Actively Recruiting
Dose Range Finding, Efficacy, and Safety Study of Nebulized CSL787 in Adults With Non-cystic Fibrosis Bronchiectasis (NCFB)
Led by CSL Behring · Updated on 2025-11-10
450
Participants Needed
13
Research Sites
133 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Dose Range Finding, Efficacy, and Safety Study of Nebulized CSL787 in Adults With Non-cystic Fibrosis Bronchiectasis (NCFB)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 85 years
- Primary diagnosis of Non-cystic Fibrosis Bronchiectasis confirmed by chest CT scan within 12 months or during screening
- History of at least 2 exacerbations requiring antibiotics in the past year, or 1 exacerbation plus SGRQ Symptoms score over 40 at screening
- Use of certain NCFB medications allowed if stable for at least 3 months
- Postbronchodilator FEV1% predicted above 35% and FEV1 at least 1 liter according to ATS/ERS standards during screening and baseline
You will not qualify if you...
- History of bronchospasm caused by inhaled therapies including antibiotics
- Known or suspected severe allergy or reaction to investigational product or immunoglobulins
- Primary diagnosis of other lung diseases such as COPD, asthma, or diffuse panbronchiolitis
- Pulmonary exacerbation needing antibiotics within 4 weeks before baseline
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 13 locations
1
The Prince Charles Hospital
Queensland, Australia
Actively Recruiting
2
Westmead Hospital
Westmead, Australia
Actively Recruiting
3
Fukuoka University Chikushi Hopsital
Chikushino-shi, Japan
Actively Recruiting
4
Kyusho Central Hospital of the Mutual Aid Association of Public School Teachers
Fukuoka, Japan
Actively Recruiting
5
Ibaraki Prefectural Central Hospital
Ibaraki, Japan
Actively Recruiting
6
Kazunori Tobino Iizuka Hospital
Iizuka-shi, Japan
Actively Recruiting
7
National Hospital Organization Minami Kyoto Hospital
Kyoto, Japan
Actively Recruiting
8
Matsusaka Municipal Hospital
Mie, Japan
Actively Recruiting
9
National Hospital Organization Kinki Chuo Chest Medical Center
Osaka, Japan
Actively Recruiting
10
Shimonoseki City Hospital
Shimonoseki-shi, Japan
Actively Recruiting
11
Japan Anti-Tuberculosis Association, Fukujuji Hospital
Tokyo, Japan
Actively Recruiting
12
Keio University Hospital
Tokyo, Japan
Actively Recruiting
13
National Hospital Organization Mie Chuo Medical Center
Tsu, Japan
Actively Recruiting
Research Team
T
Trial Registration Coordinator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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