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Clinical Trials in the USA / NCT06878261
Recruiting Phase 3

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

NCT06878261 · tracked via the Priya Life Science USA tracker
Sponsor
AstraZeneca
Phase
Phase 3
Started
2025-03-25
Last updated
2026-09-03

Condition(s) studied

Chronic Obstructive Pulmonary Disease (COPD)

Investigational drug(s) / intervention(s)

Tezepelumab →Placebo

Tezepelumab: Tezepelumab subcutaneous injection

Placebo: Placebo subcutaneous injection

Study summary

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)

Eligibility

Sex
ALL
Min age
40 Years
Max age
80 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (276)

FacilityCityRegionStatus
Research Site Cullman Alabama Recruiting
Research Site Phoenix Arizona Recruiting
Research Site Scottsdale Arizona Recruiting
Research Site Inglewood California Withdrawn
Research Site Los Angeles California Recruiting
Research Site Palo Alto California Recruiting
Research Site Redding California Suspended
Research Site San Diego California Suspended
Research Site New Britain Connecticut Recruiting
Research Site Wilmington Delaware Recruiting
Research Site Bay Pines Florida Recruiting
Research Site Boynton Beach Florida Recruiting
Research Site Clearwater Florida Completed
Research Site Fleming Island Florida Suspended
Research Site Jacksonville Florida Recruiting
Research Site Leesburg Florida Recruiting
Research Site Margate Florida Withdrawn
Research Site Miami Florida Recruiting
Research Site Miami Florida Suspended
Research Site Miami Lakes Florida Suspended
Research Site Ocala Florida Recruiting
Research Site Palmetto Bay Florida Recruiting
Research Site Winter Park Florida Recruiting
Research Site Adairsville Georgia Suspended
Research Site Atlanta Georgia Recruiting
Research Site Cordele Georgia Recruiting
Research Site Decatur Georgia Recruiting
Research Site Fort Eisenhower Georgia Withdrawn
Research Site Savannah Georgia Recruiting
Research Site Evanston Illinois Recruiting
Research Site Springfield Illinois Not Yet Recruiting
Research Site Evansville Indiana Recruiting
Research Site Indianapolis Indiana Recruiting
Research Site Indianapolis Indiana Recruiting
Research Site Kansas City Kansas Recruiting
Research Site Bowling Green Kentucky Recruiting
Research Site Owensboro Kentucky Recruiting
Research Site Baltimore Maryland Recruiting
Research Site Potomac Maryland Recruiting
Research Site Rosedale Maryland Recruiting

+ 236 more sites — see the full list on the official registry below.

On this site

📄 Tezspire (tezepelumab) drug profile →

More AstraZeneca trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06878261 on ClinicalTrials.gov ↗ ← All trials in the USA