Phase 3
N=1,178
A Study to Find Out Whether BI 1015550 Improves Lung Function in People With Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs)
Lung Diseases, Interstitial
Bottom Line
View on ClinicalTrials.gov: NCT05321082 ↗Enrolled (actual)
1,178
Serious AEs
47.1%
Results posted
Jan 2026
Primary outcome: Primary: Absolute Change From Baseline in Forced Vital Capacity (FVC) in Milliliters [mL] at Week 52 — -165.77; -84.64; -98.59 Milliliters (mL) — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- BI 1015550 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Dec 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absolute Change From Baseline in Forced Vital Capacity (FVC) in Milliliters [mL] at Week 52 |
-165.77; -84.64; -98.59 | <0.0001 sig |
| SECONDARY Key Secondary Endpoint: Time to First Occurrence of Any of the Components of the Composite Endpoint: Time to First Acute ILD Exacerbation, First Hospitalisation for Respiratory Cause, or Death (Whichever Occurred First) Over the Duration of the Trial |
44; 34; 30; 82; 70; 74 | 0.0507 |
| SECONDARY Time to First Acute ILD Exacerbation or Death Over the Duration of the Trial |
57; 46; 35; 40; 24; 24 | 0.0258 sig |
| SECONDARY Time to Hospitalisation for Respiratory Cause or Death Over the Duration of the Trial |
113; 90; 94; 18; 13; 9 | 0.0237 sig |
| SECONDARY Time to Death Over the Duration of the Trial |
64; 36; 34 | 0.0017 sig |
| SECONDARY Absolute Change From Baseline in Forced Vital Capacity (FVC) Percent (%) Predicted at Week 52 |
-4.88; -2.69; -2.94 | <0.0001 sig |
| SECONDARY Time to Absolute Decline in Forced Vital Capacity (FVC) % Predicted of >10% From Baseline or Death Over the Duration of the Trial |
130; 95; 100; 39; 30; 24 | 0.0018 sig |
| SECONDARY Absolute Change From Baseline in Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) % Predicted (Corrected for Hb) at Week 52 |
-2.48; -3.38; -2.97 | 0.3793 |
| 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 |
49; 53; 52; 58; 35; 32 | 0.2967 |
| SECONDARY Absolute Change From Baseline in Living With Pulmonary Fibrosis (L-PF) Symptoms Dyspnea Domain Score at Week 52 |
5.75; 4.87; 4.48 | 0.4748 |
| SECONDARY Absolute Change From Baseline in Living With Pulmonary Fibrosis (L-PF) Symptoms Cough Domain Score at Week 52 |
3.05; 1.17; 3.19 | 0.2506 |
| SECONDARY Absolute Change From Baseline in Living With Pulmonary Fibrosis (L-PF) Symptoms Fatigue Domain Score at Week 52 |
2.95; 3.01; 3.89 | 0.9668 |
Summary
This study is open to adults with Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs). People who have a form of PF-ILD other than Idiopathic Pulmonary Fibrosis (IPF) can join the study. If they already take nintedanib, 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 PF-ILD. 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 ≥18 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 progressive fibrosing ILD other than IPF (physician confirmed).
- Patients may be either:
- on a stable therapy* with nintedanib for at least 12 weeks prior to Visit 1 and during screening and are planning to stay on this background treatment after randomization. (*stable therapy is defined as a tolerated regimen of nintedanib (with no dose changes) for at least 12 weeks)
- not on treatment with nintedanib 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.
- 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
- Patients treated with permitted immunosuppressive agents (other than corticosteroids) for an underlying systemic disease (e.g. Methotrexate (MTX), Azathioprine (AZA)) need to be on a stable treatment for at least 12 weeks prior to Visit 1 and during the screening period.
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 (NCT05321082). 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.