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

Part of paid clinical trials in Orange, California.

Sponsor
AstraZeneca
Study ID
NCT07088926
Phase
PHASE2
Status
Recruiting

Conditions

  • Bronchiectasis With Pseudomonas Aeruginosa Colonization

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

Start date
Nov 6, 2025
Status verified
Jun 2026
Primary completion
Dec 9, 2027
Completion
Jun 14, 2028

Study Design

Enrollment
435 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: High-dose
    High-Dose AZD0292 administered starting on Day 1, subsequent administrations per schedule of assessments.
  • Experimental: Low-dose
    Low-dose AZD0292 administered starting on Day 1, subsequent administrations per schedule of assessments.
  • Placebo Comparator: Placebo
    Placebo administered starting on Day 1, subsequent administrations per schedule of assessments.

Primary Outcome Measure

Annualized rate of exacerbations over a variable follow-up time [ Time Frame: Min 28 weeks, max 52 weeks ]

Central Contacts

Locations (25)

FacilityCityStateZIPSite coordinators
Research SiteOrangeCalifornia92868-
Research SiteSan FranciscoCalifornia94143-
Research SiteDenverColorado80206-
Research SiteWashington D.C.District of Columbia20007-
Research SiteJacksonvilleFlorida32209-
Research SiteMiami LakesFlorida33014-
Research SiteNaplesFlorida34102-
Research SiteOrmond BeachFlorida32174-
Research SitePlantationFlorida33324-
Research SiteRinconGeorgia31326-
Research SiteKansas CityKansas66160-
Research SiteAnn ArborMichigan48109-
Research SiteDetroitMichigan48202-
Research SiteRochesterMinnesota55905-
Research SiteSt LouisMissouri63130-
Research SiteNew YorkNew York10016-
Research SiteNew BernNorth Carolina28562-
Research SiteWinston-SalemNorth Carolina27104-
Research SiteTulsaOklahoma74133-
Research SiteDuBoisPennsylvania15801-
Research SitePhiladelphiaPennsylvania19104-
Research SiteCharlestonSouth Carolina29425-
Research SiteRock HillSouth Carolina29732-
Research SiteAustinTexas78705-
Research SiteMansfieldTexas76063-

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