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

May 6, 2026 updated by: AstraZeneca

A Randomised, Double-blind, Placebo-controlled, Parallel Group, Multicentre, Phase III Study to Evaluate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease

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)

Study Overview

Status

Recruiting

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

990

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: AstraZeneca Clinical Study Information Center
Phone Number: 1-877-240-9479
Email: information.center@astrazeneca.com

Study Locations

Brazil
- - Bragança Paulista, Brazil, 12916-542
    - Recruiting
    - Research Site
  - Brasília, Brazil, 70200-730
    - Recruiting
    - Research Site
  - Campinas, Brazil, 13060-080
    - Recruiting
    - Research Site
  - Chapecó, Brazil, 89812-210
    - Recruiting
    - Research Site
  - Curitiba, Brazil, 80030-110
    - Recruiting
    - Research Site
  - Jaú, Brazil, 17201-130
    - Recruiting
    - Research Site
  - Mossoró, Brazil, 59603-020
    - Recruiting
    - Research Site
  - Porto Alegre, Brazil, 90035-903
    - Recruiting
    - Research Site
  - Porto Alegre, Brazil, 91350-200
    - Recruiting
    - Research Site
  - Porto Alegre, Brazil, 9061-000
    - Recruiting
    - Research Site
  - Porto Alegre, Brazil, 90480-000
    - Recruiting
    - Research Site
  - Porto Alegre, Brazil, 90560-003
    - Recruiting
    - Research Site
  - Salvador, Brazil, 40050-410
    - Recruiting
    - Research Site
  - São José do Rio Preto, Brazil, 15090-000
    - Recruiting
    - Research Site
  - Vitória, Brazil, 29062-110
    - Recruiting
    - Research Site
Canada
- Alberta
  - Calgary, Alberta, Canada, T3R 1W7
    - Recruiting
    - Research Site
- British Columbia
  - Vancouver, British Columbia, Canada, V5Z 1M9
    - Recruiting
    - Research Site
- Ontario
  - Ajax, Ontario, Canada, L1S 2J5
    - Recruiting
    - Research Site
  - Burlington, Ontario, Canada, L7N 3V2
    - Recruiting
    - Research Site
  - Scarborough Village, Ontario, Canada, M1P 2V5
    - Recruiting
    - Research Site
  - Toronto, Ontario, Canada, M5T 3A9
    - Withdrawn
    - Research Site
  - Winchester, Ontario, Canada, K0C 2K0
    - Recruiting
    - Research Site
  - Windsor, Ontario, Canada, N8X-5A6
    - Recruiting
    - Research Site
- Quebec
  - Montreal, Quebec, Canada, H3T 1E2
    - Withdrawn
    - Research Site
  - Montreal, Quebec, Canada, H1T 2M4
    - Withdrawn
    - Research Site
  - Québec, Quebec, Canada, G1V 4G5
    - Recruiting
    - Research Site
  - Québec, Quebec, Canada, G1G 3Y8
    - Recruiting
    - Research Site
  - Saint-Charles-Borromée, Quebec, Canada, J6E 2B4
    - Recruiting
    - Research Site
  - Saint-Laurent, Quebec, Canada, H4R3C8
    - Recruiting
    - Research Site
  - Trois-Rivières, Quebec, Canada, G8T 7A1
    - Recruiting
    - Research Site
- Saskatchewan
  - Saskatoon, Saskatchewan, Canada, S7N 0W8
    - Not yet recruiting
    - Research Site
Chile
- - Concepción, Chile, 4070094
    - Recruiting
    - Research Site
  - Curicó, Chile, 3341643
    - Recruiting
    - Research Site
  - Quillota, Chile, 2260000
    - Recruiting
    - Research Site
  - Santiago, Chile, 7500010
    - Recruiting
    - Research Site
  - Santiago, Chile, 7501126
    - Recruiting
    - Research Site
  - Santiago, Chile, 7500657
    - Recruiting
    - Research Site
  - Santiago, Chile, 8380453
    - Recruiting
    - Research Site
  - Santiago, Chile, 7750495
    - Recruiting
    - Research Site
  - Talca, Chile, 3481349
    - Recruiting
    - Research Site
China
- - Anyang, China, 455099
    - Recruiting
    - Research Site
  - Beijing, China, 100191
    - Recruiting
    - Research Site
  - Beijing, China, 100020
    - Recruiting
    - Research Site
  - Changchun, China, 130021
    - Recruiting
    - Research Site
  - Changsha, China, 410008
    - Recruiting
    - Research Site
  - Changsha, China, 430033
    - Recruiting
    - Research Site
  - Changsha, China, 410015
