New shot could tame COPD Flare-Ups in severe patients
NCT ID NCT06878261
First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 2 times
Summary
This Phase 3 trial tests whether tezepelumab, a biologic drug given as a shot, can reduce the number of moderate to severe COPD flare-ups in adults aged 40 to 80. About 990 participants with moderate to very severe COPD will receive either tezepelumab or a placebo for up to 76 weeks. The study also looks at changes in lung function and safety.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- tezepelumab (a biologic drug given as a shot under the skin)
- What this could lead to
- If it works, tezepelumab could offer a new way to reduce serious COPD flare-ups and improve lung function for people with moderate to very severe disease.
- What could go wrong
- This is still an early Phase 3 trial, so results may not confirm benefit. Tezepelumab may not work for all COPD patients, and side effects are possible. The study is large but not yet complete.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 990 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2025
- Expected to finish
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Jun 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 considered not appropriate, ≥3 consecutive months prior to V1 5. ≥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 6. EOS ≥ 150 cells/μL during screening 7. CAT ≥15 at screening 8. Former or current smokers ≥10 pack-years Exclusion Criteria: 1. Clin. important pulmonary disease or radiological findings suggestive of a respiratory 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 6. LTOT \>4.0 L/min or O2 saturation \<89% despite LTOT
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Chronic obstructive pulmonary disease (COPD) are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
249 sites in 22 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Research Site
RECRUITINGCullman, Alabama, 35055, United States
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RECRUITINGPhoenix, Arizona, 85044, United States
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RECRUITINGScottsdale, Arizona, 85258, United States
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WITHDRAWNInglewood, California, 90301, United States
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RECRUITINGLos Angeles, California, 90048, United States
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RECRUITINGPalo Alto, California, 94304, United States
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SUSPENDEDRedding, California, 96001, United States
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SUSPENDEDSan Diego, California, 92108, United States
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RECRUITINGNew Britain, Connecticut, 06051, United States
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RECRUITINGWilmington, Delaware, 19803, United States
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RECRUITINGBay Pines, Florida, 33744, United States
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RECRUITINGBoynton Beach, Florida, 33435, United States
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COMPLETEDClearwater, Florida, 33765, United States
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SUSPENDEDFleming Island, Florida, 32003, United States
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RECRUITINGJacksonville, Florida, 32209, United States
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RECRUITINGLeesburg, Florida, 34748, United States
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WITHDRAWNMargate, Florida, 33063, United States
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RECRUITINGMiami, Florida, 33126, United States
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SUSPENDEDMiami, Florida, 33155, United States
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SUSPENDEDMiami Lakes, Florida, 33014, United States
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RECRUITINGOcala, Florida, 34470, United States
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RECRUITINGPalmetto Bay, Florida, 33157, United States
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RECRUITINGWinter Park, Florida, 32789, United States
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SUSPENDEDAdairsville, Georgia, 30103, United States
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RECRUITINGAtlanta, Georgia, 30349, United States
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RECRUITINGCordele, Georgia, 31015, United States
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RECRUITINGDecatur, Georgia, 30033, United States
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WITHDRAWNFort Eisenhower, Georgia, 30905, United States
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RECRUITINGSavannah, Georgia, 31406, United States
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RECRUITINGEvanston, Illinois, 60201, United States
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NOT_YET_RECRUITINGSpringfield, Illinois, 62703, United States
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RECRUITINGEvansville, Indiana, 47725, United States
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RECRUITINGIndianapolis, Indiana, 46202, United States
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RECRUITINGIndianapolis, Indiana, 46268, United States
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RECRUITINGKansas City, Kansas, 66160, United States
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RECRUITINGBowling Green, Kentucky, 42101, United States
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RECRUITINGOwensboro, Kentucky, 42301, United States
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RECRUITINGBaltimore, Maryland, 21224, United States
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RECRUITINGPotomac, Maryland, 20854, United States
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RECRUITINGRosedale, Maryland, 21237, United States
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RECRUITINGAnn Arbor, Michigan, 48109, United States
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RECRUITINGMinneapolis, Minnesota, 55425, United States
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RECRUITINGHannibal, Missouri, 63401, United States
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RECRUITINGStaten Island, New York, 10309, United States
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RECRUITINGSyracuse, New York, 13203, United States
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NOT_YET_RECRUITINGThe Bronx, New York, 10459, United States
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RECRUITINGCharlotte, North Carolina, 28277, United States
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NOT_YET_RECRUITINGConcord, North Carolina, 28025, United States
