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 (NCT07048262)

The purpose of this study is to see if CSL787 is safe to use and helpful to treat NCFB by reducing germs in the lungs, leading to fewer lung problems. This study is designed to explore the efficacy, safety, and tolerability of 2 active treatment regimens of CSL787 (immunoglobulin G [IgG] inhalation solution) compared with placebo over a period of ≥ 6 months but not exceeding 12 months to prolong the time to first (TTF) exacerbation as a primary endpoint.

Trial phase

Phase 2

Trial participation type

This trial has been designed for the Clinical Research of a Drug.

Principal investigator

Prof Peter Wark

Key inclusion data

INCLUSION: Adults 18-85 with primary diagnosis of NCFB; History of 2 pulmonary exacerbation within previous 12 months requiring antibiotics; Post bronchodilator FEV1 >35% EXCLUSION: Primary diagnosis of other pulmonary disorders, including chronic obstructive pulmonary disease (COPD) asthma, or diffuse panbronchiolitis (DPB); History of bronchospasm in response to inhaled therapies including inhaled antibiotics