Randomised Clinical Trial to Investigate Efficacy and Safety of Benralizumab 30 mg SC as an add-on Therapy in Uncontrolled Eosinophilic Asthma Patients Treated With Medium-dose ICS-LABA Compared to Conventional Escalation to High-dose ICS-LABA Treatment

Part of paid clinical trials in Chandler, Arizona.

Sponsor
AstraZeneca
Study ID
NCT06750289
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Eosinophilic Asthma

Eligibility Criteria

Sex
ALL
Age
12 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • ICS-LABA — COMBINATION_PRODUCT
    ICS-LABA inhalation
  • benralizumab — COMBINATION_PRODUCT
    Benralizumab. SC injection.
  • Placebo for Benralizumab — COMBINATION_PRODUCT
    Placebo for Benralizumab (aka, "placebo"). SC injection.

Study Details

This study evaluates the efficacy and safety of benralizumab as an add-on therapy in uncontrolled eosinophilic asthma participants treated with medium-dose ICS-LABA compared to the conventional treatment step of escalation of inhaled therapy to high-dose ICS-LABA.

Key Dates

Start date
Mar 28, 2025
Status verified
May 2026
Primary completion
Nov 3, 2028
Completion
Nov 3, 2028

Study Design

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

Arms

  • Active Comparator: Medium-dose ICS-LABA + benralizumab
    Participants will be randomised 1:1 to one of the 2 study arms. Participants will receive up to 7 SC injections during study, with the first 3 doses administered every 4 weeks and then subsequent doses every 8 weeks.
  • Active Comparator: High-dose ICS-LABA + placebo
    Participants will be randomised 1:1 to one of the 2 study arms. Participants will receive up to 7 SC injections during study, with the first 3 doses administered every 4 weeks and then subsequent doses every 8 weeks.

Primary Outcome Measure

Annualized asthma exacerbation rate [ Time Frame: Baseline through Week 48 ]

Central Contacts

Locations (34)

FacilityCityStateZIPSite coordinators
Research SiteChandlerArizona85224-
Research SiteSun CityArizona85351-
Research SiteTucsonArizona85704-
Research SiteBakersfieldCalifornia93301-
Research SiteInglewoodCalifornia90301-
Research SiteModestoCalifornia95355-
Research SiteNewport BeachCalifornia92663-
Research SitePasadenaCalifornia91101-
Research SiteDenverColorado80206-
Research SiteCape CoralFlorida33990-
Research SiteHialeahFlorida33015-
Research SiteLauderdale LakesFlorida33313-
Research SiteLeesburgFlorida34748-
Research SiteMiamiFlorida33122-
Research SiteMiamiFlorida33155-
Research SiteMiamiFlorida33175-
Research SiteOrlandoFlorida32819-
Research SitePlantationFlorida33324-
Research SiteTampaFlorida33607-
Research SiteWinter ParkFlorida32789-
Research SiteAnn ArborMichigan48109-
Research SiteHendersonNevada89052-
Research SiteNorthfieldNew Jersey08225-
Research SiteUnion CityNew Jersey07087-
Research SiteNew Hyde ParkNew York11042-
Research SiteThe BronxNew York10459-
Research SiteOklahoma CityOklahoma73103-
Research SiteOklahoma CityOklahoma73111-
Research SiteDuBoisPennsylvania15801-
Research SiteWarwickRhode Island02886-
Research SiteGreenvilleSouth Carolina29607-
Research SiteHoustonTexas77099-
Research SiteMcKinneyTexas75069-
Research SiteSan AntonioTexas78251-

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Research Site· Chandler, AZResearch Site· Sun City, AZResearch Site· Tucson, AZResearch Site· Bakersfield, CAResearch Site· Inglewood, CAResearch Site· Modesto, CA

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