1305-0031: Extension trial of the long-term safety and efficacy of BI 1015550
Research type
Research Study
Full title
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)
IRAS ID
1009187
Contact name
Medical Information
Contact email
Sponsor organisation
Boehringer Ingelheim Ltd.
Research summary
Lay Title
A follow-up study to test long-term treatment with BI 1015550 in people with pulmonary fibrosis who took part in a previous study with BI 1015550
Brief Summary
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 BI 1015550 (study 1305-0014 or 1305-0023).
The goal of this study is to find out how well people with pulmonary fibrosis tolerate long term treatment with BI 1015550. The study also tests whether BI 1015550 improves lung function and prolongs the time until symptoms get worse, participants need to go to the hospital, or die.
Every participant takes BI 1015550 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.REC name
East of England - Cambridge South Research Ethics Committee
REC reference
24/EE/0046
Date of REC Opinion
12 Apr 2024
REC opinion
Further Information Favourable Opinion