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NCT06102005CompletedPhase 2

Dose Ranging Study of Lunsekimig Compared With Placebo-control in Adult Participants With Moderate-to-severe Asthma

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose Ranging Study to Assess the Efficacy, Safety, and Tolerability of Subcutaneous Lunsekimig in Adult Participants With Moderate-to-severe Asthma

Source: ClinicalTrials.gov · Last updated 17 Mar 2026

Brief summary (registry, in English)

This is a Phase 2b, global, multicenter, randomized, double-blind, placebo-controlled, parallel group, dose ranging study to assess the efficacy, safety, and tolerability of add-on therapy with SC lunsekimig in adult participants aged 18 to 80 years, (inclusive) with moderate-to-severe asthma.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
685 (actual)
First submitted
20 Oct 2023
Start date
16 Oct 2023
Primary completion date
23 Feb 2026
Lead sponsor
Sanofi
Diseases
Asthma
NCT number
NCT06102005

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 685
  • From 16 Oct 2023 to the primary completion date, 23 Feb 2026
  • 156 sites in 14 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

  • Participants who experience a deterioration of asthma that results in emergency treatment or hospitalization, or treatment with systemic steroids within 1 month prior to the Screening
  • Participants who have experienced an upper or lower respiratory tract infection within the 4 weeks prior to Screening
  • For participants on chronic OCS use for the maintenance treatment of asthma: history of a serious infection requiring hospitalization within the past 12 months prior to Randomization (Visit 2).
  • Participants with active tuberculosis (TB), latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection, or who are at high risk of contracting TB (such as close contact with individuals with active or latent TB) or received Bacillus Calmette-Guérin (BCG)-vaccination within 12 weeks prior to Screening
  • Severe concomitant illness that would in the Investigator's opinion inhibit the participant's participation in the study, including for example, but not limited to, hypertension, renal disease, neurological conditions, heart failure and pulmonary disease

Other illness

  • Chronic obstructive or other lung diseases (eg, COPD, idiopathic pulmonary fibrosis, etc) which may impair lung function, or another diagnosed pulmonary or systemic disease.
  • Current smoker or former smoker with cessation within 6 months of Screening or history of \>10 pack-years. Active vaping of any products and/or marijuana smoking within 6 months of Screening.

Other

  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial

Who the study is looking for

  • A physician-diagnosed moderate-to-severe asthma for ≥12 months based on GINA guidelines Steps 4 and 5
  • Participants with existing treatment with moderate-to-high doses of ICS therapy for in combination with at least 1 but no more than 2 additional controller medications at least 3 months with a stable dose ≥1 month prior to Visit 1
  • At least 1 asthma exacerbation in the past year, with at least one exacerbation occurring while on treatment with moderate to high doses of ICS therapy
  • ACQ-5 score more than 1.5 at Screening (Visit 1)

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (156)

