CSL Behring CSL787_2001

A Phase 2b, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Dose Range Finding Study to Evaluate the Efficacy, Safety, and Tolerability of Nebulized CSL787 in Adults (18 to 85 years) with Non-cystic Fibrosis Bronchiectasis

Study Population

Non-cystic fibrosis bronchiectasis (NCFB) is a chronic lung problem In this disease, the airways in the lungs widen and get damaged. This makes it easier for viruses to cause infections and swelling in the lungs. People with NCFB frequently have a persistent cough, produce a large amount of mucus, and get chest infections.

Approximately 450 participants with NCFB are planned to be randomized in to this study.

This study is designed to investigate whether CSL787 inhalation containing human antibodies is safe to use and helpful to treat NCFB by reducing germs in the lungs leading to fewer lung problems.

Eligible participants:

• male or female, between 18 and 85 years of age.
• primary diagnosis of NCFB confirmed by chest CT scan
• has had 2 or more NCFB exacerbations in the last 12 months (requiring urgent care or hospitalisation) OR 1 exacerbation and a St. George’s Respiratory Questionnaire (SGRQ) total score > 40 at Screening

Subjects with an undiagnosed or unstable disease, or primary diagnosis of other pulmonary disorders, including chronic obstructive pulmonary disease (COPD) asthma, or diffuse panbronchiolitis will not be eligible to participate in the study.

Study Visits

• A total of 7 onsite visits and 5 phone calls over approximately 8 to 14 months
• The planned study duration for each participant comprises the Screening Period (up to 4 weeks), the Treatment Period (≥ 6 months but not exceeding 12 months), and the Follow-up Period (1 month).

Study Requirements

• Inhaled nebulised medication once every afternoon or evening (provided by PARI Pharma)
• Lung function test, blood tests, ECG at selected onsite visits
• CT scan at study entry (if none available in the last 12 months)
• Completion of questionnaires on an electronic diary
  

Clinical Trials Link

https://www.clinicaltrials.gov/study/NCT07048262