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NCT07190209RecruitingPhase 3

Efficacy, Safety, and Tolerability Study of Lunsekimig Compared With Placebo in Adult Participants With Inadequately Controlled Chronic Obstructive Pulmonary Disease (COPD) Characterized by an Eosinophilic Phenotype

A Phase 2b/Phase 3, Randomized, Double-blind, Placebocontrolled, Multicenter Study, to Investigate the Efficacy and Safety of Lunsekimig in Adult Participants With Inadequately Controlled Chronic Obstructive Pulmonary Disease (COPD) Characterized by an Eosinophilic Phenotype

Source: ClinicalTrials.gov · Last updated 19 Oct 2026

Brief summary (registry, in English)

This is a parallel, Phase 2b/Phase 3, 3-arm study to investigate the efficacy, safety, and tolerability of subcutaneous (SC) treatment with lunsekimig compared with placebo in adult participants (aged 40 to 80 years, inclusive) with inadequately controlled Chronic obstructive pulmonary disease (COPD) characterized by an eosinophilic phenotype. Participation to the study consists of 3 periods: * Screening period of up to 4 weeks * Randomized intervention period of approximately 48 weeks * Follow-up period: Approximately 8 weeks The study duration will be up to 60 weeks.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
942 (estimated)
First submitted
17 Sept 2025
Start date
Sept 2025
Primary completion date
Nov 2029
Lead sponsor
Sanofi
Diseases
COPD
NCT number
NCT07190209
EU CT number
2024-518016-39-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 942
  • From Sept 2025 to the primary completion date, Nov 2029
  • 314 sites in 25 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Long-term oxygen therapy \>4.0 L/min or requirement of \>2.0 L/min to maintain oxygen saturation \>88% at rest
  • Concomitant therapies:
    • long-term macrolides or phosphodiesterase Type 3 (PDE-3) or PDE-4 inhibitors unless on stable therapy for \>6 months
    • any biologic therapy or systemic immunosuppressant within 4 months or 5 half-lives prior to Screening
    • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial

Other illness

  • Asthma, including pediatric asthma, or asthma-COPD overlap syndrome (ACOS)
  • Significant pulmonary disease other than COPD
  • Unstable disorder that can impact participants safety or study outcomes
  • Active or incompletely treated tuberculosis
  • Current or past malignancies

Other

  • Participants are excluded from the study if any of the following criteria apply:

Who the study is looking for

  • Between 40 to 80 years of age
  • Physician diagnosed chronic obstructive pulmonary disease (COPD) ≥1 year
  • Post-bronchodilator forced expiratory volume in 1 second (post-BD FEV1) ≥ 20% and ≤ 70% of predicted value and FEV1/FVC (forced expiratory volume in 1 second /forced vital capacity) \<0.70
  • Former or current smokers ≥10 pack-years
  • Chronic Airways Assessment Test (CAAT) ≥10
  • ≥2 moderate or ≥1 severe COPD exacerbations in the prior year
  • Triple (ICS+LABA+LAMA) COPD therapy ≥12 consecutive weeks
  • EOS (blood eosinophil count) ≥ 150 cells/μL
  • 18.0 ≤ Body Mass Index ≤ 40.0 kg/m2

