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

Last updated: March 3, 2026
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

3

Condition

Chronic Bronchitis

Chronic Obstructive Lung Disease

Bronchiectasis

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, 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: 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

    Active - Recruiting

  • Research Site

    Bragança Paulista 3469092, 12916-542
    Brazil

    Site Not Available

  • Research Site

    Brasilia, 70200-730
    Brazil

    Site Not Available

  • Research Site

    Brasília, 70200-730
    Brazil

    Active - Recruiting

  • Research Site

    Brasília 3469058, 70200-730
    Brazil

    Site Not Available

  • Research Site

    Campinas, 13060-080
    Brazil

    Active - Recruiting

  • Research Site

    Campinas 3467865, 13060-080
    Brazil

    Site Not Available

  • Research Site

    Chapeco, 89812-210
    Brazil

    Site Not Available

  • Research Site

    Chapecó, 89812-210
    Brazil

    Active - Recruiting

  • Research Site

    Chapecó 3466296, 89812-210
    Brazil

    Site Not Available

  • Research Site

    Curitiba, 80030-110
    Brazil

    Active - Recruiting

  • Research Site

    Curitiba 3464975, 80030-110
    Brazil

    Site Not Available

  • Research Site

    Jaú, 17201-130
    Brazil

    Active - Recruiting

  • Research Site

    Jaú 3460005, 17201-130
    Brazil

    Site Not Available

  • Research Site

    Mossoro, 59603-020
    Brazil

    Site Not Available

  • Research Site

    Mossoró, 59603-020
    Brazil

    Active - Recruiting

  • Research Site

    Mossoró 3394682, 59603-020
    Brazil

    Site Not Available

  • Research Site

    Porto Alegre, 91350-200
    Brazil

    Active - Recruiting

  • Research Site

    Porto Alegre 3452925, 90035-903
    Brazil

    Site Not Available

  • Research Site

    Salvador, 40050-410
    Brazil

    Active - Recruiting

  • Research Site

    Salvador 3450554, 40050-410
    Brazil

    Site Not Available

  • Research Site

    Sao Jose Do Rio Preto, 15090-000
    Brazil

    Site Not Available

  • Research Site

    São José do Rio Preto, 15090-000
    Brazil

    Active - Recruiting

  • Research Site

    São José do Rio Preto 3448639, 15090-000
    Brazil

    Site Not Available

  • Research Site

    Vitoria, 29062-110
    Brazil

    Site Not Available

  • Research Site

    Vitória, 29062-110
    Brazil

    Active - Recruiting

  • Research Site

    Vitória 3444924, 29062-110
    Brazil

    Site Not Available

  • Research Site

    Votuporanga, 15501-405
    Brazil

    Site Not Available

  • Research Site

    Votuporanga 3444864, 15501-405
    Brazil

    Site Not Available

  • Research Site

    Calgary, Alberta T3R 1W7
    Canada

    Active - Recruiting

  • Research Site

    Calgary 5913490, Alberta 5883102 T3R 1W7
    Canada

    Site Not Available

  • Research Site

    Vancouver, British Columbia V5Z 1M9
    Canada

    Active - Recruiting

  • Research Site

    Vancouver 6173331, British Columbia 5909050 V5Z 1M9
    Canada

    Site Not Available

  • Research Site

    Ajax, Ontario L1S 2J5
    Canada

    Active - Recruiting

  • Research Site

    Burlington, Ontario L7N 3V2
    Canada

    Active - Recruiting

  • Research Site

    Scarborough, Ontario M1P 2V5
    Canada

    Site Not Available

  • Research Site

    Scarborough Village, Ontario M1P 2V5
    Canada

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  • Research Site

    Toronto, Ontario M5T 3A9
    Canada

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  • Research Site

    Winchester, Ontario K0C 2K0
    Canada

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  • Research Site

    Windsor, Ontario N8X-5A6
    Canada

    Active - Recruiting

  • Research Site

    Ajax 5882873, Ontario 6093943 L1S 2J5
    Canada

    Site Not Available

  • Research Site

    Burlington 5911592, Ontario 6093943 L7N 3V2
    Canada

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  • Research Site

    Scarborough Village 6141900, Ontario 6093943 M1P 2V5
    Canada

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  • Research Site

    Toronto 6167865, Ontario 6093943 M5T 3A9
    Canada

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    Winchester 6182823, Ontario 6093943 K0C 2K0
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    Windsor 6182962, Ontario 6093943 N8X-5A6
    Canada

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    Montreal, Quebec H1T 2M4
    Canada

