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GRemubamab ErAdication Trial (GREAT-2)
EU CTIS ID: 2022-502494-41-00
What this study is testing
To evaluate the efficacy of Gremubamab on P. aeruginosa bacterial burden in sputum at week 12
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
- P. 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
You likely can't join if
- Known hypersensitivity to Gremubamab or any excipient of the investigational product
- Treatment with immunosuppressives within previous 6 months prior to screening.
- Participants with a primary diagnosis of Chronic obstructive pulmonary disease (COPD) associated with >10 pack years smoking history
- 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
- Glomerular filtration rate (eGFR) below 25ml/min/1.73m2 or requiring dialysis. This will be determined at screening
See the full eligibility criteria
- 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
- P. 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
- Known hypersensitivity to Gremubamab or any excipient of the investigational product
- Treatment with immunosuppressives within previous 6 months prior to screening.
- Participants with a primary diagnosis of Chronic obstructive pulmonary disease (COPD) associated with >10 pack years smoking history
- 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
- Glomerular filtration rate (eGFR) below 25ml/min/1.73m2 or requiring dialysis. This will be determined at 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.
- 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.
- Pregnant or lactating females.
- Women of child baring age or male partners of women of child baring age and not practicing a method of acceptable birth control
- Known clinical diagnosis of Cystic fibrosis
- Immunodeficiency requiring replacement immunoglobulin.
- Active tuberculosis or nontuberculous mycobacterial infection (currently under treatment, or requiring treatment in the opinion of the investigator).
- 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
- Receipt of antipseudomonal antibiotics for an exacerbation during the screening period
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.