A study to test whether BI 1819479 improves lung function in people with idiopathic pulmonary fibrosis (IPF)

JRCT ID: jRCT2071240055

Registered date:04/09/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: idiopathic pulmonary fibrosis (IPF)
• Date of first enrollment: 10/09/2024
• Target sample size: 30
• Countries of recruitment: Germany,Japan,Greece,Japan,Hungary,Japan,Norway,Japan,Poland,Japan,Spain,Japan,Sweden,Japan,Argentina,Japan,Brazil,Japan,Canada,Japan,Australia,Japan,China,Japan,Malaysia,Japan,Singapore,Japan,Thailand,Japan,Austria,Japan,Belgium,Japan,Czech republic,Japan,Denmark,Japan,Italy,Japan,Finland,Japan,France,Japan,United states,Japan,New zealand,Japan,United kingdom,Japan,South korea,Japan
• Study type: Interventional
• Intervention(s): IMP BI 1819479

Outcome(s)

• Primary Outcome: the annual rate of decline in FVC [mL/year] assessed over a treatment period up to a maximum of 52 weeks
• Secondary Outcome: the absolute change from baseline in FVC at Week 24 [in mL]

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Trial participants >=40 years old at the time of signed informed consent.
Diagnosis of IPF based on the 2022 ATS/ERS/JRS/ALAT Guideline
On stable treatment with nintedanib or pirfenidone for at least 12 weeks prior to Visit 1 and during screening or not on treatment with either nintedanib or pirfenidone for at least 12 weeks prior to Visit 1 and during screening.
Forced Vital Capacity (FVC) >=45% of predicted normal at Visit 1.
DLCO >=25% of predicted normal corrected for hemoglobin (Hb) at Visit 1.

Exclude criteria

Pre-bronchodilator FEV1/FVC <0.7 at Visit 1
Acute exacerbation of IPF within at least 12 weeks prior to screening and/or during the screening period (investigator-determined)
Treated with immunosuppressive medications (other than oral corticosteroids) or prednisone >15 mg/day or equivalent for respiratory or pulmonary reasons
Lower respiratory tract infection requiring treatment within 4 weeks prior to Visit 1 and/or during the screening period.

Related Information

• Primary Sponsor: Zhu Tong