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A study to test whether BI 1819479 improves lung function in people with idiopathic pulmonary fibrosis (IPF)

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2071240055
Enrollment
30
Registered
2024-09-04
Start date
2024-09-10
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

idiopathic pulmonary fibrosis (IPF)

Interventions

IMP BI 1819479

Sponsors

Adachi Sayaka
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Trial participants >=40 years old at the time of signed informed consent. Diagnosis of IPF based on the 2022 ATS/ERS/JRS/ALAT Guideline On stable treatment with nintedanib or pirfenidone for at least 12 weeks prior to Visit 1 and during screening or not on treatment with either nintedanib or pirfenidone for at least 12 weeks prior to Visit 1 and during screening. Forced Vital Capacity (FVC) >=45% of predicted normal at Visit 1. DLCO >=25% of predicted normal corrected for hemoglobin (Hb) at Visit 1.

Exclusion criteria

Exclusion criteria: Pre-bronchodilator FEV1/FVC 15 mg/day or equivalent for respiratory or pulmonary reasons Lower respiratory tract infection requiring treatment within 4 weeks prior to Visit 1 and/or during the screening period.

Design outcomes

Primary

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

Secondary

MeasureTime frame
the absolute change from baseline in FVC at Week 24 [in mL]

Countries

Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Czech republic, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Japan, Malaysia, New zealand, Norway, Poland, Singapore, South korea, Spain, Sweden, Thailand, United kingdom, United states

Contacts

Public ContactTetsuya Katakabe

Boehringer Ingelheim

medchiken.jp@boehringer-ingelheim.com+81-120-189-779

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026