NCT07088926

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

A Phase IIb Randomized, Double-blind, Placebo-controlled, Parallel, Multidose Study to Evaluate the Efficacy, Safety, and PK of AZD0292 in Participants 12 Years of Age and Older With Bronchiectasis and Chronic Pseudomonas Aeruginosa Colonization

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 435 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Bronchiectasis With Pseudomonas Aeruginosa Colonization

Interventions

Type	Name	Description
BIOLOGICAL	AZD0292	AZD0292 high-dose or low-dose administered starting on Day 1 via IV infusion, subsequent administrations per schedule of assessments.
OTHER	Placebo	Placebo administered starting on Day 1 via IV infusion, subsequent administrations per schedule of assessments.

Timeline

• Start date: 2025-11-06
• Primary completion: 2027-12-09
• Completion: 2028-06-14
• First posted: 2025-07-28
• Last updated: 2026-04-03

Locations

182 sites across 25 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, Denmark, France, Germany, Greece, Israel, Italy, Japan, Malaysia, Netherlands, Peru, Philippines, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, Vietnam

Regulatory

• FDA-regulated drug study