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RECRUITINGPhase 2INTERVENTIONAL

Dose Range Finding, Efficacy, and Safety Study of Nebulized CSL787 in Adults With Non-cystic Fibrosis Bronchiectasis (NCFB)

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

BIOLOGICAL

CSL787

CSL787 high or low doses once daily (QD) will be administered via inhalation over a period of 6 to 12 months.

DRUG

Placebo

Participants will receive a matching volume of placebo QD over a period of 6 to 12 months.

DEVICE

Nebulizer

The nebulizer is a CE-marked device.

Locations (13)

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