A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00006)

Part of paid clinical trials in Foley, Alabama.

Sponsor
AstraZeneca
Study ID
NCT06883305
Phase
PHASE3
Status
Recruiting
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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 18, 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 (67)

FacilityCityStateZIPSite coordinators
Research SiteFoleyAlabama36535-
Research SiteMobileAlabama36609-
Research SiteSheffieldAlabama35660-
Research SitePhoenixArizona85012-
Research SitePhoenixArizona85027-
Research SiteTucsonArizona85704-
Research SiteGarden GroveCalifornia92844-
Research SiteNewport BeachCalifornia92663-
Research SiteTorranceCalifornia90502-
Research SiteClearwaterFlorida33765-
Research SiteCutler BayFlorida33157-
Research SiteCutler BayFlorida33189-
Research SiteDeBaryFlorida32713-
Research SiteGainesvilleFlorida32608-
Research SiteHomesteadFlorida33032-
Research SiteMiamiFlorida33125-
Research SiteMiamiFlorida33125-
Research SiteMiamiFlorida33155-
Research SiteMiamiFlorida33175-
Research SiteOrlandoFlorida32807-
Research SiteTampaFlorida33606-
Research SiteTampaFlorida33607-
Research SiteAtlantaGeorgia30344-
Research SiteLithoniaGeorgia30038-
Research SiteRinconGeorgia31326-
Research SiteChicagoIllinois60611-
Research SitePalos HillsIllinois60465-
Research SiteWinfieldIllinois60190-
Research SiteMunsterIndiana46321-
Research SiteBaltimoreMaryland21201-
Research SiteColumbiaMaryland21045-
Research SiteNorth DartmouthMassachusetts02747-
Research SiteFarmington HillsMichigan48336-
Research SiteSaint CloudMinnesota56303-
Research SiteSt LouisMissouri63103-
Research SiteMissoulaMontana59808-
Research SitePapillionNebraska68046-
Research SiteLas VegasNevada89106-
Research SiteSewellNew Jersey08080-
Research SiteToms RiverNew Jersey08755-
Research SiteBuffaloNew York14203-
Research SiteBuffaloNew York14215-
Research SiteCortlandNew York13045-
Research SiteHorseheadsNew York14845-
Research SiteHigh PointNorth Carolina27260-
Research SiteKings MountainNorth Carolina28086-
Research SiteNew BernNorth Carolina28562-
Research SiteWilmingtonNorth Carolina28412-
Research SiteWinston-SalemNorth Carolina27103-
Research SiteColumbusOhio43213-
Research SiteOklahoma CityOklahoma73120-
Research SiteDuBoisPennsylvania15801-
Research SitePhiladelphiaPennsylvania19140-
Research SiteRock HillSouth Carolina29732-
Research SiteFranklinTennessee37067-
Research SiteJohnson CityTennessee37604-
Research SiteDallasTexas75254-
Research SiteFort WorthTexas76104-
Research SiteHoustonTexas77084-
Research SiteHoustonTexas77090-
Research SiteHumbleTexas77338-
Research SiteKerrvilleTexas78028-
Research SiteMansfieldTexas76063-
Research SiteClearfieldUtah84015-
Research SiteMorgantownWest Virginia26501-
Research SiteCudahyWisconsin53110-
Research SiteMilwaukeeWisconsin53295-

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