Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs) MedDRA version: 23.1 Level: LLT Classification code 10084309 Term: Progressive fibrosing interstitial lung disease 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
INN or Proposed INN: None yet
Current Sponsor code: BI 1015550
Other descriptive name:
Sponsors
Boehringer Ingelheim International GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients =18 years old at the time of signed informed consent. 2. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial. 3. Diagnosis of progressive fibrosing ILD other than IPF (physician confirmed; Section 3.3.1) 4. 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 AF-treatment naïve or previously discontinued) and do not plan to start or re-start antifibrotic treatment. 5. Forced Vital Capacity (FVC) =45% of predicted normal at Visit 1. 6. DLCO corrected for Hemoglobin (Hb) [Visit 1] =25% predicted of normal at Visit 1. 7. Women of childbearing potential (WOCBP)1 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. 8. Patients treated with permitted immunosuppressive agents (other than corticosteroids) for an underlying systemic disease (e.g. MTX, AZA) need to be on a stable treatment for at least 12 weeks prior to Visit 1 and during the screening period. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 600 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 441
Exclusion criteria
Exclusion criteria: 1. Prebronchodilator FEV1/FVC 2.5 x ULN or total Bilirubin >1.5 x ULN at Visit 1. 9. eGFR =30 mL/min/1.73 m2 at Visit 1. (Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula or Japanese version of CKD-EPI for Japanese patients) 10. Patients with underlying liver disease (Child Pugh A, B, or C hepatic impairment). 11. Cardiovascular diseases, any of the following: a. Severe hypertension (uncontrolled under treatment =160/100 mmHg at multiple occasions) within 3 months of Visit 1 b. Myocardial infarction, stroke or transient ischemic attack within 6 months of Visit 1 c. Unstable cardiac angina within 6 months of Visit 1 12. Use of any of the following medications: prednisone >15mg/day or equivalent within 4 weeks of Visit 1; cyclophosphamide, tocilizumab, mycophenolate, pirfenidone within 8 weeks of Visit 1; rituximab within 6 months of Visit 1. Further criteria apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The trial will evaluate efficacy and safety of BI 1015550. 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 progressive fibrosing ILDs.;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 ILD exacerbations, hospitalization for respiratory cause or death over the duration of the trial when compared to placebo in patients with progressive fibrosing ILDs. An additional secondary objective of the trial is to show an effect of BI 1015550 on symptoms and lung function.;Primary end point(s): 1) absolute change from baseline in Forced Vital Capacity (FVC) [mL] at Week 52;Timepoint(s) of evaluation of this end point: 1) 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 (L-PF) Symptoms Dyspnea domain score at Week 52 8) Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms Cough domain score at Week 52 9) Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) 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, 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, Türkiye, United Kingdom, United States
Contacts
Public ContactCT Disclosure & Data Transparency
Boehringer Ingelheim Pharma GmbH & Co. KG
Outcome results
None listed