Chronic Obstructive Pulmonary Disease (COPD)Phase 3EMBARKNCT06883305

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

A Phase 3 study testing Tezepelumab in people with Chronic Obstructive Pulmonary Disease (COPD), run by AstraZeneca at 305 sites in 18 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial 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) Read more about this study

Who is it for?: Ages 40 to 80 years
Conditions the study is for: Chronic Obstructive Pulmonary Disease (COPD)
What is being tested?: Tezepelumab
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 990 participants
Where: 305 sitesin 18 countries
Study dates: 18 Mar 2025to 5 Jun 2029
Phase: Phase 3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

≥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

Who cannot join

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:

Show all 9Show fewer

Macrolides (less than 6 months)
Systemic immuno-suppressive, -modulating medications
LTOT >4.0 L/min or O2 saturation <89% despite LTOT

Trial locations and contacts

305 sites in 18 countries. Contact the study team or a site near you to ask about taking part.

AstraZeneca Clinical Study Information Center contact

1-877-240-9479

information.center@astrazeneca.com

Country

City, postcode or hospital

Sites recruiting now only

305 sites in 18 countries

United States73 sites, 68 recruiting

Research Site
Albuquerque, New Mexico, 87102
Not yet recruiting
Research Site
Atlanta, Georgia, 30344
Recruiting
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Baltimore, Maryland, 21201
Recruiting
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Buffalo, New York, 14203
Withdrawn
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Buffalo, New York, 14215
Recruiting
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Chicago, Illinois, 60611
Withdrawn
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Clearfield, Utah, 84015
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Clearwater, Florida, 33765
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Columbia, Maryland, 21045
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Columbus, Ohio, 43213
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Cortland, New York, 13045
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Cudahy, Wisconsin, 53110
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Cutler Bay, Florida, 33157
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Cutler Bay, Florida, 33189
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Dallas, Texas, 75254
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DeBary, Florida, 32713
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DuBois, Pennsylvania, 15801
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Farmington Hills, Michigan, 48336
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Foley, Alabama, 36535
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Forney, Texas, 75126
Not yet recruiting
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Fort Worth, Texas, 76104
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Franklin, Tennessee, 37067
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Gainesville, Florida, 32608
Not yet recruiting
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Garden Grove, California, 92844
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High Point, North Carolina, 27260
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Homestead, Florida, 33032
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Horseheads, New York, 14845
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Houston, Texas, 77084
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Houston, Texas, 77090
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Humble, Texas, 77338
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Johnson City, Tennessee, 37604
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Kerrville, Texas, 78028
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Kings Mountain, North Carolina, 28086
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Las Vegas, Nevada, 89106
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Lithonia, Georgia, 30038
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Mansfield, Texas, 76063
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Massapequa, New York, 11758
Not yet recruiting
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Meridian, Idaho, 83646
Not yet recruiting
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Miami, Florida, 33125
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Miami, Florida, 33155
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Miami, Florida, 33175
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Millville, New Jersey, 08332
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Milwaukee, Wisconsin, 53295
Not yet recruiting
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Missoula, Montana, 59808
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Mobile, Alabama, 36609
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Morgantown, West Virginia, 26501
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Munster, Indiana, 46321
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New Bern, North Carolina, 28562
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Newport Beach, California, 92663
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North Dartmouth, Massachusetts, 02747
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Oklahoma City, Oklahoma, 73120
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Orlando, Florida, 32807
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Palos Hills, Illinois, 60465
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Papillion, Nebraska, 68046
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Philadelphia, Pennsylvania, 19140
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Phoenix, Arizona, 85012
Not yet recruiting
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Phoenix, Arizona, 85027
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Rincon, Georgia, 31326
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Rock Hill, South Carolina, 29732
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Saint Cloud, Minnesota, 56303
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Sewell, New Jersey, 08080
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Sheffield, Alabama, 35660
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St Louis, Missouri, 63103
Not yet recruiting
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St Louis, Missouri, 63103
Withdrawn
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Tampa, Florida, 33606
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Tampa, Florida, 33607
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The Bronx, New York, 10455
Not yet recruiting
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Toms River, New Jersey, 08755
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Torrance, California, 90502
Recruiting
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Tucson, Arizona, 85704
Withdrawn
Research Site
Wilmington, North Carolina, 28412
Completed
Research Site
Winfield, Illinois, 60190
Recruiting
Research Site
Winston-Salem, North Carolina, 27103
Recruiting

