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

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

Argentina
- - Alberdi, Argentina, X5033DCE
    - Recruiting
    - Research Site
  - Buenos Aires, Argentina, C1425BEN
    - Recruiting
    - Research Site
  - Ciudad de Buenos Aires, Argentina, C1414AIF
    - Recruiting
    - Research Site
  - Florida, Argentina, B1602DQD
    - Recruiting
    - Research Site
  - La Plata, Argentina, B1904
    - Recruiting
    - Research Site
  - La Plata, Argentina, B1900
    - Recruiting
    - Research Site
  - Mar del Plata, Argentina, 7600
    - Recruiting
    - Research Site
  - Mendoza, Argentina, M5500CCG
    - Recruiting
    - Research Site
  - Quilmes, Argentina, B1878FNR
    - Recruiting
    - Research Site
  - Rosario, Argentina, 2000
    - Recruiting
    - Research Site
  - San Fernando, Argentina, B1646EBJ
    - Recruiting
    - Research Site
  - San Juan Bautista, Argentina, 1888
    - Recruiting
    - Research Site
Australia
- - Coffs Harbour, Australia, 02450
    - Recruiting
    - Research Site
  - Frankston, Australia, 3199
    - Recruiting
    - Research Site
  - Garran, Australia, 2605
    - Withdrawn
    - Research Site
  - Nedlands, Australia, 6009
    - Recruiting
    - Research Site
  - New Lambton, Australia, 2310
    - Recruiting
    - Research Site
  - Spearwood, Australia, 6163
    - Recruiting
    - Research Site
  - Wollongong, Australia, 2500
    - Withdrawn
    - Research Site
  - Woodville South, Australia, 5011
    - Recruiting
    - Research Site
Belgium
- - Genk, Belgium, 3600
    - Recruiting
    - Research Site
  - Ghent, Belgium, 9000
    - Recruiting
    - Research Site
  - Jette, Belgium, 1090
    - Recruiting
    - Research Site
  - Leuven, Belgium, 3000
    - Recruiting
    - Research Site
  - Mechelen, Belgium, 2800
    - Recruiting
    - Research Site
  - Namur, Belgium, 5101
    - Recruiting
    - Research Site
Bulgaria
- - Dupnitsa, Bulgaria, 2600
    - Recruiting
    - Research Site
  - Haskovo, Bulgaria, 6300
    - Recruiting
    - Research Site
  - Lovech, Bulgaria, 5500
    - Withdrawn
    - Research Site
  - Pleven, Bulgaria, 5800
    - Recruiting
    - Research Site
  - Plovdiv, Bulgaria, 4003
    - Recruiting
    - Research Site
  - Rousse, Bulgaria, 7000
    - Withdrawn
    - Research Site
  - Rousse, Bulgaria, 7000
    - Recruiting
    - Research Site
  - Sofia, Bulgaria, 1000
    - Recruiting
    - Research Site
  - Sofia, Bulgaria, 1431
    - Recruiting
    - Research Site
  - Sofia, Bulgaria, 1756
    - Recruiting
    - Research Site
  - Sofia, Bulgaria, 1202
    - Withdrawn
    - Research Site
  - Stara Zagora, Bulgaria, 6003
    - Recruiting
    - Research Site
  - Varna, Bulgaria, 9000
    - Withdrawn
    - Research Site
  - Veliko Tanovo, Bulgaria, 5000
    - Recruiting
    - Research Site
  - Veliko Tarnovo, Bulgaria, 5000
    - Recruiting
    - Research Site
  - Vidin, Bulgaria, 3700
    - Recruiting
    - Research Site
  - Yambol, Bulgaria, 8600
    - Recruiting
    - Research Site
Colombia
- - Armenia, Colombia, 630004
    - Not yet recruiting
    - Research Site
  - Barranquilla, Colombia, 080020
    - Recruiting
    - Research Site
  - Bogotá, Colombia, 110131
    - Recruiting
    - Research Site
  - Cali, Colombia, 760042
    - Recruiting
    - Research Site
  - Ibague, Colombia, 730006
    - Recruiting
    - Research Site
  - Manizales, Colombia, 170004
    - Recruiting
    - Research Site
