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
AstraZeneca · NCT07088926
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 12+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 2
- Target enrollment
- 435
- US sites recruiting
- 16
- Study start
- November 6, 2025
- Record last updated
- October 2, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
AZD0292 is a bispecific IgG1k mAb being evaluated for the prevention of exacerbations in bronchiectasis patients chronically colonized with PsA.
Being studied: AZD0292; Placebo
Conditions: Bronchiectasis With Pseudomonas Aeruginosa Colonization
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- 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.
- 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
- Participants who are clinically stable and free from an exacerbation of bronchiectasis for 4 weeks prior to randomization
- 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
- 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.
- 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
- Primary lung diagnosis other than bronchiectasis
- 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
- 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
- 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
- AIDS or Advanced human immunodeficiency virus disease (CD4 count of \< 200 cells/mm3)
- 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
- Treatment with long term anti-PsA antibiotics, macrolides, or DPP-1 inhibitors, which are newly initiated within the 3 months prior to screening
- Chronic immunosuppressive therapy (including prednisolone > 5 mg or equivalent) newly initiated within the last 3 months
- Receipt of investigational products indicated for the treatment or prevention of bronchiectasis exacerbations or expected receipt during the study
- Participants with CF on CFTR modulator therapies which are newly initiated within the previous 3 months prior to screening
- 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
Recruiting US locations
Research Site
Orange, CA 92868
Research Site
San Francisco, CA 94143
Research Site
Washington D.C., DC 20007
Research Site
Jacksonville, FL 32209
Research Site
Naples, FL 34102
Research Site
Ormond Beach, FL 32174
Research Site
Plantation, FL 33324
Research Site
Rincon, GA 31326
Research Site
Kansas City, KS 66160
Research Site
Ann Arbor, MI 48109
Research Site
St Louis, MO 63130
Research Site
New York, NY 10016
Research Site
New Bern, NC 28562
Research Site
Philadelphia, PA 19104
Research Site
Charleston, SC 29425
Research Site
Mansfield, TX 76063
Study contacts (from the official record)
- AstraZeneca Clinical Study Information Center · 1-877-240-9479 · information.center@astrazeneca.com