GB43374 Ph 3 follow up study of Astegolimab in Patients with Chronic Obstructive Pulmonary Disease
Research type
Research Study
Full title
A Phase III Open-Label Extension Study to evaluate the long-term safety of Astegolimab in patients with chronic obstructive pulmonary disease
IRAS ID
1008083
Contact name
Head of CTRM Clinical Trial Regulatory Management, Product Development Regulatory
Contact email
Sponsor organisation
F. Hoffmann-La Roche AG
Research summary
Chronic obstructive pulmonary disease (COPD) is a group of conditions that affect the lungs. COPD causes symptoms such as breathlessness and cough. Some people experience episodes when their symptoms flare up (known as ‘COPD exacerbations’). Having COPD exacerbations can affect how the lungs work and is linked to a worsening quality of life. Standard of care treatments for COPD include inhalers of corticosteroids (to reduce inflammation) and bronchodilators (to relax lung muscles and widen airways). Better treatments are needed to prevent COPD from getting worse, reduce exacerbations and improve overall health-related quality of life. Astegolimab is a type of drug called a monoclonal antibody that may effectively reduce COPD exacerbations. Astegolimab is an experimental drug, which means health authorities have not approved it for treating COPD. In two previous clinical trials (called ‘parent’ trials or studies), people with COPD were given astegolimab or placebo (a substance with no active ingredients which looked like astegolimab) as a subcutaneous injection.
This clinical trial is called an ‘extension’ trial or study - people who completed one of the parent trials and agree to join the extension trial will be given astegolimab on a long-term basis. About 2000 people will take part in this extension study and it aims to test the long-term safety of astegolimab in combination with standard of care COPD treatment. Participants will be seen by the trial staff every 2 weeks to be given astegolimab treatment (two injections under the skin). Participants will be seen in the clinic about 2 weeks after the final treatment dose and 3 months later for a follow-up visit. The total time of participation in the clinical trial will be up to 4 years, depending on if astegolimab is approved by health authorities for treating COPD in the participants’ country or if the sponsor decides to stop the trial. Participants can stop treatment and leave the clinical trial at any time.REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
23/YH/0135
Date of REC Opinion
31 Aug 2023
REC opinion
Further Information Favourable Opinion