GREAT-2: a trial of gremubamab compared to placebo in participants with bronchiectasis and chronic Pseudomonas aeruginosa infection
GREAT-2 is a randomised, double-blind, placebo-controlled clinical trial testing Gremubamab – an intravenous anti-pseudomonal bispecific monoclonal antibody drug – in patients with bronchiectasis chronically infected with P. aeruginosa. The study was run from University of Dundee. Participants were randomised using a GCP-compliant Interactive Web-based Randomisation System to one of three treatment arms. Randomisation were stratified by inhaled antibiotic use. Depending on randomisation participants received either gremubamab 1500 mg per dose, gremubamab 500 mg per dose or placebo. Participants received trial treatment via intravenous infusion every 4 weeks a total of three times. Participants were assessed during the treatment period (3 months) and for a 3-month period following completion of trial treatment. Inclusion criteria included a previous CT scan of the chest demonstrating bronchiectasis in 1 or more lobes and  a sputum sample that is culture or PCR positive for P. aeruginosa. Primary outcome was efficacy of gremubamab on P. aeruginosa bacterial burden in sputum measured by change from baseline to Days 7, 14, 28 and 56 in Quantitative sputum cultures. Study was registered with ISRCTN (ISRCTN70034823).
GREAT-2 is a randomised, double-blind, placebo-controlled clinical trial testing Gremubamab – an intravenous anti-pseudomonal bispecific monoclonal antibody drug – in patients with bronchiectasis chronically infected with P. aeruginosa. The study was run from University of Dundee. Participants were randomised using a GCP-compliant Interactive Web-based Randomisation System to one of three treatment arms. Randomisation were stratified by inhaled antibiotic use. Depending on randomisation participants received either gremubamab 1500 mg per dose, gremubamab 500 mg per dose or placebo. Participants received trial treatment via intravenous infusion every 4 weeks a total of three times. Participants were assessed during the treatment period (3 months) and for a 3-month period following completion of trial treatment. Inclusion criteria included a previous CT scan of the chest demonstrating bronchiectasis in 1 or more lobes and  a sputum sample that is culture or PCR positive for P. aeruginosa. Primary outcome was efficacy of gremubamab on P. aeruginosa bacterial burden in sputum measured by change from baseline to Days 7, 14, 28 and 56 in Quantitative sputum cultures. Study was registered with ISRCTN (ISRCTN70034823).
respiratory research group, university of dundee