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

Last updated: March 31, 2025
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

3

Condition

Chronic Bronchitis

Bronchiectasis

Emphysema

Treatment

Placebo

Tezepelumab

Clinical Study ID

NCT06883305
D5241C00006
  • 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 ≥3 consecutive months prior toV1

  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

  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: Placebo
Phase: 3
Study Start date:
March 18, 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

    Bragança Paulista, 12916-542
    Brazil

    Site Not Available

  • Research Site

    Brasilia, 70200-730
    Brazil

    Site Not Available

  • Research Site

    Campinas, 13060-080
    Brazil

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    Chapeco, 89812-210
    Brazil

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    Curitiba, 80030-110
    Brazil

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    Jaú, 17201-130
    Brazil

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    Mossoro, 59603-020
    Brazil

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    Porto Alegre, 90480-000
    Brazil

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    Salvador, 40050-410
    Brazil

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    Sao Jose Do Rio Preto, 15090-000
    Brazil

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  • Research Site

    Vitoria, 29062-110
    Brazil

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  • Research Site

    Votuporanga, 15501-405
    Brazil

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    Calgary, Alberta T3B 0M3
    Canada

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    Vancouver, British Columbia V5Z 1M9
    Canada

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    Ajax, Ontario L1S 2J5
    Canada

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    Burlington, Ontario L7N 3V2
    Canada

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    Toronto, Ontario M5T 3A9
    Canada

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    Winchester, Ontario K0C 2K0
    Canada

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    Windsor, Ontario N8X-5A6
    Canada

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    Montreal, Quebec H1T 2M4
    Canada

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    St Charles Borromee, Quebec J6E 2B4
    Canada

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    Trois-Rivières, Quebec G8T 7A1
    Canada

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    Saskatoon, Saskatchewan S7N 0W8
    Canada

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    Quebec, G1G 3Y8
    Canada

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    Curico, 3341643
    Chile

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    Quillota, 2260000
    Chile

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    Santiago, 7501126
    Chile

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    Talca, 3481349
    Chile

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    Anyang, 455099
    China

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    Changchun, 130021
    China

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    Changsha, 410015
    China

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    Chengdu, 611130
    China

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    Chongqing, 401320
    China

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    Fuzhou, 350031
    China

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    Guangzhou, 510150
    China

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    Haikou, 570311
    China

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    Hangzhou, 310005
    China

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    Hefei, 230061
    China

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    Hengyang City, 421001
    China

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    Heze, 274099
    China

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    Hohhot, 750306
    China

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    Huizhou, 516002
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    Jinan, 250013
    China

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    Jinhua, 321000
    China

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    Linhai, 317000
    China

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    Nan Chong, 637000
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    Nanchang, 330006
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    Nanjing, 211100
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    Nanning, 530021
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    Pingxiang, 337055
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    Qingdao, 266011
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    Sanya, 572000
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    Shanghai, 200040
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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, 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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    Xinxiang, 453100
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    Yangzhou, 225001
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    Yinchuan, 750004
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    Zhangzhou, 363099
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    Brandys nad Labem, 250 01
    Czechia

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    Brno, 625 00
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    Jindrichuv Hradec, 377 01
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    Lovosice, 410 02
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    Ostrava, 700 30
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    Plzen, 301 00
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    Praha 1, 110 00
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    Praha 16, 15300
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    Teplice, 415 01
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    Varnsdorf, 407 47
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    København NV, 2400
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    Bendorf, 56170
    Germany

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    Berlin, 10787
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    Haltern Am See, 45721
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    Hannover, D-30173
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    Immenhausen, 34376
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    Lübeck, 23552
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    Kolkata, 700053
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    Lucknow, 226003
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    Pune, 411 018
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    Firenze, 50134
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    Milan, 20122
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    Montebelluna, 31044
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    Napoli, 80131
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    Pavia, 27100
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    Roma, 00128
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    Sassari, 07100
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    Telese Terme, 82037
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    Tradate, 21049
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    Anyang-si, 14068
    Korea, Republic of

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    Daegu, 42415
    Korea, Republic of

