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Dose Range Finding, Efficacy, and Safety Study of Nebulized CSL787 in Adults With Non-cystic Fibrosis Bronchiectasis (NCFB)
Sponsor: CSL Behring
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
450
Start Date
2025-09-03
Completion Date
2028-03-28
Last Updated
2025-11-10
Healthy Volunteers
No
Conditions
Interventions
CSL787
CSL787 high or low doses once daily (QD) will be administered via inhalation over a period of 6 to 12 months.
Placebo
Participants will receive a matching volume of placebo QD over a period of 6 to 12 months.
Nebulizer
The nebulizer is a CE-marked device.
Locations (13)
The Prince Charles Hospital
Queensland, Australia
Westmead Hospital
Westmead, Australia
Fukuoka University Chikushi Hopsital
Chikushino-shi, Japan
Kyusho Central Hospital of the Mutual Aid Association of Public School Teachers
Fukuoka, Japan
Ibaraki Prefectural Central Hospital
Ibaraki, Japan
Kazunori Tobino Iizuka Hospital
Iizuka-shi, Japan
National Hospital Organization Minami Kyoto Hospital
Kyoto, Japan
Matsusaka Municipal Hospital
Mie, Japan
National Hospital Organization Kinki Chuo Chest Medical Center
Osaka, Japan
Shimonoseki City Hospital
Shimonoseki-shi, Japan
Japan Anti-Tuberculosis Association, Fukujuji Hospital
Tokyo, Japan
Keio University Hospital
Tokyo, Japan
National Hospital Organization Mie Chuo Medical Center
Tsu, Japan