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

About the Study

Non-cystic fibrosis bronchiectasis (NCFB) is a chronic lung condition where the airways become widened and damaged, making it easier for infections and inflammation to occur. People with NCFB often experience:

• Persistent cough
• Excess mucus production
• Frequent chest infections

This study will investigate whether CSL787, an inhaled medication containing human antibodies, is safe and effective in reducing harmful germs in the lungs and lowering the risk of lung problems.

• Global enrollment: ~450 participants
• Monash Health Clayton site: ~6 participants

Who Can Join?

You may qualify if you:

• Are 18 to 85 years old
• Have a primary diagnosis of NCFB confirmed by chest CT scan
• Have had:
• • 2 or more NCFB exacerbations in the past 12 months (requiring urgent care or hospitalization), OR
  • 1 exacerbation and a St. George’s Respiratory Questionnaire (SGRQ) score > 40 at screening

Exclusions:

• Undiagnosed or unstable disease
• Primary diagnosis of other lung disorders (COPD, asthma, diffuse panbronchiolitis)

Study Details

• Visits: 7 onsite visits + 5 phone calls
• Duration: 8–14 months
• Phases:
• • Screening: up to 4 weeks
  • Treatment: 6–12 months
  • Follow-up: 1 month

What’s Involved?

• Daily inhaled medication via nebulizer (provided by PARI Pharma)
• Lung function tests, blood tests, ECG at selected visits
• CT scan at study entry (if none available in past 12 months)
• Completion of electronic questionnaires

Clinical Trials Link

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