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

Who can take part?

You may be able to take part if you have non‑cystic fibrosis bronchiectasis (NCFB), a condition where the airways become widened and damaged, making it easier for infections and inflammation to occur.

You may be eligible if you:

• Are 18 to 85 years of age
• Have a confirmed diagnosis of bronchiectasis based on a CT scan
• Have experienced:
• • Two or more flare‑ups (exacerbations) in the past 12 months requiring urgent care or hospitalisation; or
  • One flare‑up and ongoing symptoms affecting your quality of life

You would not be able to take part if:

• You have another primary lung condition (such as COPD or asthma)
• You have an unstable or undiagnosed health condition
• The study doctor feels that participation may not be safe for you

What is involved?

This study is looking at whether CSL787, an inhaled medication containing antibodies, may help reduce harmful bacteria in the lungs and lower the risk of flare‑ups.

Participants will be randomly assigned to receive the study medication.

• Study duration: Approximately 8 to 14 months
• Clinic visits: 7 onsite visits
• Phone calls: 5 study calls

The study includes:

• A screening period (up to 4 weeks)
• A treatment period (6 to 12 months)
• A follow‑up period (1 month)

What will I need to do?

If you take part, you will be asked to:

• Take the study medication daily using a nebuliser
• Attend clinic visits and study appointments
• Take part in assessments, which may include:
• • Breathing tests
  • Blood tests
  • A heart tracing (ECG)
  • Questionnaires about your health
• Have a CT scan at the start of the study (if a recent scan is not available)

You will also have regular contact with the study team throughout the study.

More information

You can read more about this study here:

• ClinicalTrials.gov – CSL787 Study