Health Condition 1: J841- Other interstitial pulmonary diseases with fibrosis
Conditions
Interventions
Intervention1: BI 1015550: Dose: 9 mg bid, 18 mg bid
Route: oral
Duration: At least 52 weeks and up to approximately 130 weeks
Control Intervention1: Matching Placebo: Dose: Twice a day
Route: Oral
Sponsors
Boehringer Ingelheim
IQVIA RDS INDIA PRIVATE LIMITED
Eligibility
Inclusion 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; Section 3.3.1) (Please refer to Protocol version 2.0 dated 26 Jul 2022). Patients may be either: o 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. o 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 - Forced Vital Capacity (FVC) =45% of predicted normal at Visit 1. - DLCO corrected for Hemoglobin (Hb) [Visit 1] =25% and predicted of normal at Visit 1. - Women of childbearing potential (WOCBP)1 must be ready and able to use highly effective methods of birth control. Of note, oral hormonal contraceptives are not considered a highly effective method due to potential drug-drug interactions; please refer to Section 4.2.2.3 (Please refer to Protocol version 2.0 dated 26 Jul 2022) - Patients treated with permitted immunosuppressive agents 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.
Exclusion criteria
Exclusion criteria: 1. Relevant airways obstruction (prebronchodilator FEV1/FVC 2. In the opinion of the Investigator, other clinically significant pulmonary abnormalities. 3. Acute ILD exacerbation within 3 months prior to Visit 1 and/or during the screening period (investigator-determined). 4. Relevant chronic or acute infections including human immunodeficiency virus (HIV) and viral hepatitis. 5. Patients having developed ILD due to SARS-CoV-2 infection/COVID-19 within 12 months of screening (based on investigators judgement). 6. Major surgery (major according to the investigator’s assessment) performed within 6 weeks prior to Visit 2 or planned during the trial period, e.g. hip replacement. Registration on lung transplantation list would not be considered as planned major surgery. 7. Any documented active or suspected malignancy or history of malignancy within 5 years prior to Visit 1, except appropriately treated basal cell carcinoma of the skin, in situ squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix. 8. AST or ALT >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 chronic 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 b. occasions) within 3 months of Visit 1 c. Myocardial infarction, stroke or transient ischemic attack within 6 months of Visit 1 d. 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. 13. Active vasculitis, unstable or uncontrolled within 8 weeks prior to Visit 1 or during the screening period. 14. Any suicidal behavior in the past 2 years (i.e., actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behavior). 15. Any suicidal ideation of type 4 or 5 on the C-SSRS in the past 3 months or at Visit 1 and/or Visit 2 (i.e. active suicidal thought with method and intent but without specific plan; or active suicidal thought with method, intent and plan). 16. Acute or chronic severe depression defined as HADS subscore >14 at Visit 1 and/or Visit 2. 17. Patients who must or wish to continue the intake of restricted medications (see Section 4.2.2.1) or any drug considered likely to interfere with the safe conduct of the trial. Please note potent CYP 3A4 inhibitors should not be taken 5 half-life times prior to Visit 1. 18. Patients treated with PDE1, PDE3, PDE4, PDE10 inhibitors and non-selective PDE inhibitors within 30 days before Visit 1 19. Patients not expected to comply with the protocol requirements or not expected to complete the trial as scheduled (e.g. chronic alcohol or drug abuse or any other condition that, in the investigator’s opinion, makes the patient an unreliable trial participant). 20. Inability to refrain from smoking on trial visit days. 21. History of allergy or hypersensitivity or contraindications to the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 ILDsTimepoint: Week 52. | — |
Secondary
| Measure | Time frame |
|---|---|
| To demonstrate BI 1015550’s ability in reducing the occurrence of clinically meaningful events such as acute ILD exacerbation, hospitalization for respiratory cause or death over the duration of the trial when compared to placebo in patients with progressive fibrosing ILD. An additional secondary objective of the trial is to show an effect of BI 1015550 on symptoms and lung functionTimepoint: Week 52. | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Georgia, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Republic of Korea, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United States of America
Contacts
Public ContactShweta Pradhan
IQVIA RDS (India) Private Limited
Outcome results
None listed