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NCT07415044RecruitingPhase 2

LY4268989 in Adults With Moderately to Severely Active Ulcerative Colitis

A Randomized, Multicenter, Double-Blind, Placebo-Controlled Development Program to Evaluate the Efficacy and Safety of LY4268989 (MORF-057) for the Treatment of Adults With Moderately to Severely Active Ulcerative Colitis (EMERALD-3)

Source: ClinicalTrials.gov · Last updated 4 Nov 2026

Brief summary (registry, in English)

The main purpose of this study is to evaluate the safety and effectiveness of LY4268989 when compared to placebo in adult participants with moderately to severely active ulcerative colitis (UC). The study drug will be administered orally. The study will last up to approximately 108 weeks, excluding screening.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
1431 (estimated)
First submitted
6 Feb 2026
Start date
26 Mar 2026
Primary completion date
Jun 2030
Lead sponsor
Eli Lilly and Company
NCT number
NCT07415044

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 1431
  • From 26 Mar 2026 to the primary completion date, Jun 2030
  • 258 sites in 28 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

  • Have had or will need bowel resection or intestinal or intra-abdominal surgery
  • Have any prior or current evidence of cancer gastrointestinal (GI) tract, or specified lesions with increased risk of GI malignancies

Other illness

  • Have a current diagnosis of
    • Crohn's disease
    • Inflammatory Bowel Disease (IBD unclassified) (formerly known as indeterminate colitis), or
    • primary sclerosing cholangitis
  • Have an inherited immunodeficiency syndrome or known monogenic cause of UC-like colonic inflammation
  • Have a diagnosis or history of malignant disease within 5 years prior to randomization

Other

  • Have evidence of toxic megacolon, intra-abdominal abscess, or stricture or stenosis within small bowel or colon that cannot be traversed by a colonoscope or that are symptomatic

Who the study is looking for

  • Have had an established diagnosis of ulcerative colitis (UC) for ≥3 months prior to randomization, which includes endoscopic evidence of UC
  • Have moderately to severely active UC defined by a Modified Mayo Score (mMS) of 5 to 9 with an Endoscopic Score (ES)≥2 confirmed by central reader and rectal bleeding (RB)≥1
  • Have evidence of UC extending proximal to the rectum
  • Have documented evidence of having had a surveillance colonoscopy within 1 year, or according to local guidelines, to evaluate for polyps, dysplasia, or malignancy, prior to randomization, if the participant has a history of UC symptoms for more than 8 years
  • Have an inadequate response to, loss of response to, or intolerance to at least one conventional medication (including corticosteroids) or one advanced therapy (including biologics, Janus Kinase (JAK) inhibitors, or sphingosine-1-phosphate (S1P) immunomodulators). Participants with inadequate response to vedolizumab are excluded
  • Must meet contraception requirements

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

Full criteria on ClinicalTrials.gov

Sites (258)

