Status:
COMPLETED
A Study to Find Out Whether BI 1015550 Improves Lung Function in People With Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs)
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Lung Diseases, Interstitial
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 the...
Eligibility Criteria
Inclusion
- 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) \<0.7 at Visit 1
- In the opinion of the Investigator, other clinically significant pulmonary abnormalities.
- Acute Interstitial Lung Disease (ILD) exacerbation within 3 months prior to Visit 1 and/or during the screening period (investigator-determined).
- Relevant chronic or acute infections including human immunodeficiency virus (HIV) and viral hepatitis.
- Patients having developed ILD due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection/coronavirus disease 2019 (COVID-19) within 12 months of screening (based on investigators judgement).
- 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.
- 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.
- Aspartate aminotransferase (AST) or Alanine Aminotransferase (ALT) \>2.5 x upper limit of normal (ULN) or total Bilirubin \>1.5 x ULN at Visit 1.
- Further exclusion criteria apply.
Exclusion
Key Trial Info
Start Date :
November 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 14 2025
Estimated Enrollment :
1178 Patients enrolled
Trial Details
Trial ID
NCT05321082
Start Date
November 16 2022
End Date
April 14 2025
Last Update
January 9 2026
Active Locations (400)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
University of Arizona
Tucson, Arizona, United States, 85724
3
University of Southern California
Los Angeles, California, United States, 90033
4
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048