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NCT06196879CompletedPhase 2

A Study to Investigate the Efficacy and Safety of Verekitug (UPB-101) in Adult Participants With Severe Asthma (VALIANT)

A Phase 2, Randomized, Double-blind, Placebo-controlled, Multi-center, Dose-ranging Study to Evaluate the Efficacy and Safety of Verekitug (UPB-101) in Adult Participants With Severe Asthma (VALIANT)

Source: ClinicalTrials.gov · Last updated 1 May 2026

Brief summary (registry, in English)

The purpose of this study is to evaluate the efficacy and safety of verekitug (UPB-101) in participants with severe asthma. The study will evaluate the incidence of asthma exacerbations, other pharmacodynamic (PD) parameters such as lung function and asthma control, and the safety and tolerability of verekitug (UPB-101) compared to placebo.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
479 (actual)
First submitted
24 Dec 2023
Start date
27 Feb 2024
Primary completion date
16 Dec 2025
Lead sponsor
Upstream Bio Inc.
Diseases
Asthma
NCT number
NCT06196879
EU CT number
2023-507410-27-00

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 479
  • From 27 Feb 2024 to the primary completion date, 16 Dec 2025
  • 157 sites in 15 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

  • Inpatient hospitalization due to asthma at any time within 4 weeks prior to Visit 1 or during the Screening/Run-in Period.
  • Previous exposure to verekitug (UPB-101) or known allergy/sensitivity to any of its excipients.
  • Previous biologics, including those for asthma treatment, for which the appropriate washout period is not fulfilled prior to Visit 1. If the half-life is not known, a 24-week washout period prior to Visit 1 should be applied.
  • Allergen immunotherapy (unless maintenance dose) within 12 weeks prior to Visit 1 or plans to begin therapy or change dosing during the study.
  • For participants taking oral corticosteroids (OCS), the dose has not been stable for at least 2 weeks prior to Visit 1 and/or is \>10 milligram (mg) daily, or \>20 mg every other day.
  • Evidence of active or suspected bacterial, viral, fungal, or parasitic infections within 2 weeks prior to Visit 1.
  • Current tobacco smokers, nicotine vapers (including electronic cigarettes), snuff users or participants with a smoking history \>=10 pack years. (Former nicotine smokers with a smoking history of \<10 pack years, former nicotine vapers and former snuff users must have stopped for at least 6 months prior to Visit 1 to be eligible).
  • Positive coronavirus disease 2019 (COVID-19) test with lower respiratory tract symptoms within 28 days before Visit 1.

Other illness

  • History compatible with or diagnosis of a parasitic infection and has not been treated or has not responded to standard of care therapy.

Other

  • Pregnant or breastfeeding or planning to become pregnant or breastfeed during the study or unwilling to use adequate birth control, if of reproductive potential and sexually active.

Who the study is looking for

  • Signed, dated, and received a copy of the Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written informed consent form (ICF).
  • Age 18 to 80 years of age (inclusive) at the time of consent.
  • Physician-diagnosed asthma for at least 12 months prior to Visit 1.
  • Participant has evidence of bronchodilator (BD) reversibility as documented by either historical reversibility (within 12 months prior to study entry) or reversibility during screening.
  • Documented treatment with a total daily dose of either medium or high dose inhaled corticosteroids (ICS) for at least 3 months. Participants on medium dose ICS must also have been taking at least one additional maintenance asthma controller medication for at least 3 months.
  • Documented history of asthma exacerbation(s) within 12 months of Visit 1.
  • Asthma Control Questionnaire-6 (ACQ-6) score greater than or equal to (\>=) 1.5 at screening and randomization.
  • Participant must have a pre-BD FEV1 value of \>=30 percent (%) and \<=80% predicted at Screening.
  • Minimum compliance with daily diary and background asthma medication(s) as captured in the daily diary during the Run-in Period.
  • Agrees to follow the required contraceptive techniques/methods.
  • Female or male participant agrees not to donate eggs or sperm, respectively, for a period of 120 days after the last dose of the study drug intervention or at the Final Visit, whichever occurs last.

