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A double blind, randomized, placebo-controlled trial evaluating the efficacy and safety of BI 1015550 over at least 52 weeks in patients with Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs)

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-512803-37-00
Acronym
1305-0023
Enrollment
303
Registered
2024-09-18
Start date
2022-10-05
Completion date
2025-04-01
Last updated
2025-05-19

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

Conditions

Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs)

Brief summary

Absolute change from baseline in Forced Vital Capacity (FVC) [mL] at Week 52

Detailed description

Key secondary endpoint: Time to the first occurrence of any of the components of the composite endpoint: time to first acute ILD exacerbation, first hospitalization for respiratory cause, or death (whichever occurs first) over the duration of the trial, Time to first acute Interstitial Lung Disease (ILD) exacerbation or death over the duration of trial, Time to hospitalization for respiratory cause or death over the duration of trial, Time to absolute decline in Forced vital capacity (FVC) % predicted of >10% from baseline or death over the duration of the trial, Time to absolute decline in Diffusing Capacity (of Lung) for Carbon Monoxide (DLCO) % predicted of >15% from baseline or death over the duration of the trial, Time to death over the duration of trial, Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms Dyspnea domain score at Week 52, Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms Cough domain score at Week 52, Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms Fatigue domain score at Week 52, Absolute change from baseline in FVC % predicted at Week 52, Absolute change from baseline in DLCO % predicted at Week 52

Interventions

DRUGBI 1015550

Sponsors

Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Absolute change from baseline in Forced Vital Capacity (FVC) [mL] at Week 52

Secondary

MeasureTime frame
Key secondary endpoint: Time to the first occurrence of any of the components of the composite endpoint: time to first acute ILD exacerbation, first hospitalization for respiratory cause, or death (whichever occurs first) over the duration of the trial, Time to first acute Interstitial Lung Disease (ILD) exacerbation or death over the duration of trial, Time to hospitalization for respiratory cause or death over the duration of trial, Time to absolute decline in Forced vital capacity (FVC) % predicted of >10% from baseline or death over the duration of the trial, Time to absolute decline in Diffusing Capacity (of Lung) for Carbon Monoxide (DLCO) % predicted of >15% from baseline or death over the duration of the trial, Time to death over the duration of trial, Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms Dyspnea domain score at Week 52, Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms Cough domain score at Week 52, Absol

Countries

Austria, Belgium, Croatia, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Italy, Netherlands, Norway, Poland, Portugal, Slovenia, Spain, Sweden

Outcome results

None listed

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