idiopathic pulmonary fibrosis IPF
Conditions
Interventions
One group will receive a 9 mg tablet of BI 1015550 twice daily, a second group
will receive an 18 mg tablet of BI 1015550 twice daily, and the third group
will receive a placebo tablet twice daily.
Sponsors
Boehringer Ingelheim
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Patients >=40 years old at the time of signed informed consent. 2. IPF diagnosis based on 2022 ATS / ERS / JRS / ALAT Guidelines 3. Forced Vital Capacity (FVC) >=45% of predicted normal 4. DLCO >=25% of predicted normal corrected for hemoglobin (Hb) 5. On stable treatment with nintedanib or pirfenidone for at least 12 weeks or not on treatment with either nintedanib or pirfenidone for at least 8 weeks 6. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
Exclusion criteria
Exclusion criteria: 1.Prebronchodilator FEV1/FVC 15 mg/day or equivalent for respiratory or pulmonary reasons 4. Active, unstable or uncontrolled vasculitis within 8 weeks 5. Any suicidal behavior in the past 2 years 6. Any suicidal ideation of type 4 or 5 on the C-SSRS in the past 3 months 7. In the opinion of the Investigator, other clinically significant pulmonary abnormalities
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is to demonstrate a reduction in lung function decline as measured by the change from baseline in FVC for BI 1015550 when compared to placebo in patients with IPF. The primary endpoint of the trial is the absolute change from baseline in Forced Vital Capacity (FVC) [mL] at Week 52. | — |
Secondary
| Measure | Time frame |
|---|---|
| The main secondary objective of the trial is to demonstrate BI 1015550*s ability in reducing the occurrence of clinically meaningful events such as acute IPF exacerbation, hospitalization for respiratory cause or death over the duration of the trial when compared to placebo in patients with IPF. An additional secondary objective of the trial is to show an effect of BI 1015550 on symptoms and lung function. The key secondary endpoint in this trial is 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. The secondary endpoints of the trial are: - Time to first acute IPF exacerbation or death over the duration of the trial - Time to hospitalization for respiratory cause or death over the duration of the trial - Time to absolute decline in FVC % predicted of >10% from baseline or death over the duration of the trial - Time to absolute decline in (DLCO) % predicted of >15% from baseline or death over the duration of the trial - Time to death over the duration of the 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 | — |
Countries
Netherlands
Outcome results
None listed