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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-520658-12-00

Acronym

1493-0002

Enrollment

Registered

2025-10-09

Start date

2025-11-20

Completion date

Unknown

Last updated

2025-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Pulmonary Fibrosis (IPF)

Brief summary

Absolute change from baseline in FVC (mL) at 12 weeks

Detailed description

Absolute change from baseline in log10-transformed SP-D plasma concentration at 12 weeks., Absolute change from baseline in distance walked (m) during 6 meter walking test (6MWT) at 12 weeks., Absolute change from baseline in FVC % predicted at 12 weeks., Absolute change from baseline in DLCO % predicted at 12 weeks., Absolute change from baseline in oxygen saturation (SpO2) on room air at rest at 12 weeks.

Interventions

DRUGBI 765423

DRUGPlacebo to BI 765423

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Absolute change from baseline in FVC (mL) at 12 weeks	—

Secondary

Measure	Time frame
Absolute change from baseline in log10-transformed SP-D plasma concentration at 12 weeks., Absolute change from baseline in distance walked (m) during 6 meter walking test (6MWT) at 12 weeks., Absolute change from baseline in FVC % predicted at 12 weeks., Absolute change from baseline in DLCO % predicted at 12 weeks., Absolute change from baseline in oxygen saturation (SpO2) on room air at rest at 12 weeks.	—

Measure

Time frame

—

Countries

Belgium, Germany, Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026