    - Recruiting
    - Research Site
  - Chengdu, China, 610072
    - Recruiting
    - Research Site
  - Chengdu, China, 611130
    - Recruiting
    - Research Site
  - Chongqing, China, 400042
    - Recruiting
    - Research Site
  - Chongqing, China, 401320
    - Withdrawn
    - Research Site
  - Fuzhou, China, 350031
    - Recruiting
    - Research Site
  - Guangzhou, China, 510150
    - Recruiting
    - Research Site
  - Guangzhou, China, 510515
    - Recruiting
    - Research Site
  - Guangzhou, China, 510000
    - Recruiting
    - Research Site
  - Guangzhou, China, 510163
    - Recruiting
    - Research Site
  - Haikou, China, 570311
    - Recruiting
    - Research Site
  - Hangzhou, China, 310005
    - Recruiting
    - Research Site
  - Hefei, China, 230061
    - Recruiting
    - Research Site
  - Hengyang, China, 421001
    - Recruiting
    - Research Site
  - Heze, China, 274099
    - Recruiting
    - Research Site
  - Hohhot, China, 750306
    - Recruiting
    - Research Site
  - Huizhou, China, 516002
    - Recruiting
    - Research Site
  - Jinan, China, 250013
    - Recruiting
    - Research Site
  - Jinan, China, 250021
    - Recruiting
    - Research Site
  - Jinhua, China, 321000
    - Recruiting
    - Research Site
  - Linhai, China, 317000
    - Recruiting
    - Research Site
  - Loudi, China, 417099
    - Recruiting
    - Research Site
  - Nanchang, China, 330006
    - Recruiting
    - Research Site
  - Nanchong, China, 637000
    - Recruiting
    - Research Site
  - Nanjing, China, 2100008
    - Recruiting
    - Research Site
  - Nanjing, China, 211100
    - Recruiting
    - Research Site
  - Nanning, China, 530021
    - Recruiting
    - Research Site
  - Nanning, China, 530000
    - Recruiting
    - Research Site
  - Pingxiang, China, 337055
    - Recruiting
    - Research Site
  - Qingdao, China, 266011
    - Recruiting
    - Research Site
  - Qingyuan, China, 511518
    - Recruiting
    - Research Site
  - Sanya, China, 572000
    - Withdrawn
    - Research Site
  - Shanghai, China, 201199
    - Recruiting
    - Research Site
  - Shanghai, China, 200120
    - Recruiting
    - Research Site
  - Shanghai, China, 310000
    - Recruiting
    - Research Site
  - Shanghai, China, 200040
    - Withdrawn
    - Research Site
  - Shantou, China, 515041
    - Recruiting
    - Research Site
  - Shenyang, China, 110004
    - Not yet recruiting
    - Research Site
  - Shenzhen, China, 518020
    - Recruiting
    - Research Site
  - Shijiazhuang, China, 50051
    - Recruiting
    - Research Site
  - Suining Shi, China, 629000
    - Recruiting
    - Research Site
  - Taiyuan, China, 030001
    - Recruiting
    - Research Site
  - Taiyuan, China, 030032
    - Recruiting
    - Research Site
  - Taizhou, China, 318000
    - Recruiting
    - Research Site
  - Tianjin, China, 300050
    - Recruiting
    - Research Site
  - Wenzhou, China, 325027
    - Recruiting
    - Research Site
  - Wuhan, China, 430022
    - Recruiting
    - Research Site
  - Wuhan, China, 430030
    - Recruiting
    - Research Site
  - Xinxiang, China, 453100
    - Recruiting
    - Research Site
  - Xuzhou, China, 221000
    - Recruiting
    - Research Site
  - Xuzhou, China, 221009
    - Recruiting
    - Research Site
  - Yangzhou, China, 225001
    - Recruiting
    - Research Site
  - Yichang, China, 443003
    - Recruiting
    - Research Site
  - Yinchuan, China, 750001
    - Recruiting
    - Research Site
  - Yinchuan, China, 750004
    - Withdrawn
    - Research Site
  - Zhangzhou, China, 363099
    - Recruiting
    - Research Site
Czechia
- - Brandýs nad Labem, Czechia, 250 01
    - Withdrawn
    - Research Site
  - Brno, Czechia, 625 00
    - Recruiting
    - Research Site
  - Jindřichův Hradec, Czechia, 377 01
    - Recruiting
    - Research Site
  - Lovosice, Czechia, 410 02
    - Recruiting
    - Research Site
  - Ostrava, Czechia, 700 30
    - Withdrawn
    - Research Site
  - Pilsen, Czechia, 301 00
    - Recruiting
    - Research Site
