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Tests treatment safety and results for Non-cystic Fibrosis Bronchiectasis
Official title Dose Range Finding, Efficacy, and Safety Study of Nebulized CSL787 in Adults With Non-cystic Fibrosis Bronchiectasis (NCFB)
ClinicalTrials.gov ID: NCT07048262
What this study is testing
What is CSL787?
CSL787 is an investigational medicine, given as an once-daily inhaled treatment, being studied as a potential treatment for non-cystic fibrosis bronchiectasis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- Adult between the ages of 18 to 85 years
- Primary diagnosis of NCFB confirmed by chest computed tomography (CT) scan, where bronchiectasis has been documented by a radiologist. Diagnosis in...
- Exacerbation history within the previous 1 year defined as either 1 of the following:
- \>= 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...
You likely can't join if
- History of bronchospasm in response to inhaled therapies including inhaled antibiotics
- Known or suspected hypersensitivity, or other severe reactions, to the investigational product (IP), to any excipients of the IP, or to other...
- Primary diagnosis of other pulmonary disorders, including chronic obstructive pulmonary disease (COPD) asthma or, diffuse panbronchiolitis (DPB), as...
- Pulmonary exacerbation requiring antibiotic therapy within the 4 weeks before Baseline.
See the full eligibility criteria
- Adult between the ages of 18 to 85 years
- 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 historical scans is acceptable if the...
- Exacerbation history within the previous 1 year defined as either 1 of the following:
- \>= 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 \> 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...
- Postbronchodilator percentage of the predicted normal forced expiratory volume in 1 second of expiration [FEV1% predicted] \> 35% and forced expiratory volume in 1 second (FEV1) \>= 1 liter (L) obtained in accordance...
- History of bronchospasm in response to inhaled therapies including inhaled antibiotics
- Known or suspected hypersensitivity, or other severe reactions, to the investigational product (IP), to any excipients of the IP, or to other immunoglobulin.
- Primary diagnosis of other pulmonary disorders, including chronic obstructive pulmonary disease (COPD) asthma or, diffuse panbronchiolitis (DPB), as determined by the investigator.
- Pulmonary exacerbation requiring antibiotic therapy within the 4 weeks before Baseline.
The study team makes the final eligibility decision.
Where it's taking place
- Queensland, Australia
- Westmead, Australia
- Chikushino-shi, Japan
- Fukuoka, Japan
- Ibaraki, Japan
- Iizuka-shi, Japan
- Kyoto, Japan
- Mie, Japan
- Osaka, Japan
- Shimonoseki-shi, Japan
- Tokyo, Japan
- Tsu, Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Queensland, Australia; Westmead, Australia; Chikushino-shi, Japan; Fukuoka, Japan; Ibaraki, Japan; Iizuka-shi, Japan and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.