A study to find out whether BI 1015550 improves lung function in people with Idiopathic Pulmonary Fibrosis (IPF)

JRCT ID: jRCT2031220317

Registered date:03/09/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Idiopathic Pulmonary Fibrosis
• Date of first enrollment: 09/12/2022
• Target sample size: 963
• Countries of recruitment: United States,Japan,Argentina,Japan,Australia,Japan,Canada,Japan,Chile,Japan,China,Japan,Czech Republicc,Japan,Denmark,Japan,Finland,Japan,France,Japan,Germany,Japan,Hangary,Japan,Italy,Japan,Republic of Korea,Japan,Mexco,Japan,Nerherland,Japan,Poland,Japan,Austria,Japan,Belgium,Japan,Brazil,Japan,Croatia,Japan,Egypt,Japan,Estonia,Japan,Georgia,Japan,Greece,Japan,India,Japan,Ireland,Japan,Israel,Japan,Malaysia,Japan,New Zealand,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: >= 40age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

-Patients 40 years old and elder at the time of signed informed consent.
-Diagnosis of Idiopathic Pulmonary Fibrosis (IPF)
-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 or pirfenidone for at least 12 weeks or not on treatment with either nintedanib or pirfenidone for at least 8 weeks

Exclude criteria

-Relevant airways obstruction (prebronchodilator FEV1/FVC less than 0.7)
-Acute IPF exacerbation within 3 months and/or during the screening period
-Treated with immunomodulatory medications (other than oral corticosteroids) or prednisone more than15 mg/day or equivalent for respiratory or pulmonary reasons
-Active, unstable or uncontrolled vasculitis within 8 weeks
-Any suicidal behaviour 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: Saito Isao
• Secondary ID(s): NCT05321069