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

RecruitingPhase 3

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

Who can join

Ages 40 to 80 · All sexes

Full eligibility criteria
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

About the study

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)

What is being tested

Sponsor: AstraZeneca · Participants: 990 · Started: Mar 18, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06883305

Locations in the U.S.

AlabamaResearch Site, Foley
Research Site, Mobile
Research Site, Sheffield
ArizonaResearch Site, Phoenix (Not yet recruiting)
Research Site, Phoenix
CaliforniaResearch Site, Garden Grove
Research Site, Newport Beach
Research Site, Torrance
FloridaResearch Site, Clearwater
Research Site, Cutler Bay
Research Site, Cutler Bay
Research Site, DeBary
Research Site, Gainesville (Not yet recruiting)
Research Site, Homestead
Research Site, Miami
Research Site, Miami
Research Site, Miami
Research Site, Orlando
Research Site, Tampa
Research Site, Tampa
GeorgiaResearch Site, Atlanta
Research Site, Lithonia
Research Site, Rincon
IdahoResearch Site, Meridian (Not yet recruiting)
IllinoisResearch Site, Palos Hills
Research Site, Winfield
IndianaResearch Site, Munster
MarylandResearch Site, Baltimore
Research Site, Columbia
MassachusettsResearch Site, North Dartmouth
MichiganResearch Site, Farmington Hills
MinnesotaResearch Site, Saint Cloud
MissouriResearch Site, St Louis (Not yet recruiting)
MontanaResearch Site, Missoula
NebraskaResearch Site, Papillion
NevadaResearch Site, Las Vegas
New JerseyResearch Site, Millville
Research Site, Sewell
Research Site, Toms River
New MexicoResearch Site, Albuquerque (Not yet recruiting)
New YorkResearch Site, Buffalo
Research Site, Cortland
Research Site, Horseheads
Research Site, Massapequa (Not yet recruiting)
Research Site, The Bronx (Not yet recruiting)
North CarolinaResearch Site, High Point
Research Site, Kings Mountain
Research Site, New Bern
Research Site, Winston-Salem
OhioResearch Site, Columbus
OklahomaResearch Site, Oklahoma City
PennsylvaniaResearch Site, DuBois
Research Site, Philadelphia
South CarolinaResearch Site, Rock Hill
TennesseeResearch Site, Franklin
Research Site, Johnson City
TexasResearch Site, Dallas
Research Site, Forney (Not yet recruiting)
Research Site, Fort Worth
Research Site, Houston
Research Site, Houston
Research Site, Humble
Research Site, Kerrville
Research Site, Mansfield
UtahResearch Site, Clearfield
West VirginiaResearch Site, Morgantown
WisconsinResearch Site, Cudahy
Research Site, Milwaukee (Not yet recruiting)

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.