Dose Range Finding, Efficacy, and Safety Study of Nebulized CSL787 in Adults With Non-cystic Fibrosis Bronchiectasis (NCFB)
NCT ID: NCT07048262
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
450 participants
INTERVENTIONAL
2025-09-03
2028-03-28
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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CSL787 High Dose
Participants in this arm will receive a high dose of CSL787.
CSL787
CSL787 high or low doses once daily (QD) will be administered via inhalation over a period of 6 to 12 months.
Nebulizer
The nebulizer is a CE-marked device.
CSL787 Low Dose
Participants in this arm will receive a low dose of CSL787.
CSL787
CSL787 high or low doses once daily (QD) will be administered via inhalation over a period of 6 to 12 months.
Nebulizer
The nebulizer is a CE-marked device.
Placebo
Participants in this arm will receive placebo.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
85 Years
ALL
No
Sponsors
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CSL Behring
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
CSL Behring
Locations
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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
Countries
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Central Contacts
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Other Identifiers
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2024-518821-13-00
Identifier Type: CTIS
Identifier Source: secondary_id
CSL787_2001
Identifier Type: -
Identifier Source: org_study_id