A randomised, double-blind, placebo-controlled, dose-finding study evaluating efficacy, safety and tolerability of different doses of BI 1819479 over at least 24 weeks in patients with idiopathic pulmonary fibrosis (IPF).

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-508395-11-00

Acronym

1462-0004

Enrollment

123

Registered

2024-08-29

Start date

2024-09-10

Completion date

2026-01-09

Last updated

2025-12-22

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

Conditions

idiopathic pulmonary fibrosis

Brief summary

Annual rate of decline in FVC [mL/year] assessed over a treatment period up to a maximum of 52 weeks

Detailed description

Absolute change from baseline in FVC at Week 24 [in mL]

Interventions

DRUGBI 1819479

DRUGPlacebo

DRUGFilm-coated tablet

DRUGmatching in size

DRUGweight

DRUGcolour and shape to BI 1819479 (both unit strengths)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Annual rate of decline in FVC [mL/year] assessed over a treatment period up to a maximum of 52 weeks	—

Secondary

Measure	Time frame
Absolute change from baseline in FVC at Week 24 [in mL]	—

Countries

Austria, Belgium, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Norway, Poland, Spain, Sweden

Outcome results

None listed

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