Age in the registry: 40 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (314)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
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Buenos AiresArgentinaRecruiting
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Buenos AiresArgentinaRecruiting
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Buenos AiresArgentinaRecruiting
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Buenos AiresArgentinaRecruiting
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Buenos AiresArgentinaRecruiting
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Buenos AiresArgentinaRecruiting
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La PlataArgentinaRecruiting
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LobosArgentinaRecruiting
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RosarioArgentinaRecruiting
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RosarioArgentinaRecruiting
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San Miguel de TucumánArgentinaRecruiting
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San Miguel de TucumánArgentinaRecruiting
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BrusselsBelgiumRecruiting
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EdegemBelgiumRecruiting
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ErpentBelgiumRecruiting
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LeuvenBelgiumRecruiting
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MechelenBelgiumRecruiting
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YvoirBelgiumRecruiting
Chronos Pesquisa Clínica- Site Number : 0760012
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BrasíliaBrazilRecruiting
CETI - Centro de Estudos em Terapias Inovadoras- Site Number : 0760013
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CuritibaBrazilRecruiting
Hospital Universitário Onofre Lopes- Site Number : 0760016
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NatalBrazilRecruiting
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Porto AlegreBrazilRecruiting
Instituto Ceos- Site Number : 0760005
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Porto AlegreBrazilRecruiting
Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760001
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Porto AlegreBrazilRecruiting
Hospital Copa D'Or- Site Number : 0760017
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Rio de JaneiroBrazilRecruiting
Fundação Faculdade Regional de Medicina de São José do Rio Preto- Site Number : 0760011
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São José do Rio PretoBrazilRecruiting
Centro Internacional de Pesquisa Clínica (CIPES)- Site Number : 0760008
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São José dos CamposBrazilRecruiting
Hospital Beneficência Portuguesa de São Paulo- Site Number : 0760010
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São PauloBrazilRecruiting
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AjaxCanadaRecruiting
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CalgaryCanadaRecruiting
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GuelphCanadaRecruiting
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OttawaCanadaRecruiting
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Stoney CreekCanadaRecruiting
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TorontoCanadaRecruiting
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VancouverCanadaRecruiting
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WaterlooCanadaRecruiting
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SantiagoChileRecruiting
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SantiagoChileRecruiting
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SantiagoChileRecruiting
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TalcaChileRecruiting
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ValdiviaChileRecruiting
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Viña del MarChileRecruiting
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BeijingChinaRecruiting
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BeijingChinaRecruiting
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ChangchunChinaRecruiting
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ChangshaChinaRecruiting
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ChangshaChinaRecruiting
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ChengduChinaRecruiting
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ChengduChinaRecruiting
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ChengduChinaRecruiting
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FoshanChinaRecruiting
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GuangzhouChinaRecruiting
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GuangzhouChinaRecruiting
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HangzhouChinaRecruiting
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HarbinChinaRecruiting
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HefeiChinaRecruiting
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HeifeiChinaRecruiting
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HohhotChinaRecruiting
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HuizhouChinaRecruiting
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JiaozuoChinaRecruiting
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JinanChinaRecruiting
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JinhuaChinaRecruiting
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JiningChinaRecruiting
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KunmingChinaRecruiting
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LangfangChinaRecruiting
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LiaochengChinaRecruiting
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LinhaiChinaRecruiting
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NanchangChinaRecruiting
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NanchangChinaRecruiting
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NanningChinaRecruiting
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NingboChinaRecruiting
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PingxiangChinaRecruiting
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ShanghaiChinaRecruiting
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ShanghaiChinaRecruiting
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ShenyangChinaRecruiting
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ShenzhenChinaRecruiting
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ShiheziChinaRecruiting
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TaiyuanChinaRecruiting
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TaizhouChinaRecruiting
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TianjinChinaRecruiting
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ÜrümqiChinaRecruiting
