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NCT07499232RecruitingPhase 3

A Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn's Disease

A Phase 3b, Multicenter, Randomized, Open-Label, Active-Controlled Study to Compare the Efficacy and Safety of Guselkumab Versus Risankizumab in the Treatment of Participants With Moderately to Severely Active Crohn's Disease

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

The purpose of this study is to assess how well guselkumab works when compared to risankizumab in participants with moderately to severely active Crohn's Disease (CD; a long-term condition causing severe inflammation of the intestinal tract).

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
530 (estimated)
First submitted
23 Mar 2026
Start date
21 Apr 2026
Primary completion date
15 Nov 2028
Lead sponsor
Janssen Research & Development, LLC
NCT number
NCT07499232

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 530
  • From 21 Apr 2026 to the primary completion date, 15 Nov 2028
  • 164 sites in 17 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

  • Has complications of CD such as symptomatic strictures or stenoses, short gut syndrome, active draining stoma or significant fistulizing disease or any other manifestation anticipated to require surgery within the next year, could preclude the use of the CDAI to assess response to therapy, or would possibly confound the ability to assess the effect of treatment with guselkumab or risankizumab
  • Has had any kind of bowel resection within 24 weeks, or any other intra-abdominal or other major surgery within 12 weeks, before first dose of study intervention

Other illness

  • Has an active fistula during screening or at Week 0 with an anticipated need for surgery
  • Currently has a malignancy or has a history of malignancy within 5 years before screening

Other

  • Currently has or is suspected to have an abscess

Who the study is looking for

  • Has CD or fistulizing Crohn's Disease (CD) of at least 12 weeks' duration, with colitis, ileitis, or ileocolitis, confirmed at some time in the past by radiography, histology, and/or endoscopy
  • Have moderately to severely active CD, defined as baseline Crohn's Disease Activity Index (CDAI) score greater than or equal to (\>=) 220 but less than or equal to (\<=) 450
  • Baseline endoscopic evidence of active ileal and/or colonic CD as assessed by central endoscopy reading at the screening endoscopy defined as a screening Simple Endoscopic Score for Crohn's Disease (SES CD) \>= 4 (for participants with isolated ileal disease) or \>= 6 (for participants with colonic or ileocolonic disease), based on the presence of ulceration in any 1 of the 5 ileocolonic segments, resulting in the following specified ulceration component scores:
    • a minimum score of 1 for the component of "size of ulcers" AND
    • a minimum score of 1 for the component of "ulcerated surface"
  • In the opinion of the investigator, participant's disease is appropriate to treat with the maintenance dosing regimens utilized in the study
  • Adhere to the requirements for concomitant medications for the treatment of CD as mentioned in the protocol

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

Full criteria on ClinicalTrials.gov

Sites (164)