  - Prague, Czechia, 15300
    - Recruiting
    - Research Site
  - Prague, Czechia, 110 00
    - Recruiting
    - Research Site
  - Teplice, Czechia, 415 01
    - Recruiting
    - Research Site
  - Varnsdorf, Czechia, 407 47
    - Recruiting
    - Research Site
Denmark
- - København NV, Denmark, 2400
    - Recruiting
    - Research Site
Germany
- - Bendorf, Germany, 56170
    - Recruiting
    - Research Site
  - Berlin, Germany, 10787
    - Recruiting
    - Research Site
  - Haltern am See, Germany, 45721
    - Withdrawn
    - Research Site
  - Hanover, Germany, D-30173
    - Recruiting
    - Research Site
  - Immenhausen, Germany, 34376
    - Recruiting
    - Research Site
  - Lübeck, Germany, 23552
    - Withdrawn
    - Research Site
  - Marburg, Germany, 35037
    - Recruiting
    - Research Site
  - Rosenheim, Germany, 83022
    - Recruiting
    - Research Site
  - Wiesbaden, Germany, 65183
    - Recruiting
    - Research Site
India
- - Ahmedabad, India, 380054
    - Recruiting
    - Research Site
  - Ahmedabad, India, 380053
    - Recruiting
    - Research Site
  - Belagavi, India, 590010
    - Recruiting
    - Research Site
  - Coimbatore, India, 641028
    - Recruiting
    - Research Site
  - Dehradun, India, 248001
    - Recruiting
    - Research Site
  - Delhi, India, 110029
    - Not yet recruiting
    - Research Site
  - Delhi, India, 110029
    - Recruiting
    - Research Site
  - Dwārka, India, 110075
    - Recruiting
    - Research Site
  - Faridabad, India, 121012
    - Withdrawn
    - Research Site
  - Gurgaon, India, 122001
    - Recruiting
    - Research Site
  - Kochi, India, 682027
    - Suspended
    - Research Site
  - Kolkata, India, 700053
    - Suspended
    - Research Site
  - Kozhikode, India, 673008
    - Not yet recruiting
    - Research Site
  - Lucknow, India, 226003
    - Suspended
    - Research Site
  - Madurai, India, 625107
    - Withdrawn
    - Research Site
  - Mysuru, India, 570002
    - Recruiting
    - Research Site
  - Nagpur, India, 440012
    - Recruiting
    - Research Site
  - Nagpur, India, 441108
    - Recruiting
    - Research Site
  - Pune, India, 411 018
    - Withdrawn
    - Research Site
  - Telangana, India, 500004
    - Not yet recruiting
    - Research Site
  - Vadodara, India, 391760
    - Recruiting
    - Research Site
Italy
- - Cona, Italy, 44124
    - Not yet recruiting
    - Research Site
  - Florence, Italy, 50134
    - Recruiting
    - Research Site
  - Milan, Italy, 20122
    - Withdrawn
    - Research Site
  - Montebelluna, Italy, 31044
    - Recruiting
    - Research Site
  - Naples, Italy, 80131
    - Recruiting
    - Research Site
  - Pavia, Italy, 27100
    - Recruiting
    - Research Site
  - Roma, Italy, 00128
    - Recruiting
    - Research Site
  - Sassari, Italy, 07100
    - Recruiting
    - Research Site
  - Telese Terme, Italy, 82037
    - Recruiting
    - Research Site
  - Tradate, Italy, 21049
    - Recruiting
    - Research Site
Malaysia
- - Alor Star, Malaysia, 5460
    - Recruiting
    - Research Site
  - Kajang, Malaysia, 43000
    - Recruiting
    - Research Site
  - Kota Kinabalu, Malaysia, 88200
    - Recruiting
    - Research Site
  - Kuala Lumpur, Malaysia, 50603
    - Recruiting
    - Research Site
  - Kuala Terengganu, Malaysia, 20400
    - Recruiting
    - Research Site
  - Kuantan, Malaysia, 25100
    - Recruiting
    - Research Site
  - Kuching, Malaysia, 93586
    - Recruiting
    - Research Site
Mexico
- - Benito Juárez, Mexico, 03650
    - Recruiting
    - Research Site
  - Chihuahua City, Mexico, 31000
    - Not yet recruiting
    - Research Site
  - Cuauhtémoc, Mexico, 06700
    - Not yet recruiting
    - Research Site
  - Cuernavaca, Mexico, 62290
    - Recruiting
    - Research Site
  - Guadalajara, Mexico, 44130
    - Not yet recruiting
    - Research Site
  - Monterrey, Mexico, 64460
    - Not yet recruiting
    - Research Site
  - Monterrey, Mexico, 64310
    - Not yet recruiting
    - Research Site
  - Monterrey, Mexico, 64465
    - Recruiting