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WITHDRAWNFayetteville, North Carolina, 28303, United States
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RECRUITINGOklahoma City, Oklahoma, 73102, United States
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RECRUITINGTulsa, Oklahoma, 74133, United States
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WITHDRAWNGrants Pass, Oregon, 97527, United States
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NOT_YET_RECRUITINGHorsham, Pennsylvania, 19044, United States
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NOT_YET_RECRUITINGPittsburgh, Pennsylvania, 15241, United States
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RECRUITINGSayre, Pennsylvania, 18840, United States
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RECRUITINGAnderson, South Carolina, 29621, United States
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RECRUITINGColumbia, South Carolina, 29204, United States
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RECRUITINGGaffney, South Carolina, 29340, United States
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RECRUITINGSpartanburg, South Carolina, 29303, United States
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RECRUITINGUnion, South Carolina, 29379, United States
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RECRUITINGRapid City, South Dakota, 57702, United States
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RECRUITINGKnoxville, Tennessee, 37919, United States
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RECRUITINGBoerne, Texas, 78006, United States
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RECRUITINGEl Paso, Texas, 79902, United States
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RECRUITINGHouston, Texas, 77008, United States
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RECRUITINGHouston, Texas, 77074, United States
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RECRUITINGHouston, Texas, 77094, United States
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RECRUITINGLewisville, Texas, 75067, United States
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RECRUITINGMcKinney, Texas, 75069, United States
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RECRUITINGMesquite, Texas, 75149, United States
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RECRUITINGSan Antonio, Texas, 78258, United States
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RECRUITINGColchester, Vermont, 05446, United States
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RECRUITINGWilliamsburg, Virginia, 23188, United States
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RECRUITINGEverett, Washington, 98208, United States
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RECRUITINGAlberdi, X5033DCE, Argentina
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RECRUITINGBuenos Aires, C1425BEN, Argentina
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RECRUITINGCiudad de Buenos Aires, C1414AIF, Argentina
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RECRUITINGFlorida, B1602DQD, Argentina
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RECRUITINGLa Plata, B1900, Argentina
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RECRUITINGLa Plata, B1904, Argentina
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RECRUITINGMar del Plata, 7600, Argentina
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RECRUITINGMendoza, M5500CCG, Argentina
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RECRUITINGQuilmes, B1878FNR, Argentina
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RECRUITINGRosario, 2000, Argentina
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RECRUITINGSan Fernando, B1646EBJ, Argentina
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RECRUITINGSan Juan Bautista, 1888, Argentina
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RECRUITINGCoffs Harbour, 02450, Australia
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RECRUITINGFrankston, 3199, Australia
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WITHDRAWNGarran, 2605, Australia
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RECRUITINGNedlands, 6009, Australia
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COMPLETEDNew Lambton, 2310, Australia
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RECRUITINGSpearwood, 6163, Australia
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WITHDRAWNWollongong, 2500, Australia
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COMPLETEDWoodville South, 5011, Australia
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RECRUITINGGenk, 3600, Belgium
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RECRUITINGGhent, 9000, Belgium
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RECRUITINGJette, 1090, Belgium
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RECRUITINGLeuven, 3000, Belgium
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RECRUITINGMechelen, 2800, Belgium
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RECRUITINGNamur, 5101, Belgium
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RECRUITINGDupnitsa, 2600, Bulgaria
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RECRUITINGHaskovo, 6300, Bulgaria
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WITHDRAWNLovech, 5500, Bulgaria
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RECRUITINGPleven, 5800, Bulgaria
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RECRUITINGPlovdiv, 4003, Bulgaria
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WITHDRAWNRousse, 7000, Bulgaria
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RECRUITINGRousse, 7000, Bulgaria
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RECRUITINGSofia, 1000, Bulgaria
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WITHDRAWNSofia, 1202, Bulgaria
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RECRUITINGSofia, 1431, Bulgaria
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RECRUITINGSofia, 1756, Bulgaria
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RECRUITINGStara Zagora, 6003, Bulgaria
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WITHDRAWNVarna, 9000, Bulgaria
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RECRUITINGVeliko Tanovo, 5000, Bulgaria
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RECRUITINGVeliko Tarnovo, 5000, Bulgaria
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RECRUITINGVidin, 3700, Bulgaria
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RECRUITINGYambol, 8600, Bulgaria
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RECRUITINGArmenia, 630004, Colombia
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RECRUITINGBarranquilla, 080020, Colombia
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RECRUITINGBogotá, 110131, Colombia
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RECRUITINGCali, 760042, Colombia
