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Looking for participantsPhase2

A Study to Evaluate the Efficacy, Safety, and PK of AZD0292 Administered IV in Participants 12 Years of Age and Older With Bronchiectasis and Chronic Pseudomonas Aeruginosa Colonization

Sponsor: AstraZeneca

NCT ID: NCT07088926

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
AZD0292 (biological), Placebo (other)
How long the study runs
Study runs about 31 months (dates as stated)
About the drug or intervention
AZD0292 — biological: AZD0292 high-dose or low-dose administered starting on Day 1 via IV infusion, subsequent administrations per schedule of assessments. · Placebo — other: Placebo administered starting on Day 1 via IV infusion, subsequent administrations per schedule of assessments.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
12 Years and over
Who
All
Number of participants
435
Started
2025-11-06
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for bronchiectasis with pseudomonas aeruginosa colonization
  • • Phase2 - 435 participants
  • • AZD0292 is a bispecific IgG1k mAb being evaluated for the prevention of exacerbations in bronchiectasis patients chronically colonized with PsA

Who can take part?

  • • Ages 12 Years and over
  • • Diagnosed with bronchiectasis with pseudomonas aeruginosa colonization

Where?

  • • Belfast - Research Site
  • • Birmingham - Research Site
  • • Brighton - Research Site
  • • Cambridge - Research Site
  • • +5 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

AZD0292 is a bispecific IgG1k mAb being evaluated for the prevention of exacerbations in bronchiectasis patients chronically colonized with PsA.

More detail

AZD0292 is a bispecific IgG1k mAb being evaluated for the prevention of exacerbations in bronchiectasis patients chronically colonized with PsA. This Phase IIb study aims to assess the efficacy, safety, and PK of 2 dosage regimens of AZD0292 administered IV, as compared to placebo in participants 12 years of age and older. The primary population of this study will be PsA-colonized NCFBE patients, a bronchiectasis group with frequent pulmonary exacerbations due to chronic PsA airway colonization. These PsA associated pulmonary exacerbations contribute to a decline in lung function, impair quality of life and increase mortality, highlighting the urgent need for effective therapeutic options. To investigate the broader applicability of AZD0292, bronchiectasis patients with CF who are colonized with PsA will be also included as a non-powered exploratory group in this Phase IIb study.

Bronchiectasis With Pseudomonas Aeruginosa Colonization

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 12 Years and over
  • Who can join: All genders

Biomarkers mentioned

PsAPresence of positiveculture positiveCD4

What the study is looking for

  • ✓Participant must be ≥ 12 years of age at the time of signing the agreement to take part/assent
  • ✓Weight ≥ 35 kg
  • ✓Participants who are clinically stable and free from an exacerbation of bronchiectasis for 4 weeks prior to...
  • ✓Participants with pre- or post-bronchodilator FEV1 ≥ 25% predicted value at screening.
  • ✓Presence of positive (PCR or culture) PsA in an airway sample at least once in the last 24 months prior to screening

Who cannot take part

  • ✗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
  • ✗AIDS or Advanced human immunodeficiency virus disease (CD4 count of \< 200 cells/mm3)
  • ✗Treatment with long term anti-PsA antibiotics, macrolides, or DPP-1 inhibitors, which are newly initiated within the...
See the full 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. Participants who experience an exacerbation during the screening period and receive antibiotic therapy remain eligible for the study if the presence of culture-positive PsA is confirmed prior to randomization. 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 tuberculosis 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 Is This Study? (9 UK sites)

Research Site

Belfast BT9 7AB, United Kingdom

Recruiting

Research Site

Birmingham B9 5SS, United Kingdom

Recruiting

Research Site

Brighton BN2 1ES, United Kingdom

Recruiting

Research Site

Cambridge CB2 0AY, United Kingdom

Recruiting

Research Site

Dundee DD1 9SY, United Kingdom

Recruiting

Research Site

Edinburgh EH16 4SA, United Kingdom

Recruiting

Research Site

Exeter EX2 5DW, United Kingdom

Recruiting

Research Site

Liverpool L14 3PE, United Kingdom

Recruiting

Research Site

Manchester M23 9LT, United Kingdom

Recruiting

How to Get in Touch

AstraZeneca Clinical Study Information Center

Sponsor contact

CONTACT

1-877-240-9479 information.center@astrazeneca.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09