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NCT06819891RecruitingPhase 3

A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (RO7790121) in Participants With Moderately to Severely Active Crohn's Disease

A Phase III, Multicenter, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Induction Therapy With RO7790121 in Patients With Moderately to Severely Active Crohn's Disease

Source: ClinicalTrials.gov · Last updated 26 Oct 2026

Brief summary (registry, in English)

This Phase III, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of induction therapy with Afimkibart (also known as RO7790121) in participants with moderately to severely active Crohn's disease (CD).

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
425 (estimated)
First submitted
6 Feb 2025
Start date
12 May 2025
Primary completion date
31 Dec 2028
Lead sponsor
Hoffmann-La Roche
NCT number
NCT06819891
EU CT number
2024-513054-30-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 425
  • From 12 May 2025 to the primary completion date, 31 Dec 2028
  • 231 sites in 27 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

  • Current diagnosis of ulcerative colitis (UC) or indeterminate colitis, ischemic colitis, infectious colitis, radiation colitis, microscopic colitis
  • Has received protocol-specified prohibited medicines, including known exposure to any type of anti-TL1A therapy

Other illness

  • Participant with a history of \>= 3 bowel resections (\> 2 missing segments of the 5 following segments: terminal ilelium, right colon, transverse colon, sigmoid and left colon, and rectum)
  • Diagnosis of short gut or short bowel syndrome
  • Presence of rectovaginal, enterovaginal, high output enterocutaneous fistula, enterovesical fistulas or perianal fistulas with \>3 openings
  • Any past or current evidence of cancer of gastrointestinal tract, high-grade colonic dysplasia and participants with low-grade dysplasia are eligible if lesions have been completely removed
  • History of non-gastrointestinal cancer, with the exception of adequately treated non-metastatic basal cell or squamous cell skin cancer or in situ cervical cancer
  • Evidence of infection with Clostridioides difficile (C. difficile; formerly known as Clostridium difficile), cytomegalovirus (CMV), human immunodeficiency virus (HIV), Hepatitis B (HBV), Hepatitis C (HCV) during screening
  • Has evidence of active tuberculosis (TB), latent TB not successfully treated (per local guidance) or inadequately treated TB

Other

  • Presence of an ileostomy, colostomy or ileoanal pouch
  • Participants with symptomatic bowel strictures, fulminant colitis, or toxic megacolon
  • Presence of abdominal or perianal abscess
  • Participants with symptomatic bowel strictures, fulminant colitis, or toxic megacolon
  • Current diagnosis or suspicion of primary sclerosing cholangitis
  • Pregnancy or breastfeeding, or intention of becoming pregnant during the study

Who the study is looking for

  • Confirmed diagnosis of CD
  • Moderately to severely active CD
  • Bodyweight \>= 40 kilogram (kg)
  • Demonstrated inadequate response, loss of response and/or intolerance to at least one protocol-specified conventional or advanced CD therapy
  • Males and females of childbearing potential must meet protocol criteria for contraception requirements

Age in the registry: 16 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (231)