  - Medellín, Colombia, 050030
    - Recruiting
    - Research Site
  - Medellín, Colombia, 050022
    - Recruiting
    - Research Site
Denmark
- - Aalborg, Denmark, 9000
    - Recruiting
    - Research Site
  - Hvidovre, Denmark, 2650
    - Recruiting
    - Research Site
  - Næstved, Denmark, 4700
    - Recruiting
    - Research Site
  - Odense C, Denmark, 5000
    - Recruiting
    - Research Site
  - Vejle, Denmark, 7100
    - Recruiting
    - Research Site
France
- - Brest, France, 29609
    - Recruiting
    - Research Site
  - Lyon, France, 69317
    - Recruiting
    - Research Site
  - Marseille, France, 13915
    - Recruiting
    - Research Site
  - Montpellier, France, 34295
    - Recruiting
    - Research Site
  - Paris, France, 75014
    - Recruiting
    - Research Site
  - Paris, France, 75877
    - Recruiting
    - Research Site
  - Pessac, France, 33604
    - Recruiting
    - Research Site
  - Saint-Herblain, France, 44800
    - Recruiting
    - Research Site
Greece
- - Athens, Greece, 11527
    - Recruiting
    - Research Site
  - Athens, Greece, 17562
    - Recruiting
    - Research Site
  - Athens, Greece, 11521
    - Recruiting
    - Research Site
  - Heraklion, Greece, 71110
    - Recruiting
    - Research Site
  - Ioannina, Greece, 45500
    - Recruiting
    - Research Site
  - Pátrai, Greece, 26332
    - Recruiting
    - Research Site
  - Thessaloniki, Greece, 57010
    - Recruiting
    - Research Site
  - Thessaloniki, Greece, 57001
    - Recruiting
    - Research Site
Hong Kong
- - Hong Kong, Hong Kong
    - Recruiting
    - Research Site
  - Hong Kong, Hong Kong, 999077
    - Recruiting
    - Research Site
Hungary
- - Budapest, Hungary, 1036
    - Recruiting
    - Research Site
  - Debrecen, Hungary, 4032
    - Recruiting
    - Research Site
  - Edelény, Hungary, 3780
    - Recruiting
    - Research Site
  - Gödöllő, Hungary, 2100
    - Recruiting
    - Research Site
  - Hatvan, Hungary, 3000
    - Recruiting
    - Research Site
  - Mosonmagyaróvár, Hungary, 9200
    - Recruiting
    - Research Site
  - Nyíregyháza-Sóstóhegy, Hungary, 4481
    - Recruiting
    - Research Site
  - Törökbálint, Hungary, 2045
    - Recruiting
    - Research Site
Israel
- - Ashkelon, Israel, 78278
    - Recruiting
    - Research Site
  - Haifa, Israel, 34362
    - Recruiting
    - Research Site
  - Jerusalem, Israel, 00000
    - Recruiting
    - Research Site
  - Jerusalem, Israel, 90131
    - Recruiting
    - Research Site
  - Kfar Saba, Israel, 4428164
    - Recruiting
    - Research Site
  - Ramat Gan, Israel, 52621
    - Recruiting
    - Research Site
  - Rehovot, Israel, 76100
    - Recruiting
    - Research Site
  - Tel Aviv, Israel, 6423906
    - Recruiting
    - Research Site
Japan
- - Akashi-shi, Japan, 674-0063
    - Recruiting
    - Research Site
  - Chikushino-shi, Japan, 818-8502
    - Recruiting
    - Research Site
  - Chiyoda-ku, Japan, 1020074
    - Recruiting
    - Research Site
  - Fukui-shi, Japan, 910-8526
    - Recruiting
    - Research Site
  - Fukuoka, Japan, 811-1394
    - Recruiting
    - Research Site
  - Fukuoka, Japan, 819-8555
    - Recruiting
    - Research Site
  - Gifu, Japan, 502-8558
    - Recruiting
    - Research Site
  - Iruma-Gun, Japan, 350-0495
    - Recruiting
    - Research Site
  - Ishinomaki, Japan, 986-8522
    - Recruiting
    - Research Site
  - Kasuga-shi, Japan, 816-0864
    - Recruiting
    - Research Site
  - Kitakyushu-shi, Japan, 807-8555
    - Recruiting
    - Research Site
