Condition

Patients with Non-cystic Fibrosis Bronchiectasis (NCFB)

Purpose of the study

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 over a period of greater than or equal to (>=) 6 months but not exceeding 12 months toward prolonging the TTF exacerbation. NCT07048262

Official Title

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.

Who is eligible to participate?

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:
  • o >= 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) total score > 40 at Screening.
• 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 6 weeks before Baseline.

Register your interest

To register your interest or find out more information about this clinical trial, please email: enquiries@gallipoliresearch.org.au. 

Study location

Gallipoli Medical Research, Greenslopes Private Hospital, Brisbane