Other trials in United States

China62 sites, 58 recruiting

Research Site
Anyang, 455099
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Beijing, 100020
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Beijing, 100191
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Changchun, 130021
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Changsha, 410008
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Changsha, 410015
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Changsha, 430033
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Chengdu, 610072
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Chengdu, 611130
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Chongqing, 400042
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Chongqing, 401320
Withdrawn
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Fuzhou, 350031
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Guangzhou, 510000
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Guangzhou, 510150
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Guangzhou, 510163
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Guangzhou, 510515
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Haikou, 570311
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Hangzhou, 310005
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Hefei, 230061
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Hengyang, 421001
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Heze, 274099
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Hohhot, 750306
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Huizhou, 516002
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Jinan, 250013
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Jinan, 250021
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Jinhua, 321000
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Linhai, 317000
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Loudi, 417099
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Nanchang, 330006
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Nanchong, 637000
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Nanjing, 2100008
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Nanjing, 211100
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Nanning, 530000
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Nanning, 530021
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Pingxiang, 337055
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Qingdao, 266011
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Qingyuan, 511518
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Sanya, 572000
Withdrawn
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Shanghai, 200040
Withdrawn
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Shanghai, 200120
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Shanghai, 201199
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Shanghai, 310000
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Shantou, 515041
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Shenyang, 110004
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Shenzhen, 518020
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Shijiazhuang, 50051
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Suining Shi, 629000
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Taiyuan, 030001
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Taiyuan, 030032
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Taizhou, 318000
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Tianjin, 300050
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Wenzhou, 325027
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Wuhan, 430022
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Wuhan, 430030
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Xinxiang, 453100
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Xuzhou, 221000
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Xuzhou, 221009
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Yangzhou, 225001
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Yichang, 443003
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Yinchuan, 750001
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Yinchuan, 750004
Withdrawn
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Zhangzhou, 363000
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Other trials in China

India21 sites, 13 recruiting

Research Site
Ahmedabad, 380053
Withdrawn
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Ahmedabad, 380054
Recruiting
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Aligarh, 202002
Not yet recruiting
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Belagavi, 590010
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Coimbatore, 641028
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Dehradun, 248001
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Delhi, 110029
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Dwārka, 110075
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Faridabad, 121012
Withdrawn
Research Site
Gūrgaon, 122001
Recruiting
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Kochi, 682027
Suspended
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Kolkata, 700053
Suspended
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Kozhikode, 673008
Recruiting
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Lucknow, 226003
Terminated
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Madurai, 625107
Withdrawn
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Mysuru, 570002
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Nagpur, 440012
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Nagpur, 441108
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Pune, 411 018
Withdrawn
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Telangana, 500004
Withdrawn
Research Site
Vadodara, 391760
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Other trials in India

Canada16 sites, 13 recruiting

Research Site
Ajax, Ontario, L1S 2J5
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Burlington, Ontario, L7N 3V2
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Calgary, Alberta, T3R 1W7
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Montreal, Quebec, H1T 2M4
Withdrawn
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Montreal, Quebec, H3T 1E2
Withdrawn
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Québec, Quebec, G1G 3Y8
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Québec, Quebec, G1V 4G5
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Saint-Charles-Borromée, Quebec, J6E 2B4
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Saint-Laurent, Quebec, H4R3C8
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Saskatoon, Saskatchewan, S7N 0W8
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Scarborough Village, Ontario, M1P 2V5
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Toronto, Ontario, M5T 3A9
Withdrawn
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Trois-Rivières, Quebec, G8T 7A1
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Vancouver, British Columbia, V5Z 1M9
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Winchester, Ontario, K0C 2K0
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Windsor, Ontario, N8X-5A6
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Other trials in Canada