  - Kiyose-shi, Japan, 204-8585
    - Recruiting
    - Research Site
  - Kiyose-shi, Japan, 204-8522
    - Recruiting
    - Research Site
  - Kobe, Japan, 650-0047
    - Recruiting
    - Research Site
  - Komatsu-shi, Japan, 923-8560
    - Recruiting
    - Research Site
  - Kure-shi, Japan, 737-8505
    - Recruiting
    - Research Site
  - Kyoto, Japan, 612-8555
    - Recruiting
    - Research Site
  - Matsusaka-shi, Japan, 515-8544
    - Recruiting
    - Research Site
  - Meguro-ku, Japan, 153-0051
    - Withdrawn
    - Research Site
  - Minatoku, Japan, 108-0073
    - Recruiting
    - Research Site
  - Minatoku, Japan, 105-8470
    - Recruiting
    - Research Site
  - Miyazaki, Japan, 889-1692
    - Recruiting
    - Research Site
  - Mizunami-shi, Japan, 509-6134
    - Recruiting
    - Research Site
  - Nagaoka-shi, Japan, 940-8621
    - Recruiting
    - Research Site
  - Nagasaki, Japan, 852-8501
    - Recruiting
    - Research Site
  - Nagoya, Japan, 466-8650
    - Recruiting
    - Research Site
  - Nagoya, Japan, 457-0866
    - Recruiting
    - Research Site
  - Nagoya, Japan, 457-8511
    - Recruiting
    - Research Site
  - Nerima-ku, Japan, 177-8521
    - Recruiting
    - Research Site
  - Ohta-ku, Japan, 143-0013
    - Withdrawn
    - Research Site
  - Okayama, Japan, 700-8558
    - Recruiting
    - Research Site
  - Okayama, Japan, 701-1192
    - Recruiting
    - Research Site
  - Osaka, Japan, 540-0008
    - Recruiting
    - Research Site
  - Sapporo, Japan, 064-0804
    - Recruiting
    - Research Site
  - Sendai, Japan, 980-8574
    - Recruiting
    - Research Site
  - Sendai, Japan, 983-8520
    - Recruiting
    - Research Site
  - Shinjuku-ku, Japan, 160-8582
    - Recruiting
    - Research Site
  - Shinjuku-ku, Japan, 162-8655
    - Recruiting
    - Research Site
  - Shinjuku-ku, Japan, 162-8666
    - Recruiting
    - Research Site
  - Shiogama, Japan, 985-8506
    - Recruiting
    - Research Site
  - Takamatsu, Japan, 760-0018
    - Recruiting
    - Research Site
  - Takatsuiki-shi, Japan, 569-1096
    - Withdrawn
    - Research Site
  - Tanabe-shi, Japan, 646-8558
    - Recruiting
    - Research Site
  - Toshima-ku, Japan, 171-0014
    - Withdrawn
    - Research Site
  - Ube, Japan, 755-8505
    - Recruiting
    - Research Site
  - Yokohama, Japan, 236-0004
    - Recruiting
    - Research Site
  - Yokohama, Japan, 245-8575
    - Withdrawn
    - Research Site
Netherlands
- - Eindhoven, Netherlands, 5623 EJ
    - Recruiting
    - Research Site
  - Maastricht, Netherlands, 6229 HX
    - Not yet recruiting
    - Research Site
  - Rotterdam, Netherlands, 3045 PM
    - Recruiting
    - Research Site
  - Rotterdam, Netherlands, 3083 AN
    - Recruiting
    - Research Site
  - Zutphen, Netherlands, 7207 AE
    - Recruiting
    - Research Site
New Zealand
- - Auckland, New Zealand, 0626
    - Recruiting
    - Research Site
  - Auckland, New Zealand, 2025
    - Recruiting
    - Research Site
  - Auckland, New Zealand, 1051
    - Recruiting
    - Research Site
  - Hamilton West, New Zealand, 3204
    - Recruiting
    - Research Site
  - Tauranga, New Zealand, 3112
    - Recruiting
    - Research Site
Peru
- - Cusco, Peru, CUSCO 01
    - Not yet recruiting
    - Research Site
  - Lima, Peru, 15036
    - Not yet recruiting
    - Research Site
  - Lima, Peru, 15088
    - Recruiting
    - Research Site
  - Lima, Peru, 15046
    - Recruiting
    - Research Site
  - Lima, Peru, 15036
    - Withdrawn
    - Research Site
