PROSPERO
Research type
Research Study
Full title
A Phase III, Multicentre, Randomised, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled Extension Study to Evaluate the Long-term Efficacy and Safety of Tozorakimab in Participants with Chronic Obstructive Pulmonary Disease (COPD) with a History of Exacerbations(PROSPERO)
IRAS ID
1006811
Contact name
Jay Vora
Contact email
Sponsor organisation
AstraZeneca AB
Research summary
This is a double-blind, placebo-controlled trial for participants with COPD who have already taken part and completed the predecessor study, TITANIA. This study is an extension of the predecessor studies to determine the long-term safety and efficacy of tozorakimab. Participants who meet eligibility criteria will receive tozorakimab or placebo for 1 year. Tozorakimab dosing will be compared to a placebo arm and data from this trial will be combined with data from the predecessor studies to understand if tozorakimab is safe and effective over a 2-year period. Participants with COPD will receive tozorakimab or placebo on top of their standard of care medicine, that they use to treat their COPD. The previous trials enrol former or current smokers with COPD with a history of exacerbations, who are over 40 years old, with impacted lung function, who are receiving COPD maintenance therapy, and without asthma, or any other important lung, heart, infections, or respiratory disease other than COPD. In this trial, there are 3 groups. The first group will receive a 300 mg injection of tozorakimab subcutaneously under the skin every 4 weeks; the second group will receive a 300 mg injection of tozorakimab under the skin every 8 weeks alternating with a placebo injection under the skin every 8 weeks. The third group will receive a placebo injection under the skin every 4 weeks. Participants will continue to receive checks for their physical health and disease progression.
REC name
East of England - Essex Research Ethics Committee
REC reference
23/EE/0010
Date of REC Opinion
22 Aug 2023
REC opinion
Further Information Favourable Opinion