BI 1015550 in Idiopathic Pulmonary Fibrosis

Summary

The purpose of this study is to evaluate the safety and effectiveness of 2 different doses of an experimental drug called BI 1015550 in patients with idiopathic pulmonary fibrosis (IPF). Participants will be randomly assigned to receive BI 1015550 or a placebo (inactive substance). Researchers will compare the 2 doses of BI 1015550 to placebo and assess for any side effects of the drug. Group A will receive BI 1015550, 9 mg tablet, 2 times per day; Group B will receive BI 1015550, 18 mg tablet, 2 times per day; and Group C will receive 2 placebo tablets, 2 times per day.

Inclusion Criteria

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)

Inclusion criteria

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) corrected for Haemoglobin (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.

Exclusion criteria

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 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.

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Study Location(s)

Beverly

More about this Clinical Trial

Full Title

A double blind, randomized, placebo-controlled trial evaluating the efficacy and safety of BI 1015550 over at least 52 weeks in patients with Idiopathic Pulmonary Fibrosis

Details

Disease Type/Condition

Other

Principal Investigator

Zaman, Tanzira

Age Group

Adult

Phase

III

IRB Number

STUDY00002208

ClinicalTrials.gov ID

NCT05321069

Key Eligibility

ClinicalTrials.gov

Contact

clinicaltrials@cshs.org

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