  - Lima, Peru, LIMA 01
    - Recruiting
    - Research Site
  - Lima, Peru, LIMA 1
    - Recruiting
    - Research Site
  - Lima, Peru, LIMA 21
    - Withdrawn
    - Research Site
  - Lima, Peru, Lima 33
    - Recruiting
    - Research Site
  - Piura, Peru, 20001
    - Recruiting
    - Research Site
Romania
- - Bucharest, Romania, 011461
    - Withdrawn
    - Research Site
  - Bucharest, Romania, 050159
    - Suspended
    - Research Site
  - Cluj-Napoca, Romania, 400275
    - Recruiting
    - Research Site
  - Cluj-Napoca, Romania, 400332
    - Recruiting
    - Research Site
  - Oradea, Romania, 410176
    - Recruiting
    - Research Site
  - Timișoara, Romania, 300310
    - Recruiting
    - Research Site
  - Timișoara, Romania, 300002
    - Recruiting
    - Research Site
South Africa
- - Bellville, South Africa, 7530
    - Recruiting
    - Research Site
  - Benoni, South Africa, 1501
    - Recruiting
    - Research Site
  - Cape Town, South Africa, 7700
    - Recruiting
    - Research Site
  - Durban, South Africa, 4001
    - Recruiting
    - Research Site
  - Durban, South Africa, 4093
    - Recruiting
    - Research Site
  - Kimberley, South Africa, 8301
    - Recruiting
    - Research Site
  - Somerset West, South Africa, 7130
    - Recruiting
    - Research Site
  - eMkhomazi, South Africa, 4170
    - Recruiting
    - Research Site
Sweden
- - Gothenburg, Sweden, 413 46
    - Recruiting
    - Research Site
  - Karlskrona, Sweden, 371 79
    - Recruiting
    - Research Site
  - Lund, Sweden, 22185
    - Recruiting
    - Research Site
  - Stockholm, Sweden, 171 64
    - Recruiting
    - Research Site
  - Stockholm, Sweden, 11446
    - Recruiting
    - Research Site
  - Örebro, Sweden, 703 62
    - Recruiting
    - Research Site
Thailand
- - Bang Kra So, Thailand, 11000
    - Recruiting
    - Research Site
  - Bangkok, Thailand, 10330
    - Recruiting
    - Research Site
  - Hat Yai, Thailand, 90110
    - Recruiting
    - Research Site
  - Muang, Thailand, 22000
    - Recruiting
    - Research Site
  - Muang, Thailand, 40002
    - Recruiting
    - Research Site
  - Mueang, Thailand, 20000
    - Recruiting
    - Research Site
  - Rayong, Thailand, 21000
    - Recruiting
    - Research Site
Turkey (Türkiye)
- - Adana, Turkey (Türkiye), 1330
    - Recruiting
    - Research Site
  - Ankara, Turkey (Türkiye), 6620
    - Recruiting
    - Research Site
  - Istanbul, Turkey (Türkiye), 34020
    - Recruiting
    - Research Site
  - Kayseri, Turkey (Türkiye), 38039
    - Recruiting
    - Research Site
  - Kocaeli, Turkey (Türkiye), 41380
    - Recruiting
    - Research Site
  - Mersin, Turkey (Türkiye), 33079
    - Recruiting
    - Research Site
United States
- Alabama
  - Cullman, Alabama, United States, 35055
    - Recruiting
    - Research Site
- Arizona
  - Phoenix, Arizona, United States, 85044
    - Recruiting
    - Research Site
  - Scottsdale, Arizona, United States, 85258
    - Recruiting
    - Research Site
- California
  - Inglewood, California, United States, 90301
    - Withdrawn
    - Research Site
  - Los Angeles, California, United States, 90048
    - Recruiting
    - Research Site
  - Palo Alto, California, United States, 94304
    - Recruiting
    - Research Site
  - Redding, California, United States, 96001
    - Recruiting
    - Research Site
  - San Diego, California, United States, 92108
    - Recruiting
    - Research Site
- Connecticut
  - New Britain, Connecticut, United States, 06051
