EMBARK
Research type
Research Study
Full title
A Randomised, Double-blind, Placebo-controlled, Parallel Group, Multicentre, Phase III Study to Evaluate the Efficacy and Safety of Tezepelumab in Adult Participants with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (EMBARK)
IRAS ID
1011373
Contact name
Manika Azad
Contact email
Sponsor organisation
AstraZeneca AB
Research summary
This is a clinical trial funded by AstraZeneca to assess the efficacy (whether it works) and safety of an investigational drug called tezepelumab for the treatment of chronic obstructive pulmonary disease (COPD). Researchers think that tezepelumab could help to reduce the number of exacerbations in people with COPD compared to a placebo (looks like tezepelumab but contains no medication). Exacerbations, which are periods of worsening symptoms, requiring treatment with steroids and/or antibiotics, and they can lead to hospitalisation. It is not certain that participants will directly benefit from the participation in the study. All participants will help researchers learn more about tezepelumab and treating COPD.
The study lasts for up to 98 weeks (almost 2 years) across three stages: screening (to assess suitability for the study), treatment (up to 76 weeks, visits every 4 weeks) and follow-up. This is a global trial and will include about 990 participants. To join this trial, people must be 40 to 80 years of age, have COPD, be current or former smoker, and must have had COPD exacerbations in the previous year.
Eligible participants will be randomly assigned and have an equal chance of receiving 1 of 2 different doses of tezepelumab, or the placebo (looks like tezepelumab but contains no medication). 2 injections of Tezepelumab or placebo will be given under the skin. Neither participants nor the study staff assessing them will know whether they have received tezepelumab or placebo. The trial doctor or staff will discuss the possible risks for receiving tezepelumab. The participants will continue taking their regular medication for COPD during the trial.
During the study, participants will undergo various procedures including lung function testing, computer tomography (CT) scan, Electrocardiogram (ECG), blood and urine samples will be taken. Participants will also complete various questionnaires about their symptoms and medication usage.REC name
London - City & East Research Ethics Committee
REC reference
25/LO/0116
Date of REC Opinion
27 Feb 2025
REC opinion
Further Information Favourable Opinion