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

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 25, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06878261

Locations in the U.S.

AlabamaResearch Site, Cullman
ArizonaResearch Site, Phoenix
Research Site, Scottsdale
CaliforniaResearch Site, Los Angeles
Research Site, Palo Alto
ConnecticutResearch Site, New Britain
DelawareResearch Site, Wilmington
FloridaResearch Site, Bay Pines
Research Site, Boynton Beach
Research Site, Jacksonville
Research Site, Leesburg
Research Site, Miami
Research Site, Ocala
Research Site, Palmetto Bay
Research Site, Winter Park
GeorgiaResearch Site, Atlanta
Research Site, Cordele
Research Site, Decatur
Research Site, Savannah
IllinoisResearch Site, Evanston
Research Site, Springfield (Not yet recruiting)
IndianaResearch Site, Evansville
Research Site, Indianapolis
Research Site, Indianapolis
KansasResearch Site, Kansas City
KentuckyResearch Site, Bowling Green
Research Site, Owensboro
MarylandResearch Site, Baltimore
Research Site, Potomac
Research Site, Rosedale
MichiganResearch Site, Ann Arbor
MinnesotaResearch Site, Minneapolis
MissouriResearch Site, Hannibal
New YorkResearch Site, Staten Island
Research Site, Syracuse
Research Site, The Bronx (Not yet recruiting)
North CarolinaResearch Site, Charlotte
Research Site, Concord (Not yet recruiting)
OklahomaResearch Site, Oklahoma City
Research Site, Tulsa
PennsylvaniaResearch Site, Horsham (Not yet recruiting)
Research Site, Pittsburgh (Not yet recruiting)
Research Site, Sayre
South CarolinaResearch Site, Anderson
Research Site, Columbia
Research Site, Gaffney
Research Site, Spartanburg
Research Site, Union
South DakotaResearch Site, Rapid City
TennesseeResearch Site, Knoxville
TexasResearch Site, Boerne
Research Site, El Paso
Research Site, Houston
Research Site, Houston
Research Site, Houston
Research Site, Lewisville
Research Site, McKinney
Research Site, Mesquite
Research Site, San Antonio
VermontResearch Site, Colchester
VirginiaResearch Site, Williamsburg
WashingtonResearch Site, Everett

Conditions

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