The purpose of the study is to investigate the efficacy of galvokimig versus placebo on the time to the first pulmonary exacerbation in study participants with non-cystic fibrosis bronchiectasis (NCFB)
Participant must be 18 to ≤80 years of age, inclusive, at the time of signing the informed consent form (ICF)
Participant with a documented history of Non-Cystic Fibrosis Bronchiectasis (NCFB) (cough, chronic sputum production, and/or recurrent respiratory infections) confirmed by high resolution computed tomography (HRCT) demonstrating bronchiectasis in 1 or more lobes. Confirmation of diagnosis via HRCT will be performed as close as possible to, and within 7 calendar days of the Baseline visit, in all participants who meet all inclusion criteria and no
Participant with a history of chronic expectoration who are current sputum producers and are able to provide spontaneous sputum sample at Screening. If the participant is unable to produce spontaneous sputum at Screening, the participant will be considered a screening failure and may be rescreened once
Participant with a history of at least 2 moderate or severe pulmonary exacerbations within the past 12 months prior to Screening or 1 severe pulmonary exacerbation within 6 months prior to Screening
Participant with post- Bronchodilator (BD) forced expiratory volume (FEV) 1% predicted ≥30% at Screening and Baseline
Participant has acceptable inhaler (where applicable) and spirometry techniques according to American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines during the Screening Visit. Participants who do not meet such criteria can be repeated once without being rescreened
Parallel
Galvokimig
Biological/VaccineDrug: Galvokimig Pharmaceutical form: Solution for injection
Placebo
Biological/VaccineDrug: Placebo Pharmaceutical form: Solution for injection
Time from intervention assignment to first moderate or severe pulmonary exacerbation
A moderate pulmonary exacerbation in this study is defined as having 3 or more of the following symptoms for at least 48 hours resulting in a physician's decision to prescribe oral antibiotics (with or without oral corticosteroids): Increased cough, Increased, sputum volume or change in sputum consistency, Increased sputum purulence, Increased breathlessness and/or decreased exercise tolerance, Fatigue and/or malaise, Hemoptysis. A severe pulmonary exacerbation in this study is defined as an exacerbation requiring iv antibiotics and/or hospitalization.
Annualized rate of pulmonary exacerbations
A moderate pulmonary exacerbation in this study is defined as having 3 or more of the following symptoms for at least 48 hours resulting in a physician's decision to prescribe oral antibiotics (with or without oral corticosteroids): Increased cough, Increased, sputum volume or change in sputum consistency, Increased sputum purulence, Increased breathlessness and/or decreased exercise tolerance, Fatigue and/or malaise, Hemoptysis. A severe pulmonary exacerbation in this study is defined as an exacerbation requiring iv antibiotics and/or hospitalization.
Post bronchodilator (BD) forced expiratory volume in 1 second (FEV1) at Week 24
Lung function will be measured by centrally provided spirometry equipment. Spirometry at clinical site visits should be performed in accordance with the American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines. Post-BD spirometry should be performed consistent with the mechanism of action of reliever (ie, 30 minutes \[±5 minutes\] following 4 puffs of 100μg/puff of salbutamol or albuterol). Three measurements fulfilling the ATS/ERS acceptability and repeatability criteria should be obtained at every spirometry visit.
Incidence of Treatment-Emergent (TE) Adverse Events (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A TEAE is defined as any AE with a start on or after the first administration of study intervention.
Incidence of TE Serious Adverse Events (SAEs)
An SAE is defined as any untoward medical occurrence that, at any dose, meets 1 or more of the criteria listed: Results in death Is life-threatening Requires inpatient hospitalization or prolongation of existing hospitalization Results in persistent or significant disability/incapacity Is a congenital anomaly/birth defect Other important medical events which based on medical or scientific judgement may jeopardize the patients or may require medical or surgical intervention to prevent any of the above.
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