Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 21.1 Level: PT Classification code 10021240 Term: Idiopathic pulmonary fibrosis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: BI 1015550 9 mg Film Coated Tablet
Product Code: BI 1015550
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: BI 1015550
Other descriptive name: BI 1015550
Concentration unit
Sponsors
Boehringer Ingelheim International GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients =40 years old at the time of signed consent IPF diagnosis based on 2022 ATS/ERS/JRS/ALAT Guidelines FVC =45% of predicted normal DLCO =25% and =65 years) yes F.1.3.1 Number of subjects for this age range 626
Exclusion criteria
Exclusion criteria: Relevant airways obstruction (prebronchodilator FEV1/FVC 15 mg/day or equivalent for respiratory or pulmonary reasons Active, unstable or uncontrolled vasculitis within 8 weeks Any suicidal behaviour in the past 2 years Any suicidal ideation of type 4 or 5 on the C-SSRS in the past 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: 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.;Primary end point(s): The primary endpoint is the absolute change from baseline in Force Vital Capacity (FVC) [mL] at Week 52.;Timepoint(s) of evaluation of this end point: 52 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) 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 2) Time to first acute ILD exacerbation or death over the duration of the trial 3) Time to hospitalization for respiratory cause or death over the duration of the trial 4) Time to absolute decline in FVC % predicted of >10% from baseline or death over the duration of the trial 5) Time to absolute decline in (DLCO) % predicted of >15% from baseline or death over the duration of the trial 6) Time to death over the duration of the trial 7) Absolute change from baseline in Living with Pulmonary Fibrosis (LPF) Symptoms Dyspnea domain score at Week 52 8) Absolute change from baseline in Living with Pulmonary Fibrosis (LPF) Symptoms Cough domain score at Week 52 9) Absolute change from baseline in Living with Pulmonary Fibrosis (LPF) Symptoms Fatigue domain score at Week 52 10) Absolute change from baseline in FVC % predicted at Week 52 11) Absolute change from baseline in DLCO % predicted at Week 52;Timepoint(s) of evaluation of this end point: 1) 30 months 2) 30 months 3) 30 months 4) 30 months 5) 30 months 6) 30 months 7) 52 weeks 8) 52 weeks 9) 52 weeks 10) 52 weeks 11) 52 weeks | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Croatia, Czechia, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Korea, Republic of, Malaysia, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United States
Contacts
Public ContactCT Disclosure & Data Transparency
Boehringer Ingelheim Pharma GmbH & Co. KG
Outcome results
None listed