GRemubamab ErAdication Trial (GREAT-2)
A legfontosabb adatok
- Fázis
- 2. fázis
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A vizsgálat adatai
- Ki végzi
- NHS Tayside
- Azonosító
- EU 2022-502494-41-00
- A regiszteradat frissítve
- 2024. augusztus 12.
- Eredeti leírás
To evaluate the efficacy of Gremubamab on P. aeruginosa bacterial burden in sputum at week 12A teljes eredeti leírásKevesebb
A phase 2 trial of Gremubamab compared to placebo in participants with bronchiectasis and chronic Pseudomonas aeruginosa infection
To evaluate the efficacy of Gremubamab on P. aeruginosa bacterial burden in sputum at week 12
Bevonási feltételek: 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.
Kizáró feltételek: 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.