    - Recruiting
    - Research Site
- Delaware
  - Wilmington, Delaware, United States, 19803
    - Recruiting
    - Research Site
- Florida
  - Bay Pines, Florida, United States, 33744
    - Recruiting
    - Research Site
  - Boynton Beach, Florida, United States, 33435
    - Recruiting
    - Research Site
  - Clearwater, Florida, United States, 33765
    - Recruiting
    - Research Site
  - Fleming Island, Florida, United States, 32003
    - Recruiting
    - Research Site
  - Jacksonville, Florida, United States, 32209
    - Recruiting
    - Research Site
  - Leesburg, Florida, United States, 34748
    - Recruiting
    - Research Site
  - Margate, Florida, United States, 33063
    - Withdrawn
    - Research Site
  - Miami, Florida, United States, 33155
    - Recruiting
    - Research Site
  - Miami, Florida, United States, 33126
    - Recruiting
    - Research Site
  - Miami Lakes, Florida, United States, 33014
    - Suspended
    - Research Site
  - Ocala, Florida, United States, 34470
    - Recruiting
    - Research Site
  - Palmetto Bay, Florida, United States, 33157
    - Recruiting
    - Research Site
  - Winter Park, Florida, United States, 32789
    - Recruiting
    - Research Site
- Georgia
  - Adairsville, Georgia, United States, 30103
    - Recruiting
    - Research Site
  - Atlanta, Georgia, United States, 30349
    - Recruiting
    - Research Site
  - Cordele, Georgia, United States, 31015
    - Recruiting
    - Research Site
  - Decatur, Georgia, United States, 30033
    - Not yet recruiting
    - Research Site
  - Fort Eisenhower, Georgia, United States, 30905
    - Withdrawn
    - Research Site
  - Savannah, Georgia, United States, 31406
    - Recruiting
    - Research Site
- Illinois
  - Evanston, Illinois, United States, 60201
    - Not yet recruiting
    - Research Site
- Indiana
  - Evansville, Indiana, United States, 47725
    - Recruiting
    - Research Site
  - Indianapolis, Indiana, United States, 46202
    - Recruiting
    - Research Site
  - Indianapolis, Indiana, United States, 46268
    - Recruiting
    - Research Site
- Kansas
  - Kansas City, Kansas, United States, 66160
    - Recruiting
    - Research Site
- Kentucky
  - Bowling Green, Kentucky, United States, 42101
    - Recruiting
    - Research Site
  - Owensboro, Kentucky, United States, 42301
    - Recruiting
    - Research Site
- Maryland
  - Baltimore, Maryland, United States, 21224
    - Recruiting
    - Research Site
  - Potomac, Maryland, United States, 20854
    - Recruiting
    - Research Site
- Michigan
  - Ann Arbor, Michigan, United States, 48109
    - Recruiting
    - Research Site
- Minnesota
  - Minneapolis, Minnesota, United States, 55425
    - Recruiting
    - Research Site
- Missouri
  - Hannibal, Missouri, United States, 63401
    - Recruiting
    - Research Site
- New York
  - Staten Island, New York, United States, 10309
    - Not yet recruiting
    - Research Site
  - Syracuse, New York, United States, 13203
    - Not yet recruiting
    - Research Site
- North Carolina
  - Charlotte, North Carolina, United States, 28277
    - Recruiting
    - Research Site
  - Fayetteville, North Carolina, United States, 28303
    - Withdrawn
    - Research Site
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73102
    - Recruiting
    - Research Site
  - Tulsa, Oklahoma, United States, 74133
    - Recruiting
    - Research Site
- Oregon
  - Grants Pass, Oregon, United States, 97527
    - Withdrawn
    - Research Site
