Back to Trials
NCT06883305PHASE3Recruiting

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

AstraZeneca

Start Date

3/18/2025

Completion Date

6/5/2029

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)

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.

Eligibility Criteria

Age Range: 40 years to 80 years

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

Interventions

BIOLOGICAL

Tezepelumab

OTHER

Placebo

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Locations

Research Site

Foley, Alabama 36535

United States

Research Site

Mobile, Alabama 36609

United States

Research Site

Sheffield, Alabama 35660

United States

Research Site

Phoenix, Arizona 85012

United States

Research Site

Phoenix, Arizona 85027

United States

Research Site

Tucson, Arizona 85704

United States

Research Site

Garden Grove, California 92844

United States

Research Site

Newport Beach, California 92663

United States

Research Site

Torrance, California 90502

United States

Research Site

Clearwater, Florida 33765

United States

Research Site

Cutler Bay, Florida 33157

United States

Research Site

Cutler Bay, Florida 33189

United States

Research Site

DeBary, Florida 32713

United States

Research Site

Gainesville, Florida 32608

United States

Research Site

Homestead, Florida 33032

United States

Research Site

Miami, Florida 33125

United States

Research Site

Miami, Florida 33125

United States

Research Site

Miami, Florida 33155

United States

Research Site

Miami, Florida 33175

United States

Research Site

Orlando, Florida 32807

United States

Research Site

Tampa, Florida 33606

United States

Research Site

Tampa, Florida 33607

United States

Research Site

Atlanta, Georgia 30344

United States

Research Site

Lithonia, Georgia 30038

United States

Research Site

Rincon, Georgia 31326

United States

Research Site

Chicago, Illinois 60611

United States

Research Site

Palos Hills, Illinois 60465

United States

Research Site

Winfield, Illinois 60190

United States

Research Site

Munster, Indiana 46321

United States

Research Site

Baltimore, Maryland 21201

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

Saint Cloud, Minnesota 56303

United States

Research Site

St Louis, Missouri 63103

United States

Research Site

Missoula, Montana 59808

United States

Research Site

Papillion, Nebraska 68046

United States

Research Site

Las Vegas, Nevada 89106

United States

Research Site

Sewell, New Jersey 08080

United States

Research Site

Toms River, New Jersey 08755

United States

Research Site

Buffalo, New York 14203

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

Kings Mountain, North Carolina 28086

United States

Research Site

New Bern, North Carolina 28562

United States

Research Site

Wilmington, North Carolina 28412

United States

Research Site

Winston-Salem, North Carolina 27103

United States

Research Site

Columbus, Ohio 43213

United States

Research Site

Oklahoma City, Oklahoma 73120

United States

Research Site

DuBois, Pennsylvania 15801

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 37604

United States

Research Site

Dallas, Texas 75254

United States

Research Site

Fort Worth, Texas 76104

United States

Research Site

Houston, Texas 77084

United States

Research Site

Houston, Texas 77090

United States

Research Site

Humble, Texas 77338

United States

Research Site

Kerrville, Texas 78028

United States

Research Site

Mansfield, Texas 76063

United States

Research Site

Clearfield, Utah 84015

United States

Research Site

Morgantown, West Virginia 26501

United States

Research Site

Cudahy, Wisconsin 53110

United States

Research Site

Milwaukee, Wisconsin 53295

United States

Research Site

Bragança Paulista, 12916-542

Brazil

Research Site

Brasília, 70200-730

Brazil

Research Site

Campinas, 13060-080

Brazil

Research Site

Chapecó, 89812-210

Brazil

Research Site

Curitiba, 80030-110

Brazil

Research Site

Jaú, 17201-130

Brazil

Research Site

Mossoró, 59603-020

Brazil

Research Site

Porto Alegre, 90035-903

Brazil

Research Site

Porto Alegre, 90480-000

Brazil

Research Site

Porto Alegre, 90560-003

Brazil

Research Site

Porto Alegre, 9061-000

Brazil

Research Site

Porto Alegre, 91350-200

Brazil

Research Site

Salvador, 40050-410

Brazil

Research Site

São José do Rio Preto, 15090-000

Brazil

Research Site

Vitória, 29062-110

Brazil

Research Site

Calgary, Alberta T3R 1W7

Canada

Research Site

Vancouver, British Columbia V5Z 1M9