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RECRUITINGIbague, 730006, Colombia
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RECRUITINGManizales, 170004, Colombia
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RECRUITINGMedellín, 050022, Colombia
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RECRUITINGMedellín, 050030, Colombia
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RECRUITINGAalborg, 9000, Denmark
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RECRUITINGHvidovre, 2650, Denmark
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RECRUITINGNæstved, 4700, Denmark
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RECRUITINGOdense C, 5000, Denmark
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RECRUITINGVejle, 7100, Denmark
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RECRUITINGBrest, 29609, France
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RECRUITINGLyon, 69317, France
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RECRUITINGMarseille, 13915, France
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RECRUITINGMontpellier, 34295, France
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RECRUITINGParis, 75014, France
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RECRUITINGParis, 75877, France
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RECRUITINGPessac, 33604, France
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RECRUITINGSaint-Herblain, 44800, France
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RECRUITINGAthens, 11521, Greece
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RECRUITINGAthens, 11527, Greece
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RECRUITINGAthens, 17562, Greece
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RECRUITINGHeraklion, 71110, Greece
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RECRUITINGIoannina, 45500, Greece
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RECRUITINGPátrai, 26332, Greece
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RECRUITINGThessaloniki, 57001, Greece
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RECRUITINGThessaloniki, 57010, Greece
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RECRUITINGHong Kong, 999077, Hong Kong
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RECRUITINGBudapest, 1036, Hungary
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RECRUITINGDebrecen, 4032, Hungary
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RECRUITINGEdelény, 3780, Hungary
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RECRUITINGGödöllő, 2100, Hungary
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RECRUITINGHatvan, 3000, Hungary
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RECRUITINGMosonmagyaróvár, 9200, Hungary
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RECRUITINGNyíregyháza-Sóstóhegy, 4481, Hungary
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RECRUITINGTörökbálint, 2045, Hungary
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RECRUITINGAshkelon, 78278, Israel
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RECRUITINGHaifa, 34362, Israel
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RECRUITINGJerusalem, 00000, Israel
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RECRUITINGJerusalem, 90131, Israel
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RECRUITINGKfar Saba, 4428164, Israel
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RECRUITINGRamat Gan, 52621, Israel
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RECRUITINGRehovot, 76100, Israel
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RECRUITINGTel Aviv, 6423906, Israel
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RECRUITINGAkashi-shi, 674-0063, Japan
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RECRUITINGChikushino-shi, 818-8502, Japan
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RECRUITINGChiyoda-ku, 1020074, Japan
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RECRUITINGFukui-shi, 910-8526, Japan
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RECRUITINGFukuoka, 811-1394, Japan
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RECRUITINGFukuoka, 819-8555, Japan
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RECRUITINGGifu, 502-8558, Japan
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RECRUITINGIruma-Gun, 350-0495, Japan
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RECRUITINGIshinomaki, 986-8522, Japan
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RECRUITINGKasuga-shi, 816-0864, Japan
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RECRUITINGKitakyushu-shi, 807-8555, Japan
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RECRUITINGKiyose-shi, 204-8522, Japan
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RECRUITINGKiyose-shi, 204-8585, Japan
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RECRUITINGKobe, 650-0047, Japan
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RECRUITINGKomatsu-shi, 923-8560, Japan
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RECRUITINGKure-shi, 737-8505, Japan
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RECRUITINGKyoto, 612-8555, Japan
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RECRUITINGMatsusaka-shi, 515-8544, Japan
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WITHDRAWNMeguro-ku, 153-0051, Japan
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RECRUITINGMinatoku, 105-8470, Japan
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RECRUITINGMinatoku, 108-0073, Japan
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RECRUITINGMiyazaki, 889-1692, Japan
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RECRUITINGMizunami-shi, 509-6134, Japan
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RECRUITINGNagaoka-shi, 940-8621, Japan
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RECRUITINGNagasaki, 852-8501, Japan
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RECRUITINGNagoya, 457-0866, Japan
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RECRUITINGNagoya, 457-8511, Japan
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RECRUITINGNagoya, 466-8650, Japan
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RECRUITINGNerima-ku, 177-8521, Japan
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WITHDRAWNOhta-ku, 143-0013, Japan
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RECRUITINGOkayama, 700-8558, Japan
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RECRUITINGOkayama, 701-1192, Japan
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RECRUITINGOsaka, 540-0008, Japan
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RECRUITINGSapporo, 064-0804, Japan
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RECRUITINGSendai, 980-8574, Japan
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RECRUITINGSendai, 983-8520, Japan