- Pennsylvania
  - Sayre, Pennsylvania, United States, 18840
    - Not yet recruiting
    - Research Site
- South Carolina
  - Anderson, South Carolina, United States, 29621
    - Recruiting
    - Research Site
  - Columbia, South Carolina, United States, 29204
    - Recruiting
    - Research Site
  - Gaffney, South Carolina, United States, 29340
    - Recruiting
    - Research Site
  - Spartanburg, South Carolina, United States, 29303
    - Recruiting
    - Research Site
  - Union, South Carolina, United States, 29379
    - Recruiting
    - Research Site
- South Dakota
  - Rapid City, South Dakota, United States, 57702
    - Recruiting
    - Research Site
- Tennessee
  - Knoxville, Tennessee, United States, 37919
    - Recruiting
    - Research Site
- Texas
  - Boerne, Texas, United States, 78006
    - Recruiting
    - Research Site
  - El Paso, Texas, United States, 79902
    - Recruiting
    - Research Site
  - Houston, Texas, United States, 77074
    - Recruiting
    - Research Site
  - Houston, Texas, United States, 77094
    - Not yet recruiting
    - Research Site
  - Houston, Texas, United States, 77008
    - Recruiting
    - Research Site
  - Lewisville, Texas, United States, 75067
    - Recruiting
    - Research Site
  - McKinney, Texas, United States, 75069
    - Recruiting
    - Research Site
  - Mesquite, Texas, United States, 75149
    - Recruiting
    - Research Site
  - San Antonio, Texas, United States, 78258
    - Not yet recruiting
    - Research Site
- Vermont
  - Colchester, Vermont, United States, 05446
    - Recruiting
    - Research Site
- Virginia
  - Williamsburg, Virginia, United States, 23188
    - Recruiting
    - Research Site
- Washington
  - Everett, Washington, United States, 98208
    - Recruiting
    - Research Site
Vietnam
- - Can Tho, Vietnam, 900000
    - Not yet recruiting
    - Research Site
  - Da Nang, Vietnam, 550000
    - Recruiting
    - Research Site
  - Haiphong, Vietnam, 180000
    - Recruiting
    - Research Site
  - Hanoi, Vietnam, 100000
    - Recruiting
    - Research Site
  - Ho Chi Minh City, Vietnam, 700000
    - Recruiting
    - Research Site
  - Ho Chi Minh City, Vietnam, 700000
    - Not yet recruiting
    - Research Site
  - Ho Chi Minh City, Vietnam
    - Not yet recruiting
    - Research Site
  - Huế, Vietnam, 530000
    - Recruiting
    - Research Site
  - Hồ Chí Minh, Vietnam, 700000
    - 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 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
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
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
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
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
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 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
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
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

Collaborators and Investigators

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

Sponsor

AstraZeneca

Collaborators

Amgen

Investigators

Principal Investigator: MeiLan Han, MD, University of Michigan Health, Pulmonary & Critical Care Medicine,

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 25, 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 14, 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

D5241C00007

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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