A Study to Find Out Whether BI 1015550 Improves Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF)

Completed · Phase 3 · Has a placebo group

Conditions studied: Idiopathic Pulmonary Fibrosis

In brief

This study is open to adults with a lung disease called Idiopathic Pulmonary Fibrosis (IPF). People can join the study if they are 40 years or older. If they already take nintedanib or pirfenidone for their IPF, they can continue treatment throughout the study. The purpose of this study is to find out whether a medicine called BI 1015550 helps people with IPF. 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. The doctors regularly test participants' lung function. The results of the lung function tests are compared between the groups. The doctors also regularly check participants' health and take note of any unwanted effects.

Key facts

Study ID

NCT05321069

Run by

Boehringer Ingelheim

People needed

1177

Starts

2022-10-06

Expected to finish

2024-12-17

Last updated by the study team

2025-10-20

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients ≥40 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 Idiopathic Pulmonary Fibrosis (IPF).
• 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.
• Diffusing Capacity (of Lung) for Carbon Monoxide (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.

You may not qualify if…

• 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 Idiopathic Pulmonary Fibrosis (IPF) 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.
• Confirmed infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) not fully recovered according to investigator judgement within the 4 weeks prior to randomization (Visit 2).
• 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.

Where it is running

• University of Southern California — Los Angeles, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• University of California Los Angeles — Los Angeles, California, United States
• University of California Davis — Sacramento, California, United States
• National Jewish Health — Denver, Colorado, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• Christiana Hospital — Newark, Delaware, United States
• Georgetown University — Washington D.C., District of Columbia, United States
• St. Francis Medical Institute — Clearwater, Florida, United States
• University of Florida Health Shands Hospital — Gainesville, Florida, United States
• Clinical Research Specialists LLC — Kissimmee, Florida, United States
• Advanced Pulmonary Research Institute — Loxahatchee Groves, Florida, United States
• Destin Pulmonary Critical Care — Santa Rosa Beach, Florida, United States
• Piedmont Healthcare-Atlanta-57055 — Atlanta, Georgia, United States
• Evanston Hospital Pulmonary Clinic — Evanston, Illinois, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Louisville Pulmonary Care — Louisville, Kentucky, United States
• Tulane University Hospital and Clinic — New Orleans, Louisiana, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• St. Elizabeth's Medical Center — Boston, Massachusetts, United States
• Infinity Medical Research — North Dartmouth, Massachusetts, United States
• University of Michigan Health System — Ann Arbor, Michigan, United States
• Beaumont Health — Royal Oak, Michigan, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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