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

Full criteria on ClinicalTrials.gov

Sites (157)

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

SiteCityCountrySite status
CARE - Centro de Alergia y Enfermedades Respiratorias
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Buenos AiresArgentinaUnknown status
Fundacion Respirar - Centro Medico Dra. De Salvo
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Buenos AiresArgentinaUnknown status
Fundacion Cidea
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CABAArgentinaUnknown status
InAER
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CABAArgentinaUnknown status
Centro de Medicina Respiratoria
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Concepción del UruguayArgentinaUnknown status
Centro Dr. Lazaro Langer Privado Medicina del Aparato Respiratorio
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CórdobaArgentinaUnknown status
Centro Medico Dharma
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MendozaArgentinaUnknown status
INSARES
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MendozaArgentinaUnknown status
Fundacion Scherbovsky
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MendozaArgentinaUnknown status
Fundacion Estudios Clinicos (FECLIN)
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RosarioArgentinaUnknown status
Instituto Especialidades de la Salud Rosario
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RosarioArgentinaUnknown status
Ierim Instituto de Enfermedades Respiratorias E Investigacion Medica
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San Juan BautistaArgentinaUnknown status
Office of Hector H. Altieri MD
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San Miguel de TucumánArgentinaUnknown status
Investigaciones en Patologias Respiratorias
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San Miguel de TucumánArgentinaUnknown status
Medical Center Zdrave-1 OOD
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KozloduyBulgariaCompleted
Rahila Angelova Mbal AD
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PernikBulgariaCompleted
Medical Center Medconsult Pleven OOD
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PlevenBulgariaCompleted
Diagnostic Consultative Center Sveti Georgi EOOD
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PlovdivBulgariaCompleted
Ambulatory For Specialized Outpatient Medical Care Individual Practice Dr. Nikolay Evgeniev Ruse EOOD
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RuseBulgariaCompleted
Medical Center Hermes Ruse Ltd.
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RuseBulgariaCompleted
Medical Center Pulmovision Ltd.
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SofiaBulgariaCompleted
Medical Center Hera EOOD
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SofiyaBulgariaCompleted
Medical Center Excelsior OOD
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SofiyaBulgariaCompleted
Diagnostics And Consultation Center Convex Ltd.
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SofiyaBulgariaCompleted
Medical Center New Rehabilitation Center EOOD
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Stara ZagoraBulgariaCompleted
Dynamic Drug Advancement
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AjaxCanadaUnknown status
Ottawa Allergy Research Corp
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OttawaCanadaUnknown status
Toronto Allergists
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TorontoCanadaUnknown status
Winchester Hospital
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WinchesterCanadaUnknown status
Centro Médico BIOREUMA
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ConcepciónChileUnknown status
CIMER
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ProvidenciaChileUnknown status
Sociedad medica Sy G Limitada
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SantiagoChileUnknown status
Fundacion Medica San Cristobal
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SantiagoChileUnknown status
Icegclinic
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SantiagoChileUnknown status
Fakultni Nemocnice U Sv Anny V Brne
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Brno-StredCzechiaCompleted
Hofstetr Alois MUDr. s.r.o.
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JihlavaCzechiaCompleted
Plicni Stredisko Teplice S.R.O
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TepliceCzechiaCompleted
PNEUMOLOGIE VARNSDORF s.r.o.
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VarnsdorfCzechiaCompleted
Lungenpraxis Hohenzollerndamm Research Center for Medical Studies
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BerlinGermanyCompleted
Velocity Clinical Research GmbH
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BerlinGermanyCompleted
"Pneumologisches Studienzentrum MVZ die Lungenaerzte"
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BerlinGermanyCompleted
IKF Pneumologie GmbH & Co. KG
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Frankfurt am MainGermanyCompleted
ME Clinical Respiratory Research Hamburg GmbH
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HamburgGermanyCompleted
KPPK GmbH
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KoblenzGermanyCompleted
POIS Sachsen GmbH
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LeipzigGermanyCompleted
Velocity Clinical Research Germany GmbH
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LuebeckGermanyCompleted
IKF Pneumologie GmbH & Co. KG
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MainzGermanyCompleted
Giromed Institute S.L.P.
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BarcelonaSpainCompleted
Hospital General Universitario Gregorio Marañón
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MadridSpainCompleted
Ormeau Clinical Trials Ltd
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BelfastUnited KingdomUnknown status
Heartlands Hospital, University Hospitals Birmingham NHS Trust
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BirminghamUnited KingdomUnknown status
Bradford Royal Infirmary
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BradfordUnited KingdomUnknown status
Duckworth Lane Clinical Research Facility
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BradfordUnited KingdomUnknown status
St Peter's Hospital