    - Research Site
  - Morelia, Mexico, 58000
    - Recruiting
    - Research Site
  - Mérida, Mexico, 97130
    - Recruiting
    - Research Site
  - Oaxaca City, Mexico, 68020
    - Recruiting
    - Research Site
  - San Juan del Río, Mexico, 76800
    - Recruiting
    - Research Site
  - Tijuna, Mexico, 22010
    - Not yet recruiting
    - Research Site
  - Veracruz, Mexico, 91900
    - Recruiting
    - Research Site
  - Zapopan, Mexico, 45138
    - Not yet recruiting
    - Research Site
  - Zapopan, Mexico, 45070
    - Not yet recruiting
    - Research Site
Philippines
- - Iloilo City, Philippines, 5000
    - Recruiting
    - Research Site
  - Las Piñas, Philippines, 1742
    - Recruiting
    - Research Site
  - Manadaluyong City, Philippines, 1552
    - Recruiting
    - Research Site
  - Manila, Philippines, 1000
    - Recruiting
    - Research Site
  - Marilao, Philippines, 3019
    - Recruiting
    - Research Site
  - Quezon City, Philippines, 1100
    - Recruiting
    - Research Site
  - Quezon City, Philippines, 1100
    - Not yet recruiting
    - Research Site
  - Tondo, Philippines, 1012
    - Recruiting
    - Research Site
Poland
- - Bialystok, Poland, 15-044
    - Recruiting
    - Research Site
  - Bydgoszcz, Poland, 85-796
    - Recruiting
    - Research Site
  - Bydgoszcz, Poland, 85-231
    - Recruiting
    - Research Site
  - Chrzanów, Poland, 32-500
    - Recruiting
    - Research Site
  - Karczew, Poland, 05-480
    - Recruiting
    - Research Site
  - Katowice, Poland, 40-648
    - Recruiting
    - Research Site
  - Kielce, Poland, 25-426
    - Recruiting
    - Research Site
  - Krakow, Poland, 31-513
    - Recruiting
    - Research Site
  - Lodz, Poland, 91-211
    - Withdrawn
    - Research Site
  - Lublin, Poland, 20-011
    - Recruiting
    - Research Site
  - Ostróda, Poland, 14-100
    - Recruiting
    - Research Site
  - Piaseczno, Poland, 05-500
    - Recruiting
    - Research Site
  - Poznan, Poland, 60-693
    - Recruiting
    - Research Site
  - Pruszków, Poland, 05-800
    - Recruiting
    - Research Site
  - Płock, Poland, 09-407
    - Recruiting
    - Research Site
Slovakia
- - Humenné, Slovakia, 066 01
    - Recruiting
    - Research Site
  - Košice, Slovakia, 04011
    - Recruiting
    - Research Site
  - Levice, Slovakia, 93401
    - Recruiting
    - Research Site
  - Martin, Slovakia, 03659
    - Withdrawn
    - Research Site
  - Trnava, Slovakia, 91701
    - Withdrawn
    - Research Site
South Korea
- - Anyang-si, South Korea, 14068
    - Recruiting
    - Research Site
  - Daegu, South Korea, 42415
    - Recruiting
    - Research Site
  - Iksan-si, South Korea, 54538
    - Recruiting
    - Research Site
  - Jeonju, South Korea, 54907
    - Recruiting
    - Research Site
  - Seoul, South Korea, 06591
    - Recruiting
    - Research Site
  - Seoul, South Korea, 135-710
    - Recruiting
    - Research Site
  - Seoul, South Korea, 06973
    - Recruiting
    - Research Site
  - Seoul, South Korea, 143-729
    - Recruiting
    - Research Site
  - Seoul, South Korea, 150-713
    - Recruiting
    - Research Site
  - Seoul, South Korea, 08308
    - Withdrawn
    - Research Site
  - Uijeongbu-si, South Korea, 11765
    - Recruiting
    - Research Site
  - Wŏnju, South Korea, 26426
    - Recruiting
    - Research Site
Spain
- - Barakaldo, Spain, 48903
    - Recruiting
    - Research Site
  - Barcelona, Spain, 08036
    - Recruiting
    - Research Site
  - Granada, Spain, 18014
    - Recruiting
    - Research Site
  - Madrid, Spain, 28007
    - Recruiting
    - Research Site
  - Málaga, Spain, 29010
    - Recruiting
    - Research Site
  - Palma de Mallorca, Spain, 07010
    - Recruiting
    - Research Site
  - Pamplona, Spain, 31008
    - Recruiting
    - Research Site
  - Seville, Spain, 41013
    - Recruiting
    - Research Site
  - Valencia, Spain, 46010
    - Recruiting
    - Research Site
United Kingdom
- - Bradford, United Kingdom, BD9 6RJ
    - Recruiting
    - Research Site
  - Brighton, United Kingdom, BN2 1ES
