GB43311 - Efficacy and Safety of Astegolimab in Patients with COPD
Research type
Research Study
Full title
A PHASE IIb, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ASTEGOLIMAB IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE
IRAS ID
1004092
Contact name
Eric Olson
Contact email
Sponsor organisation
Genentech, Inc.
Eudract number
2021-002045-15
Clinicaltrials.gov Identifier
Research summary
COPD is a lung condition caused by inflammation of the airways and damage to air sacs in the lungs. In COPD the airways become inflamed, narrowed & produce more mucus, making breathing harder. People with COPD have flare-ups of these symptoms. During a flare-up, people experience worsening breathlessness, increased phlegm &/or change in colour of phlegm. An increase in the number of flare-ups is linked with decline in lung function, it becomes more difficult to breathe with quality of life reduced.
The study drug, Astegolimab, is a human antibody that blocks the function of a protein called ST2. Normally, ST2 works in the immune system to trigger inflammation. With the action of ST2 reduced, it is thought that astegolimab will help people with COPD as it should reduce inflammation of lung cells and therefore should reduce the number of flare-ups they experience.
The study will look at how well astegolimab works, safety and how the drug effects the body in patients with COPD who are former or current smokers and have a history of frequent flare-ups.
The study has 3 treatment groups & patients will be randomised into one of the groups to receive either study drug (two different doses) or placebo by injection.
After screening, patients will receive treatment for up to 52 weeks followed by a safety 12-week follow-up after their last treatment. After this study there might be an opportunity for patients to continue taking astegolimab in an extension study. Patients will have tests for lung function, blood samples, physical examinations, ECG (electrocardiogram) & questionnaires.
The study will recruit approximately 930 patients globally from about 240 study sites. Approximately 28 patients will be recruited from 7 UK study sites.REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
21/YH/0246
Date of REC Opinion
30 Nov 2021
REC opinion
Further Information Favourable Opinion