← All trial listings Recruiting

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

ClinicalTrials.gov ID NCT06878261 · A Randomised, Double-blind, Placebo-controlled, Parallel Group, Multicentre, Phase III Study to Evaluate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease

Check if you may qualify View the official record

At a glance

Status
Recruiting
Condition
Chronic Obstructive Pulmonary Disease (COPD)
Phase
Phase 3
Ages
40 Years to 80 Years
Sex
All
Healthy volunteers
Not accepted
What is being studied
Tezepelumab (biological); Placebo (other)
Sponsor
AstraZeneca
Target enrollment
990 participants
Study sites
243 open in Alabama, Argentina, Arizona, Australia, Belgium, Bulgaria, California, Colombia, Connecticut, Delaware, Denmark, Florida, France, Georgia, Greece, Hong Kong, Hungary, Illinois, Indiana, Israel, Japan, Kansas, Kentucky, Maryland, Michigan, Minnesota, Missouri, Netherlands, New York, New Zealand, North Carolina, Oklahoma, Pennsylvania, Peru, Romania, South Africa, South Carolina, South Dakota, Sweden, Tennessee, Texas, Thailand, Turkey (Türkiye), Vermont, Vietnam, Virginia, Washington
Start date
2025-03-25
Primary completion
2029-03-13

Common questions

Is NCT06878261 still recruiting?

ClinicalTrials.gov lists this trial as recruiting (checked 5 October 2026). It has 243 open or upcoming sites.

Who can take part in NCT06878261?

The record lists people aged 40 to 80 years with chronic obstructive pulmonary disease (copd). The study team decides who is eligible, and the full criteria are on this page and in the official record.

Where is NCT06878261 running?

243 sites in Alabama, Argentina, Arizona, Australia, Belgium, Bulgaria, California, Colombia, Connecticut, Delaware, Denmark, Florida, France, Georgia, Greece, Hong Kong, Hungary, Illinois, Indiana, Israel, Japan, Kansas, Kentucky, Maryland, Michigan, Minnesota, Missouri, Netherlands, New York, New Zealand, North Carolina, Oklahoma, Pennsylvania, Peru, Romania, South Africa, South Carolina, South Dakota, Sweden, Tennessee, Texas, Thailand, Turkey (Türkiye), Vermont, Vietnam, Virginia, Washington, according to ClinicalTrials.gov.

What is being studied in NCT06878261?

It is a Phase 3 trial. The record lists these interventions: Tezepelumab and Placebo. The sponsor is AstraZeneca.

How many people will NCT06878261 enroll?

The record gives a target of 990 participants.

How do I sign up for NCT06878261?

Use "Check if you may qualify" on this page to answer a few screening questions, or contact the study team listed on ClinicalTrials.gov.

About this trial

From the ClinicalTrials.gov record.

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)

