A study to test how well BI 3720931 is tolerated and whether it improves lung function in people with cystic fibrosis (LenticlairTM 1)

You may be able to join if

• Male or female of non-childbearing potential trial participants with a CF-pulmonary phenotype and a confirmed diagnosis of CF: - Positive sweat chloride ≥60 mEq/L by pilocarpine iontophoresis OR - Genotype with 2 identifiable CF-causing mutations accompanied by one or more clinical features if sweat chloride testing is between 30 and 59 mmol/L
• Trial participants who are not eligible for treatment with CFTRmt due to their genotype with 2 identified CFTR-mutations (including Class I CFTR gene mutations) and are also not expected to become eligible during the trial according to investigator´s opinion
• Trial participants able to perform acceptable spirometric maneuvers according to American Thoracic Society/European Respiratory Society 2019 standards
• FEV1pp ≥50% and ≤100% of predicted normal at Visit 1. Predicted value based on Global Lung Initiative lung function reference equations
• Stable CF disease with no pulmonary exacerbation 4 weeks prior to the screening visit and during the screening period and stable drug- and non-drug therapy for CF in the 4 weeks prior to dosing
• Trial participants either naïve to prior gene therapy or exposed to prior viral or non-viral gene therapies for cystic fibrosis. If prior exposure to gene therapy for CF exists, then the following applies as per investigator judgement: a. No apparent residual side effects associated with prior gene therapy as per investigator assessment, and b. Drug-free interval of -- 6 months after last dose of prior non-viral gene therapy -- 24 months after last dose of prior viral gene therapy