A Study to Investigate the Efficacy and Safety of Tezepelumab Compared With Placebo in Children 5 to < 12 Years Old With Severe Asthma

Part of paid clinical trials in Montgomery, Alabama.

Sponsor
AstraZeneca
Study ID
NCT06023589
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
5 Years - 11 Years
Healthy Volunteers
Not accepted

Interventions

  • Tezepelumab — BIOLOGICAL
    Participants will be receiving subcutaneous injection of tezepelumab
  • Placebo — OTHER
    Participants will be receiving subcutaneous injection of matching placebo

Study Details

To assess the efficacy and safety of tezepelumab in pediatric participants with severe uncontrolled asthma on medium to high-dose inhaled corticosteroids (ICS) and at least one additional asthma controller medication with or without oral corticosteroids.

Key Dates

Start date
Aug 24, 2023
Status verified
May 2026
Primary completion
May 31, 2028
Completion
Aug 23, 2030

Study Design

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

Arms

  • Experimental: Tezepelumab
    Participants will be receiving tezepelumab subcutaneous injection
  • Placebo Comparator: Placebo
    Participants will be receiving placebo through a subcutaneous injection

Primary Outcome Measure

Annualized severe asthma exacerbation rate (AAER) [ Time Frame: From Baseline to Week 52 ]

Central Contacts

Locations (30)

FacilityCityStateZIPSite coordinators
Research SiteMontgomeryAlabama36106-
Research SitePhoenixArizona85016-
Research SiteLittle RockArkansas72202-
Research SiteLa JollaCalifornia92037-
Research SiteLong BeachCalifornia90806-
Research SiteOrangeCalifornia92868-
Research SiteSan DiegoCalifornia92123-
Research SiteAtlantaGeorgia30322-
Research SiteSavannahGeorgia31406-
Research SiteBaltimoreMaryland21287-
Research SiteBostonMassachusetts02114-
Research SiteBostonMassachusetts02115-
Research SiteAnn ArborMichigan48105-
Research SiteDetroitMichigan48201-
Research SiteNorthfieldNew Jersey08225-
Research SiteHawthorneNew York10532-
Research SiteSchenectadyNew York12304-
Research SiteStaten IslandNew York10305-
Research SiteChapel HillNorth Carolina27514-
Research SiteCincinnatiOhio45229-3039-
Research SiteClevelandOhio44106-
Research SiteToledoOhio43617-
Research SiteOklahoma CityOklahoma73120-
Research SiteColumbiaSouth Carolina29203-
Research SiteCoppellTexas75019-
Research SiteDallasTexas75246-
Research SiteFriscoTexas75034-
Research SiteHoustonTexas77030-
Research SiteSan AntonioTexas78249-
Research SiteTempleTexas76508-

Find similar trials in Montgomery, AL

By condition
Asthma
By specialty
PulmonologyLung disease
By research site
Research Site· Montgomery, ALResearch Site· Phoenix, AZResearch Site· Little Rock, ARResearch Site· La Jolla, CAResearch Site· Long Beach, CAResearch Site· Orange, CA

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