Where it's running

SiteCityStateStatus
Research SiteCullmanAlabamaRecruiting
Research SitePhoenixArizonaRecruiting
Research SiteScottsdaleArizonaRecruiting
Research SiteLos AngelesCaliforniaRecruiting
Research SitePalo AltoCaliforniaRecruiting
Research SiteNew BritainConnecticutRecruiting
Research SiteWilmingtonDelawareRecruiting
Research SiteBay PinesFloridaRecruiting
Research SiteBoynton BeachFloridaRecruiting
Research SiteJacksonvilleFloridaRecruiting
Research SiteLeesburgFloridaRecruiting
Research SiteMiamiFloridaRecruiting
Research SiteOcalaFloridaRecruiting
Research SitePalmetto BayFloridaRecruiting
Research SiteWinter ParkFloridaRecruiting
Research SiteAtlantaGeorgiaRecruiting
Research SiteCordeleGeorgiaRecruiting
Research SiteDecaturGeorgiaRecruiting
Research SiteSavannahGeorgiaRecruiting
Research SiteEvanstonIllinoisRecruiting
Research SiteSpringfieldIllinoisNot yet recruiting
Research SiteEvansvilleIndianaRecruiting
Research SiteIndianapolisIndianaRecruiting
Research SiteIndianapolisIndianaRecruiting
Research SiteKansas CityKansasRecruiting
Research SiteBowling GreenKentuckyRecruiting
Research SiteOwensboroKentuckyRecruiting
Research SiteBaltimoreMarylandRecruiting
Research SitePotomacMarylandRecruiting
Research SiteRosedaleMarylandRecruiting
Research SiteAnn ArborMichiganRecruiting
Research SiteMinneapolisMinnesotaRecruiting
Research SiteHannibalMissouriRecruiting
Research SiteStaten IslandNew YorkRecruiting
Research SiteSyracuseNew YorkRecruiting
Research SiteThe BronxNew YorkNot yet recruiting
Research SiteCharlotteNorth CarolinaRecruiting
Research SiteConcordNorth CarolinaNot yet recruiting
Research SiteOklahoma CityOklahomaRecruiting
Research SiteTulsaOklahomaRecruiting
Research SiteHorshamPennsylvaniaNot yet recruiting
Research SitePittsburghPennsylvaniaNot yet recruiting
Research SiteSayrePennsylvaniaRecruiting
Research SiteAndersonSouth CarolinaRecruiting
Research SiteColumbiaSouth CarolinaRecruiting
Research SiteGaffneySouth CarolinaRecruiting
Research SiteSpartanburgSouth CarolinaRecruiting
Research SiteUnionSouth CarolinaRecruiting
Research SiteRapid CitySouth DakotaRecruiting
Research SiteKnoxvilleTennesseeRecruiting
Research SiteBoerneTexasRecruiting
Research SiteEl PasoTexasRecruiting
Research SiteHoustonTexasRecruiting
Research SiteHoustonTexasRecruiting
Research SiteHoustonTexasRecruiting
Research SiteLewisvilleTexasRecruiting
Research SiteMcKinneyTexasRecruiting
Research SiteMesquiteTexasRecruiting
Research SiteSan AntonioTexasRecruiting
Research SiteColchesterVermontRecruiting
Research SiteWilliamsburgVirginiaRecruiting
Research SiteEverettWashingtonRecruiting
Research SiteAlberdiArgentinaRecruiting
Research SiteBuenos AiresArgentinaRecruiting
Research SiteCiudad de Buenos AiresArgentinaRecruiting
Research SiteFloridaArgentinaRecruiting
Research SiteLa PlataArgentinaRecruiting
Research SiteLa PlataArgentinaRecruiting
Research SiteMar del PlataArgentinaRecruiting
Research SiteMendozaArgentinaRecruiting
Research SiteQuilmesArgentinaRecruiting
Research SiteRosarioArgentinaRecruiting
Research SiteSan FernandoArgentinaRecruiting
Research SiteSan Juan BautistaArgentinaRecruiting
Research SiteCoffs HarbourAustraliaRecruiting
Research SiteFrankstonAustraliaRecruiting
Research SiteNedlandsAustraliaRecruiting
Research SiteSpearwoodAustraliaRecruiting
Research SiteGenkBelgiumRecruiting
Research SiteGhentBelgiumRecruiting
Research SiteJetteBelgiumRecruiting
Research SiteLeuvenBelgiumRecruiting
Research SiteMechelenBelgiumRecruiting
Research SiteNamurBelgiumRecruiting
Research SiteDupnitsaBulgariaRecruiting
Research SiteHaskovoBulgariaRecruiting
Research SitePlevenBulgariaRecruiting
Research SitePlovdivBulgariaRecruiting
Research SiteRousseBulgariaRecruiting
Research SiteSofiaBulgariaRecruiting
Research SiteSofiaBulgariaRecruiting
Research SiteSofiaBulgariaRecruiting
Research SiteStara ZagoraBulgariaRecruiting
Research SiteVeliko TanovoBulgariaRecruiting
Research SiteVeliko TarnovoBulgariaRecruiting
Research SiteVidinBulgariaRecruiting
Research SiteYambolBulgariaRecruiting
Research SiteArmeniaColombiaRecruiting
Research SiteBarranquillaColombiaRecruiting
Research SiteBogotáColombiaRecruiting
Research SiteCaliColombiaRecruiting
Research SiteIbagueColombiaRecruiting
Research SiteManizalesColombiaRecruiting
Research SiteMedellínColombiaRecruiting
Research SiteMedellínColombiaRecruiting
Research SiteAalborgDenmarkRecruiting
Research SiteHvidovreDenmarkRecruiting
Research SiteNæstvedDenmarkRecruiting
Research SiteOdense CDenmarkRecruiting
Research SiteVejleDenmarkRecruiting
Research SiteBrestFranceRecruiting
Research SiteLyonFranceRecruiting
Research SiteMarseilleFranceRecruiting
Research SiteMontpellierFranceRecruiting
Research SiteParisFranceRecruiting
Research SiteParisFranceRecruiting
Research SitePessacFranceRecruiting
Research SiteSaint-HerblainFranceRecruiting
Research SiteAthensGreeceRecruiting
