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Clinical Trials in the UK / NCT06883305
Recruiting Phase 3

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

NCT06883305 · tracked via the Priya Life Science UK tracker
Sponsor
AstraZeneca
Phase
Phase 3
Started
2025-03-18
Last updated
2026-09-03

Condition(s) studied

Chronic Obstructive Pulmonary Disease (COPD)

Investigational drug(s) / intervention(s)

TezepelumabPlacebo

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 (305)

FacilityCityRegionStatus
Research Site Foley Alabama Recruiting
Research Site Mobile Alabama Recruiting
Research Site Sheffield Alabama Recruiting
Research Site Phoenix Arizona Not Yet Recruiting
Research Site Phoenix Arizona Recruiting
Research Site Tucson Arizona Withdrawn
Research Site Garden Grove California Recruiting
Research Site Newport Beach California Recruiting
Research Site Torrance California Recruiting
Research Site Clearwater Florida Recruiting
Research Site Cutler Bay Florida Recruiting
Research Site Cutler Bay Florida Recruiting
Research Site DeBary Florida Recruiting
Research Site Gainesville Florida Not Yet Recruiting
Research Site Homestead Florida Recruiting
Research Site Miami Florida Recruiting
Research Site Miami Florida Recruiting
Research Site Miami Florida Recruiting
Research Site Orlando Florida Recruiting
Research Site Tampa Florida Recruiting
Research Site Tampa Florida Recruiting
Research Site Atlanta Georgia Recruiting
Research Site Lithonia Georgia Recruiting
Research Site Rincon Georgia Recruiting
Research Site Meridian Idaho Not Yet Recruiting
Research Site Chicago Illinois Withdrawn
Research Site Palos Hills Illinois Recruiting
Research Site Winfield Illinois Recruiting
Research Site Munster Indiana Recruiting
Research Site Baltimore Maryland Recruiting
Research Site Columbia Maryland Recruiting
Research Site North Dartmouth Massachusetts Recruiting
Research Site Farmington Hills Michigan Recruiting
Research Site Saint Cloud Minnesota Recruiting
Research Site St Louis Missouri Not Yet Recruiting
Research Site St Louis Missouri Withdrawn
Research Site Missoula Montana Recruiting
Research Site Papillion Nebraska Recruiting
Research Site Las Vegas Nevada Recruiting
Research Site Millville New Jersey Recruiting

+ 265 more sites — see the full list on the official registry below.

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 NCT06883305 on ClinicalTrials.gov ↗ ← All trials in the UK