NCT07048262

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: CSL Behring · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-cystic Fibrosis Bronchiectasis

Interventions

Type	Name	Description
BIOLOGICAL	CSL787	CSL787 high or low doses once daily (QD) will be administered via inhalation over a period of 6 to 12 months.
DRUG	Placebo	Participants will receive a matching volume of placebo QD over a period of 6 to 12 months.
DEVICE	Nebulizer	The nebulizer is a CE-marked device.

Timeline

• Start date: 2025-09-03
• Primary completion: 2028-02-28
• Completion: 2028-03-28
• First posted: 2025-07-02
• Last updated: 2025-11-10

Locations

13 sites across 2 countries: Australia, Japan

Regulatory

• FDA-regulated drug study
• FDA-regulated device study