Research SiteAthensGreeceRecruiting
Research SiteAthensGreeceRecruiting
Research SiteHeraklionGreeceRecruiting
Research SiteIoanninaGreeceRecruiting
Research SitePátraiGreeceRecruiting
Research SiteThessalonikiGreeceRecruiting
Research SiteThessalonikiGreeceRecruiting
Research SiteHong KongHong KongRecruiting
Research SiteBudapestHungaryRecruiting
Research SiteDebrecenHungaryRecruiting
Research SiteEdelényHungaryRecruiting
Research SiteGödöllőHungaryRecruiting
Research SiteHatvanHungaryRecruiting
Research SiteMosonmagyaróvárHungaryRecruiting
Research SiteNyíregyháza-SóstóhegyHungaryRecruiting
Research SiteTörökbálintHungaryRecruiting
Research SiteAshkelonIsraelRecruiting
Research SiteHaifaIsraelRecruiting
Research SiteJerusalemIsraelRecruiting
Research SiteJerusalemIsraelRecruiting
Research SiteKfar SabaIsraelRecruiting
Research SiteRamat GanIsraelRecruiting
Research SiteRehovotIsraelRecruiting
Research SiteTel AvivIsraelRecruiting
Research SiteAkashi-shiJapanRecruiting
Research SiteChikushino-shiJapanRecruiting
Research SiteChiyoda-kuJapanRecruiting
Research SiteFukui-shiJapanRecruiting
Research SiteFukuokaJapanRecruiting
Research SiteFukuokaJapanRecruiting
Research SiteGifuJapanRecruiting
Research SiteIruma-GunJapanRecruiting
Research SiteIshinomakiJapanRecruiting
Research SiteKasuga-shiJapanRecruiting
Research SiteKitakyushu-shiJapanRecruiting
Research SiteKiyose-shiJapanRecruiting
Research SiteKiyose-shiJapanRecruiting
Research SiteKobeJapanRecruiting
Research SiteKomatsu-shiJapanRecruiting
Research SiteKure-shiJapanRecruiting
Research SiteKyotoJapanRecruiting
Research SiteMatsusaka-shiJapanRecruiting
Research SiteMinatokuJapanRecruiting
Research SiteMinatokuJapanRecruiting
Research SiteMiyazakiJapanRecruiting
Research SiteMizunami-shiJapanRecruiting
Research SiteNagaoka-shiJapanRecruiting
Research SiteNagasakiJapanRecruiting
Research SiteNagoyaJapanRecruiting
Research SiteNagoyaJapanRecruiting
Research SiteNagoyaJapanRecruiting
Research SiteNerima-kuJapanRecruiting
Research SiteOkayamaJapanRecruiting
Research SiteOkayamaJapanRecruiting
Research SiteOsakaJapanRecruiting
Research SiteSapporoJapanRecruiting
Research SiteSendaiJapanRecruiting
Research SiteSendaiJapanRecruiting
Research SiteShinjuku-kuJapanRecruiting
Research SiteShinjuku-kuJapanRecruiting
Research SiteShinjuku-kuJapanRecruiting
Research SiteShiogamaJapanRecruiting
Research SiteTakamatsuJapanRecruiting
Research SiteTanabe-shiJapanRecruiting
Research SiteUbeJapanRecruiting
Research SiteYokohamaJapanRecruiting
Research SiteEindhovenNetherlandsRecruiting
Research SiteMaastrichtNetherlandsRecruiting
Research SiteRotterdamNetherlandsRecruiting
Research SiteRotterdamNetherlandsRecruiting
Research SiteZutphenNetherlandsRecruiting
Research SiteAucklandNew ZealandRecruiting
Research SiteAucklandNew ZealandRecruiting
Research SiteHamilton WestNew ZealandRecruiting
Research SiteTaurangaNew ZealandRecruiting
Research SiteCallaoPeruNot yet recruiting
Research SiteLimaPeruRecruiting
Research SiteLimaPeruRecruiting
Research SiteLimaPeruRecruiting
Research SiteLimaPeruRecruiting
Research SiteLimaPeruRecruiting
Research SiteLimaPeruRecruiting
Research SitePiuraPeruRecruiting
Research SiteBucharestRomaniaNot yet recruiting
Research SiteBucharestRomaniaRecruiting
Research SiteCluj-NapocaRomaniaRecruiting
Research SiteCluj-NapocaRomaniaRecruiting
Research SiteOradeaRomaniaRecruiting
Research SiteTimișoaraRomaniaRecruiting
Research SiteTimișoaraRomaniaRecruiting
Research SiteBellvilleSouth AfricaRecruiting
Research SiteBenoniSouth AfricaRecruiting
Research SiteCape TownSouth AfricaRecruiting
Research SiteDurbanSouth AfricaRecruiting
Research SiteDurbanSouth AfricaRecruiting
Research SiteeMkhomaziSouth AfricaRecruiting
Research SiteSomerset WestSouth AfricaRecruiting
Research SiteGothenburgSwedenRecruiting
Research SiteKarlskronaSwedenRecruiting
Research SiteLundSwedenRecruiting
Research SiteÖrebroSwedenRecruiting
Research SiteStockholmSwedenRecruiting
Research SiteStockholmSwedenRecruiting
Research SiteBangkokThailandRecruiting
Research SiteHat YaiThailandRecruiting
Research SiteMuangThailandRecruiting
Research SiteMuangThailandRecruiting
Research SiteMueangThailandRecruiting
Research SiteNonthaburiThailandRecruiting
Research SiteRayongThailandRecruiting
Research SiteAdanaTurkey (Türkiye)Recruiting
Research SiteAnkaraTurkey (Türkiye)Recruiting
Research SiteIstanbulTurkey (Türkiye)Recruiting
Research SiteKayseriTurkey (Türkiye)Recruiting
Research SiteKocaeliTurkey (Türkiye)Recruiting
Research SiteMersinTurkey (Türkiye)Recruiting
Research SiteCan ThoVietnamNot yet recruiting
Research SiteDa NangVietnamRecruiting
Research SiteHaiphongVietnamRecruiting
Research SiteHanoiVietnamRecruiting
Research SiteHo Chi Minh CityVietnamRecruiting
Research SiteHo Chi Minh CityVietnamRecruiting
Research SiteHồ Chí MinhVietnamRecruiting
Research SiteHuếVietnamRecruiting
Full eligibility criteria (from the record)