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

SiteCityCountrySite status
Instituto Medico CER
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QuilmesArgentinaRecruiting
CICE 9 de Julio
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San Miguel de TucumánArgentinaRecruiting
Ordensklinikum Linz GmbH
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LinzAustriaRecruiting
Klinikum Wels-Grieskirchen GmbH
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WelsAustriaRecruiting
Lyell McEwin Hospital
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AdelaideAustraliaRecruiting
Footscray Hospital
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FootscrayAustraliaRecruiting
Coral Sea Clinical Research Institute
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MackayAustraliaWithdrawn
Macquarie University Hospital
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Macquarie ParkAustraliaRecruiting
Royal Melbourne Hospital
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ParkvilleAustraliaRecruiting
Sydney Adventist Hospital
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WahroongaAustraliaRecruiting
CHU Saint-Pierre
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BrusselsBelgiumRecruiting
Universitair Ziekenhuis Antwerpen
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EdegemBelgiumRecruiting
AZ Sint-Lucas & Volkskliniek
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GentBelgiumRecruiting
UZ Brussel
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JetteBelgiumRecruiting
CHC MontLégia
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LiègeBelgiumRecruiting
Centre Hospitalier Universitaire de Liège
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LiègeBelgiumRecruiting
Cliniques Universitaires Saint-Luc
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Sint-Lambrechts-WoluweBelgiumRecruiting
Multiprofile Hospital For Active Treatment-Uni Hospital Ltd.
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PanagyurishteBulgariaRecruiting
Medical Centre Futuremeds EOOD
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PlovdivBulgariaRecruiting
Medical Center St. Ivan Rilski Chudotvorets 2010 EOOD
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PlovdivBulgariaRecruiting
Newdata Clinical Trials
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AracajuBrazilRecruiting
CECIP - Centro de Estudos Clínicos do Interior Paulista
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JaúBrazilRecruiting
Hospital Moinhos de Vento
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Porto AlegreBrazilRecruiting
Hospital de Base de Sao Jose do Rio Preto
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São José do Rio PretoBrazilRecruiting
Hospital Sirio Libanes
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São PauloBrazilWithdrawn
Instituto Lobus Unimed Volta Redonda
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Volta RedondaBrazilRecruiting
Barrie GI Associates
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BarrieCanadaRecruiting
GNRR Digestive Clinics and Research Center Inc.
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BramptonCanadaRecruiting
London Health Sciences Centre Uni Campus
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LondonCanadaWithdrawn
LDDI Clinical Trials Inc.
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LondonCanadaRecruiting
CIUSSS de l Est de l Ile de Montreal - Hopital Maisonneuve Rosemont
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MontrealCanadaRecruiting
Toronto Immune and Digestive Health Institute
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North YORKCanadaRecruiting
Medicina de Precisión - Celerity
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Las CondesChileRecruiting
Medwal
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SantiagoChileRecruiting
Centro de Investigación Clínica UC-CICUC
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SantiagoChileRecruiting
Beijing Union Hospital
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BeijingChinaRecruiting
Sichuan Provincial People's Hospital
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ChengduChinaRecruiting
First Affiliated Hospital Of Gannan Medical University
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GanzhouChinaRecruiting
Zhujiang Hospital, Southern Medical University
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GuangzhouChinaRecruiting
Guangzhou First People's Hospital
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GuangzhouChinaRecruiting
Hainan General Hospital
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HaikouChinaRecruiting
Huai'an First People's Hospital
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Huai'anChinaRecruiting
Huizhou First Hospital
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HuizhouChinaRecruiting
Jinhua Municipal Central Hospital
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JinhuaChinaRecruiting
The First Affilliated Hospital of Kunming Medical University
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KunmingChinaRecruiting
The Second Affiliated Hospital of Nanchang University
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NanchangChinaRecruiting
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
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ShanghaiChinaRecruiting
