- Active not recruitingPHASE1, PHASE2
A Long-term Study to Monitor the Health Status of People With Cystic Fibrosis Who Took Part in a Previous Study With BI 3720931 (Lenticlair™-ON)
This study looks at the long-term health of people with cystic fibrosis who previously took part in a trial for a medicine called BI 3720931. Participants won't receive new medicine in this study, but their health will be monitored for many years to see how they are doing.
For: Cystic FibrosisFrance · Italy · Netherlands - Ongoing, recruitingPhase I and Phase II (Integrated)- First administration to humans
A seamless Phase I/II trial with an initial open-label dose escalation part and a subsequent randomised, double-blind, placebo-controlled expansion part to evaluate the safety, tolerability, and efficacy of a single dose of BI 3720931, an inhaled lentiviral vector gene therapy, in adult people with cystic fibrosis who are ineligible for CFTR modulators (LenticlairTM 1)
This study is testing a new inhaled gene therapy, BI 3720931, for adults with cystic fibrosis who can't use other treatments. It will check if the treatment is safe, how well people tolerate it, and if it improves lung function (FEV1pp).
For: Cystic fibrosisItaly · Spain · Netherlands