Tests inhaled CSL787 in adults with non-cystic fibrosis bronchiectasis
Tests an inhaled antibody treatment against placebo in adults with bronchiectasis.
Plain-language title generated from the registry record
Registry title: Dose Range Finding, Efficacy, and Safety Study of Nebulized CSL787 in Adults With Non-cystic Fibrosis Bronchiectasis (NCFB)
Key facts
- Where
- Queensland and Westmead, AustraliaSee the 2 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 85 years old?
Source: NCT07048262, who can take part
Where in Australia
- The Prince Charles HospitalQueensland, AustraliaTaking people
- Westmead HospitalWestmead, AustraliaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- CSL Behring
- Trial code
- NCT07048262EU 2024-518821-13-00
- Record updated
- 19 October 2026
- Original description
This study is a proof-of-concept phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose selection study designed to explore the efficacy, safety, and tolerability of 2 active treatment regimens of CSL787 (human normal immunoglobulin G [IgG] inhalation solution) compared with placebo over 52 weeks.Read full original descriptionShow less
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
This study is a proof-of-concept phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose selection study designed to explore the efficacy, safety, and tolerability of 2 active treatment regimens of CSL787 (human normal immunoglobulin G [IgG] inhalation solution) compared with placebo over 52 weeks.
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 time to first (TTF) exacerbation.
Inclusion: Adult between the ages of 18 to 85 years; Capable of spontaneous sputum production at Screening; Primary diagnosis of NCFB confirmed by chest computed tomography (CT) scan, where bronchiectasis has been documented by a radiologist. Diagnosis in the medical records based on documented historical scans is acceptable if the chest CT, scan confirming the participant's NCFB diagnosis was performed within 12 months before enrollment. Participants for whom no chest CT scan results are available within the previous 12 months will undergo a chest CT scan during the Screening Period; Exacerbation history within the previous 1 year defined as one of the following:; greater than or equal (≥) 2 documented exacerbations requiring oral and/or intravenous (IV) antibiotic therapy to treat a pulmonary infection; OR; 1 documented exacerbation requiring oral and/or IV antibiotic therapy to treat a pulmonary infection and a St. George's Respiratory Questionnaire (SGRQ) Symptoms score of greater than (>) 40 at Screening; Note: Other medications to treat NCFB such as: oral macrolides, or dipeptidyl peptidase-1 (DPP-1) inhibitors are allowed, provided ≥ 1 historical exacerbation occurred while on the medication for ≥ 3 months at a stable dose; Postbronchodilator percent predicted forced expiratory volume in 1 second (FEV1%) > 35% and forced expiratory volume in 1 second (FEV1) ≥ 1 L obtained in accordance with American Thoracic Society (ATS) / European Respiratory Society (ERS) standards for spirometry during Screening and at Baseline on Day 1.
Exclusion: Known or suspected hypersensitivity, or other severe reactions, to the investigational product (IP), to any excipients of the IP, or to other immunoglobulins; Use of oral, IV, or inhaled antibiotic therapy to treat a pulmonary exacerbation or any other condition within 4 weeks before Baseline measurements on Day 1; History of severe or uncontrolled asthma, or bronchospasm in response to inhaled therapies including inhaled antibiotics; Primary diagnosis of other pulmonary disorders, including chronic obstructive pulmonary disease (COPD), asthma, or diffuse panbronchiolitis (DPB), as determined by the investigator.