NCT07048262 Dose Range Finding, Efficacy, and Safety Study of Nebulized CSL787 in Adults With Non-cystic Fibrosis Bronchiectasis (NCFB)
| NCT ID | NCT07048262 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | CSL Behring |
| Condition | Non-cystic Fibrosis Bronchiectasis |
| Study Type | INTERVENTIONAL |
| Enrollment | 450 participants |
| Start Date | 2025-09-03 |
| Primary Completion | 2028-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 450 participants in total. It began in 2025-09-03 with a primary completion date of 2028-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion 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 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 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 stable dose. * 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 with American Thoracic Society (ATS) / European Respiratory Society (ERS) standards for spirometry during Screening and at Baseline. Exclusion Criteria: * 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.
Contact & Investigator
Study Director
STUDY DIRECTOR
CSL Behring
Frequently Asked Questions
Who can join the NCT07048262 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Non-cystic Fibrosis Bronchiectasis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07048262 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07048262 currently recruiting?
Yes, NCT07048262 is actively recruiting participants. Contact the research team at clinicaltrials@cslbehring.com for enrollment information.
Where is the NCT07048262 trial being conducted?
This trial is being conducted at Queensland, Australia, Westmead, Australia, Chikushino-shi, Japan, Fukuoka, Japan and 9 additional locations.
Who is sponsoring the NCT07048262 clinical trial?
NCT07048262 is sponsored by CSL Behring. The principal investigator is Study Director at CSL Behring. The trial plans to enroll 450 participants.