GRemubamab ErAdication Trial (GREAT-2)
- Conditions
- bronchiectasis and chronic Pseudomonas aeruginosa infectionMedDRA version: 23.0Level: LLTClassification code: 10083611Term: Non-cystic fibrosis bronchiectasis Class: 10038738MedDRA version: 20.0Level: LLTClassification code: 10045053Term: Tuberculous bronchiectasis tubercle bacilli found (in sputum) by microscopy Class: 10021881Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- CTIS2022-502494-41-00
- Lead Sponsor
- HS Tayside
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 90
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of Gremubamab on P. aeruginosa bacterial burden in sputum at week 12;Secondary Objective: To evaluate the efficacy of Gremubamab on P. aeruginosa bacterial burden in sputum, To determine the persistent effects of Gremubamab on P. aeruginosa bacterial burden following discontinuation of treatment (week 24), To determine if Gremubamab can achieve eradication of P. aeruginosa in some individuals, To determine the effect of Gremubamab on health-related quality of life, To determine the effect of Gremubamab on time to first exacerbation, To determine the effect of Gremubamab on pulmonary function, To assess the safety of Gremubamab in patients with bronchiectasis, To evaluate the PK of Gremubamab;Primary end point(s): Day 84
- Secondary Outcome Measures
Name Time Method Secondary end point(s):From Baseline to; Days 7, 14, 28 and 56;Secondary end point(s):From Baseline to; Day 168;Secondary end point(s):From Baseline to; Days 84 and 168;Secondary end point(s):From Baseline to; Days 28, 56, 84 and 168;Secondary end point(s):From Baseline to; First event from visit 1 to day 84;Secondary end point(s):From Baseline to; Day 28, 56 and 84;Secondary end point(s):From Baseline to; Over 168 days;Secondary end point(s):From Baseline to; Over 168 days