GREAT-2: a trial of gremubamab compared to placebo in participants with bronchiectasis and chronic Pseudomonas aeruginosa infectio

Phase 2

• Conditions: Bronchiectasis; Respiratory

• Registration Number: ISRCTN70034823
• Lead Sponsor: niversity of Dundee

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-05-26
• Last Update Posted: 5 February 2024
• Study Completion: 2024-10-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

1. Age 18 = 86 years
2. Clinical diagnosis of bronchiectasis.
3. Able to and provided informed consent.
4. Previous CT scan of the chest demonstrating bronchiectasis in 1 or more lobes
5. P. aeruginosa in sputum, bronchoalveolar lavage or another airway sample at least once in the 24 months prior to screening.
6. A sputum sample that is culture positive for P. aeruginosa sent at the screening visit and within 35 days of randomization.

Exclusion Criteria

1. Known hypersensitivity to gremubamab or any excipient of the investigational product
2. Known clinical diagnosis of cystic fibrosis
3. Immunodeficiency requiring replacement immunoglobulin.
4. Active tuberculosis or nontuberculous mycobacterial infection (currently under treatment, or requiring treatment in the opinion of the investigator).
5. Active allergic bronchopulmonary aspergillosis (receiving treatment with corticosteroids and/or antifungal medication).
6. Recent significant haemoptysis (a volume requiring clinical intervention, within the previous 4 weeks prior to screening).
7. Treatment with long-term inhaled, systemic or nebulized anti-pseudomonal antibiotics which are newly initiated within the previous 3 months prior to screening.
8. Chronic treatment with cyclical doses of inhaled or nebulized antibiotics e.g. 28 days on and 28 days off at the time of screening.
9. Receipt of antipseudomonal antibiotics for an exacerbation during the screening period.
10. Treatment with immunosuppressives within previous 6 months prior to screening.
11. Participants with a primary diagnosis of COPD associated with >10 pack years smoking history.
12. Participants with a primary diagnosis of asthma or asthma which is considered to be poorly controlled at screening.
13. Participants with FEV1 <25% predicted value at screening.
14. Glomerular filtration rate (eGFR) below 25 ml/min/1.73m² or requiring dialysis. This will be determined at screening.
15. Use of any investigational drugs within five times of the elimination half-life after the last dose or within 30 days, whichever is longer.
16. 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.
17. Pregnant or lactating females.
18. Women of child baring age or male partners of women of childbearing age and not practicing a method of acceptable birth control

Study & Design

• Study Type: Interventional
• Study Design: Not specified