A Phase 2 interventional study of AZD0292 and Placebo in Bronchiectasis With Pseudomonas Aeruginosa Colonization, sponsored by AstraZeneca. Recruiting at 186 sites in 25 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by AstraZeneca · Phase 2, Interventional, and Prevention
AZD0292 is a bispecific IgG1k mAb being evaluated for the prevention of exacerbations in bronchiectasis patients chronically colonized with PsA.
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.
Exclusion Criteria:
High-Dose AZD0292 administered starting on Day 1, subsequent administrations per schedule of assessments.
Biological: AZD0292
Low-dose AZD0292 administered starting on Day 1, subsequent administrations per schedule of assessments.
Biological: AZD0292
Placebo administered starting on Day 1, subsequent administrations per schedule of assessments.
Other: Placebo
AZD0292 high-dose or low-dose administered starting on Day 1 via IV infusion, subsequent administrations per schedule of assessments.
Placebo administered starting on Day 1 via IV infusion, subsequent administrations per schedule of assessments.
Annualized rate of exacerbations over a variable follow-up time
To evaluate the effect of IV AZD0292 compared to placebo on the rate of moderate-to-severe pulmonary exacerbations in participants with NCFBE and chronic colonization with PsA.
Time frame: Min 28 weeks, max 52 weeks
Annualized rate of severe exacerbations over a variable follow-up time
To evaluate the effect of AZD0292 compared to placebo on severe exacerbations in participants with NCFBE and chronic colonization with PsA
Time frame: Min 28 weeks, max 52 weeks
Change from baseline in QOL-B-RSS
To evaluate the effect of AZD0292 compared to placebo on quality of life, as assessed by QoL-B-RSS over the observation period
Time frame: Over the observation period (Week 0 to Final Dose+4 weeks)
Change from baseline in SGRQ score
To evaluate the effect of AZD0292 compared to placebo on quality of life, as assessed by SGRQ over the observation period.
Time frame: Over the observation period (Week 0 to Final Dose +4 weeks)
Time to first moderate or severe exacerbation
To evaluate the effect of AZD0292 compared to placebo on time to first pulmonary exacerbation in participants with NCFBE and chronic colonization with PsA.
Time frame: Through study completion (Final Dose +24 weeks)
Serum PK Concentrations
To evaluate the PK of IV doses of AZD0292 in participants with bronchiectasis and chronic colonization with PsA
Time frame: At specified timepoints between Week 0 and Final Dose+12 weeks
Incidence of ADA and ADA titers to AZD0292
To evaluate the immunogenicity of IV doses of AZD0292 in participants with bronchiectasis and chronic colonization with PsA
Time frame: At specified timepoints between Week 0 and Final Dose +12 weeks
Incidence of AEs, SAEs, AESIs and MAAEs
To assess the safety of AZD0292 compared with placebo in participants with bronchiectasis and chronic colonization with PsA
Time frame: Occurrence of AEs; first dose through 12 weeks after last study intervention administration. Occurrence of SAEs, AESIs, and MAAEs; through study completion (Final Dose+24 weeks)
Showing the first 100 of 186 sites across 25 countries.
Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Supporting information: Study protocol
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