Xinhua Hospital Affiliated To Shanghai Jiao tong University School of Medicine
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ShanghaiChinaRecruiting
Shengjing Hospital Of China Medical University
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ShenyangChinaRecruiting
Hebei Medical University - The Second Hospital
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ShijiazhuangChinaRecruiting
The Second Affiliated Hospital of Soochow University
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SuzhouChinaRecruiting
The First Affiliated hospital of Xiamen University
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XiamenChinaRecruiting
The Second Affiliated Hospital of Xi'an Jiao Tong University
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Xi'anChinaRecruiting
Affiliated Hospital of Jiangsu University
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ZhenjiangChinaRecruiting
Clinica Colsanitas S.A. - Sede Clinica Reina Sofia
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BogotáColombiaRecruiting
Clínica de la Mujer
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BogotáColombiaWithdrawn
Hospital Universitario San Ignacio
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BogotáColombiaRecruiting
Oncomédica S.A.
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MonteríaColombiaRecruiting
Fundacion Cardiovascular de Colombia - KM 7 Autopista
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PiedecuestaColombiaRecruiting
Hepato-Gastroenterologie HK, s.r.o.
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Hradec KrálovéCzechiaRecruiting
Gastroenterologie s.r.o.
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Hradec KrálovéCzechiaRecruiting
Fakultni nemocnice Ostrava
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OstravaCzechiaRecruiting
ISCARE a.s.
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PragueCzechiaRecruiting
Institute for Clinical and Experimental Medicine
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PragueCzechiaRecruiting
Krajska zdravotni a.s.
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Usti Nad LabemCzechiaRecruiting
Gastroenterologische Spezialpraxis - Berlin-Karlshorst
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BerlinGermanyRecruiting
Universitaetsklinikum Heidelberg AöR
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HeidelbergGermanyRecruiting
Universitaetsklinikum Jena KöR
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JenaGermanyRecruiting
Klinikum Ernst von Bergmann gGmbH
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PotsdamGermanyRecruiting
Universitaetsklinikum Ulm AoR
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UlmGermanyRecruiting
Hospital Universitario Fundación Alcorcón
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AlcorcónSpainRecruiting
Hospital Universitario de Fuenlabrada
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FuenlabradaSpainRecruiting
Hospital General Universitario Gregorio Marañón
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MadridSpainRecruiting
Hospital Universitario Puerta de Hierro de Majadahonda
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MajadahondaSpainRecruiting
Hospital Clinico Universitario Lozano Blesa
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ZaragozaSpainRecruiting
Centre Hospitalier Regional Universitaire De Tours
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Chambray Les ToursFranceRecruiting
University Hospital Of Clermont-Ferrand
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Clermont-FerrandFranceRecruiting
Assistance Publique Hopitaux De Paris
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Creteil CedexFranceRecruiting
Centre Hospitalier Departemental Vendee
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La Roche Sur Yon Cedex 9FranceRecruiting
Centre Hospitalier Universitaire de Lille
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LilleFranceRecruiting
Centre Hospitalier Et Universitaire De Limoges
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Limoges Cedex 1FranceRecruiting
Centre Hospitalier Universitaire De Montpellier
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Montpellier Cedex 5FranceRecruiting
Centre Medico Chirurgical Ambroise Pare Hartmann
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Neuilly-Sur-SeineFranceRecruiting
Hopital Saint Louis
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ParisFranceRecruiting
Hospices Civils de Lyon
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Pierre-BéniteFranceRecruiting
Centre Hospitalier Universitaire de Saint Etienne
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Saint-Priest-en-JarezFranceRecruiting
CHRU De Nancy
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Vandoeuvre Les NancyFranceRecruiting
Southmead Hospital
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BristolUnited KingdomRecruiting
Fairfield General Hospital
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BuryUnited KingdomRecruiting
Bronglais General Hospital
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LlanrhystudUnited KingdomRecruiting
Royal London Hospital
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LondonUnited KingdomRecruiting
Royal Victoria Infirmary
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Newcastle upon TyneUnited KingdomRecruiting