Mexico16 sites, 13 recruiting

Research Site
Benito Juárez, 03650
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Chihuahua City, 31000
Withdrawn
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Cuauhtémoc, 06700
Withdrawn
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Cuernavaca, 62290
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Guadalajara, 44130
Not yet recruiting
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Mérida, 97130
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Monterrey, 64310
Not yet recruiting
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Monterrey, 64460
Not yet recruiting
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Monterrey, 64465
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Morelia, 58000
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Oaxaca City, 68020
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San Juan del Río, 76800
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Tijuna, 22010
Withdrawn
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Veracruz, 91900
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Zapopan, 45070
Not yet recruiting
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Zapopan, 45138
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Other trials in Mexico

Brazil15 sites, 15 recruiting

Research Site
Bragança Paulista, 12916-542
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Brasília, 70200-730
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Campinas, 13060-080
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Chapecó, 89812-210
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Curitiba, 80030-110
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Jaú, 17201-130
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Mossoró, 59603-020
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Porto Alegre, 90035-903
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Porto Alegre, 90480-000
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Porto Alegre, 90560-003
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Porto Alegre, 9061-000
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Porto Alegre, 91350-200
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Salvador, 40050-410
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São José do Rio Preto, 15090-000
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Vitória, 29062-110
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Other trials in Brazil

Poland15 sites, 14 recruiting

Research Site
Bialystok, 15-044
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Bydgoszcz, 85-231
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Bydgoszcz, 85-796
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Chrzanów, 32-500
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Karczew, 05-480
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Katowice, 40-648
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Kielce, 25-426
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Krakow, 31-513
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Lodz, 91-211
Withdrawn
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Lublin, 20-011
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Ostróda, 14-100
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Piaseczno, 05-500
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Płock, 09-407
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Poznan, 60-693
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Pruszków, 05-800
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Other trials in Poland

South Korea12 sites, 10 recruiting

Research Site
Anyang-si, 14068
Recruiting
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Daegu, 42415
Recruiting
Research Site
Iksan-si, 54538
Recruiting
Research Site
Jeonju, 54907
Withdrawn
Research Site
Seoul, 06591
Recruiting
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Seoul, 06973
Recruiting
Research Site
Seoul, 08308
Withdrawn
Research Site
Seoul, 135-710
Recruiting
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Seoul, 143-729
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Research Site
Seoul, 150-713
Recruiting
Research Site
Uijeongbu-si, 11765
Recruiting
Research Site
Wŏnju, 26426
Recruiting

Other trials in South Korea

Italy10 sites, 9 recruiting

Research Site
Cona, 44124
Recruiting
Research Site
Florence, 50134
Recruiting
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Milan, 20122
Withdrawn
Research Site
Montebelluna, 31044
Recruiting
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Naples, 80131
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Pavia, 27100
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Roma, 00128
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Sassari, 07100
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Research Site
Telese Terme, 82037
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Research Site
Tradate, 21049
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Other trials in Italy

Chile9 sites, 9 recruiting

Research Site
Chile, 7770484
Recruiting
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Concepción, 4070094
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Curicó, 3341643
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Quillota, 2260000
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Santiago, 7500010
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Santiago, 7501126
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Santiago, 7750495
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Santiago, 8380453
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Talca, 3481349
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Other trials in Chile

Czechia9 sites, 8 recruiting

Research Site
Brandýs nad Labem, 250 01
Withdrawn
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Brno, 625 00
Recruiting
Research Site
Jindřichův Hradec, 377 01
Recruiting
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Lovosice, 410 02
Recruiting
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Pilsen, 301 00
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Prague, 110 00
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Prague, 15300
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Teplice, 415 01
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Varnsdorf, 407 47
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Other trials in Czechia

Germany9 sites, 7 recruiting

Research Site
Bendorf, 56170
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Berlin, 10787
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Haltern am See, 45721
Withdrawn
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Hanover, D-30173
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Immenhausen, 34376
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Lübeck, 23552
Withdrawn
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Marburg, 35037
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Rosenheim, 83022
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Wiesbaden, 65183
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Other trials in Germany

