A study to find out whether BI 1015550 improves lung function in people with Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs)

JRCT ID: jRCT2031220475

Registered date:29/11/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Progressive Fibrosing Interstitial Lung Diseases
• Date of first enrollment: 08/12/2022
• Target sample size: 1041
• Countries of recruitment: Argentina,Japan,Australia,Japan,Austria,Japan,Belgium,Japan,Brazil,Japan,Canada,Japan,Chile,Japan,China,Japan,Croatia,Japan,Czech Republic,Japan,Denmark,Japan,Egypt,Japan,Estonia,Japan,Finland,Japan,France,Japan,Georgia,Japan,Germany,Japan,Greece,Japan,Hungary,Japan,India,Japan,Israel,Japan,Korea, Republic of,Japan,Malaysia,Japan,Mexico,Japan,Netherlands,Japan,New Zealand,Japan,Norway,Japan,Poland,Japan,Portugal,Japan,Saudi Arabia,Japan
• Study type: Interventional
• Intervention(s): Take BI 1015550 9 mg or BI 1015550 18 mg, placebo as tablet twice a day

Outcome(s)

• Primary Outcome: Absolute change from baseline in Forced Vital Capacity (FVC) (mL) at Week 52
• Secondary Outcome: Time to the first occurrence of any of the components of the composite endpoint: time to first acute IPF exacerbation, first hospitalization for respiratory cause, or death (whichever occurs first) over the duration of the trial

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable

Include criteria

-Patients 18 years old and older at the time of signed consent
-Progressive fibrosing ILD other than IPF based on predefined criteria
-Forced Vital Capacity (FVC) 45% and grater of predicted normal
-Diffusing Capacity for Carbon Monoxide (DLCO) 25% and grater and less than 90% predicted of normall
-On stable treatment with nintedanib for at least 12 weeks or not on treatment with nintedanib for at least 8 weeks

Exclude criteria

-Relevant airways obstruction (prebronchodilator FEV1/FVC less than 0.7)
-Acute ILD exacerbation within 3 months and/or during the screening period
-Treated with prednisone more than15 mg/day or equivalent within 4 weeks; cyclophosphamide, tocilizumab, mycophenolate, pirfenidone within 8 weeks; rituximab within 6 months
-Active, unstable or uncontrolled vasculitis within 8 weeks
-Any suicidal behavior in the past 2 years
-Any suicidal ideation of type 4 or 5 on the C-SSRS in the past 3 months

Related Information

• Primary Sponsor: Yamamoto Akiko
• Secondary ID(s): NCT05321082