VIGILANT
Research type
Research Study
Full title
A multicenter, randomized, double-blind, parallel group, placebo-controlled study of the efficacy and safety of early depemokimab initiation as add-on treatment in COPD patients with Type 2 inflammation.
IRAS ID
1013067
Contact name
Derek Moriarty
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Ltd
Clinicaltrials.gov Identifier
Research summary
Chronic Obstructive Pulmonary Disease (COPD) is a long-term medical condition that makes breathing difficult. It can cause symptoms such as frequent coughing, shortness of breath, and a feeling of tightness in the chest due to the build-up of sticky fluid in the lungs. In some cases, COPD involves a type of lung irritation, called inflammation, with high levels of certain white blood cells called eosinophils. This type of inflammation has been shown to respond to treatments that specifically target it.
This study is testing a medicine called depemokimab, which aims to reduce inflammation and help prevent symptoms from worsening, alongside regular COPD treatments. Depemokimab is an injectable medicine that is being developed as a COPD treatment.
This study will assess how safe depemokimab is and how well it works as an additional medicine given to people with COPD who are at risk for future exacerbations despite their regular COPD treatment.
This is a “double-blind” study, meaning neither the participants nor the study doctor will be aware who is getting depemokimab and who is getting the placebo, during the study duration. Participants will either receive depemokimab or placebo during the study duration.
The study will include three main phases – the screening phase, treatment phase and follow-up phase.
• Screening phase: This part will check if participants could join the study by assessing their medical history and blood test results.
• Treatment phase: Participants who qualify will receive the medicine or placebo alongside their regular COPD medications. The treatment period will last from one year up to three years.
• Follow-up phase: After completing the treatment phase, participants will be monitored to see how they’re doing.
Additionally, some participants might be asked to have lung scans to help researchers further understand how the medicine affects their lungs.REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
26/NE/0017
Date of REC Opinion
19 Feb 2026
REC opinion
Further Information Favourable Opinion