Chronic Obstructive Pulmonary Disease (COPD)Phase 3JOURNEYNCT06878261
A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00007)
A Phase 3 study testing Tezepelumab in people with Chronic Obstructive Pulmonary Disease (COPD), run by AstraZeneca at 284 sites in 22 countries.
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
- 284 sitesin 22 countries
- Study dates
- 25 Mar 2025to 5 Jun 2029
- Phase
- Phase 3
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
284 sites in 22 countries. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
284 sites in 22 countries
United States80 sites, 66 recruiting
- Suspended
Research Site
Adairsville, Georgia, 30103
- Recruiting
Research Site
Anderson, South Carolina, 29621
- Recruiting
Research Site
Ann Arbor, Michigan, 48109
- Recruiting
Research Site
Atlanta, Georgia, 30349
- Recruiting
Research Site
Baltimore, Maryland, 21224
- Recruiting
Research Site
Bay Pines, Florida, 33744
- Not yet recruiting
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Birmingham, Alabama, 35205
- Recruiting
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Boerne, Texas, 78006
- Recruiting
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Bowling Green, Kentucky, 42101
- Recruiting
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Boynton Beach, Florida, 33435
- Recruiting
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Charlotte, North Carolina, 28277
- Completed
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Clearwater, Florida, 33765
- Recruiting
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Colchester, Vermont, 05446
- Recruiting
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Columbia, South Carolina, 29204
- Not yet recruiting
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Concord, North Carolina, 28025
- Recruiting
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Cordele, Georgia, 31015
- Recruiting
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Cullman, Alabama, 35055
- Recruiting
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Decatur, Georgia, 30033
- Recruiting
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El Paso, Texas, 79902
- Recruiting
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Evanston, Illinois, 60201
- Recruiting
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Evansville, Indiana, 47725
- Recruiting
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Everett, Washington, 98208
- Withdrawn
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Fayetteville, North Carolina, 28303
- Suspended
Research Site
Fleming Island, Florida, 32003
- Withdrawn
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Fort Eisenhower, Georgia, 30905
- Recruiting
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Gaffney, South Carolina, 29340
- Withdrawn
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Grants Pass, Oregon, 97527
- Recruiting
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Hannibal, Missouri, 63401
- Not yet recruiting
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Hendersonville, Tennessee, 37075
- Not yet recruiting
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Hinsdale, Illinois, 60521
- Not yet recruiting
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Horsham, Pennsylvania, 19044
- Recruiting
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Houston, Texas, 77008
- Recruiting
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Houston, Texas, 77074
- Recruiting
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Houston, Texas, 77094
- Recruiting
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Indianapolis, Indiana, 46202
- Recruiting
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Indianapolis, Indiana, 46268
- Withdrawn
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Inglewood, California, 90301
- Recruiting
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Jacksonville, Florida, 32209
- Recruiting
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Kansas City, Kansas, 66160
- Not yet recruiting
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Kenosha, Wisconsin, 53142
- Recruiting
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Knoxville, Tennessee, 37919
- Not yet recruiting
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Lebanon, Tennessee, 37087
- Recruiting
Research Site
Leesburg, Florida, 34748
- Recruiting
Research Site
Lewisville, Texas, 75067
- Suspended
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Little River, South Carolina, 29566
- Suspended
Research Site
Los Angeles, California, 90048
- Withdrawn
Research Site
Margate, Florida, 33063
- Recruiting
Research Site
McKinney, Texas, 75069
- Recruiting
Research Site
Mesquite, Texas, 75149
- Recruiting
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Miami, Florida, 33126
- Suspended
Research Site
Miami, Florida, 33155
- Suspended
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Miami Lakes, Florida, 33014
- Recruiting
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Minneapolis, Minnesota, 55425
- Recruiting
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New Britain, Connecticut, 06051
- Recruiting
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Ocala, Florida, 34470
- Recruiting
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Oklahoma City, Oklahoma, 73102
- Recruiting
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Owensboro, Kentucky, 42301
- Suspended
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Palmetto Bay, Florida, 33157
- Recruiting
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Palo Alto, California, 94304
- Recruiting
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Phoenix, Arizona, 85044
- Not yet recruiting
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Pittsburgh, Pennsylvania, 15241
