BI 1015550 in People With Progressive Fibrosing Interstitial Lung Diseases
The purpose of this study is to find out whether a medicine called BI 1015550 helps people 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 they already take nintedanib, they can continue treatment throughout the study.
Participants are put into 3 groups randomly, which means by chance. Participants in 2 groups take different doses of BI 1015550 as tablets twice a day. Participants in the placebo group take placebo tablets twice a day. Placebo tablets look like BI 1015550 tablets but do not contain any medicine.
Participants are in the study for up to two and a half years. During the first year, they visit the study site 10 times. Afterwards, they visit the study site every 3 months. .
- Study Sponsor: Boehringer Ingelheim
- Start Date: October 2022
- Estimated Primary Completion Date: November 2024
- Phase 3, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of BI 1015550 over at least 52 weeks in patients with progressive fibrosing interstitial lung diseases (PF-ILDs)
Primary Outcome Measure:
- Absolute change from baseline in Forced Vital Capacity (FVC) (mL) at Week 52 [Time Frame: at baseline, at week 52]
- 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 or pirfenidone for at least 12 weeks prior to Visit 1 and during screening and are planning to stay on this background treatment after randomization. Combination of nintedanib plus pirfenidone is not allowed. (*stable therapy is defined as the individually and general tolerated regimen of either nintedanib or pirfenidone (no dose changes) for at least 12 weeks.)
- not on a treatment with nintedanib or pirfenidone 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 corrected for Hemoglobin (Hb) [Visit 1] ≥25% and <90% 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.
- Patients treated with permitted immunosuppressive agents 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.
- Relevant airways obstruction (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.