NCT07774403 A Study of AZD0292 in Chinese Participants With Bronchiectasis and Chronic Pseudomonas Aeruginosa Colonization
| NCT ID | NCT07774403 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | AstraZeneca |
| Condition | Bronchiectasis With Pseudomonas Aeruginosa Colonization |
| Study Type | INTERVENTIONAL |
| Enrollment | 84 participants |
| Start Date | 2026-06-24 |
| Primary Completion | 2028-01-18 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 84 participants in total. It began in 2026-06-24 with a primary completion date of 2028-01-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
AZD0292 is a bispecific IgG1k mAb being evaluated for the prevention of exacerbations in bronchiectasis patients chronically colonized with PsA.
Eligibility Criteria
Inclusion Criteria: * Participant must be ≥ 18 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. * 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 TB 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 * Participation with a study intervention used within the last 30 days or 5 half-lives of the investigational product from the other clinical study, whichever is longer, 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07774403 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Bronchiectasis With Pseudomonas Aeruginosa Colonization. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07774403 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07774403 currently recruiting?
Yes, NCT07774403 is actively recruiting participants. Contact the research team at information.center@astrazeneca.com for enrollment information.
Where is the NCT07774403 trial being conducted?
This trial is being conducted at Anyang, China, Beijing, China, Beijing, China, Beijing, China and 11 additional locations.
Who is sponsoring the NCT07774403 clinical trial?
NCT07774403 is sponsored by AstraZeneca. The trial plans to enroll 84 participants.