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Purpose

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)

Condition

Eligibility

Eligible Ages
Between 40 Years and 80 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion 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, if triple therapy is considered not appropriate, ≥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. At least one of the previous exacerbations should be confirmed to have occurred while the participant was on triple or dual inhaled maintenance therapy 6. EOS ≥ 150 cells/μL during screening 7. CAT ≥15 at screening 8. Former or current smokers ≥10 pack-years

Exclusion Criteria

  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 Concomitant therapies: - Macrolides (less than 6 months) - Systemic immuno-suppressive, -modulating medications 6. LTOT >4.0 L/min or O2 saturation <89% despite LTOT

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Participants will be randomised in a ratio of 1:1:1 to receive Dose 1 of tezepelumab, Dose 2 of tezepelumab or matching placebo.
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Double-blinded

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Dose 1 of Tezepelumab 		Tezepelumab, SC, Q4W
  • Biological: Tezepelumab
    Tezepelumab subcutaneous injection
Experimental
Dose 2 of Tezepelumab 		Tezepelumab, SC, Q4W
  • Biological: Tezepelumab
    Tezepelumab subcutaneous injection
Placebo Comparator
Matching Placebo 		Matching placebo, SC, Q4W
  • Other: Placebo
    Placebo subcutaneous injection

Recruiting Locations

Research Site
Cullman, Alabama 35055

Research Site
Phoenix, Arizona 85044

Research Site
Scottsdale, Arizona 85258

Research Site
Los Angeles, California 90048

Research Site
Palo Alto, California 94304

Research Site
New Britain, Connecticut 06051

Research Site
Wilmington, Delaware 19803

Research Site
Bay Pines, Florida 33744

Research Site
Boynton Beach, Florida 33435

Research Site
Jacksonville, Florida 32209

Research Site
Leesburg, Florida 34748

Research Site
Miami, Florida 33126

Research Site
Ocala, Florida 34470

Research Site
Palmetto Bay, Florida 33157

Research Site
Winter Park, Florida 32789

Research Site
Atlanta, Georgia 30349

Research Site
Cordele, Georgia 31015

Research Site
Decatur, Georgia 30033

Research Site
Savannah, Georgia 31406

Research Site
Evanston, Illinois 60201

Research Site
Evansville, Indiana 47725

Research Site
Indianapolis, Indiana 46202

Research Site
Indianapolis, Indiana 46268

Research Site
Kansas City, Kansas 66160

Research Site
Bowling Green, Kentucky 42101

Research Site
Owensboro, Kentucky 42301

Research Site
Baltimore, Maryland 21224

Research Site
Potomac, Maryland 20854

Research Site
Rosedale, Maryland 21237

Research Site
Ann Arbor, Michigan 48109

Research Site
Minneapolis, Minnesota 55425

Research Site
Hannibal, Missouri 63401

Research Site
Staten Island, New York 10309

Research Site
Syracuse, New York 13203

Research Site
Charlotte, North Carolina 28277

Research Site
Oklahoma City, Oklahoma 73102

Research Site
Tulsa, Oklahoma 74133

Research Site
Sayre, Pennsylvania 18840

Research Site
Anderson, South Carolina 29621

Research Site
Columbia, South Carolina 29204

Research Site
Gaffney, South Carolina 29340

Research Site
Spartanburg, South Carolina 29303

Research Site
Union, South Carolina 29379

Research Site
Rapid City, South Dakota 57702

Research Site
Knoxville, Tennessee 37919

Research Site
Boerne, Texas 78006

Research Site
El Paso, Texas 79902

Research Site
Houston, Texas 77008

Research Site
Houston, Texas 77074

Research Site
Houston, Texas 77094

Research Site
Lewisville, Texas 75067

Research Site
McKinney, Texas 75069

Research Site
Mesquite, Texas 75149

Research Site
San Antonio, Texas 78258

Research Site
Colchester, Vermont 05446

Research Site
Williamsburg, Virginia 23188

Research Site
Everett, Washington 98208

More Details

Status
Recruiting
Sponsor
AstraZeneca

Study Contact

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

Detailed Description

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of tezepelumab in adults with moderate to very severe chronic obstructive pulmonary disease (COPD) receiving inhaled maintenance therapy and having had at least 2 moderate, or 1 severe, COPD exacerbations in the 12 months prior to Visit 1. Subjects will receive monthly subcutaneous injection of one of two different doses of tezepelumab, or placebo, with a maximum treatment duration of 76 weeks and a minimum of 52 weeks. The study also includes a off-treatment safety follow-up period of 12 weeks.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.