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  • Research Site

    Québec, Quebec G1G 3Y8
    Canada

    Active - Recruiting

  • Research Site

    Saint-Charles-Borromée, Quebec J6E 2B4
    Canada

    Active - Recruiting

  • Research Site

    Saint-Laurent, Quebec H4R3C8
    Canada

    Active - Recruiting

  • Research Site

    St Charles Borromee, Quebec J6E 2B4
    Canada

    Site Not Available

  • Research Site

    Trois-Rivières, Quebec G8T 7A1
    Canada

    Active - Recruiting

  • Research Site

    Montreal 6077243, Quebec 6115047 H3T 1E2
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    Site Not Available

  • Research Site

    Québec 6325494, Quebec 6115047 G1G 3Y8
    Canada

    Site Not Available

  • Research Site

    Saint-Charles-Borromée 6137579, Quebec 6115047 J6E 2B4
    Canada

    Site Not Available

  • Research Site

    Saint-Laurent 6138610, Quebec 6115047 H4R3C8
    Canada

    Site Not Available

  • Research Site

    Trois-Rivières 6169141, Quebec 6115047 G8T 7A1
    Canada

    Site Not Available

  • Research Site

    Saskatoon, Saskatchewan S7N 0W8
    Canada

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  • Research Site

    Saskatoon 6141256, Saskatchewan 6141242 S7N 0W8
    Canada

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  • Research Site

    Quebec, G1G 3Y8
    Canada

    Site Not Available

  • Research Site

    Concepción, 4070094
    Chile

    Active - Recruiting

  • Research Site

    Concepción 3893894, 4070094
    Chile

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  • Research Site

    Curico, 3341643
    Chile

    Site Not Available

  • Research Site

    Curicó, 3341643
    Chile

    Active - Recruiting

  • Research Site

    Curicó 3892870, 3341643
    Chile

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  • Research Site

    Quillota, 2260000
    Chile

    Active - Recruiting

  • Research Site

    Quillota 3874119, 2260000
    Chile

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  • Research Site

    Santiago, 7501126
    Chile

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    Santiago 3871336, 7501126
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  • Research Site

    Talca, 3481349
    Chile

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  • Research Site

    Talca 3870294, 3481349
    Chile

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  • Research Site

    Anyang, 455099
    China

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  • Research Site

    Anyang 1785294, 455099
    China

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    Beijing, 100020
    China

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    Beijing 1816670, 100020
    China

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    Changchun, 130021
    China

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  • Research Site

    Changchun 2038180, 130021
    China

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    Changsha, 410015
    China

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    Changsha 1815577, 410015
    China

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    Chengdu, 610072
    China

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  • Research Site

    Chengdu 1815286, 610072
    China

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    Chongqing, 401320
    China

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  • Research Site

    Chongqing 1814906, 401320
    China

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  • Research Site

    Fuzhou, 350031
    China

    Active - Recruiting

  • Research Site

    Fuzhou 1810821, 350031
    China

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  • Research Site

    Guangzhou, 510000
    China

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  • Research Site

    Guangzhou 1809858, 510150
    China

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  • Research Site

    Haikou, 570311
    China

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  • Research Site

    Haikou 1809078, 570311
    China

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  • Research Site

    Hangzhou, 310005
    China

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  • Research Site

    Hangzhou 1808926, 310005
    China

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  • Research Site

    Hefei, 230061
    China

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  • Research Site

    Hefei 1808722, 230061
    China

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  • Research Site

    Hengyang, 421001
    China

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  • Research Site

    Hengyang 1808370, 421001
    China

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  • Research Site

    Hengyang City, 421001
    China

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  • Research Site

    Heze, 274099
    China

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  • Research Site

    Heze 1808198, 274099
    China

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  • Research Site

    Hohhot, 750306
    China

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  • Research Site

    Hohhot 2036892, 750306
    China

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  • Research Site

    Huizhou, 516002
    China

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  • Research Site

    Huizhou 1806776, 516002
    China

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  • Research Site

    Jinan, 250021
    China

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  • Research Site

    Jinan 1805753, 250013
    China

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  • Research Site

    Jinhua, 321000
    China

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  • Research Site

    Jinhua 1805528, 321000
    China

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  • Research Site

    Linhai, 317000
    China

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  • Research Site

    Linhai 1803422, 317000
    China

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    Linhai 9906214, 317000
    China

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  • Research Site

    Loudi, 417099
    China

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  • Research Site

    Loudi 1802238, 417099
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  • Research Site