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

SiteCityCountrySite status
Investigational Site Number : 0320007
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BerazateguiArgentinaUnknown status
Investigational Site Number : 0320004
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Buenos AiresArgentinaUnknown status
Investigational Site Number : 0320001
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Buenos AiresArgentinaUnknown status
Investigational Site Number : 0320005
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Buenos AiresArgentinaUnknown status
Investigational Site Number : 0320003
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La PlataArgentinaUnknown status
Investigational Site Number : 0320009
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MendozaArgentinaUnknown status
Investigational Site Number : 0320002
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RosarioArgentinaUnknown status
Investigational Site Number : 0320006
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RosarioArgentinaUnknown status
Investigational Site Number : 0320008
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San Miguel de TucumánArgentinaUnknown status
Investigational Site Number : 0320010
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Santa FeArgentinaUnknown status
Hospital Dia do Pulmão- Site Number : 0760005
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BlumenauBrazilUnknown status
Centro de Estudos em Terapias Inovadoras- Site Number : 0760002
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CuritibaBrazilUnknown status
Universidade Federal de Goias- Site Number : 0760007
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GoiâniaBrazilUnknown status
Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760001
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Porto AlegreBrazilUnknown status
Inst de Medicina Integral Professor Fernando Figueira- Site Number : 0760009
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RecifeBrazilUnknown status
CCBR / IBPClin - Instituto Brasil de Pesquisa Clínica- Site Number : 0760006
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Rio de JaneiroBrazilUnknown status
Associacao Proar- Site Number : 0760003
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SalvadorBrazilUnknown status
Incor - Instituto do Coracao- Site Number : 0760011
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São PauloBrazilUnknown status
Investigational Site Number : 1240003
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HamiltonCanadaUnknown status
Investigational Site Number : 1240004
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SherbrookeCanadaUnknown status
Investigational Site Number : 1240005
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Stoney CreekCanadaUnknown status
Investigational Site Number : 1240001
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Trois-RivièresCanadaUnknown status
Investigational Site Number : 1520008
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QuillotaChileUnknown status
Investigational Site Number : 1520002
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SantiagoChileUnknown status
Investigational Site Number : 1520006
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SantiagoChileUnknown status
Investigational Site Number : 1520005
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SantiagoChileUnknown status
Investigational Site Number : 1520004
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SantiagoChileUnknown status
Investigational Site Number : 1520009
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SantiagoChileUnknown status
Investigational Site Number : 1520001
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TalcaChileUnknown status
Investigational Site Number : 1520010
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ValdiviaChileUnknown status
Investigational Site Number : 1520011
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Viña del MarChileUnknown status
Investigational Site Number : 1560011
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BeijingChinaUnknown status
Investigational Site Number : 1560010
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ChangchunChinaUnknown status
Investigational Site Number : 1560017
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ChangshaChinaUnknown status
Investigational Site Number : 1560008
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ChengduChinaUnknown status
Investigational Site Number : 1560009
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GuangzhouChinaUnknown status
Investigational Site Number :1560001
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GuangzhouChinaUnknown status
Investigational Site Number : 1560006
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HefeiChinaUnknown status
Investigational Site Number : 1560014
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HohhotChinaUnknown status
Investigational Site Number : 1560018
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MianyangChinaUnknown status
Investigational Site Number : 1560007
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NanchangChinaUnknown status
Investigational Site Number : 1560002
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PingxiangChinaUnknown status
Investigational Site Number : 1560013
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ShanghaiChinaUnknown status
Investigational Site Number : 1560015
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ShenyangChinaUnknown status
Investigational Site Number : 1560005
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WenzhouChinaUnknown status
Investigational Site Number : 1560003
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WuhanChinaUnknown status
Investigational Site Number : 1560004
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XuzhouChinaUnknown status
Investigational Site Number : 1560016
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YangzhouChinaUnknown status
Investigational Site Number : 1560012
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ZhanjiangChinaUnknown status
Investigational Site Number : 8260003
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BirminghamUnited KingdomUnknown status
Investigational Site Number : 8260008
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BradfordUnited KingdomUnknown status
Investigational Site Number : 8260009
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BristolUnited KingdomUnknown status
Investigational Site Number : 8260001
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CambridgeUnited KingdomUnknown status
Investigational Site Number : 8260005
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ChertseyUnited KingdomUnknown status
Investigational Site Number : 8260004
