
• Have a confirmed diagnosis of IPF
• Meet certain lung function requirements based on breathing tests and scans
• Are able to complete a walking test

You would not be able to take part if:

• You have another unstable or undiagnosed health condition
• The study doctor feels that participation may not be safe for you

What is involved?

This study is looking at whether a new investigational medication (BI‑765423) may help people with IPF.

• Study duration: Approximately 8 months
• Clinic visits: Every 4 weeks during treatment

The study includes:

• A screening period (up to 5 weeks)
• A treatment period (between 12 and 24 weeks)
• A follow-up period (14 weeks)

Participants in this study will be randomly assigned to receive either the study medication or a placebo.

What will I need to do?

If you take part, you will be asked to:

• Receive the study medication as an intravenous (IV) infusion every 4 weeks
• Attend clinic visits for tests, which may include:
• • Breathing tests
  • A walking test (6-minute walk test)
  • Blood tests
  • A heart tracing (ECG)
• Complete questionnaires about your health

More information

You can read more about this study here:

• ClinicalTrials.gov – BI‑765423 Study