GRemubamab ErAdication Trial (GREAT-2)

Who can take part

• Age >18 to <86
• Clinical diagnosis of Bronchiectasis
• Able to and provided informed consent
• Previous computerised tomography (CT) scan of the chest demonstrating bronchiectasis in 1 or more lobes
• aeruginosa in sputum, bronchoalveolar lavage or another airway sample at least once in the 24 months prior to screening; A sputum sample that is culture or PCR positive for P. aeruginosa sent at the screening visit and within 35 days of randomization

Who cannot take part

• Known hypersensitivity to Gremubamab or any excipient of the investigational product
• Treatment with immunosuppressives within previous 6 months prior to screening
• Use of any investigational drugs within five times of the elimination half-life after the last dose or within 30 days, whichever is longer
• Active allergic bronchopulmonary aspergillosis (receiving treatment with corticosteroids and/or antifungal medication)
• Recent significant haemoptysis (a volume requiring clinical intervention, within the previous 4 weeks prior to screening)
• Treatment with long term inhaled, systemic or nebulized anti-pseudomonal antibiotics which are newly initiated within the previous 3 months prior to screening
• Chronic treatment with cyclical doses of inhaled or nebulized antibiotics e.g 28 days on and 28 days off at the time of screening
• Participants with a primary diagnosis of Chronic obstructive pulmonary disease (COPD) associated with >10 pack years smoking history
• Unstable co-morbidities (e.g. cardiovascular disease, active malignancy) which in the opinion of the investigator would make participation in the trial not in the participant’s best interest
• Active tuberculosis or nontuberculous mycobacterial infection (currently under treatment, or requiring treatment in the opinion of the investigator)
• Glomerular filtration rate (eGFR) below 25ml/min/1.73m2 or requiring dialysis. This will be determined at screening
• Women of child baring age or male partners of women of child baring age and not practicing a method of acceptable birth control
• Participants with a primary diagnosis of asthma or asthma which is considered to be poorly controlled at screening
• Participants with FEV1 <25% predicted value at screening
• Pregnant or lactating females
• Known clinical diagnosis of Cystic fibrosis
• Immunodeficiency requiring replacement immunoglobulin
• Receipt of antipseudomonal antibiotics for an exacerbation during the screening period