RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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)

Official Title

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

Quick Facts

Study Start:2025-03-25
Study Completion:2029-06-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06878261

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.

Ages Eligible for Study:40 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. ≥40 to ≤80 years old
  2. 2. COPD diagnosis ≥1 year,
  3. 3. Post-BD FEV1 ≥ 20% and ≤ 70% PN, FEV1/FVC \<0.70 at screening
  4. 4. Triple (ICS+LABA+LAMA) or dual inhaled COPD therapy ≥3 consecutive months prior to V1
  5. 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. 6. EOS ≥ 150 cells/μL during screening
  7. 7. CAT ≥15 at screening
  8. 8. Former or current smokers ≥10 pack-years
  1. 1. Clin. important pulmonary disease or radiological findings suggestive of a respiratory disease other than COPD
  2. 2. Asthma, incl. pediatric, or ACOS
  3. 3. Any unstable disorder that can impact participants safety or study outcomes
  4. 4. Tuberculosis requiring treatment within 12 months prior V2
  5. 5. Malignancies current or past
  6. * Macrolides (less than 6 months)
  7. * Systemic immuno-suppressive, -modulating medications
  8. 6. LTOT \>4.0 L/min or O2 saturation \<89% despite LTOT

Contacts and Locations

Study Contact

AstraZeneca Clinical Study Information Center
CONTACT
1-877-240-9479
information.center@astrazeneca.com

Principal Investigator

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

Study Locations (Sites)

Research Site
Tempe, Arizona, 85283
United States
Research Site
Redding, California, 96001
United States
Research Site
San Diego, California, 92108
United States
Research Site
Boynton Beach, Florida, 33435
United States
Research Site
Clearwater, Florida, 33765
United States
Research Site
Jacksonville, Florida, 32209
United States
Research Site
Margate, Florida, 33063
United States
Research Site
Miami Lakes, Florida, 33014
United States
Research Site
Miami, Florida, 33126
United States
Research Site
Miami, Florida, 33155
United States
Research Site
Ocala, Florida, 34470
United States
Research Site
Palmetto Bay, Florida, 33157
United States
Research Site
Adairsville, Georgia, 30103
United States
Research Site
Atlanta, Georgia, 30349
United States
Research Site
Fort Eisenhower, Georgia, 30905
United States
Research Site
Savannah, Georgia, 31406
United States
Research Site
Evansville, Indiana, 47710
United States
Research Site
Indianapolis, Indiana, 46202
United States
Research Site
Indianapolis, Indiana, 46268
United States
Research Site
Kansas City, Kansas, 66160
United States
Research Site
Bowling Green, Kentucky, 42101
United States
Research Site
Owensboro, Kentucky, 42301
United States
Research Site
Baltimore, Maryland, 21224
United States
Research Site
Potomac, Maryland, 20854
United States
Research Site
Minneapolis, Minnesota, 55425
United States
Research Site
Hannibal, Missouri, 63401
United States
Research Site
Charlotte, North Carolina, 28277
United States
Research Site
Fayetteville, North Carolina, 28303
United States
Research Site
Oklahoma City, Oklahoma, 73102
United States
Research Site
Tulsa, Oklahoma, 74133
United States
Research Site
Grants Pass, Oregon, 97527
United States
Research Site
Anderson, South Carolina, 29621
United States
Research Site
Columbia, South Carolina, 29204
United States
Research Site
Gaffney, South Carolina, 29340
United States
Research Site
Spartanburg, South Carolina, 29303
United States
Research Site
Union, South Carolina, 29379
United States
Research Site
Rapid City, South Dakota, 57702
United States
Research Site
Knoxville, Tennessee, 37919
United States
Research Site
Boerne, Texas, 78006
United States
Research Site
El Paso, Texas, 79902
United States
Research Site
Houston, Texas, 77008
United States
Research Site
Lewisville, Texas, 75067
United States
Research Site
McKinney, Texas, 75069
United States
Research Site
Colchester, Vermont, 05446
United States
Research Site
Williamsburg, Virginia, 23188
United States
Research Site
Everett, Washington, 98208
United States

Collaborators and Investigators

Sponsor: AstraZeneca

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-25
Study Completion Date2029-06-05

Study Record Updates

Study Start Date2025-03-25
Study Completion Date2029-06-05

Terms related to this study

Keywords Provided by Researchers

  • COPD
  • Moderate COPD
  • Severe COPD
  • Very Severe COPD
  • chronic obstructive pulmonary disease

Additional Relevant MeSH Terms

  • Chronic Obstructive Pulmonary Disease (COPD)