A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00007)
AstraZeneca · with Amgen · NCT06878261
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 40–80 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 3
- Target enrollment
- 990
- US sites recruiting
- 57
- Study start
- March 25, 2025
- Record last updated
- October 9, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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)
Being studied: Tezepelumab; Placebo
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- ≥40 to ≤80 years old
- COPD diagnosis ≥1 year,
- Post-BD FEV1 ≥ 20% and ≤ 70% PN, FEV1/FVC \<0.70 at screening
- Triple (ICS+LABA+LAMA) or dual inhaled COPD therapy, if triple therapy is considered not appropriate, ≥3 consecutive months prior to V1
- ≥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
- EOS ≥ 150 cells/μL during screening
- CAT ≥15 at screening
- Former or current smokers ≥10 pack-years
Exclusion Criteria
- Clin. important pulmonary disease or radiological findings suggestive of a respiratory disease other than COPD
- Asthma, incl. pediatric, or ACOS
- Any unstable disorder that can impact participants safety or study outcomes
- Tuberculosis requiring treatment within 12 months prior V2
- Malignancies current or past
Concomitant therapies
- Macrolides (less than 6 months)
- Systemic immuno-suppressive, -modulating medications
- LTOT >4.0 L/min or O2 saturation \<89% despite LTOT
Recruiting US locations
Research Site
Cullman, AL 35055
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Phoenix, AZ 85044
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Scottsdale, AZ 85258
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Palo Alto, CA 94304
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Redding, CA 96001
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New Britain, CT 06051
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Wilmington, DE 19803
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Bay Pines, FL 33744
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Boynton Beach, FL 33435
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Jacksonville, FL 32209
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Leesburg, FL 34748
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Miami, FL 33126
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Ocala, FL 34470
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Winter Park, FL 32789
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Atlanta, GA 30349
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Cordele, GA 31015
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Decatur, GA 30033
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Savannah, GA 31406
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Evanston, IL 60201
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Evansville, IN 47725
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Indianapolis, IN 46202
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Indianapolis, IN 46268
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Kansas City, KS 66160
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Bowling Green, KY 42101
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Owensboro, KY 42301
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Baltimore, MD 21224
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Potomac, MD 20854
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Rosedale, MD 21237
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Ann Arbor, MI 48109
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Minneapolis, MN 55425
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Hannibal, MO 63401
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Staten Island, NY 10309
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Syracuse, NY 13203
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The Bronx, NY 10459
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Charlotte, NC 28277
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Oklahoma City, OK 73102
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Tulsa, OK 74133
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Sayre, PA 18840
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Anderson, SC 29621
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Columbia, SC 29204
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Gaffney, SC 29340
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Spartanburg, SC 29303
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Union, SC 29379
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Rapid City, SD 57702
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Knoxville, TN 37919
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Boerne, TX 78006
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El Paso, TX 79902
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Houston, TX 77008
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Houston, TX 77074
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Houston, TX 77094
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Lewisville, TX 75067
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McKinney, TX 75069
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Mesquite, TX 75149
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San Antonio, TX 78258
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Colchester, VT 05446
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Williamsburg, VA 23188
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Everett, WA 98208
Study contacts (from the official record)
- AstraZeneca Clinical Study Information Center · 1-877-240-9479 · information.center@astrazeneca.com