Phase 2b Study of Nebulized CSL787 to Test Different Doses for Safety and Effectiveness in Adults 18 to 85 Years With Non-cystic Fibrosis Bronchiectasis

What this Trial Is About

Researchers are evaluating CSL787, an inhaled immunoglobulin G solution, in adults with Non-cystic Fibrosis Bronchiectasis NCFB. This phase 2b, randomized, double-blind, placebo-controlled study aims to explore the effectiveness, safety, and tolerability of two different doses of CSL787 compared to placebo over 6 to 12 months. The main goal is to understand how CSL787 affects the time to first exacerbation and its dose response. Participants will be randomly assigned to receive either a high dose of CSL787, a low dose of CSL787, or a placebo. The treatment is given once daily using a nebulizer device. The study may last from 6 to 12 months depending on the participants course. This trial is conducted at multiple centers and uses a double-blind design to compare the effects of the different treatment groups. During the study, participants will attend regular visits for assessments including lung function tests, monitoring for exacerbations, quality of life questionnaires, and sputum sample collection to check for bacteria. Safety will be monitored by tracking any adverse events throughout the study and for one month after treatment ends. The primary measurement is the time to the first exacerbation, with additional outcomes such as exacerbation rates, symptom improvement, and safety events evaluated over the study period.

Dose Range Finding, Efficacy, and Safety Study of Nebulized CSL787 in Adults With Non-cystic Fibrosis Bronchiectasis (NCFB)