    Nan Chong, 637000
    China

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    Nanchang, 330006
    China

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    Nanchang 1800163, 330006
    China

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    Nanchong, 637000
    China

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    Nanchong 1800146, 637000
    China

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  • Research Site

    Nanjing, 2100008
    China

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  • Research Site

    Nanjing 1799962, 211100
    China

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  • Research Site

    Nanning, 530021
    China

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  • Research Site

    Nanning 1799869, 530000
    China

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  • Research Site

    Pingxiang, 337055
    China

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  • Research Site

    Pingxiang 1798654, 337055
    China

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  • Research Site

    Qingdao, 266011
    China

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  • Research Site

    Qingdao 1797929, 266011
    China

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  • Research Site

    Qingyuan, 511518
    China

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  • Research Site

    Qingyuan 1797945, 511518
    China

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  • Research Site

    Sanya, 572000
    China

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  • Research Site

    Sanya 1796556, 572000
    China

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  • Research Site

    Shanghai, 201199
    China

    Active - Recruiting

  • Research Site

    Shanghai 1796236, 310000
    China

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  • Research Site

    Shantou, 515041
    China

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  • Research Site

    Shantou 1795940, 515041
    China

    Site Not Available

  • Research Site

    Shenyang, 110004
    China

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  • Research Site

    Shenyang 2034937, 110004
    China

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  • Research Site

    Shenzhen, 518020
    China

    Active - Recruiting

  • Research Site

    Shenzhen 1795565, 518020
    China

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  • Research Site

    Shijiazhuang, 50051
    China

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  • Research Site

    Shijiazhuang 1795270, 50051
    China

    Site Not Available

  • Research Site

    Suining Shi, 629000
    China

    Active - Recruiting

  • Research Site

    Taiyuan, 030001
    China

    Active - Recruiting

  • Research Site

    Taiyuan 1793511, 030032
    China

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  • Research Site

    Taizhou, 318000
    China

    Active - Recruiting

  • Research Site

    Taizhou 1793505, 318000
    China

    Site Not Available

  • Research Site

    Tianjin, 300050
    China

    Active - Recruiting

  • Research Site

    Tianjin 1792947, 300050
    China

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  • Research Site

    Wenzhou, 325027
    China

    Active - Recruiting

  • Research Site

    Wenzhou 1791388, 325027
    China

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  • Research Site

    Wuhan, 430022
    China

    Active - Recruiting

  • Research Site

    Wuhan 1791247, 430030
    China

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  • Research Site

    Xinxiang, 453100
    China

    Active - Recruiting

  • Research Site

    Xinxiang 1788572, 453100
    China

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  • Research Site

    Xuzhou, 221000
    China

    Active - Recruiting

  • Research Site

    Xuzhou 10630003, 221000
    China

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  • Research Site

    Yangzhou, 225001
    China

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  • Research Site

    Yangzhou 1787227, 225001
    China

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    Yichang, 443003
    China

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  • Research Site

    Yichang 1786764, 443003
    China

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  • Research Site

    Yinchuan, 750001
    China

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    Yinchuan 1786657, 750004
    China

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    Zhangzhou, 363099
    China

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  • Research Site

    Zhangzhou 1785018, 363099
    China

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  • Research Site

    Brandys nad Labem, 250 01
    Czechia

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  • Research Site

    Brandýs nad Labem, 250 01
    Czechia

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  • Research Site

    Brandýs nad Labem 3078838, 250 01
    Czechia

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  • Research Site

    Brno, 625 00
    Czechia

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  • Research Site

    Brno 3078610, 625 00
    Czechia

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    Jindrichuv Hradec, 377 01
    Czechia

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  • Research Site

    Jindřichův Hradec, 377 01
    Czechia

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  • Research Site

    Jindřichův Hradec 3074149, 377 01
    Czechia

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  • Research Site

    Lovosice, 410 02
    Czechia

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  • Research Site

    Lovosice 3071480, 410 02
    Czechia

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    Ostrava, 700 30
    Czechia

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  • Research Site

    Ostrava 3068799, 700 30
    Czechia

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    Pilsen, 301 00
    Czechia

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  • Research Site

    Pilsen 3068160, 301 00
    Czechia

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  • Research Site

    Plzen, 301 00
    Czechia

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  • Research Site

    Prague, 15300
    Czechia

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  • Research Site

    Prague 3067696, 15300
    Czechia

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    Praha 1, 110 00
    Czechia

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    Praha 16, 15300
    Czechia

