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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age12+
SponsorAstraZeneca

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • AZD0292
  • Placebo

Treatment groups

435 Participants
are divided into 3 treatment groups

Sponsors and collaborators