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    Iksan-si, 54538
    Korea, Republic of

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    Jeonju, 54907
    Korea, Republic of

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    Seoul, 150-713
    Korea, Republic of

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    Uijeongbu-si, 11765
    Korea, Republic of

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  • Research Site

    Wonju-si, 26426
    Korea, Republic of

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    Alor Setar, 5460
    Malaysia

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    Kajang, 43000
    Malaysia

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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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    Benito Juarez, 03650
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    Chihuahua, 31000
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    Cuauhtémoc, 06700
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    Cuernavaca, 62290
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    Guadalajara, 44130
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    Merida, 97130
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    Monterrey, 64465
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    Morelia, 58000
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    Oaxaca, 68020
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    San Juan del Rio, 76800
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    Tijuna, 22010
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    Veracruz, 91900
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    Zapopan, 45138
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    Iloilo, 5000
    Philippines

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    Iloilo City, 5000
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    Las Pinas, 1742
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    Manadaluyong City, 1552
    Philippines

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    Manila, 1000
    Philippines

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    Marilao, 3019
    Philippines

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    Quezon City, 1100
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    Tondo, 1012
    Philippines

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    Białystok, 15-044
    Poland

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    Bydgoszcz, 85-231
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    Chrzanów, 32-500
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    Grodzisk Mazowiecki, 05-825
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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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    Kraków, 31-419
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    Lodz, 91-211
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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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    Poznań, 60-693
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    Płock, 09-407
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    Humenne, 066 01
    Slovakia

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    Košice, 04011
    Slovakia

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    Levice, 93401
    Slovakia

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    Martin, 03659
    Slovakia

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    Barakaldo, 48903
    Spain

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    Barcelona, 08036
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    Granada, 18014
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    Madrid, 28007
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    Málaga, 29010
    Spain

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    Palma de Mallorca, 07010
    Spain

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    Pamplona, 31008
    Spain

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    Sevilla, 41013
    Spain

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    Valencia, 46010
    Spain

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    Bradford, BD9 6RJ
    United Kingdom

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    Brighton, BN2 1ES
    United Kingdom

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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
    United Kingdom

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    Portsmouth, PO6 3LY
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    Tyne And Wear, NE29 8NH
    United Kingdom

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    Wakefield, WF1 4DG
    United Kingdom

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    Sheffield, Alabama 35660
    United States

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    Tucson, Arizona 85704
    United States

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    Newport Beach, California 92663
    United States

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    Cutler Bay, Florida 33157
    United States

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    DeBary, Florida 32713
    United States

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    Homestead, Florida 33032
    United States

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    Miami, Florida 33125
    United States

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    Orlando, Florida 32807
    United States

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    Tampa, Florida 33607
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    Rincon, Georgia 31326
    United States

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    Evanston, Illinois 60208
    United States

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    Winfield, Illinois 60190
    United States

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    Columbia, Maryland 21045
    United States

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    North Dartmouth, Massachusetts 02747
    United States

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    Farmington Hills, Michigan 48336
    United States

    Active - Recruiting

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    Missoula, Montana 59808
    United States

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    Papillion, Nebraska 68046
    United States

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    Toms River, New Jersey 08755
    United States

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    Buffalo, New York 14215
    United States

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    Cortland, New York 13045
    United States

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    Horseheads, New York 14845
    United States

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  • Research Site

    High Point, North Carolina 27260
    United States

    Active - Recruiting

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    New Bern, North Carolina 28562
    United States

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    Wilmington, North Carolina 28401
    United States

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    Winston-Salem, North Carolina 27103
    United States

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    Dublin, Ohio 43016
    United States

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    Oklahoma City, Oklahoma 73120
    United States

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    Philadelphia, Pennsylvania 19140
    United States

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    Rock Hill, South Carolina 29732
    United States

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    Franklin, Tennessee 37067
    United States

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    Johnson City, Tennessee 37601
    United States

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    Houston, Texas 77084
    United States

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    Kerrville, Texas 78028
    United States

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    Mansfield, Texas 76063
    United States

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    Cudahy, Wisconsin 53110
    United States

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