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

Description

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)

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

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Study Overview

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Study Details

Study overview

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)

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

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

Condition
Chronic Obstructive Pulmonary Disease (COPD)
Intervention / Treatment

-

Contacts and Locations

Sheffield

Research Site, Sheffield, Alabama, United States, 35660

Tucson

Research Site, Tucson, Arizona, United States, 85704

Newport Beach

Research Site, Newport Beach, California, United States, 92663

Cutler Bay

Research Site, Cutler Bay, Florida, United States, 33157

DeBary

Research Site, DeBary, Florida, United States, 32713

Homestead

Research Site, Homestead, Florida, United States, 33032

Miami

Research Site, Miami, Florida, United States, 33125

Miami

Research Site, Miami, Florida, United States, 33155

Orlando

Research Site, Orlando, Florida, United States, 32807

Tampa

Research Site, Tampa, Florida, United States, 33607

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 ≥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
  • 6. EOS ≥ 150 cells/μL during screening
  • 7. CAT ≥15 at screening
  • 8. Former or current smokers ≥10 pack-years
  • 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
  • * Macrolides (less than 6 months)
  • * Systemic immuno-suppressive, -modulating medications
  • 6. LTOT \>4.0 L/min or O2 saturation \<89% despite LTOT

Ages Eligible for Study

40 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

AstraZeneca,

Dave Singh, MD, PRINCIPAL_INVESTIGATOR, Division of Infection, Immunity & Resp Medicine, The University of Manchester, United Kingdom

Study Record Dates

2029-06-05