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An Open-label Extension Trial of the Long-term Safety and Efficacy of BI 1015550 Taken Orally in Patients With Idiopathic Pulmonary Fibrosis (IPF) and Progressive Pulmonary Fibrosis (PPF) (FIBRONEER™-ON)
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
University of Alabama at Birmingham
Birmingham, Alabama, United States
University of Arizona
Tucson, Arizona, United States
University of Southern California
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
University of California Los Angeles
Los Angeles, California, United States
University of California Davis
Sacramento, California, United States
National Jewish Health
Denver, Colorado, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Christiana Hospital
Newark, Delaware, United States
Georgetown University
Washington D.C., District of Columbia, United States
Start Date
May 6, 2024
Primary Completion Date
April 28, 2027
Completion Date
May 5, 2027
Last Updated
March 18, 2026
1,700
ESTIMATED participants
Nerandomilast
DRUG
Lead Sponsor
Boehringer Ingelheim
NCT07299695
NCT07466420
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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