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  • Research Site

    Teplice, 415 01
    Czechia

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  • Research Site

    Teplice 3064288, 415 01
    Czechia

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    Varnsdorf, 407 47
    Czechia

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  • Research Site

    Varnsdorf 3063375, 407 47
    Czechia

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  • Research Site

    København NV, 2400
    Denmark

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    København NV 11746894, 2400
    Denmark

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  • Research Site

    Bendorf, 56170
    Germany

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  • Research Site

    Bendorf 2951111, 56170
    Germany

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    Berlin, 10787
    Germany

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  • Research Site

    Berlin 2950159, 10787
    Germany

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    Haltern am See, 45721
    Germany

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  • Research Site

    Haltern am See 2911395, 45721
    Germany

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    Hannover, D-30173
    Germany

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    Hanover, D-30173
    Germany

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    Hanover 2910831, D-30173
    Germany

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    Immenhausen, 34376
    Germany

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    Immenhausen 2896279, 34376
    Germany

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    Lübeck, 23552
    Germany

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    Lübeck 2875601, 23552
    Germany

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    Marburg, 35037
    Germany

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    Marburg 2873759, 35037
    Germany

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    Rosenheim, 83022
    Germany

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    Rosenheim 2844988, 83022
    Germany

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    Stuttgart, 70376
    Germany

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    Stuttgart 2825297, 70376
    Germany

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    Wiesbaden, 65183
    Germany

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    Wiesbaden 2809346, 65183
    Germany

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    Ahmedabad, 380054
    India

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    Ahmedabad 1279233, 380054
    India

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    Belagavi, 590010
    India

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  • Research Site

    Belagavi 1276533, 590010
    India

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    Coimbatore, 641028
    India

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    Coimbatore 1273865, 641028
    India

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    Dehradun, 248001
    India

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    Dehradun 1273313, 248001
    India

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    Delhi, 110029
    India

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    Delhi 1273294, 110029
    India

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    Dwārka, 110075
    India

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  • Research Site

    Dwārka 1272140, 110075
    India

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    Faridabad, 121012
    India

    Suspended

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    Faridabad 1271951, 121012
    India

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    Gurgaon, 122001
    India

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    Gurgaon 10547511, 122001
    India

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    Gūrgaon 10330624, 122001
    India

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    Kochi, 682027
    India

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    Kochi 1273874, 682027
    India

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    Kolkata, 700053
    India

    Suspended

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    Kolkata 1275004, 700053
    India

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    Lucknow, 226003
    India

    Suspended

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    Lucknow 1264733, 226003
    India

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    Madurai, 625107
    India

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    Madurai 1264521, 625107
    India

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    Mysuru, 570002
    India

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    Mysuru 1262321, 570002
    India

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    Nagpur, 441108
    India

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    Nagpur 1262180, 440012
    India

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    Pune, 411 018
    India

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    Pune 1259229, 411 018
    India

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    Vadodara, 391760
    India

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    Vadodara 1253573, 391760
    India

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    Firenze, 50134
    Italy

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    Florence, 50134
    Italy

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    Florence 3176959, 50134
    Italy

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    Milan, 20122
    Italy

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    Milan 6951411, 20122
    Italy

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    Milano, 20122
    Italy

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    Montebelluna, 31044
    Italy

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    Montebelluna 3173029, 31044
    Italy

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    Napoli, 80131
    Italy

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    Napoli 9031661, 80131
    Italy

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    Pavia, 27100
    Italy

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    Pavia 3171366, 27100
    Italy

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    Roma, 00128
    Italy

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    Roma 8957247, 00128
    Italy

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    Sassari, 07100
    Italy

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    Sassari 3167096, 07100
    Italy

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    Site Not Available

  • Research Site

    Mansfield 4709013, Texas 4736286 76063
    United States

    Site Not Available

  • Research Site

    Clearfield, Utah 84015
    United States

    Active - Recruiting

  • Research Site

    Clearfield 5772959, Utah 5549030 84015
    United States

    Site Not Available

  • Research Site

    Morgantown, West Virginia 26501
    United States

    Site Not Available

  • Research Site

    Morgantown 4815352, West Virginia 4826850 26501
    United States

    Site Not Available

  • Research Site

    Cudahy, Wisconsin 53110
    United States

    Active - Recruiting

  • Research Site

    Milwaukee, Wisconsin 53295
    United States

    Site Not Available

  • Research Site

    Cudahy 5249871, Wisconsin 5279468 53110
    United States

    Site Not Available

  • Research Site

    Milwaukee 5263045, Wisconsin 5279468 53295
    United States

    Site Not Available

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