Stepping Hill Hospital
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StockportUnited KingdomActive, not recruiting
KBC Zagreb
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Grad ZagrebCroatiaRecruiting
Poliklinika Borzan d.o.o.
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OsijekCroatiaRecruiting
Klinička bolnica Dubrava
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ZagrebCroatiaRecruiting
Semmelweis University
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BudapestHungaryRecruiting
Endomedix Kft.
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BudapestHungaryRecruiting
Geomedical Kft.
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Budapest VIHungaryRecruiting
Central Hospital Of Northern Pest Military Hospital
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Budapest VIHungaryRecruiting
Vas-Oxy Kft
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SzombathelyHungaryRecruiting
Shaare Zedek Medical Center
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JerusalemIsraelRecruiting
Hadassah medical Center
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JerusalemIsraelRecruiting
AIG Hospitals
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GachibowliIndiaRecruiting
SR Kalla Memorial Gastro & General Hospital
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JaipurIndiaRecruiting
SMS Superspeciality Hospital
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JaipurIndiaRecruiting
Amrita institute of Medical Sciences
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KochiIndiaRecruiting
Institute of Post Graduate Medical Education and Research (IPGMER) and SSKM Hospital
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KolkataIndiaRecruiting
Kurnool Medical College
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KurnoolIndiaRecruiting
MIDAS Multispeciality Hospital
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Nagpur (urban)IndiaRecruiting
All India Institute of Medical Sciences(AIIMS)
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New DelhiIndiaRecruiting
Shree Giriraj Multispeciality Hospital
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RajkotIndiaWithdrawn
Gandhi Hospital
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SecunderabadIndiaRecruiting
Yashoda Hospitals
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SecunderabadIndiaRecruiting
Surat Institute of Digestive Sciences Hospitals
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SuratIndiaRecruiting
Gujarat Gastro and Vascular Hospital
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SuratIndiaRecruiting
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
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BolognaItalyRecruiting
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
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BresciaItalyRecruiting
Azienda Sanitaria Locale Matera
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MateraItalyRecruiting
Ospedale San Raffaele S.r.l.
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MilanItalyRecruiting
IRCCS Ospedale Sacro Cuore Don Calabria
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NegrarItalyRecruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyRecruiting
Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon
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RomeItalyRecruiting
Policlinico San Donato S.p.A.
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San Donato MilaneseItalyRecruiting
Korea University Ansan Hospital
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Ansan-siSouth KoreaRecruiting
Yeungnam University Medical Center
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DaeguSouth KoreaRecruiting
Chosun University Hospital
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GwangjuSouth KoreaRecruiting
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
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SeoulSouth KoreaRecruiting
Hanyang University Seoul Hospital
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SeoulSouth KoreaRecruiting
Gastromed Kralisz Romatowski Stachurska Sp. j.
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BialystokPolandRecruiting
Centrum Medyczne Medis
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BydgoszczPolandRecruiting
Centrum Medyczne Kermed Renata Bijata-Bronisz I Ewa Kowalinska Sp. j.
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BydgoszczPolandRecruiting
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.
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CracowPolandRecruiting
R57 Sp. z o.o.
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CracowPolandRecruiting
Promed P.Lach R.Glowacki Sp. j.
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CracowPolandRecruiting
Szpital Miejski Sw. Jana Pawla II w Elblagu
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ElblagPolandRecruiting
Osrodek Badan Klinicznych Bd Research Sp. z o.o.
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IlawaPolandRecruiting
Centrum Zdrowia Darimed Sp. z o.o.
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KielcePolandRecruiting
MZ Badania Slowik Zymla Sp.j.
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KnurówPolandRecruiting
Amicare Sp. z o.o. S.K.
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LodzPolandRecruiting
Medrise Sp. z o.o.