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RECRUITINGShinjuku-ku, 160-8582, Japan
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RECRUITINGShinjuku-ku, 162-8655, Japan
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RECRUITINGShinjuku-ku, 162-8666, Japan
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RECRUITINGShiogama, 985-8506, Japan
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RECRUITINGTakamatsu, 760-0018, Japan
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WITHDRAWNTakatsuiki-shi, 569-1096, Japan
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RECRUITINGTanabe-shi, 646-8558, Japan
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WITHDRAWNToshima-ku, 171-0014, Japan
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RECRUITINGUbe, 755-8505, Japan
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RECRUITINGYokohama, 236-0004, Japan
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WITHDRAWNYokohama, 245-8575, Japan
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RECRUITINGEindhoven, 5623 EJ, Netherlands
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RECRUITINGMaastricht, 6229 HX, Netherlands
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RECRUITINGRotterdam, 3045 PM, Netherlands
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RECRUITINGRotterdam, 3083 AN, Netherlands
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RECRUITINGZutphen, 7207 AE, Netherlands
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COMPLETEDAuckland, 0626, New Zealand
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RECRUITINGAuckland, 1051, New Zealand
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RECRUITINGAuckland, 2025, New Zealand
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RECRUITINGHamilton West, 3204, New Zealand
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RECRUITINGTauranga, 3112, New Zealand
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NOT_YET_RECRUITINGCallao, Bellavista, Peru
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WITHDRAWNCusco, CUSCO 01, Peru
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RECRUITINGLima, 15023, Peru
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RECRUITINGLima, 15036, Peru
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WITHDRAWNLima, 15036, Peru
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WITHDRAWNLima, 15038, Peru
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RECRUITINGLima, 15046, Peru
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RECRUITINGLima, 15088, Peru
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RECRUITINGLima, LIMA 01, Peru
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RECRUITINGLima, LIMA 1, Peru
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WITHDRAWNLima, LIMA 21, Peru
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WITHDRAWNLima, LIMA 33, Peru
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RECRUITINGPiura, 20001, Peru
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WITHDRAWNBucharest, 011461, Romania
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NOT_YET_RECRUITINGBucharest, 012363, Romania
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RECRUITINGBucharest, 030167, Romania
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RECRUITINGCluj-Napoca, 400275, Romania
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RECRUITINGCluj-Napoca, 400332, Romania
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RECRUITINGOradea, 410176, Romania
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RECRUITINGTimișoara, 300002, Romania
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RECRUITINGTimișoara, 300310, Romania
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RECRUITINGBellville, 7530, South Africa
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RECRUITINGBenoni, 1501, South Africa
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RECRUITINGCape Town, 7700, South Africa
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RECRUITINGDurban, 4001, South Africa
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RECRUITINGDurban, 4093, South Africa
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RECRUITINGeMkhomazi, 4170, South Africa
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WITHDRAWNKimberley, 8301, South Africa
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RECRUITINGSomerset West, 7130, South Africa
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RECRUITINGGothenburg, 413 46, Sweden
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RECRUITINGKarlskrona, 371 79, Sweden
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RECRUITINGLund, 22185, Sweden
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RECRUITINGÖrebro, 703 62, Sweden
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RECRUITINGStockholm, 11446, Sweden
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RECRUITINGStockholm, 171 64, Sweden
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RECRUITINGBangkok, 10330, Thailand
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RECRUITINGHat Yai, 90110, Thailand
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RECRUITINGMuang, 22000, Thailand
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RECRUITINGMuang, 40002, Thailand
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RECRUITINGMueang, 20000, Thailand
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RECRUITINGNonthaburi, 11000, Thailand
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RECRUITINGRayong, 21000, Thailand
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RECRUITINGAdana, 1330, Turkey (Türkiye)
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RECRUITINGAnkara, 6620, Turkey (Türkiye)
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RECRUITINGIstanbul, 34020, Turkey (Türkiye)
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RECRUITINGKayseri, 38039, Turkey (Türkiye)
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RECRUITINGKocaeli, 41380, Turkey (Türkiye)
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RECRUITINGMersin, 33079, Turkey (Türkiye)
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NOT_YET_RECRUITINGCan Tho, 900000, Vietnam
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RECRUITINGDa Nang, 550000, Vietnam
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RECRUITINGHaiphong, 180000, Vietnam
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RECRUITINGHanoi, 100000, Vietnam
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RECRUITINGHo Chi Minh City, 700000, Vietnam
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RECRUITINGHo Chi Minh City, Vietnam
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RECRUITINGHồ Chí Minh, 700000, Vietnam
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RECRUITINGHuế, 530000, Vietnam
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