JRCT ID: jRCT2071240055
Registered date:04/09/2024
A study to test whether BI 1819479 improves lung function in people with idiopathic pulmonary fibrosis (IPF)
Basic Information
Recruitment status | Pending |
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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 |
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Secondary Outcome | the absolute change from baseline in FVC at Week 24 [in mL] |
Key inclusion & exclusion criteria
Age minimum | >= 40age old |
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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 |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) |
Contact
Public contact | |
Name | Nobuko Yamada |
Address | 2-1-1, Osaki, Shinagawa-ku, Tokyo Tokyo Japan 141-6017 |
Telephone | +81-120-189-779 |
medchiken.jp@boehringer-ingelheim.com | |
Affiliation | Boehringer Ingelheim |
Scientific contact | |
Name | Tong Zhu |
Address | 2-1-1, Osaki, Shinagawa-ku, Tokyo Tokyo Japan 141-6017 |
Telephone | +81-120-189-779 |
medchiken.jp@boehringer-ingelheim.com | |
Affiliation | Boehringer Ingelheim |