AJAX

• Research type

  Research Study

• Full title

  A Phase 2a Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AZD4604 Twice Daily for Twelve Weeks in Adult Patients with Moderate-to-Severe AsthmaUncontrolled on Medium-High Dose ICS-LABA

• IRAS ID

  1008584

• Contact name

  Krishna Varsani

• Contact email

  krishna.varsani@astrazeneca.com

• Sponsor organisation

  AstraZeneca AB

• Eudract number

  2023-506000-50

• Clinicaltrials.gov Identifier

  NCT06020014

• Research summary

  Asthma is a long-term lung condition where inflammation causes the airways to narrow, swell, and create extra mucus.
  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. AZD4604 is designed to work by blocking a type of protein that increases inflammation called Janus kinase (JAK) 1.
  The possible benefits of taking AZD4604 are reduced asthma attacks, reduced hospitalizations from asthma attacks, and improved asthma symptoms, lung function, and quality of life. These benefits 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, randomized, double-blind, placebo-controlled trial. Randomized 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. Participants will be in this trial for up to about 5 months. This trial will include about 320 participants.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  23/LO/0704

• Date of REC Opinion

  12 Dec 2023

• REC opinion

  Further Information Favourable Opinion