GRemubamab ErAdication Trial (GREAT-2)
Research type
Research Study
Full title
GRemubamab ErAdication Trial (GREAT-2) A phase 2 trial of Gremubamab compared to placebo in participants with bronchiectasis and chronic Pseudomonas aeruginosa infection
IRAS ID
1005993
Contact name
James Chalmers
Contact email
Sponsor organisation
University of Dundee
Eudract number
2022-003215-28
ISRCTN Number
ISRCTN70034823
Research summary
Patients with bronchiectasis often get chest infections which are difficult to treat causing coughing, sputum (phlegm) production, breathlessness and tiredness. Approximately one third of people with bronchiectasis become infected with a bacteria called Pseudomonas aeruginosa (P. aeruginosa). P. aeruginosa can often become resistant to antibiotics. The purpose of this trial is to test whether an intravenous infusion (drip) containing a new drug called Gremubamab can reduce the amount of infection with P. aeruginosa.
The purpose of this trial is to test whether a new drug called Gremubamab, given intravenously, can reduce the amount of infection with P. aeruginosa in people with bronchiectasis. Whether Gremubamab can help reduce the number of bronchiectasis exacerbations and improves quality of life will also be examined. The safety of Gremubamab use in people with bronchiectasis will be assessed.
Gremubanab is a type of drug called a monoclonal antibody which is expected to work with the immune system to eliminate the P. aeruginosa infection.
Gremubamab is a new medication which is being developed by AstraZeneca. It has been used in a few trials already, in healthy people (Phase I trial) and people who were on a ventilator in intensive care and developed pneumonia (Phase II trial). Phase I trials look at the safety of new drugs and phase II trials look at how effective new drugs are as well as their safety. This trial is a phase II trial which will look at the safety and effectiveness of Gremubamab in people with bronchiectasis.
A total of 90 people in the UK and Spain will be enrolled.
The health of participants treated with Gremubamab will be compared with the health of participants given a placebo. The effects of two different doses will also be compared.
Participant will be in the trial for 6 months and will receive infusions of the gremubamab/placebo at monthly intervals for the first 3 months. The trial is expected to run for a total of 18 months.REC name
East of Scotland Research Ethics Service REC 2
REC reference
22/ES/0051
Date of REC Opinion
11 May 2023
REC opinion
Further Information Favourable Opinion