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

SiteCityCountrySite status
Lkh-Univ. Klinikum Graz
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GrazAustriaRecruiting
Medizinische Universitatsklinik Innsbruck
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InnsbruckAustriaRecruiting
Kepler Universitatsklinikum GmbH
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LinzAustriaRecruiting
LKH - Universitätsklinikum der PMU Salzburg
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SalzburgAustriaRecruiting
Krankenhaus der Barmherzigen Brüder
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ViennaAustriaRecruiting
Medical University Vienna
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ViennaAustriaRecruiting
Klinikum Wels-Grieskirchen
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WelsAustriaRecruiting
Universitätsklinikum Wiener Neustadt
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Wiener NeustadtAustriaRecruiting
Cliniques universitaires Saint-Luc
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BrusselsBelgiumRecruiting
ULB Erasme Ziekenhuis
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BrusselsBelgiumRecruiting
Ziekenhuis Oost-Limburg
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GenkBelgiumRecruiting
Ghent university hospital
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GhentBelgiumRecruiting
Universitair Ziekenhuis Leuven
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LeuvenBelgiumRecruiting
CHU de Liège
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LiègeBelgiumRecruiting
Algemeen Ziekenhuis Delta
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RoeselareBelgiumRecruiting
Gastroenterology and Internal Medicine Research Institute (GIRI)
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EdmontonCanadaRecruiting
Charlton Digestive Disease Centre
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HamiltonCanadaRecruiting
London Digestive Disease Institute
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LondonCanadaRecruiting
Centre Hospitalier de l'Université de Montréal
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MontrealCanadaRecruiting
Clinique IMD
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MontrealCanadaRecruiting
Taunton Surgical Centre
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OshawaCanadaRecruiting
Toronto Immune and Digestive Health Institute Inc
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TorontoCanadaRecruiting
GIRI Gastrointestinal Research Institute
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VancouverCanadaRecruiting
Changzhou No 2 Peoples Hospital
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ChangzhouChinaRecruiting
Chongqing General Hospital
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ChongqingChinaRecruiting
The First Affiliated Hospital of Fujian Medical University
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FuzhouChinaRecruiting
The Sixth Affiliated Hospital, Sun Yat-sen University
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GuangzhouChinaRecruiting
The second Affiliated Hospital of Guangzhou Medical University
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GuangzhouChinaRecruiting
Zhongda Hospital Southeast University
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NanjingChinaRecruiting
Renmin Hospital of Wuhan University
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WuhanChinaRecruiting
Vojenská Nemocnice Brno
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BrnoCzechiaRecruiting
Fakultni nemocnice Brno
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BrnoCzechiaRecruiting
Gastroenterologie, s.r.o., Hradec Kralove
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Hradec KralovaCzechiaRecruiting
Hepato-Gastroenterologie HK, s.r.o.
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Hradec KrálovéCzechiaRecruiting
Fakultni Nemocnice Ostrava
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Ostrava - PorubaCzechiaRecruiting
Fakultni Thomayerova nemocnice
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PragueCzechiaRecruiting
Fakultni nemocnice Kralovske Vinohrady
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PragueCzechiaRecruiting
Charite-Universitaetsmedizin Berlin - Campus Benjamin Franklin (CBF)
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BerlinGermanyRecruiting
GASTRO-Studien
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BerlinGermanyRecruiting
Universitätsklinikum Erlangen
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ErlangenGermanyRecruiting
Praxiszentrum Fur Gastroenterologie und Endoskopie Grevenbroich
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GrevenbroichGermanyRecruiting
Universitätsklinikum Jena
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JenaGermanyRecruiting
Universitatsklinikum Schleswig Holstein Kiel
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KielGermanyRecruiting
St. Marien und St. Annastiftskrankenhaus
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Ludwigshafen am RheinGermanyRecruiting
Universitaetsklinikum Mannheim
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MannheimGermanyRecruiting
Klinikum rechts der Isar der TU München
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MünchenGermanyRecruiting
Aarhus University Hospital
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Aarhus CDenmarkRecruiting
Sydvestjysk Sygehus
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EsbjergDenmarkRecruiting
NAU New Aalborg University Hospital
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GistrupDenmarkRecruiting
Herlev Hospital
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HerlevDenmarkRecruiting
Nordsjaellands Hospital, Hillerod
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HilleroedDenmarkRecruiting
Hvidovre Hospital
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HvidovreDenmarkRecruiting
Bispebjerg Hospital
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København NVDenmarkRecruiting
Odense UH og Svendberg sygehus
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Odense CDenmarkRecruiting
Hosp. Gral. Univ. Dr. Balmis
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AlicanteSpainRecruiting
