Recruiting

Phase 3

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

Sponsor:

AstraZeneca

Code:

NCT06878261

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Tezepelumab

Placebo

Study Details

Brief summary:

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)

Study ID

NCT06878261

Start date

Mar 25, 2025

Status verified date

Sep, 2026

Completion date

Jun 5, 2029

Anticipated

Primary completion date

Mar 13, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

990 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose 1 of Tezepelumab

Tezepelumab, SC, Q4W

experimental: Dose 2 of Tezepelumab

Tezepelumab, SC, Q4W

placebo comparator: Matching Placebo

Matching placebo, SC, Q4W

Interventions

Tezepelumab

Tezepelumab subcutaneous injection

Placebo

Placebo subcutaneous injection

Primary outcome measure

Annualised rate of moderate or severe COPD exacerbations [ Time Frame: Baseline up to 76 weeks ]

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479 information.center@astrazeneca.com

Locations

Research Site

Recruiting

Cullman, Alabama, United States, 35055

Research Site

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Phoenix, Arizona, United States, 85044

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Scottsdale, Arizona, United States, 85258

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Los Angeles, California, United States, 90048

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Palo Alto, California, United States, 94304

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New Britain, Connecticut, United States, 06051

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Wilmington, Delaware, United States, 19803

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Bay Pines, Florida, United States, 33744

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Boynton Beach, Florida, United States, 33435

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Jacksonville, Florida, United States, 32209

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Leesburg, Florida, United States, 34748

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Miami, Florida, United States, 33126

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Ocala, Florida, United States, 34470

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Palmetto Bay, Florida, United States, 33157

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Winter Park, Florida, United States, 32789

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Atlanta, Georgia, United States, 30349

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Cordele, Georgia, United States, 31015

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Decatur, Georgia, United States, 30033

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Savannah, Georgia, United States, 31406

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Evanston, Illinois, United States, 60201

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Evansville, Indiana, United States, 47725

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Indianapolis, Indiana, United States, 46202

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Indianapolis, Indiana, United States, 46268

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Kansas City, Kansas, United States, 66160

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Bowling Green, Kentucky, United States, 42101

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Owensboro, Kentucky, United States, 42301

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Baltimore, Maryland, United States, 21224

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Potomac, Maryland, United States, 20854

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Rosedale, Maryland, United States, 21237

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Ann Arbor, Michigan, United States, 48109

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Minneapolis, Minnesota, United States, 55425

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Hannibal, Missouri, United States, 63401

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Staten Island, New York, United States, 10309

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Syracuse, New York, United States, 13203

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Charlotte, North Carolina, United States, 28277

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Oklahoma City, Oklahoma, United States, 73102

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Tulsa, Oklahoma, United States, 74133

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Sayre, Pennsylvania, United States, 18840

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Anderson, South Carolina, United States, 29621

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Columbia, South Carolina, United States, 29204

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Gaffney, South Carolina, United States, 29340

Research Site

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Spartanburg, South Carolina, United States, 29303

Research Site

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Union, South Carolina, United States, 29379

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Rapid City, South Dakota, United States, 57702

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Knoxville, Tennessee, United States, 37919

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Boerne, Texas, United States, 78006

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El Paso, Texas, United States, 79902

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Houston, Texas, United States, 77008

Research Site

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Houston, Texas, United States, 77074

Research Site

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Houston, Texas, United States, 77094

Research Site

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Lewisville, Texas, United States, 75067

Research Site

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McKinney, Texas, United States, 75069

Research Site

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Mesquite, Texas, United States, 75149

Research Site

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San Antonio, Texas, United States, 78258

Research Site

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Colchester, Vermont, United States, 05446

Research Site

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Williamsburg, Virginia, United States, 23188

Research Site

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Everett, Washington, United States, 98208

More Information

Sponsor

AstraZeneca

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-09-03.