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WenzhouChinaRecruiting
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WuhanChinaRecruiting
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WuxiChinaRecruiting
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XiamenChinaRecruiting
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Xi'anChinaRecruiting
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XiangtanChinaRecruiting
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XinxiangChinaRecruiting
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XuzhouChinaRecruiting
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YangzhouChinaRecruiting
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YichangChinaRecruiting
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YinchuanChinaRecruiting
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ZhanjiangChinaRecruiting
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ZhengzhouChinaRecruiting
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ZunyiChinaRecruiting
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AhrensburgGermanyRecruiting
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AugsburgGermanyRecruiting
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BendorfGermanyRecruiting
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BerlinGermanyRecruiting
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BerlinGermanyRecruiting
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DarmstadtGermanyRecruiting
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FrankfurtGermanyRecruiting
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FrankfurtGermanyRecruiting
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Frankfurt am MainGermanyRecruiting
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HamburgGermanyRecruiting
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LeipzigGermanyRecruiting
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LübeckGermanyRecruiting
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MainzGermanyRecruiting
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MunichGermanyRecruiting
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AalborgDenmarkRecruiting
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HvidovreDenmarkRecruiting
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NæstvedDenmarkRecruiting
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OdenseDenmarkRecruiting
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VejleDenmarkRecruiting
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TallinnEstoniaRecruiting
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TartuEstoniaRecruiting
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BenalmádenaSpainRecruiting
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CáceresSpainRecruiting
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Jerez de la FronteraSpainRecruiting
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L'Hospitalet de LlobregatSpainRecruiting
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MálagaSpainRecruiting
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MéridaSpainRecruiting
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PalmaSpainRecruiting
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SevilleSpainRecruiting
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TurkuFinlandRecruiting
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BrestFranceRecruiting
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La TroncheFranceRecruiting
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Le MansFranceRecruiting
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LyonFranceRecruiting
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MontpellierFranceRecruiting
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PessacFranceRecruiting
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PontoiseFranceRecruiting
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ReimsFranceRecruiting
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SuresnesFranceRecruiting
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Vandœuvre-lès-NancyFranceRecruiting
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BradfordUnited KingdomRecruiting
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BristolUnited KingdomRecruiting
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HarrowUnited KingdomRecruiting
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LeicesterUnited KingdomRecruiting
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LondonUnited KingdomRecruiting
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LondonUnited KingdomRecruiting
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OxfordUnited KingdomRecruiting
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WorthingUnited KingdomRecruiting
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KutaisiGeorgiaRecruiting
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TbilisiGeorgiaRecruiting
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TbilisiGeorgiaRecruiting
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TbilisiGeorgiaRecruiting
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TbilisiGeorgiaRecruiting
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TbilisiGeorgiaRecruiting
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DebrecenHungaryRecruiting
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EdelényHungaryRecruiting
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GödöllőHungaryRecruiting
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GyöngyösHungaryRecruiting
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HajdúnánásHungaryRecruiting
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MosonmagyaróvárHungaryRecruiting
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PécsHungaryRecruiting
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PüspökladányHungaryRecruiting
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ConaItalyRecruiting
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano Site Number : 3800001
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MilanItalyRecruiting
Azienda Ospedale Università di Padova Site Number : 3800011
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PadovaItalyRecruiting
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PaviaItalyRecruiting
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Reggio EmiliaItalyRecruiting
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RozzanoItalyRecruiting
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Telese TermeItalyRecruiting
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Tradate (Va)ItalyRecruiting
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ChibaJapanRecruiting
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FujiedaJapanRecruiting
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FukuokaJapanRecruiting
