This study is open to adults who are at least 40 years old and have idiopathic pulmonary fibrosis (IPF). People can participate in the study if they have a forced vital capacity (FVC) greater than or equal to 45% of the predicted value and fibrosis of 20% or more confirmed by a high-resolution computed tomography (HRCT) scan. The purpose of this study is to find out if a medicine called BI 765423 can improve lung function in people with IPF. The study will compare BI 765423 with a placebo to see if there is a difference in lung capacity after 3 months of treatment and will also look at changes in certain markers related to lung health.
Participants are put into two groups randomly, which means by chance. One group receives the study medicine, and the other group receives a placebo. Placebo looks like BI 765423 but does not contain any study medicine. The study medicine is given as an infusion into a vein every four weeks.
Participants are in the study for 8-10 months. During the study, participants may continue their regular treatment for IPF. During the study they visit the study site several times for screening, treatment, and follow-up. Doctors regularly test lung function by measuring FVC and take blood samples to measure study endpoints. The results are compared between the two groups to see whether the treatment works. The doctors also check participants' health and take note of any unwanted effects.
40 years of age or older at the time of informed consent signature.
Signed and dated written informed consent in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
Permanently surgically sterilised (hysterectomy, bilateral salpingectomy and/or bilateral oophorectomy)
Women not using sex hormone medication such as hormone replacement therapy may be included if a blood sample confirms levels of follicle stimulating hormone (FSH) > 40 U/L and estradiol < 30 ng/L"
Acute exacerbation of IPF within at least 12 weeks prior to Visit 1 and/or during the screening period (investigator-determined).
Relevant airways obstruction (pre-bronchodilator forced expiratory volume in 1 second (FEV1)/FVC <0.7) at Visit 1.
Lower respiratory tract infection requiring treatment within 4 weeks prior to Visit 1 and/or during the screening period.
Previous clinical or echocardiographic evidence of significant right heart failure according to investigator's judgement
Boehringer Ingelheim
Lead sponsor