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ChertseyUnited KingdomUnknown status
Hull University Teaching Hospitals NHS Trust
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CottinghamUnited KingdomUnknown status
Asthma/COPD Clinical Research Centre
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GlasgowUnited KingdomUnknown status
Royal Liverpool University Hospital
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LiverpoolUnited KingdomUnknown status
Churchill Hospital
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OxfordUnited KingdomUnknown status
IRCCS Ospedale Policlinico San Martino
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GenoaItalyCompleted
Azienda Ospedaliera Universitaria Federico II Di Napoli
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NaplesItalyCompleted
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
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OrbassanoItalyCompleted
Fondazione IRCCS Policlinico San Matteo
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PaviaItalyCompleted
Tokyo-Eki Center-building Clinic
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Chuo-kuJapanUnknown status
Fukuwa Clinics
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Chuo-kuJapanUnknown status
Osaka Habikino Medical Center
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HabikinoJapanUnknown status
National Hospital Organization Ibarakihigashi National Hospital
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IbarakiJapanUnknown status
Kishiwada City Hospital
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KishiwadaJapanUnknown status
Osaka Metropolitan University Hospital
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OsakaJapanUnknown status
KKR Sapporo Medical Center
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SapporoJapanUnknown status
Oji General Hospital
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TomakomaiJapanUnknown status
Yokohama City University Medical Center
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YokohamaJapanUnknown status
Soonchunhyang University Bucheon Hospital
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Bucheon-siSouth KoreaUnknown status
Chungbuk National University Hospital
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Cheongju-siSouth KoreaUnknown status
Yeungnam University Hospital
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DaeguSouth KoreaUnknown status
Yonsei University Health System, Severance Hospital
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SeoulSouth KoreaUnknown status
Kyung Hee University Hospital
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SeoulSouth KoreaUnknown status
Seoul National University Hospital
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SeoulSouth KoreaUnknown status
The Catholic University of Korea Seoul St Marys Hospital
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SeoulSouth KoreaUnknown status
Samsung Medical Center
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SeoulSouth KoreaUnknown status
Eunpyeong St. Marys Hospital
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SeoulSouth KoreaUnknown status
Asan Medical Center
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SeoulSouth KoreaUnknown status
Centrum Medycyny Oddechowej Mroz sp. j.
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BialystokPolandCompleted
Centrum Medyczne All-Med Badania Kliniczne
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CracowPolandCompleted
Malopolskie Centrum Alergologii Sp. z o.o.
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CracowPolandCompleted
Uniwersyteckie Centrum Kliniczne
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GdanskPolandCompleted
NZOZ Poradnia Specjalistyczna Atopia Grażyna Jasieniak-Pinis
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KrakówPolandCompleted
Ostrowieckie Centrum Medyczne Anna Olech Cudzik Krzysztof Cudzik s.c.
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Ostrowiec ŚwiętokrzyskiPolandCompleted
Prywatny Gabinet Lekarski Małgorzata Pawlukiewicz
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RzeszówPolandCompleted
EMED Centrum Uslug Medycznych Ewa Smialek
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RzeszówPolandCompleted
ALERGO-MED OŚRODEK BADAŃ KLINICZNYCH Sp. z o.o.
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TarnówPolandCompleted
Centrum Badań Klinicznych Piotr Napora Lekarze Sp. p.
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WroclawPolandCompleted
Lekarze Specjalisci - J. Malolepszy I Partnerzy
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WroclawPolandCompleted
ALL-MED Specjalistyczna Opieka Medyczna. Medyczny Instytut Badawczy Marek Jutel
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WrocławPolandCompleted
Chernivtsi Regional Clinical Hospital
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ChernivtsiUkraineUnknown status
Municipal non-Profit Enterprise "lvano-Frankivsk Regional Phthisiology-Pulmonology Center of lvano-Frankivsk regional council
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Ivano-FrankivskUkraineUnknown status
Medical Centre "Neuromed" of Limited Liability Company "Scan Light"
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VinnytsiaUkraineUnknown status
Velocity Clinical Research, Anderson
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AndersonUnited StatesUnknown status
Kern Research, Inc
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BakersfieldUnited StatesUnknown status
AllerVie Clinical Research
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BirminghamUnited StatesUnknown status
Treasure Valley Medical Research
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BoiseUnited StatesUnknown status
WR-Notus Clinical Research, LLC
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CharlestonUnited StatesUnknown status
WR-ClinSearch, LLC
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ChattanoogaUnited StatesUnknown status
Portland Clinical Research
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ClackamasUnited StatesUnknown status
Howard County Center for Lung and Sleep Medicine LLC
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ColumbiaUnited StatesUnknown status
Advance Pharma Research
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Cutler BayUnited StatesUnknown status
