IMAGINE
Research type
Research Study
Full title
The IMAGINE study: A phase 3b open label, single arm study to assess the effect of depemokimab on airway structure and function in asthma with Type 2 inflammation characterized by an eosinophilic phenotype utilizing quantitative high-resolution CT and bronchoscopic airway sampling in a sub-study
IRAS ID
1012233
Contact name
Osi Ozuzu
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Limited
Eudract number
2024-519976-19
Clinicaltrials.gov Identifier
Research summary
This is a phase 3b study in adult patients with asthma and patients who have a history of asthma worsening for which they were prescribed steroid tablets.
This study is being conducted to test if the study drug, depemokimab, improves lung structure and how well the lungs work in patients with asthma. In particular, this study will see if the study drug can reduce mucus plugs in the lungs (mucus plugs block the airways and make it harder to breathe) and improve structural scar changes in the airways caused by inflammation and repeated asthma attacks which will be assessed using CT scans.
The study also has a bronchoscopy sub-study.
Study participants will be required to undergo certain assessments at the screening, treatment, and follow-up visits.
Blood samples will be taken 7 times during the study. In addition, repeat or unplanned samples may need to be taken for safety reasons or for technical issues with the samples.
Approximately 103 people will take part in this study. The study will last for 65 weeks for each participant. The study will include a period of up to 4 weeks where participants will be screened to check if they are eligible to participate in this study, and 52 weeks treatment period during which they will have to attend 6 visits at the study center. Study participants will receive the study drug at Visit 1 (Week 0) and Visit 4 (Week 26).
The end of study visit will be Visit 6 (Week 52). There will be a safety follow up to monitor any side effects approximately 9 weeks after Visit 6. Women who can get pregnant should continue to use adequate birth control until the follow up visit or until 35 weeks after the last dose of depemokimab, whichever is later.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
25/SC/0256
Date of REC Opinion
30 Sep 2025
REC opinion
Further Information Favourable Opinion