Spain9 sites, 9 recruiting

Research Site
Barakaldo, 48903
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Barcelona, 08036
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Granada, 18014
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Madrid, 28007
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Málaga, 29010
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Palma de Mallorca, 07010
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Pamplona, 31008
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Seville, 41013
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Valencia, 46010
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Other trials in Spain

United Kingdom9 sites, 9 recruiting

Research Site
Bradford, BD9 6RJ
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Brighton, BN2 1ES
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Cottingham, HU16 5JQ
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Glasgow, G12 0YN
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Halifax, HX3 0PW
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Leeds, LS9 7TF
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Portsmouth, PO6 3LY
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Tyne and Wear, NE29 8NH
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Wakefield, WF1 4DG
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Other trials in United Kingdom

Malaysia7 sites, 7 recruiting

Research Site
Alor Star, 5460
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Kajang, 43000
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Kota Kinabalu, 88200
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Kuala Lumpur, 50603
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Kuala Terengganu, 20400
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Kuantan, 25100
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Kuching, 93586
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Other trials in Malaysia

Philippines7 sites, 7 recruiting

Research Site
Iloilo City, 5000
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Las Piñas, 1742
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Manadaluyong City, 1552
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Manila, 1000
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Marilao, 3019
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Quezon City, 1100
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Tondo, 1012
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Other trials in Philippines

Slovakia5 sites, 3 recruiting

Research Site
Humenné, 066 01
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Research Site
Košice, 04011
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Research Site
Levice, 93401
Recruiting
Research Site
Martin, 03659
Withdrawn
Research Site
Trnava, 91701
Withdrawn

Other trials in Slovakia

Denmark1 site, 1 recruiting

Research Site
København NV, 2400
Recruiting

Other trials in Denmark

About this study

Official title: 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

Read the 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.

Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Being tested: Tezepelumab, Placebo
Keywords: COPD, Moderate COPD, Severe COPD, Very Severe COPD, chronic obstructive pulmonary disease
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TezepelumabBiological
Tezepelumab subcutaneous injection
PlaceboOther
Placebo subcutaneous injection

Study groups in NCT06883305
Study group	Role	What they receive
Dose 1 of Tezepelumab	Experimental	Tezepelumab, SC, Q4W Receives: Biological: Tezepelumab
Dose 2 of Tezepelumab	Experimental	Tezepelumab, SC, Q4W Receives: Biological: Tezepelumab
Matching Placebo	Placebo comparator	Matching placebo, SC, Q4W Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (13)

Change from baseline in post-BD FEV1
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
Measured: From baseline to Week 52
Change from baseline in pre-dose/pre-bronchodilator (pre-BD) forced expiratory volume in 1 second (FEV1)
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.
Measured: From baseline to Week 52
Change from baseline in the St. George's Respiratory Questionnaire (SGRQ) total score
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.
Measured: From baseline over 52 weeks
Annualised rate of moderate or severe COPD exacerbations among participants with EOS ≥ 300 cells/µL collected during screening visit.
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.
Measured: Baseline up to 76 weeks
Annualised rate of severe COPD exacerbations
The annualised severe COPD exacerbation rate (based on exacerbations reported by the investigator) up to 76 weeks treatment period compared to placebo.
Measured: Baseline up to 76 weeks
Annualised rate of COPD exacerbations requiring ER visit and/or hospitalisation
The annualised rate of COPD exacerbation requiring ER visit and/or hospitalisation up to 76 weeks treatment period compared to placebo.
Measured: Baseline up to 76 Weeks
Clinical meaningful improvement in St. George's Respiratory Questionnaire (SGRQ) total score
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.
Measured: From baseline over 52 weeks
Change from baseline in the COPD assessment Test (CAT) total score
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.
Measured: From baseline over 52 weeks
Clinical meaningful improvement in COPD Assessment Test (CAT) total score
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.
Measured: From baseline over 52 weeks
Time to first moderate or severe COPD exacerbation
Time to first occurrence of moderate or severe COPD exacerbation up to 76 weeks.
Measured: Baseline up to 76 weeks
Time to first severe COPD exacerbation
Time to first occurrence of severe COPD exacerbation up to 76 weeks.
Measured: Baseline up to 76 weeks
Pharmacokinetics (PK): Serum trough concentrations
Serum trough concentrations
Measured: Baseline, Week 24, Week 36, Week 52
Immunogenicity of anti-drug antibodies (ADA)
Incidence of anti-drug antibodies
Measured: Baseline, Week 24, Week 36, Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Mar 20255 Jun 2029

