CLEAR

• Research type

  Research Study

• Full title

  A Phase IIb Randomized, Double-blind, Placebo-controlled, Parallel, Multidose Study to Evaluate the Efficacy, Safety, and PK of AZD0292 in Participants 12 years of Age and Older With Bronchiectasis and Chronic Pseudomonas aeruginosa Colonization

• IRAS ID

  1012627

• Contact name

  Manika Azad

• Contact email

  UKRegulatoryAffairs@astrazeneca.com

• Sponsor organisation

  AstraZeneca AB

• Research summary

  Bronchiectasis is a condition where the airways of the lungs widen and become unable to remove mucus properly. The build up of mucus leads to exacerbations where people experience frequent coughing, spitting up mucus, and lung infections.
  Pseudomonas aeruginosa (PsA) is a type of bacteria that can cause infections in the lungs. When someone has chronic PsA colonization, it means the bacteria stays in their body for a long time, giving them frequent infections. The trial drug AZD0292 is designed to help the body’s immune system recognize and destroy PsA. Researchers believe AZD0292 could help reduce exacerbations in people who have bronchiectasis and chronic PsA colonization.
  In this trial, researchers want to learn how well AZD0292 works, how safe it is, and how it moves throughout the body over time in people with bronchiectasis and chronic PsA colonization.
  This is a Phase 2b, randomized, double-blind, placebo-controlled trial. Randomized means that a computer program will randomly assign the treatment each participant receives. Double-blind means none of the participants, researchers, trial doctors, or other trial staff will know what treatment each participant receives. Placebo-controlled means that some participants will receive a placebo. The placebo in this trial looks like AZD0292 but does not have any AZD0292 in it. Participants will be in the trial for up to 1 year and 6 months. AZD0292 is given through a needle directly into a vein over a period of time (IV infusion).
  This trial will include up to about 435 participants in total, including about 375 participants with NCFB and 60 participants with CFB. To join this trial, people must be at least 12 years old and have bronchiectasis and chronic PsA colonization. Participants must have a history of moderate or severe exacerbations in the past year.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  25/LO/0526

• Date of REC Opinion

  13 Oct 2025

• REC opinion

  Further Information Favourable Opinion