Horizon Clinical Research
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CypressUnited StatesUnknown status
Alina Clinical Trials, LLC.
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DallasUnited StatesUnknown status
AARA Research Center
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DallasUnited StatesUnknown status
National Jewish Health
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DenverUnited StatesUnknown status
Unique Clinical Trials
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DoralUnited StatesUnknown status
OK Clinical Research, LLC
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EdmondUnited StatesUnknown status
El Paso Pulmonary Association
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El PasoUnited StatesUnknown status
Exordia Medical Research Inc
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Fall RiverUnited StatesUnknown status
Pulmonary Research Institute of Southeast Michigan
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Farmington HillsUnited StatesUnknown status
AA Medical Research Center
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FlintUnited StatesUnknown status
Greater Houston Memorial Pulmonary and Sleep
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HoustonUnited StatesUnknown status
Advanced Respiratory and Sleep Medicine LLC
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HuntersvilleUnited StatesUnknown status
Sante Clinical Research
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KerrvilleUnited StatesUnknown status
M3 Wake Research
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Las VegasUnited StatesUnknown status
Velocity Clinical Research - Lafayette LA
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Los AngelesUnited StatesUnknown status
University of Wisconsin - Madison
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MadisonUnited StatesUnknown status
Mayflower Clinical
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Marble FallsUnited StatesUnknown status
Metroplex Pulmonary and Sleep Center Drive
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McKinneyUnited StatesUnknown status
Velocity Clinical Research, Medford
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MedfordUnited StatesUnknown status
Velocity Clinical Research, Meridian
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MeridianUnited StatesUnknown status
Health and Life Research Institute, LLC
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MiamiUnited StatesUnknown status
Nouvelle Clinical Research
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MiamiUnited StatesUnknown status
Research Institute of South Florida
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MiamiUnited StatesUnknown status
Phoenix Medical Research
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MiamiUnited StatesUnknown status
Summit Research Group LLC
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Munroe FallsUnited StatesUnknown status
Newport Native Md, Inc.
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Newport BeachUnited StatesUnknown status
California Medical Research Associates Inc.
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NorthridgeUnited StatesUnknown status
Anderson Allergy And Asthma, PA
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OrlandoUnited StatesUnknown status
Edward Jenner Research Group LLC
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PlantationUnited StatesUnknown status
Mayo Clinic
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RochesterUnited StatesUnknown status
Element Research Group
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San AntonioUnited StatesUnknown status
Velocity Clinical Research, Spartanburg
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SpartanburgUnited StatesUnknown status
Pivotal Research Solutions
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StonecrestUnited StatesUnknown status
RNA America Health Sciences
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Sugar HillUnited StatesUnknown status
R&B Medical Center
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TampaUnited StatesUnknown status
Urban Health Plan INC
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The BronxUnited StatesUnknown status
Toledo Institute of Clinical Research Inc.
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ToledoUnited StatesUnknown status
DM Clinical Tomball
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TomballUnited StatesUnknown status
Integrated Research of Inland, Inc.
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UplandUnited StatesUnknown status
Allergy & Asthma Clinical Research
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Walnut CreekUnited StatesUnknown status
Velocity Clinical Research
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West JordanUnited StatesUnknown status
Allianz Research Institute
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WestminsterUnited StatesUnknown status
Chesapeake Clinical Research, Inc.
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White MarshUnited StatesUnknown status
Clinical Site Partners dba Flourish research
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Winter ParkUnited StatesUnknown status
Clinical Site Partners, LLC dba Flourish Research
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Winter ParkUnited StatesUnknown status
Woodland Clinic Medical Group
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WoodlandUnited StatesUnknown status
University of Cape Town Lung Institute
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Cape TownSouth AfricaUnknown status
St Augustine's Hospital/Dr. IA Abdullah
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DurbanSouth AfricaUnknown status
Synapta Clinical Research Centre
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DurbanSouth AfricaUnknown status
Newtown Clinical Research Centre
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JohannesburgSouth AfricaUnknown status
Emmed Research
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PretoriaSouth AfricaUnknown status
FCRN Clinical Trial Centre
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VereenigingSouth AfricaUnknown status

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