    - Recruiting
    - Research Site
  - Cottingham, United Kingdom, HU16 5JQ
    - Recruiting
    - Research Site
  - Glasgow, United Kingdom, G12 0YN
    - Recruiting
    - Research Site
  - Halifax, United Kingdom, HX3 0PW
    - Recruiting
    - Research Site
  - Leeds, United Kingdom, LS9 7TF
    - Recruiting
    - Research Site
  - Portsmouth, United Kingdom, PO6 3LY
    - Recruiting
    - Research Site
  - Tyne and Wear, United Kingdom, NE29 8NH
    - Recruiting
    - Research Site
  - Wakefield, United Kingdom, WF1 4DG
    - Recruiting
    - Research Site
United States
- Alabama
  - Foley, Alabama, United States, 36535
    - Recruiting
    - Research Site
  - Mobile, Alabama, United States, 36609
    - Recruiting
    - Research Site
  - Sheffield, Alabama, United States, 35660
    - Recruiting
    - Research Site
- Arizona
  - Phoenix, Arizona, United States, 85012
    - Not yet recruiting
    - Research Site
  - Phoenix, Arizona, United States, 85027
    - Recruiting
    - Research Site
  - Tucson, Arizona, United States, 85704
    - Withdrawn
    - Research Site
- California
  - Garden Grove, California, United States, 92844
    - Recruiting
    - Research Site
  - Newport Beach, California, United States, 92663
    - Recruiting
    - Research Site
  - Torrance, California, United States, 90502
    - Recruiting
    - Research Site
- Florida
  - Clearwater, Florida, United States, 33765
    - Recruiting
    - Research Site
  - Cutler Bay, Florida, United States, 33157
    - Recruiting
    - Research Site
  - Cutler Bay, Florida, United States, 33189
    - Recruiting
    - Research Site
  - DeBary, Florida, United States, 32713
    - Recruiting
    - Research Site
  - Gainesville, Florida, United States, 32608
    - Not yet recruiting
    - Research Site
  - Homestead, Florida, United States, 33032
    - Recruiting
    - Research Site
  - Miami, Florida, United States, 33125
    - Recruiting
    - Research Site
  - Miami, Florida, United States, 33175
    - Recruiting
    - Research Site
  - Miami, Florida, United States, 33125
    - Not yet recruiting
    - Research Site
  - Miami, Florida, United States, 33155
    - Recruiting
    - Research Site
  - Orlando, Florida, United States, 32807
    - Recruiting
    - Research Site
  - Tampa, Florida, United States, 33607
    - Recruiting
    - Research Site
  - Tampa, Florida, United States, 33606
    - Recruiting
    - Research Site
- Georgia
  - Atlanta, Georgia, United States, 30344
    - Recruiting
    - Research Site
  - Lithonia, Georgia, United States, 30038
    - Recruiting
    - Research Site
  - Rincon, Georgia, United States, 31326
    - Recruiting
    - Research Site
- Illinois
  - Chicago, Illinois, United States, 60611
    - Withdrawn
    - Research Site
  - Palos Hills, Illinois, United States, 60465
    - Recruiting
    - Research Site
  - Winfield, Illinois, United States, 60190
    - Recruiting
    - Research Site
- Indiana
  - Munster, Indiana, United States, 46321
    - Recruiting
    - Research Site
- Maryland
  - Baltimore, Maryland, United States, 21201
    - Recruiting
    - Research Site
  - Columbia, Maryland, United States, 21045
    - Recruiting
    - Research Site
- Massachusetts
  - North Dartmouth, Massachusetts, United States, 02747
    - Recruiting
    - Research Site
- Michigan
  - Farmington Hills, Michigan, United States, 48336
    - Recruiting
    - Research Site
- Minnesota
  - Saint Cloud, Minnesota, United States, 56303
    - Recruiting
    - Research Site
- Missouri
  - St Louis, Missouri, United States, 63103
    - Not yet recruiting
    - Research Site
- Montana
  - Missoula, Montana, United States, 59808
    - Recruiting
    - Research Site
- Nebraska
  - Papillion, Nebraska, United States, 68046
    - Recruiting
    - Research Site
- Nevada
  - Las Vegas, Nevada, United States, 89106
    - Recruiting
    - Research Site
- New Jersey
  - Sewell, New Jersey, United States, 08080
    - Recruiting
    - Research Site
