Recruiting
Phase 2

AZD0292

Sponsor:

AstraZeneca

Code:

NCT07088926

Conditions

Bronchiectasis With Pseudomonas Aeruginosa Colonization

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

Interventions

AZD0292

Placebo

Study Details

Brief summary:

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

Conditions

Bronchiectasis With Pseudomonas Aeruginosa Colonization

Study ID

NCT07088926

Start date

Nov 6, 2025

Status verified date

Aug, 2026

Completion date

Jun 14, 2028

Anticipated

Primary completion date

Dec 9, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

435 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: High-dose

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

experimental: Low-dose

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

placebo comparator: Placebo

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

Interventions

AZD0292

AZD0292 high-dose or low-dose administered starting on Day 1 via IV infusion, subsequent administrations per schedule of assessments.

Placebo

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

Primary outcome measure

  • Annualized rate of exacerbations over a variable follow-up time [ Time Frame: Min 28 weeks, max 52 weeks ]

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479information.center@astrazeneca.com

Locations

Research Site

Recruiting

Orange, California, United States, 92868

Research Site

Recruiting

San Francisco, California, United States, 94143

Research Site

Recruiting

Washington D.C., District of Columbia, United States, 20007

Research Site

Recruiting

Jacksonville, Florida, United States, 32209

Research Site

Recruiting

Naples, Florida, United States, 34102

Research Site

Recruiting

Ormond Beach, Florida, United States, 32174

Research Site

Recruiting

Plantation, Florida, United States, 33324

Research Site

Recruiting

Rincon, Georgia, United States, 31326

Research Site

Recruiting

Kansas City, Kansas, United States, 66160

Research Site

Recruiting

Ann Arbor, Michigan, United States, 48109

Research Site

Recruiting

St Louis, Missouri, United States, 63130

Research Site

Recruiting

New York, New York, United States, 10016

Research Site

Recruiting

New Bern, North Carolina, United States, 28562

Research Site

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Research Site

Recruiting

Charleston, South Carolina, United States, 29425

Research Site

Recruiting

Rock Hill, South Carolina, United States, 29732

Research Site

Recruiting

Mansfield, Texas, United States, 76063

Research Site

Recruiting

Calgary, Alberta, Canada, T2N4Z6

Research Site

Recruiting

Vancouver, British Columbia, Canada, V5Z 1M9

Research Site

Recruiting

Ajax, Ontario, Canada, L1S 2J5

Research Site

Recruiting

Stoney Creek, Ontario, Canada, L8G 2V6

Research Site

Recruiting

Québec, Quebec, Canada, G1V 4G5

Research Site

Recruiting

Saint-Charles-Borromée, Quebec, Canada, J6E 2B4

More Information

Sponsor

AstraZeneca

Last update posted

Aug 18, 2026

Last verified

Aug, 2026

Keywords

  • Bronchiectasis Chronic Pseudomonas Aeruginosa Colonization

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-08-18.