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

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)

Talk to us

Study Overview

On this page

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 (D5241C00007)

Condition
Chronic Obstructive Pulmonary Disease (COPD)
Intervention / Treatment

-

Contacts and Locations

Tempe

Research Site, Tempe, Arizona, United States, 85283

Redding

Research Site, Redding, California, United States, 96001

San Diego

Research Site, San Diego, California, United States, 92108

Boynton Beach

Research Site, Boynton Beach, Florida, United States, 33435

Clearwater

Research Site, Clearwater, Florida, United States, 33765

Jacksonville

Research Site, Jacksonville, Florida, United States, 32209

Margate

Research Site, Margate, Florida, United States, 33063

Miami Lakes

Research Site, Miami Lakes, Florida, United States, 33014

Miami

Research Site, Miami, Florida, United States, 33126

Miami

Research Site, Miami, Florida, United States, 33155

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,

MeiLan Han, MD, PRINCIPAL_INVESTIGATOR, University of Michigan Health, Pulmonary & Critical Care Medicine,

Study Record Dates

2029-06-05