Inclusion Criteria: 1. ≥40 to ≤80 years old 2. COPD diagnosis ≥1 year, 3. Post-BD FEV1 ≥ 20% and ≤ 70% PN, FEV1/FVC \<0.70 at screening 4. Triple (ICS+LABA+LAMA) or dual inhaled COPD therapy, if triple therapy is considered not appropriate, ≥3 consecutive months prior to V1 5. ≥2 moderate or ≥1 severe COPD exacerbations in the prior year; At least 1 of 2 moderate exacerbations must require the use of systemic corticosteroids. At least one of the previous exacerbations should be confirmed to have occurred while the participant was on triple or dual inhaled maintenance therapy 6. EOS ≥ 150 cells/μL during screening 7. CAT ≥15 at screening 8. Former or current smokers ≥10 pack-years Exclusion Criteria: 1. Clin. important pulmonary disease or radiological findings suggestive of a respiratory disease other than COPD 2. Asthma, incl. pediatric, or ACOS 3. Any unstable disorder that can impact participants safety or study outcomes 4. Tuberculosis requiring treatment within 12 months prior V2 5. Malignancies current or past Concomitant therapies: * Macrolides (less than 6 months) * Systemic immuno-suppressive, -modulating medications 6. LTOT \>4.0 L/min or O2 saturation \<89% despite LTOT

Other recruiting trials: COPD (chronic obstructive pulmonary disease) clinical trials

This listing shows only what the public ClinicalTrials.gov record NCT06878261 says, last updated there on 2026-09-03. It was checked against the registry on 5 October 2026. Taking part is voluntary, and the study team decides who is eligible. For the most current details, see the official record.