- Recruiting
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Potomac, Maryland, 20854
- Recruiting
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Rapid City, South Dakota, 57702
- Recruiting
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Redding, California, 96001
- Recruiting
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Rosedale, Maryland, 21237
- Recruiting
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San Antonio, Texas, 78258
- Suspended
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San Diego, California, 92108
- Recruiting
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Savannah, Georgia, 31406
- Recruiting
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Sayre, Pennsylvania, 18840
- Recruiting
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Scottsdale, Arizona, 85258
- Recruiting
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Spartanburg, South Carolina, 29303
- Not yet recruiting
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Springfield, Illinois, 62703
- Recruiting
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Staten Island, New York, 10309
- Recruiting
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Syracuse, New York, 13203
- Recruiting
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The Bronx, New York, 10459
- Recruiting
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Tulsa, Oklahoma, 74133
- Recruiting
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Union, South Carolina, 29379
- Recruiting
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Williamsburg, Virginia, 23188
- Recruiting
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Wilmington, Delaware, 19803
- Recruiting
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Winter Park, Florida, 32789
Japan47 sites, 42 recruiting
- Recruiting
Research Site
Akashi-shi, 674-0063
- Recruiting
Research Site
Chikushino-shi, 818-8502
- Recruiting
Research Site
Chiyoda-ku, 1020074
- Recruiting
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Fukui-shi, 910-8526
- Recruiting
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Fukuoka, 811-1394
- Recruiting
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Fukuoka, 819-8555
- Recruiting
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Gifu, 502-8558
- Recruiting
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Iruma-Gun, 350-0495
- Recruiting
Research Site
Ishinomaki, 986-8522
- Recruiting
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Kasuga-shi, 816-0864
- Recruiting
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Kitakyushu-shi, 807-8555
- Recruiting
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Kiyose-shi, 204-8522
- Recruiting
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Kiyose-shi, 204-8585
- Recruiting
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Kobe, 650-0047
- Recruiting
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Komatsu-shi, 923-8560
- Recruiting
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Kure-shi, 737-8505
- Recruiting
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Kyoto, 612-8555
- Recruiting
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Matsusaka-shi, 515-8544
- Withdrawn
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Meguro-ku, 153-0051
- Recruiting
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Minatoku, 105-8470
- Recruiting
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Minatoku, 108-0073
- Recruiting
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Miyazaki, 889-1692
- Recruiting
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Mizunami-shi, 509-6134
- Recruiting
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Nagaoka-shi, 940-8621
- Recruiting
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Nagasaki, 852-8501
- Recruiting
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Nagoya, 457-0866
- Recruiting
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Nagoya, 457-8511
- Recruiting
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Nagoya, 466-8650
- Recruiting
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Nerima-ku, 177-8521
- Withdrawn
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Ohta-ku, 143-0013
- Recruiting
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Okayama, 700-8558
- Recruiting
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Okayama, 701-1192
- Recruiting
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Osaka, 540-0008
- Recruiting
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Sapporo, 064-0804
- Recruiting
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Sendai, 980-8574
- Recruiting
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Sendai, 983-8520
- Recruiting
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Shinjuku-ku, 160-8582
- Recruiting
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Shinjuku-ku, 162-8655
- Recruiting
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Shinjuku-ku, 162-8666
- Recruiting
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Shiogama, 985-8506
- Recruiting
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Takamatsu, 760-0018
- Withdrawn
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Takatsuiki-shi, 569-1096
- Recruiting
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Tanabe-shi, 646-8558
- Withdrawn
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Toshima-ku, 171-0014
- Recruiting
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Ube, 755-8505
- Recruiting
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Yokohama, 236-0004
- Withdrawn
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Yokohama, 245-8575
Bulgaria17 sites, 13 recruiting
- Recruiting
Research Site
Dupnitsa, 2600
- Recruiting
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Haskovo, 6300
- Withdrawn
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Lovech, 5500
- Recruiting
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Pleven, 5800
- Recruiting
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Plovdiv, 4003
- Withdrawn
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Rousse, 7000
- Recruiting
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Rousse, 7000
- Recruiting
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Sofia, 1000
- Withdrawn
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Sofia, 1202
- Recruiting
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Sofia, 1431
- Recruiting
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Sofia, 1756
- Recruiting
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Stara Zagora, 6003
- Withdrawn
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Varna, 9000
- Recruiting
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Veliko Tanovo, 5000
- Recruiting
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Veliko Tarnovo, 5000
- Recruiting
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Vidin, 3700
- Recruiting
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Yambol, 8600
Peru14 sites, 8 recruiting
- Not yet recruiting
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Callao, Bellavista
- Withdrawn
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Cusco, CUSCO 01
- Recruiting
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Lima, 15023
- Recruiting
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Lima, 15036
- Withdrawn
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Lima, 15036
- Withdrawn
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Lima, 15038
- Recruiting
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Lima, 15046
- Recruiting
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Lima, 15088
- Not yet recruiting
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Lima, 15131
- Suspended
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Lima, LIMA 01
- Recruiting
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Lima, LIMA 1
- Withdrawn
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Lima, LIMA 21
- Withdrawn
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Lima, LIMA 33
- Recruiting
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Piura, 20001
Argentina12 sites, 12 recruiting
- Recruiting
Research Site
Alberdi, X5033DCE
- Recruiting
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Buenos Aires, C1425BEN
- Recruiting
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Ciudad de Buenos Aires, C1414AIF
- Recruiting
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Florida, B1602DQD
- Recruiting
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La Plata, B1900
- Recruiting
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La Plata, B1904
- Recruiting
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Mar del Plata, 7600
- Recruiting
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Mendoza, M5500CCG
- Recruiting
Research Site
Quilmes, B1878FNR
- Recruiting
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Rosario, 2000
- Recruiting
Research Site
San Fernando, B1646EBJ
- Recruiting
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San Juan Bautista, 1888
South Africa9 sites, 8 recruiting
- Recruiting
Research Site
Bellville, 7530
- Recruiting
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Benoni, 1501
- Recruiting
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Cape Town, 7700
- Recruiting
Research Site
Durban, 4001
- Not yet recruiting
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Durban, 4001
- Recruiting
Research Site
Durban, 4093
- Recruiting
Research Site
eMkhomazi, 4170
- Withdrawn
Research Site
Kimberley, 8301
- Recruiting
Research Site
Somerset West, 7130
Australia8 sites, 4 recruiting
- Recruiting
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Coffs Harbour, 02450
- Recruiting
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Frankston, 3199
- Withdrawn
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Garran, 2605
- Recruiting
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Nedlands, 6009
- Completed
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New Lambton, 2310
- Recruiting
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Spearwood, 6163
- Withdrawn
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Wollongong, 2500
- Completed
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Woodville South, 5011
Colombia8 sites, 8 recruiting
- Recruiting
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Armenia, 630004
- Recruiting
Research Site
Barranquilla, 080020
- Recruiting
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Bogotá, 110131
- Recruiting
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Cali, 760042
- Recruiting
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Ibague, 730006
- Recruiting
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Manizales, 170004
- Recruiting
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Medellín, 050022
- Recruiting
Research Site
Medellín, 050030
France8 sites, 8 recruiting
- Recruiting
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Brest, 29609
- Recruiting
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Lyon, 69317
- Recruiting
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Marseille, 13915
- Recruiting
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Montpellier, 34295
- Recruiting
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Paris, 75014
- Recruiting
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Paris, 75877
- Recruiting
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Pessac, 33604
- Recruiting
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Saint-Herblain, 44800
Greece8 sites, 8 recruiting
- Recruiting
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Athens, 11521
- Recruiting
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Athens, 11527
- Recruiting
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Athens, 17562
- Recruiting
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Heraklion, 71110
- Recruiting
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Ioannina, 45500
- Recruiting
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Pátrai, 26332
- Recruiting
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Thessaloniki, 57001
- Recruiting
Research Site
Thessaloniki, 57010
Hungary8 sites, 8 recruiting
- Recruiting
Research Site
Budapest, 1036
- Recruiting
Research Site
Debrecen, 4032
- Recruiting
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Edelény, 3780
- Recruiting
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Gödöllő, 2100
- Recruiting
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Hatvan, 3000
- Recruiting
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Mosonmagyaróvár, 9200
- Recruiting
Research Site
Nyíregyháza-Sóstóhegy, 4481
- Recruiting
Research Site
Törökbálint, 2045
Israel8 sites, 8 recruiting
- Recruiting
Research Site
Ashkelon, 78278
- Recruiting
Research Site
Haifa, 34362
- Recruiting
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Jerusalem, 00000
- Recruiting
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Jerusalem, 90131
- Recruiting
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Kfar Saba, 4428164
- Recruiting
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Ramat Gan, 52621
- Recruiting
Research Site
Rehovot, 76100
- Recruiting
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Tel Aviv, 6423906
Romania8 sites, 5 recruiting
- Withdrawn
Research Site
Bucharest, 011461
- Recruiting
Research Site
Bucharest, 012363
- Recruiting
Research Site
Bucharest, 030167
- Suspended
Research Site
Cluj-Napoca, 400275
- Recruiting
Research Site
Cluj-Napoca, 400332
- Recruiting
Research Site
Oradea, 410176
- Suspended
Research Site
Timișoara, 300002
- Recruiting
Research Site
Timișoara, 300310
Vietnam8 sites, 8 recruiting
- Not yet recruiting
Research Site
Can Tho, 900000
- Recruiting
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Da Nang, 550000
- Recruiting
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Haiphong, 180000
- Recruiting
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Hanoi, 100000
- Recruiting
Research Site
Hồ Chí Minh, 700000
- Recruiting
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Ho Chi Minh City, 700000
- Recruiting
Research Site
Ho Chi Minh City
- Recruiting
Research Site
Huế, 530000
Thailand7 sites, 7 recruiting
- Recruiting
Research Site
Bangkok, 10330
- Recruiting
Research Site
Hat Yai, 90110
- Recruiting
Research Site
Muang, 22000
- Recruiting
Research Site
Muang, 40002
- Recruiting
Research Site
Mueang, 20000
- Recruiting
Research Site
Nonthaburi, 11000
- Recruiting
Research Site
Rayong, 21000
Belgium6 sites, 6 recruiting
- Recruiting
Research Site
Genk, 3600
- Recruiting
Research Site
Ghent, 9000
- Recruiting
Research Site
Jette, 1090
- Recruiting
Research Site
Leuven, 3000
- Recruiting
Research Site
Mechelen, 2800
- Recruiting
Research Site
Namur, 5101
Sweden6 sites, 6 recruiting
- Recruiting
Research Site
Gothenburg, 413 46
- Recruiting
Research Site
Karlskrona, 371 79
- Recruiting
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Lund, 22185
- Recruiting
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Örebro, 703 62
- Recruiting
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Stockholm, 11446
- Recruiting
Research Site
Stockholm, 171 64
Turkey (Türkiye)6 sites, 6 recruiting
- Recruiting
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Adana, 1330
- Recruiting
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Ankara, 6620
- Recruiting
Research Site
Istanbul, 34020
- Recruiting
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Kayseri, 38039
- Recruiting
Research Site
Kocaeli, 41380
- Recruiting
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Mersin, 33079
Denmark5 sites, 5 recruiting
- Recruiting
Research Site
Aalborg, 9000
- Recruiting
Research Site
Hvidovre, 2650
- Recruiting
Research Site
Næstved, 4700
- Recruiting
Research Site
Odense C, 5000
- Recruiting
Research Site
Vejle, 7100
Netherlands5 sites, 5 recruiting
- Recruiting
Research Site
Eindhoven, 5623 EJ
- Recruiting
Research Site
Maastricht, 6229 HX
- Recruiting
Research Site
Rotterdam, 3045 PM
- Recruiting
Research Site
Rotterdam, 3083 AN
- Recruiting
Research Site
Zutphen, 7207 AE
New Zealand5 sites, 4 recruiting
- Completed
Research Site
Auckland, 0626
- Recruiting
Research Site
Auckland, 1051
- Recruiting
Research Site
Auckland, 2025
- Recruiting
Research Site
Hamilton West, 3204
- Recruiting
Research Site
Tauranga, 3112
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
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 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.
- 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 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.
- First posted14 Mar 2025
- Study start25 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)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Amgen
- Responsible party
- Sponsor
- Investigators
- MeiLan Han, MD, Principal investigator, University of Michigan Health, Pulmonary & Critical Care Medicine,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06878261
- Sponsor's protocol ID
- D5241C00007
- Acronym
- JOURNEY
- Status last verified
- Oct 2026
- First submitted
- 3 Mar 2025
- Last updated
- 9 Oct 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.