Phase 3
N=1,177
A Study to Find Out Whether BI 1015550 Improves Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF)
Idiopathic Pulmonary Fibrosis
Bottom Line
View on ClinicalTrials.gov: NCT05321069 ↗Enrolled (actual)
1,177
Serious AEs
42.9%
Results posted
Sep 2025
Primary outcome: Primary: Absolute Change From Baseline in Forced Vital Capacity (FVC) [mL] at Week 52 — -183.48; -138.60; -114.65 Milliliters (mL) — p=0.0222
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- BI 1015550 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Aug 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absolute Change From Baseline in Forced Vital Capacity (FVC) [mL] at Week 52 |
-183.48; -138.60; -114.65 | 0.0222 sig |
| SECONDARY Key Secondary Endpoint: Time to the First Occurrence of Any of the Components of the Composite Endpoint: Time to First Acute IPF Exacerbation, First Hospitalization for Respiratory Cause, or Death (Whichever Occurs First) Over the Duration of the Trial |
38; 32; 38; 49; 45; 47 | 0.5443 |
| SECONDARY Time to First Acute IPF Exacerbation or Death Over the Duration of the Trial |
30; 31; 38; 19; 20; 12 | 0.5583 |
| SECONDARY Time to Hospitalization for Respiratory Cause or Death Over the Duration of the Trial |
59; 57; 68; 14; 11; 7 | 0.9038 |
| SECONDARY Time to Absolute Decline in Forced Vital Capacity (FVC) % Predicted of >10% From Baseline or Death Over the Duration of the Trial |
91; 89; 80; 20; 18; 14 | 0.7695 |
| SECONDARY Time to Absolute Decline in Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) Percentage Predicted by More Than 15% From Baseline or Death, Measured Over the Duration of the Trial |
38; 35; 43; 28; 24; 16 | 0.9251 |
| SECONDARY Time to Death Over the Duration of the Trial |
28; 26; 21 | 0.9084 |
| SECONDARY Absolute Change From Baseline in Living With Pulmonary Fibrosis (L-PF) Symptoms Dyspnea Domain Score at Week 52 |
7.26; 6.26; 6.63 | 0.3697 |
| SECONDARY Absolute Change From Baseline in Living With Pulmonary Fibrosis (L-PF) Symptoms Cough Domain Score at Week 52 |
4.54; 4.44; 3.95 | 0.9442 |
| SECONDARY Absolute Change From Baseline in Living With Pulmonary Fibrosis (L-PF) Symptoms Fatigue Domain Score at Week 52 |
5.40; 5.59; 5.82 | 0.8759 |
| SECONDARY Absolute Change From Baseline in Forced Vital Capacity Percent Predicted at Week 52 |
-4.92; -3.75; -3.19 | 0.0280 sig |
| SECONDARY Absolute Change From Baseline in Diffusing Capacity of the Lungs for Carbon Monoxide Percent Predicted at Week 52 |
-6.14; -3.66; -4.47 | 0.0042 sig |
Summary
This study is open to adults with a lung disease called Idiopathic Pulmonary Fibrosis (IPF). People can join the study if they are 40 years or older. If they already take nintedanib or pirfenidone for their IPF, they can continue treatment throughout the study. The purpose of this study is to find out whether a medicine called BI 1015550 helps people with IPF.
Participants are put into 3 groups randomly, which means by chance. Participants in 2 groups take different doses of BI 1015550 as tablets twice a day. Participants in the placebo group take placebo tablets twice a day. Placebo tablets look like BI 1015550 tablets but do not contain any medicine.
Participants are in the study for up to two and a half years. During the first year, they visit the study site 10 times. Afterwards, they visit the study site every 3 months. The doctors regularly test participants' lung function. The results of the lung function tests are compared between the groups. The doctors also regularly check participants' health and take note of any unwanted effects.
Eligibility Criteria
Inclusion criteria
- Patients ≥40 years old at the time of signed informed consent.
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
- Diagnosis of Idiopathic Pulmonary Fibrosis (IPF).
- Patients may be either:
- on a stable therapy* with nintedanib or pirfenidone for at least 12 weeks prior to Visit 1 and during screening and are planning to stay on this background treatment after randomization. Combination of nintedanib plus pirfenidone is not allowed. (*stable therapy is defined as the individually and general tolerated regimen of either nintedanib or pirfenidone (no dose changes) for at least 12 weeks).
- not on a treatment with nintedanib or pirfenidone for at least 8 weeks prior to Visit 1 and during the screening period (e.g. either Antifibrotic (AF)-treatment naïve or previously discontinued) and do not plan to start or re-start antifibrotic treatment.
- Forced Vital Capacity (FVC) ≥45% of predicted normal at Visit 1.
- Diffusing Capacity (of Lung) for Carbon Monoxide (DLCO) ≥25% of predicted normal corrected for hemoglobin (Hb) at Visit 1.
- Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control. WOCBP taking oral contraceptives (OCs) also have to use one barrier method.
Exclusion criteria
- Prebronchodilator Forced Expiratory Volume in 1 second (FEV1)/Forced vital capacity (FVC) 2.5 x Upper limit of normal (ULN) or total Bilirubin >1.5 x ULN at Visit 1.
Further exclusion criteria apply.
Data sourced from ClinicalTrials.gov (NCT05321069). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.