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IV AZD0292 for people 12+ with bronchiectasis and chronic Pseudomonas aeruginosa

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

Phase 2 Interventional AstraZeneca · NCT07088926

This will test whether IV AZD0292 can reduce lung exacerbations in people aged 12 and older who have bronchiectasis with chronic Pseudomonas aeruginosa colonization.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment435 (estimated)
Ages12 Years and up
SexAll
SponsorAstraZeneca Industry-sponsored
Locations183 sites (Orange, California and 182 other locations)
Trial IDNCT07088926 on ClinicalTrials.gov

What this trial studies

This Phase IIb, randomized, placebo-controlled study compares two IV dosing regimens of AZD0292 against placebo to measure effects on pulmonary exacerbations, safety, and drug pharmacokinetics. The primary population is non‑CF bronchiectasis patients chronically colonized with Pseudomonas aeruginosa, with a small exploratory group of people with cystic fibrosis and PsA colonization. Participants must be clinically stable, at least 12 years old, weigh ≥35 kg, have CT-confirmed bronchiectasis and a recent history of exacerbations; they will receive scheduled IV infusions and regular follow-up visits for monitoring. Key outcomes include number and severity of exacerbations, lung function, adverse events, and PK profiles across the dosing regimens.

Who should consider this trial

Good fit: People aged 12 or older with CT-confirmed bronchiectasis, documented Pseudomonas aeruginosa airway colonization, weight ≥35 kg, clinically stable with a history of frequent exacerbations in the past year, and FEV1 ≥25% predicted.

Not a fit: Patients without Pseudomonas aeruginosa colonization, those who are currently experiencing an exacerbation, weigh under 35 kg, or have very low lung function (FEV1 <25%) are unlikely to be eligible or to benefit from this treatment.

Why it matters

Potential benefit: If successful, AZD0292 could lower the number and severity of Pseudomonas-associated exacerbations, helping preserve lung function and improve quality of life for affected patients.

How similar studies have performed: This bispecific antibody approach is relatively novel for PsA-colonized bronchiectasis, while prior antibiotic and antibody strategies targeting Pseudomonas have shown mixed results.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Participant must be ≥ 12 years of age at the time of signing the informed consent/assent
2. Weight ≥ 35 kg
3. 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.
4. Participants who are receiving appropriate standard of care therapy per local guidelines and have a documented history of ≥ 2 moderate exacerbations or ≥ 1 severe exacerbation in the preceding 12 months requiring antibiotics
5. Participants who are clinically stable and free from an exacerbation of bronchiectasis for 4 weeks prior to randomization
6. Participants with pre- or post-bronchodilator FEV1 ≥ 25% predicted value at screening.
7. Presence of positive (PCR or culture) PsA in an airway sample at least once in the last 24 months prior to screening
8. Presence of culture positive PsA in sputum at least within 5 weeks of randomization. Participants who have previously received PsA eradication therapy, as determined appropriate by their treating provider, but remain colonized with PsA are eligible for the study.
9. Capable of giving signed informed consent/assent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol

Exclusion Criteria:

1. Primary lung diagnosis other than bronchiectasis
2. 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
3. Evidence of an active allergic bronchopulmonary aspergillosis being treated or requiring treatment
4. Need for long term supplemental oxygen. Oxygen use for ambulation and relief of breathlessness after exercise is allowed
5. Malignancy, current or within the previous 5 years, except for stable prostate cancer, adequately treated non-invasive basal cell and squamous cell carcinoma of the skin and cervical carcinoma in situ treated with apparent success more than one year prior to enrolment
6. AIDS or Advanced human immunodeficiency virus disease (CD4 count of \< 200 cells/mm3)
7. History of severe adverse reaction associated with a mAb, and/or history of severe allergic reaction (eg, anaphylaxis that required the use of epinephrine/adrenaline or hospitalization), and/or history of immune complex disease (Type III hypersensitivity reactions) to monoclonal antibody administration
8. Treatment with long term anti-PsA antibiotics, macrolides, or DPP-1 inhibitors, which are newly initiated within the 3 months prior to screening
9. Chronic immunosuppressive therapy (including prednisolone \> 5 mg or equivalent) newly initiated within the last 3 months
10. Receipt of investigational products indicated for the treatment or prevention of bronchiectasis exacerbations or expected receipt during the study
11. Participants with CF on CFTR modulator therapies which are newly initiated within the previous 3 months prior to screening
12. Female participants who are pregnant, lactating, or WOCBP and not using a highly effective method of contraception or abstinence from at least 4 weeks prior to study intervention administration and until at least 6 months after study intervention administration

Where this trial is running

Orange, California and 182 other locations

+133 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Bronchiectasis With Pseudomonas Aeruginosa ColonizationBronchiectasis Chronic Pseudomonas Aeruginosa Colonization
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.