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GlasgowUnited KingdomUnknown status
Investigational Site Number : 3760006
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AshkelonIsraelUnknown status
Investigational Site Number : 3760008
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HaifaIsraelUnknown status
Investigational Site Number : 3760001
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HaifaIsraelUnknown status
Investigational Site Number : 3760002
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JerusalemIsraelUnknown status
Investigational Site Number : 3760003
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JerusalemIsraelUnknown status
Investigational Site Number : 3760010
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Petah TikvaIsraelUnknown status
Investigational Site Number : 3760009
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Ramat GanIsraelUnknown status
Investigational Site Number : 3760004
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RehovotIsraelUnknown status
Investigational Site Number : 3760007
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Tel AvivIsraelUnknown status
Investigational Site Number : 3560002
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CoimbatoreIndiaUnknown status
Investigational Site Number : 3560006
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DelhiIndiaUnknown status
Investigational Site Number : 3560009
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HyderabadIndiaUnknown status
Investigational Site Number : 3560008
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KanpurIndiaUnknown status
Investigational Site Number : 3560007
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KozhikodeIndiaUnknown status
Investigational Site Number : 3560003
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LucknowIndiaUnknown status
Investigational Site Number : 3560001
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NagpurIndiaUnknown status
Investigational Site Number : 3560004
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PuneIndiaUnknown status
Investigational Site Number : 3920011
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ChūōJapanUnknown status
Investigational Site Number : 3920008
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FukushimaJapanUnknown status
Investigational Site Number : 3920003
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HigashiōmiJapanUnknown status
Investigational Site Number : 3920004
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KamogawaJapanUnknown status
Investigational Site Number : 3920006
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KyotoJapanUnknown status
Investigational Site Number : 3920009
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KyotoJapanUnknown status
Investigational Site Number : 3920012
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MiyazakiJapanUnknown status
Investigational Site Number : 3920002
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SakaidechōJapanUnknown status
Investigational Site Number : 3920005
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UbeJapanUnknown status
Investigational Site Number : 3920010
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YokohamaJapanUnknown status
Investigational Site Number : 4100002
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SeoulSouth KoreaUnknown status
Investigational Site Number : 4100005
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SeoulSouth KoreaUnknown status
Investigational Site Number : 4100001
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SeoulSouth KoreaUnknown status
Investigational Site Number : 4100004
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SeoulSouth KoreaUnknown status
Investigational Site Number : 4100006
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SeoulSouth KoreaUnknown status
Investigational Site Number : 4100003
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SeoulSouth KoreaUnknown status
Investigational Site Number : 4840002
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Chihuahua CityMexicoUnknown status
Investigational Site Number : 4840003
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DurangoMexicoUnknown status
Investigational Site Number : 4840001
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GuadalajaraMexicoUnknown status
Investigational Site Number : 4840007
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MéridaMexicoUnknown status
Investigational Site Number : 4840004
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MonterreyMexicoUnknown status
Investigational Site Number : 4840005
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San Juan del RíoMexicoUnknown status
Investigational Site Number : 4840008
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VeracruzMexicoUnknown status
VitaLink Research - Anderson - East Greenville- Site Number : 8400063
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AndersonUnited StatesUnknown status
Javara - Privia Medical Group - Annapolis- Site Number : 8400033
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AnnapolisUnited StatesUnknown status
University of Michigan Health System - Ann Arbor- Site Number : 8400004
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Ann ArborUnited StatesUnknown status
Allianz Research Institute CO- Site Number : 8400026
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AuroraUnited StatesUnknown status
Orion Clinical Research- Site Number : 8400001
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AustinUnited StatesUnknown status
South Texas Medical Research Institute - TTS Research- Site Number : 8400010
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BoerneUnited StatesUnknown status
Brigham & Women's Hospital- Site Number : 8400034
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BostonUnited StatesUnknown status
Appalachian Clinical Research- Site Number : 8400050
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CalhounUnited StatesUnknown status
PMG Research of Christie Clinic- Site Number : 8400066
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ChampaignUnited StatesUnknown status
Velocity Clinical Research - Charleston- Site Number : 8400061
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CharlestonUnited StatesUnknown status
Tryon Medical Partners - Charlotte - Piedmont Row Drive South- Site Number : 8400029
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CharlotteUnited StatesUnknown status
Carolina Clinical Research - Charlotte- Site Number : 8400071
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CharlotteUnited StatesUnknown status
Bernstein Clinical Research Center- Site Number : 8400016
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CincinnatiUnited StatesUnknown status
Beautiful Minds Clinical Research Center- Site Number : 8400049
