GB44332 Phase 3 study to evaluate the efficacy and safety of Astegolimab in patients with COPD
Research type
Research Study
Full title
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Astegolimab in Patients with Chronic Obstructive Pulmonary Disease
IRAS ID
1007075
Contact name
Head of CTRM Clinical Trial Regulatory Management, Product Development Regulatory
Contact email
Sponsor organisation
F. Hoffmann-La Roche AG
Eudract number
2022-002705-23
Clinicaltrials.gov Identifier
Research summary
This is a Phase III, randomised, double-blind, placebo-controlled clinical trial with the purpose of testing the safety and efficacy of a study drug called Astegolimab to find out what effects, good or bad, it has on study participants and their Chronic Obstructive Pulmunary Disease (COPD).
This research study is sponsored by F. Hoffmann-La Roche Ltd., who will be responsible for funding the study and for covering the cost of all study procedures.
The study drug being tested is called astegolimab. This is an experimental drug, which means health authorities, such as the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom, have not approved astegolimab for the treatment of any diseases. Astegolimab is a monoclonal antibody that blocks activities of interleukin-33 (IL-33), a protein that is released from airway cells in response to viral infections, allergens, irritants, and other triggers of COPD exacerbations.
Approximately 40 participants will take part in the study in the United Kingdom and 1290 worldwide.REC name
North West - Haydock Research Ethics Committee
REC reference
23/NW/0102
Date of REC Opinion
18 Aug 2023
REC opinion
Further Information Favourable Opinion