Canada

Research Site

Ajax, Ontario L1S 2J5

Canada

Research Site

Burlington, Ontario L7N 3V2

Canada

Research Site

Scarborough Village, Ontario M1P 2V5

Canada

Research Site

Toronto, Ontario M5T 3A9

Canada

Research Site

Winchester, Ontario K0C 2K0

Canada

Research Site

Windsor, Ontario N8X-5A6

Canada

Research Site

Montreal, Quebec H1T 2M4

Canada

Research Site

Montreal, Quebec H3T 1E2

Canada

Research Site

Québec, Quebec G1G 3Y8

Canada

Research Site

Québec, Quebec G1V 4G5

Canada

Research Site

Saint-Charles-Borromée, Quebec J6E 2B4

Canada

Research Site

Saint-Laurent, Quebec H4R3C8

Canada

Research Site

Trois-Rivières, Quebec G8T 7A1

Canada

Research Site

Saskatoon, Saskatchewan S7N 0W8

Canada

Research Site

Concepción, 4070094

Chile

Research Site

Curicó, 3341643

Chile

Research Site

Quillota, 2260000

Chile

Research Site

Santiago, 7500010

Chile

Research Site

Santiago, 7500657

Chile

Research Site

Santiago, 7501126

Chile

Research Site

Santiago, 7750495

Chile

Research Site

Santiago, 8380453

Chile

Research Site

Talca, 3481349

Chile

Research Site

Anyang, 455099

China

Research Site

Beijing, 100020

China

Research Site

Beijing, 100191

China

Research Site

Changchun, 130021

China

Research Site

Changsha, 410008

China

Research Site

Changsha, 410015

China

Research Site

Changsha, 430033

China

Research Site

Chengdu, 610072

China

Research Site

Chengdu, 611130

China

Research Site

Chongqing, 400042

China

Research Site

Chongqing, 401320

China

Research Site

Fuzhou, 350031

China

Research Site

Guangzhou, 510000

China

Research Site

Guangzhou, 510150

China

Research Site

Guangzhou, 510163

China

Research Site

Guangzhou, 510515

China

Research Site

Haikou, 570311

China

Research Site

Hangzhou, 310005

China

Research Site

Hefei, 230061

China

Research Site

Hengyang, 421001

China

Research Site

Heze, 274099

China

Research Site

Hohhot, 750306

China

Research Site

Huizhou, 516002

China

Research Site

Jinan, 250013

China

Research Site

Jinan, 250021

China

Research Site

Jinhua, 321000

China

Research Site

Linhai, 317000

China

Research Site

Loudi, 417099

China

Research Site

Nanchang, 330006

China

Research Site

Nanchong, 637000

China

Research Site

Nanjing, 2100008

China

Research Site

Nanjing, 211100

China

Research Site

Nanning, 530000

China

Research Site

Nanning, 530021

China

Research Site

Pingxiang, 337055

China

Research Site

Qingdao, 266011

China

Research Site

Qingyuan, 511518

China

Research Site

Sanya, 572000

China

Research Site

Shanghai, 200040

China

Research Site

Shanghai, 200120

China

Research Site

Shanghai, 201199

China

Research Site

Shanghai, 310000

China

Research Site

Shantou, 515041

China

Research Site

Shenyang, 110004

China

Research Site

Shenzhen, 518020

China

Research Site

Shijiazhuang, 50051

China

Research Site

Suining Shi, 629000

China

Research Site

Taiyuan, 030001

China

Research Site

Taiyuan, 030032

China

Research Site

Taizhou, 318000

China

Research Site

Tianjin, 300050

China

Research Site

Wenzhou, 325027

China

Research Site

Wuhan, 430022

China

Research Site

Wuhan, 430030

China

Research Site

Xinxiang, 453100

China

Research Site

Xuzhou, 221000

China

Research Site

Xuzhou, 221009

China

Research Site

Yangzhou, 225001

China

Research Site

Yichang, 443003

China

Research Site

Yinchuan, 750001

China

Research Site

Yinchuan, 750004

China

Research Site

Zhangzhou, 363099

China

Research Site

Brandýs nad Labem, 250 01

Czechia

Research Site

Brno, 625 00

Czechia

Research Site

Jindřichův Hradec, 377 01

Czechia

Research Site

Lovosice, 410 02

Czechia

Research Site

Ostrava, 700 30

Czechia

Research Site

Pilsen, 301 00

Czechia

Research Site

Prague, 110 00

Czechia

Research Site

Prague, 15300

Czechia

Research Site

Teplice, 415 01

Czechia

Research Site

Varnsdorf, 407 47

Czechia

Research Site

København NV, 2400

Denmark

Research Site

Bendorf, 56170

Germany

Research Site

Berlin, 10787

Germany

Research Site

Haltern am See, 45721

Germany

Research Site

Hanover, D-30173

Germany

Research Site

Immenhausen, 34376

Germany

Research Site

Lübeck, 23552

Germany

Research Site

Marburg, 35037

Germany

Research Site

Rosenheim, 83022

Germany

Research Site

Wiesbaden, 65183

Germany

Research Site

Ahmedabad, 380053

India

Research Site

Ahmedabad, 380054

India

Research Site

Belagavi, 590010

India

Research Site

