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

Study Population

Idiopathic pulmonary fibrosis (IPF) is a condition in which the lungs become scarred and breathing becomes increasingly difficult. This condition is part of a group of diseases called fibrotic interstitial lung diseases (ILDs).

Approximately 70 participants will be randomly assigned to either the BI 765423  or placebo cohorts. This study will assess the efficacy and safety of BI 765423 for the treatment of IPF, and also aims to better understand the studied disease and associated health problems.

BI 765423 is an antibody (a type of protein in the immune system that acts to stop things like infection from harming the body). It works by attaching to and blocking a protein that is present on the surface of different types of cells in the body, including in the lungs. Antibodies that inhibit this specific protein may lessen inflammation and other disease-related effects.

Eligible participants:

• Male or female, 40 years of age or older, with documented diagnosis of IPF.
• Extent of fibrosis ≥20% as per an HRCT within 12 months of screening.
• Lung function with FVC above 45% and DLCO above 20% predicted.
• 6 Minute Walk Test over 150 metres

Subjects with an undiagnosed or unstable disease will not be eligible to participate in the study until stable.

Study Visits

• The treatment duration lasts up to 24 weeks (minimum 12 weeks) and includes in-person clinic visits every 4 weeks.
• The study will last approximately 8-months for each participant, including the Screening Period (up to 5 weeks), the Treatment Period (up to 24 weeks), and the Follow-up Period (14 weeks).

Study Requirements

• Intravenous (IV) infusion every 4 weeks throughout the treatment period.
• Lung function test, 6 Minute Walk Test, blood tests, ECG at selected onsite visits.
• Completion of paper-based questionnaires.
  

Clinical Trials Registry:

https://clinicaltrials.gov/study/NCT07036523