Dysautonomia International

A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00006)

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

Chronic Obstructive Pulmonary Disease (COPD)

Eligibility

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

Inclusion Criteria

≥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

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

Arm	Description	Assigned 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
Foley, Alabama 36535

Research Site
Mobile, Alabama 36609

Research Site
Sheffield, Alabama 35660

Research Site
Phoenix, Arizona 85027

Research Site
Garden Grove, California 92844

Research Site
Newport Beach, California 92663

Research Site
Torrance, California 90502

Research Site
Clearwater, Florida 33765

Research Site
Cutler Bay, Florida 33157

Research Site
Cutler Bay, Florida 33189

Research Site
DeBary, Florida 32713

Research Site
Homestead, Florida 33032

Research Site
Miami, Florida 33125

Research Site
Miami, Florida 33155

Research Site
Miami, Florida 33175

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Orlando, Florida 32807

Research Site
Tampa, Florida 33606

Research Site
Tampa, Florida 33607

Research Site
Atlanta, Georgia 30344

Research Site
Lithonia, Georgia 30038

Research Site
Rincon, Georgia 31326

Research Site
Palos Hills, Illinois 60465

Research Site
Winfield, Illinois 60190

Research Site
Munster, Indiana 46321

Research Site
Baltimore, Maryland 21201

Research Site
Columbia, Maryland 21045

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North Dartmouth, Massachusetts 02747

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Farmington Hills, Michigan 48336

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Saint Cloud, Minnesota 56303

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Missoula, Montana 59808

Research Site
Papillion, Nebraska 68046

Research Site
Las Vegas, Nevada 89106

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Millville, New Jersey 08332

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Sewell, New Jersey 08080

Research Site
Toms River, New Jersey 08755

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Buffalo, New York 14215

Research Site
Cortland, New York 13045

Research Site
Horseheads, New York 14845

Research Site
High Point, North Carolina 27260

Research Site
Kings Mountain, North Carolina 28086

Research Site
New Bern, North Carolina 28562

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Winston-Salem, North Carolina 27103

Research Site
Columbus, Ohio 43213

Research Site
Oklahoma City, Oklahoma 73120

Research Site
DuBois, Pennsylvania 15801

Research Site
Philadelphia, Pennsylvania 19140

Research Site
Rock Hill, South Carolina 29732

Research Site
Franklin, Tennessee 37067

Research Site
Johnson City, Tennessee 37604

Research Site
Dallas, Texas 75254

Research Site
Fort Worth, Texas 76104

Research Site
Houston, Texas 77084

Research Site
Houston, Texas 77090

Research Site
Humble, Texas 77338

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Kerrville, Texas 78028

Research Site
Mansfield, Texas 76063

Research Site
Clearfield, Utah 84015

Research Site
Morgantown, West Virginia 26501

Research Site
Cudahy, Wisconsin 53110

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.