AZD0292 for Bronchiectasis
(CLEAR Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment, AZD0292 (an experimental drug), to help prevent flare-ups in people with bronchiectasis—a lung condition causing persistent cough and mucus build-up—who have a history of frequent exacerbations. The study compares low-dose and high-dose AZD0292 against a placebo to determine which works best. Individuals diagnosed with bronchiectasis and who have experienced at least two moderate or one severe exacerbation requiring antibiotics in the past year might be suitable for this trial. Participants must also have recently tested positive for PsA (a type of bacteria) in their airways.
As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people, offering participants a chance to contribute to significant advancements in bronchiectasis treatment.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop your current medications, but it does mention that certain treatments newly started within the last 3 months may exclude you from participating. It's best to discuss your current medications with the trial team to see if they affect your eligibility.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that AZD0292 has been tested in people before. An earlier study demonstrated that it helped reduce the amount of bacteria, indicating its potential effectiveness. Safety information from past trials suggests that most people tolerate AZD0292 well, though some may experience mild side effects.
This trial is in a middle stage, meaning the treatment has already passed initial safety tests. However, detailed information on serious side effects from earlier trials remains limited. At this stage, the treatment is being tested to further confirm its safety and effectiveness. Participation in the study helps researchers learn more about how well people tolerate AZD0292.12345Why do researchers think this study treatment might be promising for bronchiectasis?
Most treatments for bronchiectasis, like antibiotics and airway clearance techniques, focus on managing symptoms and preventing infections. But AZD0292 works differently by targeting underlying inflammation, which is a key factor in disease progression. Researchers are excited about AZD0292 because it offers a new approach by potentially reducing inflammation directly, which could improve lung function and quality of life for patients. This new mechanism of action distinguishes it from traditional therapies and provides hope for more effective management of bronchiectasis in the future.
What evidence suggests that AZD0292 could be an effective treatment for bronchiectasis?
Research has shown that AZD0292, an antibody treatment, might help reduce flare-ups in people with bronchiectasis caused by Pseudomonas aeruginosa (PsA) infections. In another study, patients with bronchiectasis and chronic PsA infections who received a similar antibody, Gremubamab, experienced a significant decrease in bacteria compared to those given a placebo. This finding suggests that AZD0292 could also reduce the bacteria causing these lung issues. The treatment aims to prevent flare-ups of this lung condition, providing significant relief for patients. These early results are promising and support further research into its effectiveness.12346
Are You a Good Fit for This Trial?
This trial is for people aged 12 and older, weighing at least 35 kg, with bronchiectasis confirmed by CT scan. They must have had a history of exacerbations treated with antibiotics and show chronic colonization by Pseudomonas Aeruginosa in their lungs. Participants should be stable without recent flare-ups.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either low-dose or high-dose AZD0292 or placebo administered IV starting on Day 1, with subsequent administrations per schedule of assessments
Follow-up
Participants are monitored for safety and effectiveness after treatment, including the occurrence of AEs, SAEs, AESIs, and MAAEs
What Are the Treatments Tested in This Trial?
Interventions
- AZD0292
Find a Clinic Near You
Who Is Running the Clinical Trial?
AstraZeneca
Lead Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology