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

Last updated: June 23, 2026
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

3

Condition

Chronic Bronchitis

Bronchiectasis

Emphysema

Treatment

Tezepelumab

Placebo

Clinical Study ID

NCT06878261
D5241C00007
  • Ages 40-80
  • All Genders

Study 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)

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. ≥40 to ≤80 years old

  2. COPD diagnosis ≥1 year,

  3. Post-BD FEV1 ≥ 20% and ≤ 70% PN, FEV1/FVC <0.70 at screening

  4. Triple (ICS+LABA+LAMA) or dual inhaled COPD therapy, if triple therapy is considerednot appropriate, ≥3 consecutive months prior to V1

  5. ≥2 moderate or ≥1 severe COPD exacerbations in the prior year; At least 1 of 2moderate exacerbations must require the use of systemic corticosteroids. At leastone of the previous exacerbations should be confirmed to have occurred while theparticipant was on triple or dual inhaled maintenance therapy

  6. EOS ≥ 150 cells/μL during screening

  7. CAT ≥15 at screening

  8. Former or current smokers ≥10 pack-years

Exclusion

Exclusion Criteria:

  1. Clin. important pulmonary disease or radiological findings suggestive of arespiratory disease other than COPD

  2. Asthma, incl. pediatric, or ACOS

  3. Any unstable disorder that can impact participants safety or study outcomes

  4. Tuberculosis requiring treatment within 12 months prior V2

  5. Malignancies current or past Concomitant therapies:

  • Macrolides (less than 6 months)

  • Systemic immuno-suppressive, -modulating medications

  1. LTOT >4.0 L/min or O2 saturation <89% despite LTOT

Study Design

Total Participants: 990
Treatment Group(s): 2
Primary Treatment: Tezepelumab
Phase: 3
Study Start date:
March 25, 2025
Estimated Completion Date:
June 05, 2029

Study 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.

Connect with a study center

  • Research Site

    Alberdi, X5033DCE
    Argentina

    Active - Recruiting

  • Research Site

    Buenos Aires, C1425BEN
    Argentina

    Active - Recruiting

  • Research Site

    Buenos Aires 3435910, C1414AIF
    Argentina

    Active - Recruiting

  • Research Site

    Ciudad de Buenos Aires, C1414AIF
    Argentina

    Active - Recruiting

  • Research Site

    Florida, B1602DQD
    Argentina

    Active - Recruiting

  • Research Site

    La Plata, B1904
    Argentina

    Active - Recruiting

  • Research Site

    La Plata 3432043, B1900
    Argentina

    Active - Recruiting

  • Research Site

    Mar del Plata, 7600
    Argentina

    Active - Recruiting

  • Research Site

    Mendoza, M5500CCG
    Argentina

    Active - Recruiting

  • Research Site

    Quilmes, B1878FNR
    Argentina

    Active - Recruiting

  • Research Site

    Rosario, 2000
    Argentina

    Active - Recruiting

  • Research Site

    San Fernando, B1646EBJ
    Argentina

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  • Research Site

    San Juan Bautista, 1888
    Argentina

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    Coffs Harbour, 02450
    Australia

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    Frankston, 3199
    Australia

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    Garran, 2605
    Australia

    Site Not Available

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    Nedlands, 6009
    Australia

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    New Lambton, 2310
    Australia

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    Spearwood, 6163
    Australia

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    Wollongong, 2500
    Australia

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    Woodville South, 5011
    Australia

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    Genk, 3600
    Belgium

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    Ghent, 9000
    Belgium

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    Jette, 1090
    Belgium

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    Leuven, 3000
    Belgium

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    Mechelen, 2800
    Belgium

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    Mechelen 2791537, 2800
    Belgium

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    Namur, 5101
    Belgium

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    Dupnitsa, 2600
    Bulgaria

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    Haskovo, 6300
    Bulgaria

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    Lovech, 5500
    Bulgaria

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    Pleven, 5800
    Bulgaria

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    Plovdiv, 4003
    Bulgaria

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    Rousse, 7000
    Bulgaria

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    Rousse 727523, 7000
    Bulgaria

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    Ruse, 7000
    Bulgaria

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    Sofia, 1756
    Bulgaria

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    Sofia 727011, 1756
    Bulgaria

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    Stara Zagora, 6003
    Bulgaria

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    Stara Zagora 726848, 6003
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    Varna, 9000
    Bulgaria

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    Veliko Tanovo, 5000
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    Veliko Tarnovo, 5000
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    Vidin, 3700
    Bulgaria

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    Yambol, 8600
    Bulgaria

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    Armenia, 630004
    Colombia

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    Barranquilla, 080020
    Colombia

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    Bogotá, 110131
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    Cali, 760042
    Colombia

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    Ibague, 730006
    Colombia

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    Manizales, 170004
    Colombia

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    Medellín, 050030
    Colombia

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    Medellín 3674962, 050030
    Colombia

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    Aalborg, 9000
    Denmark

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    Hvidovre, 2650
    Denmark

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    Næstved, 4700
    Denmark

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    Odense C, 5000
    Denmark

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    Vejle, 7100
    Denmark

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    Brest, 29609
    France

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    Lyon, 69317
    France

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    Marseille, 13915
    France

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    Montpellier, 34295
    France

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    Paris, 75014
    France

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    Paris 2988507, 75014
    France

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    Pessac, 33604
    France

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    Saint-Herblain, 44800
    France

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    Athens, 11521
    Greece

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    Athens 264371, 11527
    Greece

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    Heraklion, 71110
    Greece

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    Ioannina, 45500
    Greece

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    Pátrai, 26332
    Greece

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    Thessaloniki, 57001
    Greece

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    Thessaloniki 734077, 57001
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    Hong Kong,
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    Hong Kong 1819729,
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    Budapest, 1036
    Hungary

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    Debrecen, 4032
    Hungary

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    Edelény, 3780
    Hungary

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    Gödöllő, 2100
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    Hatvan, 3000
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    Mosonmagyaróvár, 9200
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    Nyíregyháza-Sóstóhegy, 4481
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    Törökbálint, 2045
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    Ashkelon, 78278
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    Jerusalem, 90131
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    Jerusalem 281184, 90131
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    Kfar Saba, 4428164
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    Ramat Gan, 52621
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    Rehovot, 76100
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    Tel Aviv, 6423906
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    Akashi-shi, 674-0063
    Japan

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    Chikushino-shi, 818-8502
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    Chiyoda-ku, 1020074
    Japan

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    Fukui-shi, 910-8526
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    Fukuoka, 811-1394
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    Fukuoka 1863967, 811-1394
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    Fukuoka-shi, 811-1394
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    Gifu, 502-8558
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    Iruma-Gun, 350-0495
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    Ishinomaki, 986-8522
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    Kasuga-shi, 816-0864
    Japan

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    Kitakyushu-shi, 807-8555
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    Kiyose-shi, 204-8522
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    Kobe, 650-0047
    Japan

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    Komatsu-shi, 923-8560
    Japan

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    Kure-shi, 737-8505
    Japan

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    Kyoto, 612-8555
    Japan

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    Matsusaka-shi, 515-8544
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    Meguro-ku, 153-0051
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    Minato-ku, 108-0073
    Japan

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    Minatoku, 108-0073
    Japan

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    Minatoku 11191118, 108-0073
    Japan

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    Miyazaki, 889-1692
    Japan

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    Mizunami-shi, 509-6134
    Japan

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    Nagaoka-shi, 940-8621
    Japan

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    Nagasaki, 852-8501
    Japan

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    Nagoya, 457-0866
    Japan

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    Nagoya 1856057, 457-0866
    Japan

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    Nagoya-shi, 457-0866
    Japan

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    Nerima-ku, 177-8521
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    Ohta-ku, 143-0013
    Japan

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    Okayama, 701-1192
    Japan

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    Okayama 1854383, 701-1192
    Japan

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    Okayama-shi, 701-1192
    Japan

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    Osaka, 540-0008
    Japan

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  • Research Site

    Sapporo, 064-0804
    Japan

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  • Research Site

    Sendai, 980-8574
    Japan

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    Sendai 2111149, 980-8574
    Japan

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    Sendai-shi, 983-8520
    Japan

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  • Research Site

    Shinjuku-ku, 162-8655
    Japan

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  • Research Site

    Shiogama, 985-8506
    Japan

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  • Research Site

    Takamatsu, 760-0018
    Japan

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    Takatsuiki-shi, 569-1096
    Japan

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  • Research Site

    Tanabe-shi, 646-8558
    Japan

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    Toshima-ku, 171-0014
    Japan

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  • Research Site

    Ube, 755-8505
    Japan

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  • Research Site

    Yokohama, 245-8575
    Japan

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  • Research Site

    Yokohama 1848354, 236-0004
    Japan

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    Yokohama-shi, 236-0004
    Japan

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  • Research Site

    Eindhoven, 5623 EJ
    Netherlands

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  • Research Site

    Maastricht, 6229 HX
    Netherlands

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  • Research Site

    Rotterdam, 3045 PM
    Netherlands

    Active - Recruiting

  • Research Site

    Rotterdam 2747891, 3083 AN
    Netherlands

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  • Research Site

    Zutphen, 7207 AE
    Netherlands

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  • Research Site

    Auckland, 1051
    New Zealand

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  • Research Site

    Auckland 2193733, 0626
    New Zealand

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    Hamilton West, 3204
    New Zealand

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    Tauranga, 3112
    New Zealand

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    Cusco, CUSCO 01
    Peru

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    Lima, 15036
    Peru

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    Lima 3936456, LIMA 21
    Peru

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    Piura, 20001
    Peru

    Active - Recruiting

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    Bucharest, 050159
    Romania

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    Bucharest 683506, 011461
    Romania

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    Cluj-Napoca, 400275
    Romania

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    Cluj-Napoca 681290, 400275
    Romania

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    Oradea, 410176
    Romania

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    Timisoara, 300002
    Romania

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    Timișoara, 300002
    Romania

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    Timișoara 665087, 300002
    Romania

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    Bellville, 7530
    South Africa

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    Benoni, 1501
    South Africa

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    Cape Town, 7700
    South Africa

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    Durban, 4001
    South Africa

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    Durban 1007311, 4001
    South Africa

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    Kimberley, 8301
    South Africa

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    Somerset West, 7130
    South Africa

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    eMkhomazi, 4170
    South Africa

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    Gothenburg, 413 46
    Sweden

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    Karlskrona, 371 79
    Sweden

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    Lund, 22185
    Sweden

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    Stockholm, 171 64
    Sweden

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    Stockholm 2673730, 171 64
    Sweden

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    Örebro, 703 62
    Sweden

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    Bang Kra So, 11000
    Thailand

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    Bangkok, 10330
    Thailand

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    Hat Yai, 90110
    Thailand

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    Muang, 40002
    Thailand

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    Mueang, 20000
    Thailand

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    Rayong, 21000
    Thailand

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    Adana, 1330
    Turkey (Türkiye)

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    Ankara, 6620
    Turkey (Türkiye)

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    Istanbul, 34020
    Turkey (Türkiye)

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    Kayseri, 38039
    Turkey (Türkiye)

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    Kocaeli, 41380
    Turkey (Türkiye)

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    Mersin, 33079
    Turkey (Türkiye)

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  • Research Site

    Cullman, Alabama 35055
    United States

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    Phoenix, Arizona 85044
    United States

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    Scottsdale, Arizona 85258
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    Inglewood, California 90301
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    Los Angeles, California 90048
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    Palo Alto, California 94304
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    Redding, California 96001
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    San Diego, California 92108
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    New Britain, Connecticut 06051
    United States

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    Wilmington, Delaware 19803
    United States

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    Bay Pines, Florida 33744
    United States

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    Boynton Beach, Florida 33435
    United States

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    Clearwater, Florida 33765
    United States

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    Fleming Island, Florida 32003
    United States

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    Jacksonville, Florida 32209
    United States

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    Leesburg, Florida 34748
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    Margate, Florida 33063
    United States

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    Miami, Florida 33126
    United States

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    Miami Lakes, Florida 33014
    United States

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    Ocala, Florida 34470
    United States

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    Palmetto Bay, Florida 33157
    United States

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    Winter Park, Florida 32789
    United States

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    Miami 4164138, Florida 4155751 33126
    United States

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    Adairsville, Georgia 30103
    United States

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    Atlanta, Georgia 30349
    United States

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    Cordele, Georgia 31015
    United States

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    Decatur, Georgia 30033
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    Fort Eisenhower, Georgia 30905
    United States

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    Savannah, Georgia 31406
    United States

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    Evanston, Illinois 60201
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    Evansville, Indiana 47725
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    Indianapolis, Indiana 46202
    United States

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    Indianapolis 4259418, Indiana 4921868 46202
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    Kansas City, Kansas 66160
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    Bowling Green, Kentucky 42101
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    Owensboro, Kentucky 42301
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    Baltimore, Maryland 21224
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    Potomac, Maryland 20854
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    Ann Arbor, Michigan 48109
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    Minneapolis, Minnesota 55425
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    Hannibal, Missouri 63401
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    Staten Island, New York 10309
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    Charlotte, North Carolina 28277
    United States

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    Fayetteville, North Carolina 28303
    United States

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    Oklahoma City, Oklahoma 73102
    United States

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    Tulsa, Oklahoma 74133
    United States

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    Grants Pass, Oregon 97527
    United States

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    Sayre, Pennsylvania 18840
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    Anderson, South Carolina 29621
    United States

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    Columbia, South Carolina 29204
    United States

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    Gaffney, South Carolina 29340
    United States

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    Spartanburg, South Carolina 29303
    United States

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    Union, South Carolina 29379
    United States

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    Rapid City, South Dakota 57702
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    Knoxville, Tennessee 37919
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    Boerne, Texas 78006
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    El Paso, Texas 79902
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    Houston, Texas 77094
    United States

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    Lewisville, Texas 75067
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    McKinney, Texas 75069
    United States

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    Mesquite, Texas 75149
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    San Antonio, Texas 78258
    United States

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    Houston 4699066, Texas 4736286 77074
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    Colchester, Vermont 05446
    United States

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    Williamsburg, Virginia 23188
    United States

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    Everett, Washington 98208
    United States

    Active - Recruiting

  • Research Site

    Can Tho, 900000
    Vietnam

    Site Not Available

  • Research Site

    Da Nang, 550000
    Vietnam

    Active - Recruiting

  • Research Site

    Haiphong, 180000
    Vietnam

    Active - Recruiting

  • Research Site

    Hanoi, 100000
    Vietnam

    Active - Recruiting

  • Research Site

    Hanoi 1581130, 100000
    Vietnam

    Site Not Available

  • Research Site

    Ho Chi Minh, 700000
    Vietnam

    Site Not Available

  • Research Site

    Ho Chi Minh City, 700000
    Vietnam

    Active - Recruiting

  • Research Site

    Ho Chi Minh City 1566083,
    Vietnam

    Site Not Available

  • Research Site

    Huế, 530000
    Vietnam

    Active - Recruiting

  • Research Site

    Hồ Chí Minh, 700000
    Vietnam

    Active - Recruiting

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