Phase 3Active, not recruitingAge-related condition
A Follow-up Study to Test Long-term Treatment With Nerandomilast in People With Pulmonary Fibrosis Who Took Part in a Previous Study With Nerandomilast (FIBRONEER™-ON)
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)
- Sponsor
- Boehringer Ingelheim (Industry)
- Enrollment
- 1,666 enrolled
- Conditions
- Idiopathic Pulmonary Fibrosis; Progressive Pulmonary Fibrosis
- Interventions
- Nerandomilast
- Ages
- adults, older adults
- Registry
- NCT06238622, CTIS2023-507353-15-00
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- 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
History
Study completion expected
Primary completion expected
Last registry update
Started
Registered