ARTEMISIA
Research type
Research Study
Full title
A Randomised, Double-blind, Parallel Group, Placebo Controlled, 4-Week, Phase II Study to Evaluate the Effect of AZD4604 on Airway Inflammation and Biomarkers in Adults with Asthma
IRAS ID
1009687
Contact name
Emma Greening
Contact email
Sponsor organisation
AstraZeneca AB
Research summary
The trial drug, AZD4604, is taken through an inhaler. There are other asthma treatments taken through inhalers that are currently available, but these may not work well enough for everyone or may cause too many medical problems. AZD4604 is designed to work differently than currently available inhaled asthma treatments, by blocking a type of protein that increases inflammation called Janus kinase (JAK) 1.
It is hoped that taking AZD4604 will reduce asthma attacks, reduce hospitalisations from asthma attacks, and improve asthma symptoms, lung function, and quality of life. It is not yet known whether these benefits exist, and they are not guaranteed.
There are oral tablet or capsule treatments that also block JAKs. They are used to treat inflammatory conditions other than asthma. These treatments may not work well enough for people with asthma or be as safe as inhaled treatments because oral medications can affect the whole body. Because AZD4604 is inhaled, it specifically targets the airways. So, researchers think AZD4604 could help people with asthma that is not controlled well enough by currently available inhaled treatments.
This is a Phase 2, randomised, double-blind, placebo-controlled trial. Randomised means that the treatment each participant takes will be randomly assigned by a computer program. Double-blind means none of the participants, researchers, trial doctors, or other trial staff will know what treatment each participant takes. Placebo-controlled means that some participants will take a placebo. The placebo in this trial looks like AZD4604 but does not have any AZD4604 in it.
The aim of this study is to understand how AZD4604 affects the airways of people with asthma. Participants will be in this trial for up to about 10 weeks. This trial will include about 48 participants.REC name
London - London Bridge Research Ethics Committee
REC reference
24/LO/0168
Date of REC Opinion
22 May 2024
REC opinion
Further Information Favourable Opinion