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

Recruiting · NCT06883305 · Interventional (participants receive a specific treatment) · Lead sponsor: AstraZeneca

View the official record on ClinicalTrials.gov →

Interventions studied

What this trial is about

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)

Who can take part

Age range

40 Years to 80 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 3

Study type

Interventional (participants receive a specific treatment)

Inclusion criteria

≥40 to ≤80 years old
COPD diagnosis ≥1 year,
Post-BD FEV1 ≥ 20% and ≤ 70% PN, FEV1/FVC \<0.70 at screening
Triple (ICS+LABA+LAMA) or dual inhaled COPD therapy, if triple therapy is considered not appropriate, ≥3 consecutive months prior to V1
≥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
EOS ≥ 150 cells/μL during screening
CAT ≥15 at screening
Former or current smokers ≥10 pack-years

Exclusion criteria

Clin. important pulmonary disease or radiological findings suggestive of a respiratory disease other than COPD
Asthma, incl. pediatric, or ACOS
Any unstable disorder that can impact participants safety or study outcomes
Tuberculosis requiring treatment within 12 months prior V2
Malignancies current or past
Concomitant therapies:
Macrolides (less than 6 months)
Systemic immuno-suppressive, -modulating medications
LTOT \>4.0 L/min or O2 saturation \<89% despite LTOT

Where it is running

60 locations listed across 29 US states.

Research Site - Foley, Alabama, United States
Research Site - Mobile, Alabama, United States
Research Site - Sheffield, Alabama, United States
Research Site - Phoenix, Arizona, United States
Research Site - Phoenix, Arizona, United States
Research Site - Tucson, Arizona, United States
Research Site - Garden Grove, California, United States
Research Site - Newport Beach, California, United States
Research Site - Torrance, California, United States
Research Site - Clearwater, Florida, United States
Research Site - Cutler Bay, Florida, United States
Research Site - Cutler Bay, Florida, United States
Research Site - DeBary, Florida, United States
Research Site - Gainesville, Florida, United States
Research Site - Homestead, Florida, United States
Research Site - Miami, Florida, United States
Research Site - Miami, Florida, United States
Research Site - Miami, Florida, United States
Research Site - Orlando, Florida, United States
Research Site - Tampa, Florida, United States
Research Site - Tampa, Florida, United States
Research Site - Atlanta, Georgia, United States
Research Site - Lithonia, Georgia, United States
Research Site - Rincon, Georgia, United States
Research Site - Meridian, Idaho, United States
Research Site - Chicago, Illinois, United States
Research Site - Palos Hills, Illinois, United States
Research Site - Winfield, Illinois, United States
Research Site - Munster, Indiana, United States
Research Site - Baltimore, Maryland, United States
Research Site - Columbia, Maryland, United States
Research Site - North Dartmouth, Massachusetts, United States
Research Site - Farmington Hills, Michigan, United States
Research Site - Saint Cloud, Minnesota, United States
Research Site - St Louis, Missouri, United States
Research Site - St Louis, Missouri, United States
Research Site - Missoula, Montana, United States
Research Site - Papillion, Nebraska, United States
Research Site - Las Vegas, Nevada, United States
Research Site - Millville, New Jersey, United States
Research Site - Sewell, New Jersey, United States
Research Site - Toms River, New Jersey, United States
Research Site - Albuquerque, New Mexico, United States
Research Site - Buffalo, New York, United States
Research Site - Buffalo, New York, United States
Research Site - Cortland, New York, United States
Research Site - Horseheads, New York, United States
Research Site - Massapequa, New York, United States
Research Site - The Bronx, New York, United States
Research Site - High Point, North Carolina, United States
Research Site - Kings Mountain, North Carolina, United States
Research Site - New Bern, North Carolina, United States
Research Site - Wilmington, North Carolina, United States
Research Site - Winston-Salem, North Carolina, United States
Research Site - Columbus, Ohio, United States
Research Site - Oklahoma City, Oklahoma, United States
Research Site - DuBois, Pennsylvania, United States
Research Site - Philadelphia, Pennsylvania, United States
Research Site - Rock Hill, South Carolina, United States
Research Site - Franklin, Tennessee, United States

Showing 60 of 305 listed sites. See the official record for the complete list.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →