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CLEARBronchiectasis and Pseudomonas Aeruginosa Colonization Prevention Study for AZD0292 in Participants 12 and Older

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Study Aim

This study aims to prevent bronchiectasis and Pseudomonas aeruginosa colonization in individuals aged 12 and above using AZD0292. It will assess how many moderate-to-severe lung exacerbations occur with AZD0292 compared to a placebo.

What is being tested

AZD0292

+ Placebo

BiologicalOther
Who is being recruted

Over 12 Years
+21 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Placebo-ControlledPhase 2
Interventional
Study Start: November 2025
See protocol details

Summary

Principal SponsorAstraZeneca
Study ContactAstraZeneca Clinical Study Information Center
Last updated: December 19, 2025
Sourced from a government-validated database.Claim as a partner

Study start date: November 6, 2025

Actual date on which the first participant was enrolled.

This clinical trial is focused on testing a new treatment, AZD0292, for people aged 12 and older who have a lung condition called bronchiectasis and are chronically affected by a bacteria known as Pseudomonas aeruginosa. This bacteria can cause frequent worsening of lung symptoms, which can lead to a decline in lung health, impact daily life, and increase the risk of serious health issues. The study is important because it seeks to find an effective way to prevent these worsening episodes, which could significantly improve the lives of those living with this condition. Additionally, the treatment is also being explored in patients with cystic fibrosis who have similar bacterial colonization. In the study, participants will receive AZD0292 through an intravenous (IV) infusion, which means the medicine is delivered directly into the bloodstream. The study will compare the effects of AZD0292 given in two different doses to a placebo, which is a substance with no active medication. Researchers will look at how well the treatment works, its safety, and how the body processes the drug. While the study will primarily focus on patients with non-cystic fibrosis bronchiectasis, it will also include patients with cystic fibrosis as an exploratory group to understand the potential wider application of the treatment.

Official TitleA 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 
NCT07088926
Principal SponsorAstraZeneca
Study ContactAstraZeneca Clinical Study Information Center
Last updated: December 19, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

435 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 12 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

9 inclusion criteria required to participate
Participant must be ≥ 12 years of age at the time of signing the informed consent/assent

Weight ≥ 35 kg

Bronchiectasis diagnosed by a physician and confirmed by CT demonstrating abnormal bronchial dilation in ≥ 1 lobe. Note: A historical CT scan within the past 5 years is acceptable. If not available, a CT scan should be conducted at screening to confirm eligibility.

Documented history of ≥ 2 moderate exacerbations or ≥ 1 severe exacerbation in the preceding 12 months requiring antibiotics

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12 exclusion criteria prevent from participating
Evidence of active tuberculosis or active nontuberculous mycobacteria being treated or requiring treatment. Participants currently receiving treatment for active TB or nontuberculous mycobacteria may be considered after completion of an appropriate course of therapy

Primary lung diagnosis other than bronchiectasis

Evidence of an active allergic bronchopulmonary aspergillosis being treated or requiring treatment

Need for long term supplemental oxygen. Oxygen use for ambulation and relief of breathlessness after exercise is allowed

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
High-Dose AZD0292 administered starting on Day 1, subsequent administrations per schedule of assessments.

Group II

Experimental
Low-dose AZD0292 administered starting on Day 1, subsequent administrations per schedule of assessments.

Group III

Placebo
Placebo administered starting on Day 1, subsequent administrations per schedule of assessments.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 161 locations

Recruiting

Research Site

Miami Lakes, United StatesSee the location
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Research Site

Plantation, United States
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Research Site

Rincon, United States
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Research Site

Rock Hill, United States
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161 Study Centers