  - Toms River, New Jersey, United States, 08755
    - Recruiting
    - Research Site
- New York
  - Buffalo, New York, United States, 14215
    - Recruiting
    - Research Site
  - Buffalo, New York, United States, 14203
    - Withdrawn
    - Research Site
  - Cortland, New York, United States, 13045
    - Recruiting
    - Research Site
  - Horseheads, New York, United States, 14845
    - Recruiting
    - Research Site
- North Carolina
  - High Point, North Carolina, United States, 27260
    - Recruiting
    - Research Site
  - Kings Mountain, North Carolina, United States, 28086
    - Recruiting
    - Research Site
  - New Bern, North Carolina, United States, 28562
    - Recruiting
    - Research Site
  - Wilmington, North Carolina, United States, 28412
    - Completed
    - Research Site
  - Winston-Salem, North Carolina, United States, 27103
    - Recruiting
    - Research Site
- Ohio
  - Columbus, Ohio, United States, 43213
    - Recruiting
    - Research Site
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73120
    - Recruiting
    - Research Site
- Pennsylvania
  - DuBois, Pennsylvania, United States, 15801
    - Recruiting
    - Research Site
  - Philadelphia, Pennsylvania, United States, 19140
    - Recruiting
    - Research Site
- South Carolina
  - Rock Hill, South Carolina, United States, 29732
    - Recruiting
    - Research Site
- Tennessee
  - Franklin, Tennessee, United States, 37067
    - Recruiting
    - Research Site
  - Johnson City, Tennessee, United States, 37604
    - Recruiting
    - Research Site
- Texas
  - Dallas, Texas, United States, 75254
    - Recruiting
    - Research Site
  - Fort Worth, Texas, United States, 76104
    - Recruiting
    - Research Site
  - Houston, Texas, United States, 77090
    - Recruiting
    - Research Site
  - Houston, Texas, United States, 77084
    - Recruiting
    - Research Site
  - Humble, Texas, United States, 77338
    - Recruiting
    - Research Site
  - Kerrville, Texas, United States, 78028
    - Recruiting
    - Research Site
  - Mansfield, Texas, United States, 76063
    - Recruiting
    - Research Site
- Utah
  - Clearfield, Utah, United States, 84015
    - Recruiting
    - Research Site
- West Virginia
  - Morgantown, West Virginia, United States, 26501
    - Recruiting
    - Research Site
- Wisconsin
  - Cudahy, Wisconsin, United States, 53110
    - Recruiting
    - Research Site
  - Milwaukee, Wisconsin, United States, 53295
    - Not yet recruiting
    - Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Matching Placebo Matching placebo, SC, Q4W	Other: Placebo Placebo subcutaneous injection
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Annualised rate of moderate or severe COPD exacerbations Time Frame: Baseline up to 76 weeks	The annualised moderate or severe COPD exacerbation rate (based on exacerbations reported by the investigator) up to 76 weeks treatment period compared to placebo.	Baseline up to 76 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in the St. George's Respiratory Questionnaire (SGRQ) total score Time Frame: From baseline over 52 weeks	Change from baseline in the SGRQ total score over 52 weeks compared to placebo. SGRQ is a disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Scores range from 0 to 100, with lower scores indicating better health status.	From baseline over 52 weeks
Clinical meaningful improvement in St. George's Respiratory Questionnaire (SGRQ) total score Time Frame: From baseline over 52 weeks	Participants achieving a clinically meaningful improvement from baseline in SGRQ total score (4-point score decrease) over 52 weeks. SGRQ is a disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Scores range from 0 to 100, with lower scores indicating better health status.	From baseline over 52 weeks
Change from baseline in the COPD assessment Test (CAT) total score Time Frame: From baseline over 52 weeks	Change from baseline in the CAT total score over 52 weeks CAT is an 8-item PRO that measures the impact of COPD on the health status of patients with COPD. The CAT has a scoring range of 0-40 with higher scores indicative of greater COPD impact on health status.	From baseline over 52 weeks