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

SiteCityCountrySite status
GEDYT
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Buenos AiresArgentinaRecruiting
Stat Research S.A.
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Buenos AiresArgentinaRecruiting
Mautalen Salud e Investigación
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Buenos AiresArgentinaRecruiting
Sanatorio Maipú
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MendozaArgentinaRecruiting
CER medical Institute
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QuilmesArgentinaRecruiting
Hospital Provincial del Centenario
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RosarioArgentinaRecruiting
INECO Neurociencias Oroño
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RosarioArgentinaRecruiting
Instituto Médico de Alta Complejidad San Isidro Sa
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San IsidroArgentinaRecruiting
C.I.C.E. 9 de Julio
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San Miguel de TucumánArgentinaRecruiting
Loema Instituto de Pesquisa Clinica
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CampinasBrazilRecruiting
Fundação Universidade de Caxias do Sul (FUCS)
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Caxias do SulBrazilRecruiting
HNSG
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CuritibaBrazilRecruiting
Centro de Oncologia Leonardo Da Vinci - ATO Terapias
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FortalezaBrazilRecruiting
Hospital Ernesto Dornelles
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Porto AlegreBrazilRecruiting
Instituto D'Or de Pesquisa e Ensino (IDOR) - Filial Salvador
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SalvadorBrazilRecruiting
Irmandade da Santa Casa da Misericórdia de Santos
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SantosBrazilRecruiting
BR Trials-Ensaios Clinicos e Consultoria
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São PauloBrazilRecruiting
Clínica Hepatogastro JK
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São PauloBrazilRecruiting
BRA - Clínica Médica e Terapia Assistida
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TajaíBrazilRecruiting
Health Sciences North
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Greater SudburyCanadaRecruiting
QEII Health Sciences Centre, Victoria General Site
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HalifaxCanadaNot yet recruiting
London Digestive Disease Institute
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LondonCanadaRecruiting
Binzhou Medical University Hospital
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BinzhouChinaRecruiting
Changzhou Second People's Hospital
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ChangzhouChinaRecruiting
Sichuan Provincial People's Hospital
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ChengduChinaRecruiting
Chongqing General Hospital
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ChongqingChinaRecruiting
The First People's Hospital of Foshan
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FoshanChinaRecruiting
The Sixth Affiliated Hospital of Sun Yat-sen University
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GuangzhouChinaRecruiting
Heilongjiang Provincial Hospital
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HarbinChinaRecruiting
The First Affiliated Hospital of Anhui Medical University
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HefeiChinaRecruiting
Huizhou Central People's Hospital
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HuizhouChinaRecruiting
First Affiliated Hospital of Kunming Medical University
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KunmingChinaRecruiting
Liaocheng People's Hospital
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LiaochengChinaRecruiting
Meihekou Central Hospital
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MeihekouChinaRecruiting
The Affiliated Hospital of Qingdao University
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QingdaoChinaRecruiting
Shanghai Tenth People's Hospital
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ShanghaiChinaRecruiting
Shanghai Pudong New District Zhoupu Hospital
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ShanghaiChinaRecruiting
Yuebei People's Hospital Guangdong
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ShaoguanChinaRecruiting
Peking University Shenzhen Hospital
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ShenzhenChinaRecruiting
The First Affiliated Hospital of Soochow University
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SuzhouChinaRecruiting
Taian City Central Hospital
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TaianChinaRecruiting
Wuhan Union Hospital
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WuhanChinaRecruiting
Renmin Hospital of Wuhan University
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WuhanChinaRecruiting
Zunyi Medical College - No.1 Affiliated Hospital
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ZunyiChinaRecruiting
Clínica de la Costa S.A.S
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BarranquillaColombiaNot yet recruiting
Hospital Universitario Mayor Méderi
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BogotáColombiaNot yet recruiting
Hospital Universitario San Ignacio
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BogotáColombiaNot yet recruiting
Fundacion Santa Fe de Bogota
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BogotáColombiaNot yet recruiting
Hospital Pablo Tobón Uribe
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MedellínColombiaNot yet recruiting
Hepato-Gastroenterologie HK
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Hradec KrálovéCzechiaRecruiting
Nemocnice Pardubickeho kraje
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PardubiceCzechiaRecruiting
MEDICON
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PragueCzechiaRecruiting
ISCARE klinické centrum
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PragueCzechiaRecruiting
Clinoxus
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PragueCzechiaRecruiting
Nemocnice Slany
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SlanýCzechiaRecruiting
Nemocnice AGEL Šternberk
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SternberkCzechiaSuspended
Clinical Trials Service s.r.o.
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Uherské HradištěCzechiaRecruiting
Gastro-nell
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VsetínCzechiaRecruiting
Centres Médico Chirurgicaux - Clinique Ambroise Paré
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Neuilly-sur-SeineFranceNot yet recruiting
CHU Bordeaux Haut-Leveque
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PessacFranceRecruiting
Centre Hospitalier Lyon-Sud
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Pierre-BéniteFranceRecruiting
CHU Rangueil
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ToulouseFranceRecruiting
Thoracic General Hospital of Athens "I Sotiria"
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AthensGreeceRecruiting