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LublinPolandRecruiting
EMC Instytut Medyczny S.A.
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PoznanPolandRecruiting
Rivermed Sp. z o.o.
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PoznanPolandRecruiting
Clinical Research Center Sp z o o Medic R Sp k
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PoznanPolandRecruiting
Endoskopia Sp z o.o.
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SopotPolandRecruiting
Wojewódzki Szpital Specjalistyczny nr 5 im. św. Barbary w Sosnowcu
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SosnowiecPolandRecruiting
Nowe Zdrowie-CK Kieltucki I Wspolnicy Sp. j.
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StaszówPolandRecruiting
Twoja Przychodnia-Szczecinskie Centrum Medyczne Sp. z o. o.
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SzczecinPolandRecruiting
Sonomed Sp. z o.o.
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SzczecinPolandRecruiting
GASTROMED Sp. z o.o.
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TorunPolandRecruiting
Eb Group Sp. z o.o.
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WarsawPolandRecruiting
Vivamed Sp. z o.o.
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WarsawPolandRecruiting
Medical Network Sp z o o
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WarsawPolandRecruiting
Medon Clinical Research Sp. z o.o.
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WarsawPolandRecruiting
Vistamed & Vertigo Sp Z O O
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WroclawPolandRecruiting
Centrum Medyczne Oporow
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WroclawPolandRecruiting
PlanetMed Sp. z o.o.
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WroclawPolandRecruiting
Galenus Group Of Puerto Rica Inc
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ManatiPuerto RicoRecruiting
CCAB Centro Clinico Academico Braga Associacao
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BragaPortugalRecruiting
Unidade Local De Saude De Santa Maria E.P.E.
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LisbonPortugalRecruiting
Unidade Local de Saude de Sao Joao E.P.E.
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PortoPortugalRecruiting
Unidade Local De Saude De Entre O Douro E Vouga E.P.E.
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Santa Maria Da FeiraPortugalRecruiting
Unidade Local De Saude De Viseu Dao-Lafoes E.P.E.
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ViseuPortugalRecruiting
Tvm Med Serv S.R.L.
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Cluj-NapocaRomaniaNot yet recruiting
KM Management spol. s r.o.
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NitraSlovakiaRecruiting
Fakultna nemocnica s poliklinikou Nove Zamky
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Nové ZámkySlovakiaRecruiting
Abawi spol. s r.o.
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VrakunaSlovakiaRecruiting
Morehouse School of Medicine
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AtlantaUnited StatesRecruiting
Mercy Medical Center
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BaltimoreUnited StatesRecruiting
Baton Rouge General Medical Center
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Baton RougeUnited StatesRecruiting
Clinical Inquest Center
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BeavercreekUnited StatesRecruiting
Ellipsis Research Group
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BrooklynUnited StatesRecruiting
Charlotte Gastroenterology and Hepatology, P.L.L.C
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CharlotteUnited StatesRecruiting
FOMAT Medical Research - Chevy Chase Clinical Research
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Chevy ChaseUnited StatesRecruiting
The University Of Chicago
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ChicagoUnited StatesRecruiting
Cleveland Clinic Foundation
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ClevelandUnited StatesRecruiting
Peak Gastroenterology Associates
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Colorado SpringsUnited StatesRecruiting
Va Heartland Network - Harry S. Truman Memorial Veterans' Hospital
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ColumbiaUnited StatesRecruiting
Gastro One
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CordovaUnited StatesRecruiting
University of Texas Southwestern Medical Center - Multidisciplinary Spine Clinic - James W. Aston Ambulatory Care Center
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DallasUnited StatesRecruiting
J&A Clinical Research
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DoralUnited StatesRecruiting
Digestive Health Specialists of the Southeast
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DothanUnited StatesRecruiting
Gastrointestinal Associates Research
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FlowoodUnited StatesRecruiting
GI Alliance - Fort Worth
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Fort WorthUnited StatesRecruiting
Intercity Gastroenterology
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Fresh MeadowsUnited StatesRecruiting
GI Alliance
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GarlandUnited StatesRecruiting
Sun City Clinical Research