Hosp Clinic de Barcelona
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BarcelonaSpainRecruiting
Hosp. Arquitecto Marcide
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FerrolSpainRecruiting
Hosp. de Cabuenes
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GijónSpainRecruiting
Hosp. Univ. Dr. Josep Trueta
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GironaSpainRecruiting
Hosp. Univ. de Torrejon
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MadridSpainRecruiting
Hosp. de Navarra
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NavarraSpainRecruiting
Hosp. Clinico Univ. de Santiago
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Santiago de CompostelaSpainRecruiting
Hosp. Virgen Macarena
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SevilleSpainRecruiting
Chu Amiens Picardie
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AmiensFranceRecruiting
Clermont-Ferrand University Hospital
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Clermont-FerrandFranceRecruiting
Institut Prive MICI Clinique des Cedres
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ÉchirollesFranceRecruiting
APHM - Hopital Nord
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MarseilleFranceRecruiting
CHU Nantes-Hotel Dieu
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NantesFranceRecruiting
Clinique Ambroise Pare
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Neuilly-sur-SeineFranceRecruiting
CHU Nîmes
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NîmesFranceRecruiting
APHP-Hôpital Bichat - Claude Bernard
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ParisFranceRecruiting
APHP - Hôpital Saint Antoine
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ParisFranceRecruiting
Hospices Civils de Lyon CHU Lyon Sud
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Pierre-BéniteFranceRecruiting
CHU de Reims
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ReimsFranceRecruiting
Centre Hospitalier Universitaire de Nancy - Hôpital Central
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Vandœuvre-lès-NancyFranceRecruiting
Barts Health NHS Trust
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Greater LondonUnited KingdomRecruiting
London North West University Healthcare NHS Trust
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Greater LondonUnited KingdomRecruiting
West Middlesex University Hospital
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IselworthUnited KingdomRecruiting
Chelsea And Westminster Hospital
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LondonUnited KingdomRecruiting
Imperial College London
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LondonUnited KingdomRecruiting
Royal Free Hospital
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LondonUnited KingdomRecruiting
University College London Hospitals NHS Foundation Trust
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LondonUnited KingdomRecruiting
Norfolk and Norwich University Hospital
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NorwichUnited KingdomRecruiting
New Cross Hospital
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WolverhamptonUnited KingdomRecruiting
Endomedix
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BudapestHungaryRecruiting
Obudai Egeszsegugyi Centrum Kft
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BudapestHungaryRecruiting
Semmelweis Egyetem
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BudapestHungaryRecruiting
Semmelweis Egyetem 2
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BudapestHungaryRecruiting
Semmelweis Egyetem 1
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BudapestHungaryRecruiting
Pannónia Magánorvosi Centrum Kft
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BudapestHungaryRecruiting
Clinexpert Gyöngyös Kft.
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GyöngyösHungaryRecruiting
Szegedi Tudomanyegyetem
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SzegedHungaryRecruiting
A O U Sant Orsola Malpighi
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BolognaItalyRecruiting
Azienda Sanitaria dell'Alto Adige - Ospedale di Bolzano
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BolzanoItalyRecruiting
Azienda Ospedaliero Universitaria San Martino
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GenovaItalyRecruiting
IRCCS Ospedale San Raffaele
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MilanItalyRecruiting
Fondazione Policlinico Universitario A. Gemelli IRCCS
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RomaItalyRecruiting
Istituto Clinico Humanitas
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RozzanoItalyRecruiting
Ospedale Mauriziano Torino
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TorinoItalyRecruiting
Maastricht UMC
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MaastrichtNetherlandsRecruiting
Radboud Umcn
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NijmegenNetherlandsRecruiting
St. Elisabeth Ziekenhuis
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TilburgNetherlandsRecruiting
Centrum Medyczne Medis ManerMed Sp Z O O
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BydgoszczPolandRecruiting
Centrum Medyczne PROMED
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KrakowPolandRecruiting
Centrum Medyczne Plejady
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KrakowPolandRecruiting
Centrum Medyczne 'Medyk' Sp. z o.o. K.
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RzeszówPolandRecruiting
Twoja Przychodnia - Szczecinskie Centrum Medyczne
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SzczecinPolandRecruiting
GASTROMED Kopon Zmudzinski i wspolnicy SP j Specjalistyczne Centrum Gastrologii i Endoskopii
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TorunPolandRecruiting
Medical Network Sp z o o
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WarsawPolandRecruiting
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
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WarsawPolandRecruiting
Linkoping University Hospital
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LinköpingSwedenRecruiting
Sahlgrenska Universitetssjukhuset, Mölndal Sjukhus
