A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00007)

Part of paid clinical trials in Cullman, Alabama.

Sponsor
AstraZeneca
Study ID
NCT06878261
Phase
PHASE3
Status
Recruiting

Conditions

  • Chronic Obstructive Pulmonary Disease (COPD)

Eligibility Criteria

Sex
ALL
Age
40 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Tezepelumab — BIOLOGICAL
    Tezepelumab subcutaneous injection
  • Placebo — OTHER
    Placebo subcutaneous injection

Study Details

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)

Key Dates

Start date
Mar 25, 2025
Status verified
May 2026
Primary completion
Mar 13, 2029
Completion
Jun 5, 2029

Study Design

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

Arms

  • Experimental: Dose 1 of Tezepelumab
    Tezepelumab, SC, Q4W
  • Experimental: Dose 2 of Tezepelumab
    Tezepelumab, SC, Q4W
  • Placebo Comparator: Matching Placebo
    Matching placebo, SC, Q4W

Primary Outcome Measure

Annualised rate of moderate or severe COPD exacerbations [ Time Frame: Baseline up to 76 weeks ]

Central Contacts

Locations (68)

FacilityCityStateZIPSite coordinators
Research SiteCullmanAlabama35055-
Research SitePhoenixArizona85044-
Research SiteScottsdaleArizona85258-
Research SiteInglewoodCalifornia90301-
Research SiteLos AngelesCalifornia90048-
Research SitePalo AltoCalifornia94304-
Research SiteReddingCalifornia96001-
Research SiteSan DiegoCalifornia92108-
Research SiteNew BritainConnecticut06051-
Research SiteWilmingtonDelaware19803-
Research SiteBay PinesFlorida33744-
Research SiteBoynton BeachFlorida33435-
Research SiteClearwaterFlorida33765-
Research SiteFleming IslandFlorida32003-
Research SiteJacksonvilleFlorida32209-
Research SiteLeesburgFlorida34748-
Research SiteMargateFlorida33063-
Research SiteMiamiFlorida33126-
Research SiteMiamiFlorida33155-
Research SiteMiami LakesFlorida33014-
Research SiteOcalaFlorida34470-
Research SitePalmetto BayFlorida33157-
Research SiteWinter ParkFlorida32789-
Research SiteAdairsvilleGeorgia30103-
Research SiteAtlantaGeorgia30349-
Research SiteCordeleGeorgia31015-
Research SiteDecaturGeorgia30033-
Research SiteFort EisenhowerGeorgia30905-
Research SiteSavannahGeorgia31406-
Research SiteEvanstonIllinois60201-
Research SiteEvansvilleIndiana47725-
Research SiteIndianapolisIndiana46202-
Research SiteIndianapolisIndiana46268-
Research SiteKansas CityKansas66160-
Research SiteBowling GreenKentucky42101-
Research SiteOwensboroKentucky42301-
Research SiteBaltimoreMaryland21224-
Research SitePotomacMaryland20854-
Research SiteAnn ArborMichigan48109-
Research SiteMinneapolisMinnesota55425-
Research SiteHannibalMissouri63401-
Research SiteStaten IslandNew York10309-
Research SiteSyracuseNew York13203-
Research SiteCharlotteNorth Carolina28277-
Research SiteFayettevilleNorth Carolina28303-
Research SiteOklahoma CityOklahoma73102-
Research SiteTulsaOklahoma74133-
Research SiteGrants PassOregon97527-
Research SiteSayrePennsylvania18840-
Research SiteAndersonSouth Carolina29621-
Research SiteColumbiaSouth Carolina29204-
Research SiteGaffneySouth Carolina29340-
Research SiteSpartanburgSouth Carolina29303-
Research SiteUnionSouth Carolina29379-
Research SiteRapid CitySouth Dakota57702-
Research SiteKnoxvilleTennessee37919-
Research SiteBoerneTexas78006-
Research SiteEl PasoTexas79902-
Research SiteHoustonTexas77008-
Research SiteHoustonTexas77074-
Research SiteHoustonTexas77094-
Research SiteLewisvilleTexas75067-
Research SiteMcKinneyTexas75069-
Research SiteMesquiteTexas75149-
Research SiteSan AntonioTexas78258-
Research SiteColchesterVermont05446-
Research SiteWilliamsburgVirginia23188-
Research SiteEverettWashington98208-

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