First posted19 Mar 2025
Study start18 Mar 2025
Primary completion13 Mar 2029 (estimated)
Study completion5 Jun 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 990 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06883305
Sponsor's protocol ID: D5241C00006
Acronym: EMBARK
Status last verified: Sep 2026
First submitted: 3 Mar 2025
Last updated: 3 Sep 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: 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.

Interested in taking part?

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive

All Chronic Obstructive Pulmonary Disease (COPD) trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT06883305
Acronym / sponsor ID: EMBARK / D5241C00006
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD, Moderate COPD, Severe COPD, Very Severe COPD, chronic obstructive pulmonary disease
Phase: Phase 3
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 990 participants (estimated)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: Amgen
Study start: 18 Mar 2025 (actual)
Primary completion: 13 Mar 2029 (estimated)
Study completion: 5 Jun 2029 (estimated)
First posted: 19 Mar 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3
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.

Arm	Type	Receives
Dose 1 of Tezepelumab	Experimental	Biological: TezepelumabTezepelumab, SC, Q4W
Dose 2 of Tezepelumab	Experimental	Biological: TezepelumabTezepelumab, SC, Q4W
Matching Placebo	Placebo comparator	Other: PlaceboMatching placebo, SC, Q4W

Who may qualify

Ages: 40 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

≥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

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TezepelumabTezepelumab subcutaneous injection	Biological	Dose 1 of Tezepelumab, Dose 2 of Tezepelumab
PlaceboPlacebo subcutaneous injection	Other	Matching Placebo

Primary outcome

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.

13 secondary outcomes

Change from baseline in post-BD FEV1
Time frame: From baseline to 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 the St. George's Respiratory Questionnaire (SGRQ) total score
Time frame: From baseline over 52 weeks
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
Annualised rate of severe COPD exacerbations
Time frame: Baseline up to 76 weeks
Annualised rate of COPD exacerbations requiring ER visit and/or hospitalisation
Time frame: Baseline up to 76 Weeks
Clinical meaningful improvement in St. George's Respiratory Questionnaire (SGRQ) total score
Time frame: From baseline over 52 weeks
Change from baseline in the COPD assessment Test (CAT) total score
Time frame: From baseline over 52 weeks
Clinical meaningful improvement in COPD Assessment Test (CAT) total score
Time frame: From baseline over 52 weeks
Time to first moderate or severe COPD exacerbation
Time frame: Baseline up to 76 weeks
Time to first severe COPD exacerbation
Time frame: Baseline up to 76 weeks
Pharmacokinetics (PK): Serum trough concentrations
Time frame: Baseline, Week 24, Week 36, Week 52
Immunogenicity of anti-drug antibodies (ADA)
Time frame: Baseline, Week 24, Week 36, Week 52

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
Individual participant dataSharing planned: Yes. 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.

Related trials for Chronic Obstructive Pulmonary Disease (COPD)

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

AstraZeneca Clinical Study Information Center contact

1-877-240-9479

information.center@astrazeneca.com

Dave Singh, MD principal investigator

Division of Infection, Immunity & Resp Medicine, The University of Manchester, United Kingdom

305 sites in 18 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tezepelumab in people with Chronic Obstructive Pulmonary Disease (COPD), run by AstraZeneca at 305 sites in 18 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 305 sites in United States, China, India, Canada, Mexico and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Annualised rate of moderate or severe COPD exacerbations (time frame: Baseline up to 76 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06883305.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.