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MölndalSwedenRecruiting
Ersta sjukhus
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StockholmSwedenRecruiting
Södersjukhuset
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StockholmSwedenRecruiting
Karolinska Universitetssjukhuset
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StockholmSwedenRecruiting
Akademiska sjukhuset
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UppsalaSwedenRecruiting
FNsP F. D. Roosevelta Banska Bystrica
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Banská BystricaSlovakiaRecruiting
Cliniq s.r.o.
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BratislavaSlovakiaRecruiting
ENDOMED, s.r.o.
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KošiceSlovakiaRecruiting
Fakultna nemocnica s poliklinikou Nove Zamky
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Nové ZámkySlovakiaRecruiting
GASTRO I., s.r.o.
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PrešovSlovakiaRecruiting
Gastro LM s.r.o.
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PrešovSlovakiaRecruiting
Vseobecna nemocnica Rimavska Sobota
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Rimavská SobotaSlovakiaRecruiting
Clinnova Research
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AnaheimUnited StatesRecruiting
Morehouse School of Medicine
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AtlantaUnited StatesRecruiting
Atlanta Gastroenterology Associates
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AtlantaUnited StatesSuspended
Westchester Putnam Gastroenterology
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CarmelUnited StatesRecruiting
DFW Clinical Trials
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CarrolltonUnited StatesRecruiting
University of North Carolina at Chapel Hill
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Chapel HillUnited StatesRecruiting
Charlotte Gastroenterology and Hepatology, PLLC
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CharlotteUnited StatesRecruiting
Heartland Medical Research, Inc.
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CliveUnited StatesRecruiting
Peak Gastroenterology Associates
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Colorado SpringsUnited StatesRecruiting
Digestive Health Specialists of the Southeast
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DothanUnited StatesRecruiting
Michigan Center of Medical Research
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Farmington HillsUnited StatesRecruiting
Woodholme Gastroenterology Associates
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Glen BurnieUnited StatesRecruiting
Medical Research Center of Connecticut
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HamdenUnited StatesRecruiting
Green Leaf Clinical Trials
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JacksonvilleUnited StatesRecruiting
Gastroenterology Clinic of Acadiana
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LafayetteUnited StatesRecruiting
Gastro Care Institute
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LancasterUnited StatesRecruiting
United Gastroenterologists
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Los AlamitosUnited StatesRecruiting
TLC Clinical Research Inc
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Los AngelesUnited StatesRecruiting
GastroIntestinal Bioscience
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Los AngelesUnited StatesRecruiting
Lubbock Gastroenterology
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LubbockUnited StatesRecruiting
Gastroenterology Associates of Central GA
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MaconUnited StatesRecruiting
Great Lakes Gastroenterology Research, LLC
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MentorUnited StatesRecruiting
Sanchez Clinical Research ,Inc
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MiamiUnited StatesRecruiting
Biodax Medical Research Trials
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MiamiUnited StatesRecruiting
East View Medical Research
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MobileUnited StatesRecruiting
GI PROS Research
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NaplesUnited StatesRecruiting
Lucida Clinical Trials
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New BedfordUnited StatesRecruiting
Lenox Hill Hospital
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New YorkUnited StatesSuspended
New York Gastroenterology Associates
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New YorkUnited StatesRecruiting
Comprehensive Gastrointestinal Health Libertyville
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NorthbrookUnited StatesRecruiting
Digestive Disease Specialists, Inc
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Oklahoma CityUnited StatesRecruiting
Orlando Health Digestive Health Institute
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OrlandoUnited StatesRecruiting
Southern Star Research Institute, LLC
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San AntonioUnited StatesRecruiting
Gastroenterology Research of America, LLC
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San AntonioUnited StatesRecruiting
Medical Associates Research Group, Inc.
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San DiegoUnited StatesRecruiting
Louisiana State University Health Sciences Center Shreveport
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ShreveportUnited StatesRecruiting
Palmetto Primary and Specialty Care Physicians, Charleston
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SummervilleUnited StatesRecruiting
GCP Clinical Research
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TampaUnited StatesRecruiting
Cotton O'Neil Clinical Research Center
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TopekaUnited StatesRecruiting
The University of Texas Health Science Center at Tyler
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TylerUnited StatesRecruiting
Frontier Clinical Research
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UniontownUnited StatesRecruiting

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