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GlendaleUnited StatesRecruiting
Peters Medical Research (PMR), LLC
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High PointUnited StatesRecruiting
Integrity Advanced Therapeutics, PLLC
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HoustonUnited StatesRecruiting
University Physicians and Surgeons, Inc dba Marshall Health
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HuntingtonUnited StatesWithdrawn
University of Kansas Medical Center
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Kansas CityUnited StatesRecruiting
Auzmer Research
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LakelandUnited StatesRecruiting
NYU Langone Long Island Clinical Research Associates
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Lake SuccessUnited StatesRecruiting
Om Research LLC
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LancasterUnited StatesRecruiting
Dartmouth-Hitchcock Medical Center/Norris Cotton Cancer Center
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LebanonUnited StatesRecruiting
Galenus Group Inc
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Lehigh AcresUnited StatesRecruiting
One GI: GHP - Gastroenterology Health Partners Louisville
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LouisvilleUnited StatesRecruiting
Robley Rex VA Medical Center
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LouisvilleUnited StatesRecruiting
Texas Digestive Disease Consultants-Lubbock powered by GI Alliance
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LubbockUnited StatesRecruiting
Homestead Associates in Research Inc.
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MiamiUnited StatesRecruiting
Allied Biomedical Research Institute, Inc
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MiamiUnited StatesRecruiting
Rejuvaline Medical Research
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MiamiUnited StatesRecruiting
Miami Beach Clinical Research Center
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Miami BeachUnited StatesRecruiting
Eminat Research Group
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MiramarUnited StatesRecruiting
Virtua Crohns and Colitis Center
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MoorestownUnited StatesRecruiting
Vanderbilt University Medical Center
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NashvilleUnited StatesRecruiting
Robert Wood Johnson University Hospital
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New BrunswickUnited StatesRecruiting
Hoag Memorial Hospital Presbyterian;Hoag Center for Research and Education
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Newport BeachUnited StatesRecruiting
University of Massachusetts Memorial Medical Center
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North WorcesterUnited StatesRecruiting
Digestive and Liver Center of Florida
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OrlandoUnited StatesRecruiting
University of Pennsylvania
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesRecruiting
Empire Clinical Research
Coordinator of this site? Confirm its status
PomonaUnited StatesWithdrawn
Advanced Medical Research Center
Coordinator of this site? Confirm its status
Port OrangeUnited StatesRecruiting
University Gastroenterology
Coordinator of this site? Confirm its status
ProvidenceUnited StatesRecruiting
Stanford Medicine Outpatient Center
Coordinator of this site? Confirm its status
Redwood CityUnited StatesRecruiting
GI Alliance Richmond
Coordinator of this site? Confirm its status
RichmondUnited StatesRecruiting
Carta - Clinical Associates in Research Therapeutics of America, LLC
Coordinator of this site? Confirm its status
San AntonioUnited StatesRecruiting
Clinical Applications Laboratories, Inc.
Coordinator of this site? Confirm its status
San DiegoUnited StatesRecruiting
Amicis Research Center
Coordinator of this site? Confirm its status
Santa ClaritaUnited StatesRecruiting
Virginia Mason Medical Center
Coordinator of this site? Confirm its status
SeattleUnited StatesRecruiting
Louisiana Research Center - GastroIntestinal Associates
Coordinator of this site? Confirm its status
ShreveportUnited StatesRecruiting
Specialists in Gastroenterology
Coordinator of this site? Confirm its status
St LouisUnited StatesRecruiting
Washington Gastroenterology
Coordinator of this site? Confirm its status
TacomaUnited StatesRecruiting
Santos Research Center, CORP
Coordinator of this site? Confirm its status
TampaUnited StatesRecruiting
James J. Peters Veterans Affairs Medical Center
Coordinator of this site? Confirm its status
The BronxUnited StatesRecruiting
Tyler Research Institute, LLC
Coordinator of this site? Confirm its status
TylerUnited StatesRecruiting
University of Texas Health Center at Tyler
Coordinator of this site? Confirm its status
TylerUnited StatesRecruiting
Digestive Disease Medicine Of Central New York
Coordinator of this site? Confirm its status
UticaUnited StatesRecruiting
TDDC GI Alliance research Webster
Coordinator of this site? Confirm its status
WebsterUnited StatesRecruiting
Cleveland Clinic Florida
Coordinator of this site? Confirm its status
WestonUnited StatesRecruiting
Gastroenterology Associates of Western Michigan, P.L.C.
Coordinator of this site? Confirm its status
WyomingUnited StatesRecruiting

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