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FukushimaJapanRecruiting
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HachiōjiJapanRecruiting
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Himeji-ShiJapanRecruiting
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HiroshimaJapanRecruiting
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IizukaJapanRecruiting
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KagoshimaJapanRecruiting
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KamakuraJapanRecruiting
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KashiharaJapanRecruiting
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KawasakiJapanRecruiting
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KitaJapanRecruiting
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KiyoseJapanRecruiting
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KobeJapanRecruiting
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KōnanJapanRecruiting
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KumamotoJapanRecruiting
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KumamotoJapanRecruiting
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KureJapanRecruiting
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KurumeJapanRecruiting
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KyotoJapanRecruiting
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NagoyaJapanRecruiting
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SagaJapanRecruiting
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UbeJapanRecruiting
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YokohamaJapanRecruiting
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YonezawaJapanRecruiting
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DaugavpilsLatviaRecruiting
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RigaLatviaRecruiting
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RigaLatviaRecruiting
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DurangoMexicoRecruiting
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Mexico CityMexicoRecruiting
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MonterreyMexicoRecruiting
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VeracruzMexicoRecruiting
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BialystokPolandRecruiting
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ElblagPolandRecruiting
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KatowicePolandRecruiting
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KatowicePolandRecruiting
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PiasecznoPolandRecruiting
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SosnowiecPolandRecruiting
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WroclawPolandRecruiting
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AlmadaPortugalRecruiting
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BragaPortugalRecruiting
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GuimarãesPortugalRecruiting
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Matosinhos MunicipalityPortugalRecruiting
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PortoPortugalRecruiting
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JeddahSaudi ArabiaRecruiting
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RiyadhSaudi ArabiaRecruiting
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RiyadhSaudi ArabiaRecruiting
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SolnaSwedenRecruiting
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UmeåSwedenRecruiting
Wellness Clinical Research - Allen- Site Number : 8400085
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AllenUnited StatesRecruiting
AnMed Oglesby Center- Site Number : 8400074
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AndersonUnited StatesRecruiting
University of Michigan Health System - Ann Arbor- Site Number : 8400090
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Ann ArborUnited StatesRecruiting
REX Clinical Trials - Beaumont- Site Number : 8400014
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BeaumontUnited StatesRecruiting
Novel Research - Bellaire- Site Number : 8400116
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BellaireUnited StatesRecruiting
South Texas Medical Research Institute - TTS Research- Site Number : 8400018
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BoerneUnited StatesRecruiting
Brigham & Women's Hospital- Site Number : 8400148
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BostonUnited StatesRecruiting
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Boynton BeachUnited StatesRecruiting
TEN20 Clinical Research - Carrollton- Site Number : 8400141
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CarrolltonUnited StatesRecruiting
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ChandlerUnited StatesRecruiting
University of Illinois-Chicago - College of Medicine- Site Number : 8400055
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ChicagoUnited StatesRecruiting
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Chicago RidgeUnited StatesRecruiting
Epic Medical Research - Chickasha- Site Number : 8400097
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ChickashaUnited StatesRecruiting
Private Practice - Dr. David Kavtaradze- Site Number : 8400006
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CordeleUnited StatesRecruiting
Corsicana Medical Research- Site Number : 8400134
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CorsicanaUnited StatesRecruiting
Beautiful Minds Clinical Research Center- Site Number : 8400017
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Cutler BayUnited StatesRecruiting
Syri Research Center- Site Number : 8400069
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CypressUnited StatesRecruiting
Texas Health Presbyterian Hospital Dallas- Site Number : 8400032
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DallasUnited StatesRecruiting
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DaytonUnited StatesRecruiting
Epic Medical Research - De Soto- Site Number : 8400095
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DeSotoUnited StatesRecruiting
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DoralUnited StatesCompleted
Duke Asthma, Allergy and Airway Center- Site Number : 8400047
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DurhamUnited StatesRecruiting
Sanmora Bespoke Clinical Research Solutions- Site Number : 8400144
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East OrangeUnited StatesRecruiting
NorthShore Medical Group - Evanston ( Endeavor Health)- Site Number : 8400073
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EvanstonUnited StatesRecruiting
Plains Clinical Research Center- Site Number : 8400140
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FargoUnited StatesRecruiting
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FayettevilleUnited StatesRecruiting
