Clinical Trial

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

Recruiting Phase 2
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Summary
This study is a phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose range finding study 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 to 12 months independent of the occurrence of pulmonary exacerbations. The primary aim of the study is to characterize the overall effect of CSL787 as well as the dose response of 2 active treatment regimens of inhaled CSL787 administered to participants with NCFB toward prolonging the TTF exacerbation.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-06-24; most recent amendment 2025-11-06.
Status change: Not Yet Recruiting → Recruiting 2025-10-31
Trial Details
NCT Number NCT07048262
Lead Sponsor CSL Behring
Conditions Non-cystic Fibrosis Bronchiectasis
Enrollment 450 participants
Start Date 2025-09-03
Primary Completion 2028-02-28 (estimated)
Study Completion 2028-03-28 (estimated)
Updated on ClinicalTrials.gov 2025-11-10