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BI 1819479 in Idiopathic Pulmonary Fibrosis
NCT06335303Phase 2
Key facts
- Status
- Completed
- Start
- Sep 2024
- Primary completion
- Nov 2025
- Countries
- 28
- Sponsor
- Boehringer Ingelheim
- Modality
- Small Molecules
- Drugs
- BI1819479
- Conditions
- idiopathic pulmonary fibrosis (IPF)
01
Overview
Phase 2, randomised, double-blind trial of BI1819479 in idiopathic pulmonary fibrosis (IPF) (4 arms), sponsored by Boehringer Ingelheim. Primary endpoint: Annual rate of decline in Forced Vital Capacity at 52 weeks. Started Sep 2024; status: completed.
02
Design
4 arms- Study design
- RandomizedDouble-blind
BI 1819479 low dose treatment group
Participants receive low dose BI 1819479 orally.
BI 1819479 medium dose treatment group
Participants receive medium dose BI 1819479 orally.
BI 1819479 high dose treatment group
Participants receive high dose BI 1819479 orally.
Placebo group
Participants receive placebo matching BI 1819479 orally.
03
Who it enrols
Adults ≥40 years with Idiopathic Pulmonary Fibrosis (IPF), either on stable treatment with nintedanib or pirfenidone for ≥12 weeks or not on either for ≥12 weeks, with FVC ≥45% and DLCO ≥25% of predicted normal.
04
Endpoints
Primary
Annual rate of decline in Forced Vital Capacity
Secondary
Absolute change from baseline in FVC
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