AZD0292 is a bispecific IgG1k mAb being evaluated for the prevention of exacerbations in bronchiectasis patients chronically colonized with PsA.
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
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
Parallel
AZD0292
Biological/VaccineAZD0292 high-dose or low-dose administered starting on Day 1 via IV infusion, subsequent administrations per schedule of assessments.
Placebo
Other interventionPlacebo 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.
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
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
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 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.
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