New York Hospital Queens- Site Number : 8400058
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FlushingUnited StatesRecruiting
Eastern Medical Group Research- Site Number : 8400020
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Fort MyersUnited StatesRecruiting
Valley Institute of Research- Site Number : 8400118
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HarlingenUnited StatesRecruiting
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HendersonUnited StatesRecruiting
Advanced Respiratory and Sleep Medicine - Hickory- Site Number : 8400013
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HickoryUnited StatesRecruiting
HDH Research, Inc.- Site Number : 8400104
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HoustonUnited StatesRecruiting
Baylor College of Medicine- Site Number : 8400076
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HoustonUnited StatesRecruiting
Gulf Coast Clinical Research - Houston- Site Number : 8400049
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HoustonUnited StatesRecruiting
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HoustonUnited StatesRecruiting
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IndianapolisUnited StatesRecruiting
University of Kansas Medical Center- Site Number : 8400054
Coordinator of this site? Confirm its status
Kansas CityUnited StatesRecruiting
Lumi Research - Kingwood- Site Number : 8400120
Coordinator of this site? Confirm its status
KingwoodUnited StatesRecruiting
Syri Research Center- Site Number : 8400136
Coordinator of this site? Confirm its status
KingwoodUnited StatesRecruiting
Premier Medical Associates- Site Number : 8400012
Coordinator of this site? Confirm its status
Lady LakeUnited StatesCompleted
Radiance Clinical Research - Lampasas - West Avenue East- Site Number : 8400063
Coordinator of this site? Confirm its status
LampasasUnited StatesRecruiting
MD First Research - Lancaster- Site Number : 8400102
Coordinator of this site? Confirm its status
LancasterUnited StatesRecruiting
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Coordinator of this site? Confirm its status
La PalmaUnited StatesRecruiting
Long Beach Research Institute- Site Number : 8400027
Coordinator of this site? Confirm its status
Long BeachUnited StatesRecruiting
Downtown L.A. Research Center- Site Number : 8400009
Coordinator of this site? Confirm its status
Los AngelesUnited StatesRecruiting
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Coordinator of this site? Confirm its status
Madison HeightsUnited StatesRecruiting
Nuren Medical & Research Center- Site Number : 8400030
Coordinator of this site? Confirm its status
MiamiUnited StatesRecruiting
University of Miami Dermatology Clinical Trials Unit- Site Number : 8400078
Coordinator of this site? Confirm its status
MiamiUnited StatesRecruiting
-
Coordinator of this site? Confirm its status
MiamiUnited StatesRecruiting
Reed Medical Research Corp- Site Number : 8400167
Coordinator of this site? Confirm its status
MiamiUnited StatesRecruiting
My Community Research Center- Site Number : 8400164
Coordinator of this site? Confirm its status
MiamiUnited StatesRecruiting
Deluxe Health Center- Site Number : 8400010
Coordinator of this site? Confirm its status
Miami LakesUnited StatesRecruiting
Science 37, Llc- Site Number : 8400154
Coordinator of this site? Confirm its status
MorrisvilleUnited StatesRecruiting
Meharry Medical College- Site Number : 8400133
Coordinator of this site? Confirm its status
NashvilleUnited StatesRecruiting
-
Coordinator of this site? Confirm its status
Newport BeachUnited StatesRecruiting
Omega Research Consultants - Orlando - Forest City- Site Number : 8400015
Coordinator of this site? Confirm its status
OrlandoUnited StatesRecruiting
Pharmakon Medical Research- Site Number : 8400156
Coordinator of this site? Confirm its status
Palm Beach GardensUnited StatesRecruiting
Broward Research Center - Pembroke Pines- Site Number : 8400053
Coordinator of this site? Confirm its status
Pembroke PinesUnited StatesRecruiting
Temple University Hospital- Site Number : 8400059
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesRecruiting
Pulmonary Associates - Phoenix - East Bell Road- Site Number : 8400114
Coordinator of this site? Confirm its status
PhoenixUnited StatesRecruiting
Preferred Primary Care Physicians - Pleasant Hills- Site Number : 8400092
Coordinator of this site? Confirm its status
PittsburghUnited StatesRecruiting
Oregon Health & Science University (OHSU)- Site Number : 8400155
Coordinator of this site? Confirm its status
PortlandUnited StatesRecruiting
Paradigm Research - Redding- Site Number : 8400108
Coordinator of this site? Confirm its status
ReddingUnited StatesRecruiting
Mayo Clinic in Rochester - Minnesota- Site Number : 8400005
Coordinator of this site? Confirm its status
RochesterUnited StatesRecruiting
-
Coordinator of this site? Confirm its status
San AntonioUnited StatesRecruiting
Discovery Clinical Trials - San Antonio- Site Number : 8400031
Coordinator of this site? Confirm its status
San AntonioUnited StatesRecruiting
Bandera Family Health Care - San Antonio- Site Number : 8400021
Coordinator of this site? Confirm its status
San AntonioUnited StatesRecruiting
-
Coordinator of this site? Confirm its status
Sioux FallsUnited StatesRecruiting
Epic Medical Research - Surprise- Site Number : 8400096
Coordinator of this site? Confirm its status
SurpriseUnited StatesRecruiting
Clinical Research Trials of Florida- Site Number : 8400011
Coordinator of this site? Confirm its status
TampaUnited StatesRecruiting
Deluxe Health Center-Tampa- Site Number : 8400056
Coordinator of this site? Confirm its status
TampaUnited StatesRecruiting
Amicis Research Center - Valencia- Site Number : 8400119
Coordinator of this site? Confirm its status
ValenciaUnited StatesRecruiting
Tidewater Physicians Multispecialty Group Clinical Research - Williamsburg- Site Number : 8400081
Coordinator of this site? Confirm its status
WilliamsburgUnited StatesRecruiting
Atrium Health Wake Forest Baptist Pulmonary, Sleep And Allergy- Site Number : 8400048
Coordinator of this site? Confirm its status
Winston-SalemUnited StatesRecruiting
Southern Clinical Research - Zachary- Site Number : 8400113
Coordinator of this site? Confirm its status
ZacharyUnited StatesRecruiting
-
Coordinator of this site? Confirm its status
AdanaTurkey (Türkiye)Recruiting
-
Coordinator of this site? Confirm its status
AnkaraTurkey (Türkiye)Recruiting
-
Coordinator of this site? Confirm its status
AnkaraTurkey (Türkiye)Recruiting
-
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GaziantepTurkey (Türkiye)Recruiting
-
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IstanbulTurkey (Türkiye)Recruiting
-
Coordinator of this site? Confirm its status
IzmirTurkey (Türkiye)Recruiting
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MersinTurkey (Türkiye)Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.