BI 1015550 in Progressive Fibrosing Interstitial Lung Diseases

Summary

The purpose of this study is to evaluate the safety, effectiveness, and side effects of 2 different doses of an investigational drug called BI 1015550 in people with any interstitial lung disease (ILD) that is progressing. Participants will be randomly assigned to 1 of 3 groups. Group A will receive BI 1015550 as a 9 mg tablet, 2 times per day; Group B will receive BI 1015550 as 18 mg tablet, 2 times per day; and Group C will receive placebo tablets (inactive substance) 2 times per day.

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).

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 corrected for Hemoglobin (Hb) [Visit 1] ≥25% and <90% predicted of normal at Visit 1.
Women of childbearing potential (WOCBP) 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.

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 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.

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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 Progressive Fibrosing Interstitial Lung Diseases

Details

Disease Type/Condition

Other

Principal Investigator

Zaman, Tanzira

Age Group

Adult

Phase

III

IRB Number

STUDY00002240

ClinicalTrials.gov ID

NCT05321082

Key Eligibility

ClinicalTrials.gov

Contact

clinicaltrials@cshs.org

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