This study is open to people with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF). They can only take part if they have completed treatment in a previous study with a medicine called nerandomilast or BI 1015550. The goal of this study is to find out how well people with pulmonary fibrosis tolerate long- term treatment with nerandomilast. The study also tests whether nerandomilast improves lung function and prolongs the time until symptoms get worse, participants need to go to the hospital, or die. Every participant takes nerandomilast as tablets for up to 1 year and 10 months. The participants may also continue their regular treatment for pulmonary fibrosis during the study. Participants visit their doctors regularly. During these visits, the doctors collect information on any health problems of the participants. Participants also regularly do lung function tests.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1,700
Nerandomilast
University of Alabama at Birmingham
Birmingham, Alabama, United States
RECRUITINGUniversity of Arizona
Tucson, Arizona, United States
NOT_YET_RECRUITINGUniversity of Southern California
Los Angeles, California, United States
RECRUITINGCedars-Sinai Medical Center
Los Angeles, California, United States
Occurrence of any adverse event over the course of the extension trial (yes/no) i.e. up until the follow-up/end of study visit planned at the latest at week 99
Time frame: Up to 99 weeks and 3 days
Absolute change from baseline in Forced vital capacity (FVC) (mL) over time
Time frame: Up to 98 weeks
Absolute change from baseline in % predicted in Forced vital capacity (FVC) over time
Time frame: Up to 98 weeks
Time to absolute decline in FVC % predicted of >10% from baseline over the duration of the trial
Time frame: Up to 98 weeks
Time to first acute Idiopathic Pulmonary Fibrosis/Progressive Pulmonary Fibrosis (IPF/PPF) exacerbation, first hospitalisation for respiratory cause, or death (whichever occurs first) over the duration of the trial
Time frame: Up to 98 weeks
Time to first acute Idiopathic Pulmonary Fibrosis/Progressive Pulmonary Fibrosis (IPF/PPF) exacerbation or death over the duration of the trial
Time frame: Up to 98 weeks
Time to hospitalisation for respiratory cause or death over the duration of the trial
Time frame: Up to 98 weeks
Time to absolute decline in Forced vital capacity (FVC) % predicted of >10% from baseline or death over the duration of the trial
Time frame: Up to 98 weeks
Time to relative decline in Forced vital capacity (FVC) % predicted of >10% from baseline or death over the duration of the trial
Time frame: Up to 98 weeks
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University of California Los Angeles
Los Angeles, California, United States
RECRUITINGUniversity of California Davis
Sacramento, California, United States
RECRUITINGNational Jewish Health
Denver, Colorado, United States
RECRUITINGYale University School of Medicine
New Haven, Connecticut, United States
RECRUITINGChristiana Hospital
Newark, Delaware, United States
COMPLETEDGeorgetown University
Washington D.C., District of Columbia, United States
RECRUITING...and 362 more locations