Clinical meaningful improvement in COPD Assessment Test (CAT) total score Time Frame: From baseline over 52 weeks	Participants achieving a clinically meaningful improvement from baseline in CAT total score (2-point score decrease) over 52 weeks. CAT is an 8-item PRO that measures the impact of COPD on the health status of patients with COPD. The CAT has a scoring range of 0-40 with higher scores indicative of greater COPD impact on health status.	From baseline over 52 weeks
Pharmacokinetics (PK): Serum trough concentrations Time Frame: Baseline, Week 24, Week 36, Week 52	Serum trough concentrations	Baseline, Week 24, Week 36, Week 52
Change from baseline in pre-dose/pre-bronchodilator (pre-BD) forced expiratory volume in 1 second (FEV1) Time Frame: From baseline to Week 52	Change from baseline in pre-BD FEV1 at Week 52 compared to placebo. FEV1 is defined as the volume of air exhaled from the lungs in the first second of a forced expiration.	From baseline to Week 52
Annualised rate of severe COPD exacerbations Time Frame: Baseline up to 76 weeks	The annualised severe COPD exacerbation rate (based on exacerbations reported by the investigator) up to 76 weeks treatment period compared to placebo.	Baseline up to 76 weeks
Time to first severe COPD exacerbation Time Frame: Baseline up to 76 weeks	Time to first occurrence of severe COPD exacerbation up to 76 weeks.	Baseline up to 76 weeks
Change from baseline in post-BD FEV1 Time Frame: From baseline to Week 52	Change from baseline in post-BD FEV1 at Week 52 compared to placebo. FEV1 is defined as the volume of air exhaled from the lungs in the first second of a forced expiration	From baseline to Week 52
Annualised rate of moderate or severe COPD exacerbations among participants with EOS ≥ 300 cells/µL collected during screening visit. Time Frame: Baseline up to 76 weeks	The annualised moderate or severe COPD exacerbation rate (based on exacerbations reported by the investigator) up to 76 weeks treatment period compared to placebo among participants with EOS ≥ 300 cells/µL collected during screening visit.	Baseline up to 76 weeks
Annualised rate of COPD exacerbations requiring ER visit and/or hospitalisation Time Frame: Baseline up to 76 Weeks	The annualised rate of COPD exacerbation requiring ER visit and/or hospitalisation up to 76 weeks treatment period compared to placebo.	Baseline up to 76 Weeks
Time to first moderate or severe COPD exacerbation Time Frame: Baseline up to 76 weeks	Time to first occurrence of moderate or severe COPD exacerbation up to 76 weeks.	Baseline up to 76 weeks
Immunogenicity of anti-drug antibodies (ADA) Time Frame: Baseline, Week 24, Week 36, Week 52	Incidence of anti-drug antibodies	Baseline, Week 24, Week 36, Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Collaborators

Amgen

Investigators

Principal Investigator: Dave Singh, MD, Division of Infection, Immunity & Resp Medicine, The University of Manchester, United Kingdom

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2025

Primary Completion (Estimated)

March 13, 2029

Study Completion (Estimated)

June 5, 2029

Study Registration Dates

First Submitted

March 3, 2025

First Submitted That Met QC Criteria

March 12, 2025

First Posted (Actual)

March 19, 2025

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

D5241C00006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

IPD Sharing Supporting Information Type

STUDY_PROTOCOL
SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Investigators

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

IPD Sharing Time Frame

IPD Sharing Access Criteria

IPD Sharing Supporting Information Type

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Chronic Obstructive Pulmonary Disease (COPD)

Clinical Trials on Placebo

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