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
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
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.
Inclusion Criteria:
Exclusion Criteria:
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Ciudad de Buenos Aires, C1180AAX, Argentina
Macquarie University, 2109, Australia
München-Pasing, 81241, Germany
Hiratsuka-shi, 254-8502, Japan
Kamogawa-shi, 296-0041, Japan
Kiyose-shi, 204-8522, Japan
Kiyose-shi, 204-8585, Japan
Kurashiki-shi, 710-8602, Japan
Shinjuku-ku, 160-8582, Japan
Shinjuku-ku, 162-8655, Japan
Urayasu-shi, 279-0021, Japan
Zutphens, 7207 AE, Netherlands
Muang, 40002, Thailand
Muang, 50200, Thailand