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Cutler BayUnited StatesUnknown status
Baylor University Medical Center- Site Number : 8400002
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DallasUnited StatesUnknown status
Clinical Research Associates of Central PA - Dubois- Site Number : 8400069
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DuBoisUnited StatesUnknown status
OK Clinical Research- Site Number : 8400021
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EdmondUnited StatesUnknown status
Western Sky Medical Research- Site Number : 8400023
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El PasoUnited StatesUnknown status
Velocity Clinical Research - Denver- Site Number : 8400027
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EnglewoodUnited StatesUnknown status
Clinical Research Of Gastonia- Site Number : 8400013
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GastoniaUnited StatesUnknown status
Qway Research - Hialeah- Site Number : 8400015
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HialeahUnited StatesUnknown status
Velocity Clinical Research Lafayette Site Number : 8400060
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LafayetteUnited StatesUnknown status
Antelope Valley Clinical Trials- Site Number : 8400020
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LancasterUnited StatesUnknown status
Javara - Mankato Clinic- Site Number : 8400051
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MankatoUnited StatesUnknown status
Metroplex Pulmonary and Sleep Center- Site Number : 8400022
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McKinneyUnited StatesUnknown status
Velocity Clinical Research - Medford- Site Number : 8400059
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MedfordUnited StatesUnknown status
New Access Medical Center- Site Number : 8400043
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MiamiUnited StatesUnknown status
Innovations Biotech- Site Number : 8400040
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MiamiUnited StatesUnknown status
Clintex Research Group - Miami - Coral Way- Site Number : 8400048
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MiamiUnited StatesUnknown status
High Quality Research- Site Number : 8400039
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MiamiUnited StatesUnknown status
Deluxe Health Center- Site Number : 8400045
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Miami LakesUnited StatesUnknown status
Circuit Clinical - Middletown Medical - 111 Maltese Drive- Site Number : 8400065
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MiddletownUnited StatesUnknown status
Advanced Research Institute - New Port Richey- Site Number : 8400044
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New Port RicheyUnited StatesUnknown status
Icahn School of Medicine at Mount Sinai- Site Number : 8400058
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New YorkUnited StatesUnknown status
Amicis Research Center - Northridge - Nordhoff Street- Site Number : 8400032
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NorthridgeUnited StatesUnknown status
Pines Care Research Center- Site Number : 8400057
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Pembroke PinesUnited StatesUnknown status
Allergy & Clinical Immunology Associates Pittsburgh- Site Number : 8400007
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PittsburghUnited StatesUnknown status
VAST Clinical Research- Site Number : 8400062
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PlanoUnited StatesUnknown status
Circuit Clinical - PMSI Comprehensive Healthcare for Life - Pottstown - Medical Drive- Site Number : 8400064
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PottstownUnited StatesUnknown status
Optimus Medical- Site Number : 8400046
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San FranciscoUnited StatesUnknown status
Allergy and Asthma Associates of Santa Clara Valley Research Center- Site Number : 8400038
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San JoseUnited StatesUnknown status
Windom Allergy, Asthma and Sinus Specialists- Site Number : 8400019
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SarasotaUnited StatesUnknown status
Allergy, Asthma & Immunology Associates- Site Number : 8400009
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ScottsdaleUnited StatesUnknown status
Midwest Clinical Research Center - St. Louis- Site Number : 8400006
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St LouisUnited StatesUnknown status
Clinical Trials Management Services - Thousand Oaks- Site Number : 8400053
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Thousand OaksUnited StatesUnknown status
Asthma & Allergy Center - Toledo- Site Number : 8400017
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ToledoUnited StatesUnknown status
Western States Clinical Research- Site Number : 8400014
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Wheat RidgeUnited StatesUnknown status
Yuma Pulmonary & Sleep Research, LLC- Site Number : 8400072
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YumaUnited StatesUnknown status
Investigational Site Number : 7100004
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BenoniSouth AfricaUnknown status
Investigational Site Number : 7100005
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BenoniSouth AfricaUnknown status
Investigational Site Number : 7100002
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Cape TownSouth AfricaUnknown status
Investigational Site Number : 7100003
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Cape TownSouth AfricaUnknown status
Investigational Site Number : 7100001
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DurbanSouth AfricaUnknown status
Investigational Site Number : 7100006
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Lochner ROADSouth AfricaUnknown status
Investigational Site Number : 7920001
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AkdenizTurkey (Türkiye)Unknown status
Investigational Site Number : 7920006
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BursaTurkey (Türkiye)Unknown status
Investigational Site Number : 7920002
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IstanbulTurkey (Türkiye)Unknown status
Investigational Site Number : 7920003
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IstanbulTurkey (Türkiye)Unknown status
Investigational Site Number : 7920004
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IzmirTurkey (Türkiye)Unknown status
Investigational Site Number : 7920005
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İzmitTurkey (Türkiye)Unknown status
Investigational Site Number : 7920007
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KayseriTurkey (Türkiye)Unknown status

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