RECRUITING

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

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:2025-03-18
Study Completion:2029-06-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06883305

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

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

Study Locations (Sites)

Research Site
Sheffield, Alabama, 35660
United States
Research Site
Tucson, Arizona, 85704
United States
Research Site
Newport Beach, California, 92663
United States
Research Site
Cutler Bay, Florida, 33157
United States
Research Site
DeBary, Florida, 32713
United States
Research Site
Homestead, Florida, 33032
United States
Research Site
Miami, Florida, 33125
United States
Research Site
Miami, Florida, 33155
United States
Research Site
Orlando, Florida, 32807
United States
Research Site
Tampa, Florida, 33607
United States
Research Site
Rincon, Georgia, 31326
United States
Research Site
Evanston, Illinois, 60208
United States
Research Site
Winfield, Illinois, 60190
United States
Research Site
Columbia, Maryland, 21045
United States
Research Site
North Dartmouth, Massachusetts, 02747
United States
Research Site
Farmington Hills, Michigan, 48336
United States
Research Site
Missoula, Montana, 59808
United States
Research Site
Papillion, Nebraska, 68046
United States
Research Site
Toms River, New Jersey, 08755
United States
Research Site
Buffalo, New York, 14215
United States
Research Site
Cortland, New York, 13045
United States
Research Site
Horseheads, New York, 14845
United States
Research Site
High Point, North Carolina, 27260
United States
Research Site
New Bern, North Carolina, 28562
United States
Research Site
Wilmington, North Carolina, 28401
United States
Research Site
Winston-Salem, North Carolina, 27103
United States
Research Site
Dublin, Ohio, 43016
United States
Research Site
Oklahoma City, Oklahoma, 73120
United States
Research Site
Philadelphia, Pennsylvania, 19140
United States
Research Site
Rock Hill, South Carolina, 29732
United States
Research Site
Franklin, Tennessee, 37067
United States
Research Site
Johnson City, Tennessee, 37601
United States
Research Site
Houston, Texas, 77084
United States
Research Site
Houston, Texas, 77090
United States
Research Site
Kerrville, Texas, 78028
United States
Research Site
Mansfield, Texas, 76063
United States
Research Site
Cudahy, Wisconsin, 53110
United States

Collaborators and Investigators

Sponsor: AstraZeneca

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

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 Date2025-03-18
Study Completion Date2029-06-05

Study Record Updates

Study Start Date2025-03-18
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)