A Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled, Time-to-first Asthma Exacerbation Phase III Efficacy and Safety Study of Benralizumab in Paediatric Patients With Severe Eosinophilic Asthma (DOMINICA)

Part of paid clinical trials in Mobile, Alabama.

Sponsor
AstraZeneca
Study ID
NCT05692180
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
6 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Benralizumab — DRUG
    Benralizumab active solution will be administered SC to the patients.
  • Placebo — DRUG
    Placebo solution will be administered SC to the patients.

Study Details

A study to evaluate the efficacy and safety of benralizumab administered subcutaneously in patients ≥ 6 to \< 18 years of age with severe eosinophilic asthma, including a well-documented history of asthma exacerbations and uncontrolled asthma receiving high-dose inhaled corticosteroid (ICS) plus at least one additional controller medication.

Key Dates

Start date
Apr 5, 2023
Status verified
May 2026
Primary completion
May 5, 2030
Completion
May 16, 2032

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Benralizumab
    Patients will receive Benralizumab as an active solution via a subcutaneous (SC) injection.
  • Placebo Comparator: Placebo
    Patients will receive a matching solution of the placebo via SC injection.

Primary Outcome Measure

Time to first asthma exacerbation [ Time Frame: From Baseline (Week 0) to End of Treatment (EOT) in DB treatment period ]

Central Contacts

Locations (28)

FacilityCityStateZIPSite coordinators
Research SiteMobileAlabama36608-
Research SiteMontgomeryAlabama36106-
Research SiteTucsonArizona85724-
Research SiteLittle RockArkansas72202-
Research SiteMaderaCalifornia93636-
Research SiteTorranceCalifornia90505-
Research SiteWashington D.C.District of Columbia20010-
Research SiteMiamiFlorida33144-
Research SiteMiamiFlorida33184-
Research SiteOcalaFlorida34471-
Research SiteOwensboroKentucky42301-
Research SiteLafayetteLouisiana70508-
Research SiteNew OrleansLouisiana70112-
Research SiteGlenn DaleMaryland20769-
Research SiteBostonMassachusetts02114-
Research SiteRidgelandMississippi39157-
Research SiteKansas CityMissouri64108-
Research SiteLincolnNebraska68510-
Research SiteBrickNew Jersey08724-
Research SiteNorthfieldNew Jersey08225-
Research SiteThe BronxNew York10459-
Research SiteCincinnatiOhio45229-
Research SiteClevelandOhio44106-
Research SiteCharlestonSouth Carolina29425-
Research SiteDallasTexas75235-
Research SiteSan AntonioTexas78229-
Research SiteTylerTexas75708-
Research SiteMorgantownWest Virginia26506-

Find similar trials in Mobile, AL

By condition
Asthma
By specialty
PulmonologyLung disease
By research site
Research Site· Mobile, ALResearch Site· Montgomery, ALResearch Site· Tucson, AZResearch Site· Little Rock, ARResearch Site· Madera, CAResearch Site· Torrance, CA

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