Coimbatore, 641028

India

Research Site

Dehradun, 248001

India

Research Site

Delhi, 110029

India

Research Site

Delhi, 110029

India

Research Site

Dwārka, 110075

India

Research Site

Faridabad, 121012

India

Research Site

Gurgaon, 122001

India

Research Site

Kochi, 682027

India

Research Site

Kolkata, 700053

India

Research Site

Kozhikode, 673008

India

Research Site

Lucknow, 226003

India

Research Site

Madurai, 625107

India

Research Site

Mysuru, 570002

India

Research Site

Nagpur, 440012

India

Research Site

Nagpur, 441108

India

Research Site

Pune, 411 018

India

Research Site

Telangana, 500004

India

Research Site

Vadodara, 391760

India

Research Site

Cona, 44124

Italy

Research Site

Florence, 50134

Italy

Research Site

Milan, 20122

Italy

Research Site

Montebelluna, 31044

Italy

Research Site

Naples, 80131

Italy

Research Site

Pavia, 27100

Italy

Research Site

Roma, 00128

Italy

Research Site

Sassari, 07100

Italy

Research Site

Telese Terme, 82037

Italy

Research Site

Tradate, 21049

Italy

Research Site

Alor Star, 5460

Malaysia

Research Site

Kajang, 43000

Malaysia

Research Site

Kota Kinabalu, 88200

Malaysia

Research Site

Kuala Lumpur, 50603

Malaysia

Research Site

Kuala Terengganu, 20400

Malaysia

Research Site

Kuantan, 25100

Malaysia

Research Site

Kuching, 93586

Malaysia

Research Site

Benito Juárez, 03650

Mexico

Research Site

Chihuahua City, 31000

Mexico

Research Site

Cuauhtémoc, 06700

Mexico

Research Site

Cuernavaca, 62290

Mexico

Research Site

Guadalajara, 44130

Mexico

Research Site

Mérida, 97130

Mexico

Research Site

Monterrey, 64310

Mexico

Research Site

Monterrey, 64460

Mexico

Research Site

Monterrey, 64465

Mexico

Research Site

Morelia, 58000

Mexico

Research Site

Oaxaca City, 68020

Mexico

Research Site

San Juan del Río, 76800

Mexico

Research Site

Tijuna, 22010

Mexico

Research Site

Veracruz, 91900

Mexico

Research Site

Zapopan, 45070

Mexico

Research Site

Zapopan, 45138

Mexico

Research Site

Iloilo City, 5000

Philippines

Research Site

Las Piñas, 1742

Philippines

Research Site

Manadaluyong City, 1552

Philippines

Research Site

Manila, 1000

Philippines

Research Site

Marilao, 3019

Philippines

Research Site

Quezon City, 1100

Philippines

Research Site

Quezon City, 1100

Philippines

Research Site

Tondo, 1012

Philippines

Research Site

Bialystok, 15-044

Poland

Research Site

Bydgoszcz, 85-231

Poland

Research Site

Bydgoszcz, 85-796

Poland

Research Site

Chrzanów, 32-500

Poland

Research Site

Karczew, 05-480

Poland

Research Site

Katowice, 40-648

Poland

Research Site

Kielce, 25-426

Poland

Research Site

Krakow, 31-513

Poland

Research Site

Lodz, 91-211

Poland

Research Site

Lublin, 20-011

Poland

Research Site

Ostróda, 14-100

Poland

Research Site

Piaseczno, 05-500

Poland

Research Site

Poznan, 60-693

Poland

Research Site

Pruszków, 05-800

Poland

Research Site

Płock, 09-407

Poland

Research Site

Humenné, 066 01

Slovakia

Research Site

Košice, 04011

Slovakia

Research Site

Levice, 93401

Slovakia

Research Site

Martin, 03659

Slovakia

Research Site

Trnava, 91701

Slovakia

Research Site

Anyang-si, 14068

South Korea

Research Site

Daegu, 42415

South Korea

Research Site

Iksan-si, 54538

South Korea

Research Site

Jeonju, 54907

South Korea

Research Site

Seoul, 06591

South Korea

Research Site

Seoul, 06973

South Korea

Research Site

Seoul, 08308

South Korea

Research Site

Seoul, 135-710

South Korea

Research Site

Seoul, 143-729

South Korea

Research Site

Seoul, 150-713

South Korea

Research Site

Uijeongbu-si, 11765

South Korea

Research Site

Wŏnju, 26426

South Korea

Research Site

Barakaldo, 48903

Spain

Research Site

Barcelona, 08036

Spain

Research Site

Granada, 18014

Spain

Research Site

Madrid, 28007

Spain

Research Site

Málaga, 29010

Spain

Research Site

Palma de Mallorca, 07010

Spain

Research Site

Pamplona, 31008

Spain

Research Site

Seville, 41013

Spain

Research Site

Valencia, 46010

Spain

Research Site

Bradford, BD9 6RJ

United Kingdom

Research Site

Brighton, BN2 1ES

United Kingdom

Research Site

Cottingham, HU16 5JQ

United Kingdom

Research Site

Glasgow, G12 0YN

United Kingdom

Research Site

Halifax, HX3 0PW

United Kingdom

Research Site

Leeds, LS9 7TF

United Kingdom

Research Site

Portsmouth, PO6 3LY

United Kingdom

Research Site

Tyne and Wear, NE29 8NH

United Kingdom

Research Site

Wakefield, WF1 4DG

United Kingdom