NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
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
Health condition(s) or Problem(s) studiedidiopathic pulmonary fibrosis (IPF)
Date of first enrollment10/09/2024
Target sample size30
Countries of recruitmentGermany,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 typeInterventional
Intervention(s)IMP BI 1819479

Outcome(s)

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

Key inclusion & exclusion criteria

Age minimum>= 40age old
Age maximumNot applicable
GenderBoth
Include criteriaTrial 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 criteriaPre-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

Contact

Public contact
Name Nobuko Yamada
Address 2-1-1, Osaki, Shinagawa-ku, Tokyo Tokyo Japan 141-6017
Telephone +81-120-189-779
E-mail 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
E-mail medchiken.jp@boehringer-ingelheim.com
Affiliation Boehringer Ingelheim