Evangelismos General Hospital of Athens
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AthensGreeceRecruiting
University General Hospital of Heraklion
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HeraklionGreeceRecruiting
Ippokrateio General Hospital of Thessaloniki
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ThessalonikiGreeceNot yet recruiting
Opca bolnica Bjelovar
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BjelovarCroatiaNot yet recruiting
Poliklinika Borzan
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OsijekCroatiaRecruiting
Klinički Bolnički Centar Split
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SplitCroatiaNot yet recruiting
Klinicki Bolnicki Centar Zagreb
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ZagrebCroatiaNot yet recruiting
Óbudai Egészségügyi Centrum
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BudapestHungaryRecruiting
Semmelweis University
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BudapestHungaryRecruiting
Clinexpert Gyongyos
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GyöngyösHungaryRecruiting
Komarom-Esztergom Varmegyei Szent Borbala Korhaz
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TatabányaHungaryRecruiting
Assuta Ashdod Medical Center
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AshdodIsraelRecruiting
Barzilai Medical Center
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AshkelonIsraelRecruiting
Rambam Health Care Campus
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HaifaIsraelRecruiting
Clalit Health Services - Lev Talpiot Clinic
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JerusalemIsraelRecruiting
Meir Medical Center
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Kfar SabaIsraelRecruiting
Yitzhak Shamir Medical Center
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TsrifinIsraelRecruiting
Motilal Nehru Medical College Hospital
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AllahabādIndiaNot yet recruiting
KLES Dr. Prabhakar Kore Hospital & M.R.C
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BelagaviIndiaRecruiting
Belagavi Institute of Medical Sciences - Belagavi
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BelgaviIndiaRecruiting
Mahavir Hospital & Research Centre - Hyderabad
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HyderabadIndiaRecruiting
SR Kalla Memorial Gastro & General Hospital
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JaipurIndiaRecruiting
Lakeshore Hospital
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KochiIndiaRecruiting
Dr Ram Manohar Lohia Institute of Medical Sciences
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LucknowIndiaNot yet recruiting
Topiwala National Medical College & B. Y. L. Nair Charitable Hospital
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MumbaiIndiaRecruiting
Orbit Multispeciality Hospital
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NagpurIndiaNot yet recruiting
All India Institute of Medical Sciences (AIIMS) - Nagpur
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NagpurIndiaNot yet recruiting
Midas Multispeciality Hospital Pvt.Ltd.
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NagpurIndiaRecruiting
All India Institute of Medical Sciences
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New DelhiIndiaNot yet recruiting
Yatharth Super Speciality Hospital - Noida Extension
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NoidaIndiaRecruiting
Lifepoint Multispeciality Hospital
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PuneIndiaRecruiting
Gastrohub Hospital
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PuneIndiaRecruiting
Ospedale San Raffaele
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MilanItalyNot yet recruiting
IRCCS Policlinico San donato
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MilanItalyNot yet recruiting
Ospedale Di Circolo
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RhoItalyRecruiting
Azienda Ospedaliera San Camillo Forlanini
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RomeItalyNot yet recruiting
Fondazione Policlinico Tor Vergata
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RomeItalyNot yet recruiting
Ospedale Isola Tiberina - Gemelli Isola
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RomeItalyNot yet recruiting
Humanitas
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RozzanoItalyNot yet recruiting
Asahikawa Medical University Hospital
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AsahikawaJapanRecruiting
Juntendo University Hospital
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Bunkyō CityJapanRecruiting
Sai Gastroenterology/Proctology Clinic
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FujiideraJapanRecruiting
Fukuoka University Hospital
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FukuokaJapanRecruiting
National Hospital Organization Hirosaki General Medical Center
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HirosakiJapanRecruiting
Sameshima Hospital
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KagoshimaJapanRecruiting
Tsujinaka Hospital Kashiwanoha
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KashiwaJapanRecruiting
Kyorin University Hospital
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MitakaJapanRecruiting
Saiseikai Niigata Hospital
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NiigataJapanRecruiting
Hyogo Medical University Hospital
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NishinomiyaJapanRecruiting
Okayama University Hospital
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OkayamaJapanRecruiting
Tokitokai Tokito Clinic Coloproctology Center
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SaitamaJapanRecruiting
Sapporo Higashi Tokushukai Hospital
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SapporoJapanRecruiting
The University of Osaka Hospital
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SuitaJapanRecruiting
Tokyo Yamate Medical Center
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TokyoJapanRecruiting
Dong-A University Hospital
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BusanSouth KoreaRecruiting
Pusan National University Yangsan Hospital
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BusanSouth KoreaRecruiting
Kyungpook National University Hospital
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DaeguSouth KoreaRecruiting
The Catholic University of Korea, Daejeon ST.Mary's Hospital
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DaejeonSouth KoreaRecruiting
Chosun University Hospital
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GwangjuSouth KoreaRecruiting
Yeungnam Univeristy Medical Center
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Gyeongsan-siSouth KoreaRecruiting
Inje University Haeundae Paik Hospital
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PusanSouth KoreaRecruiting
Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaRecruiting
Seoul National University Hospital
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SeoulSouth KoreaRecruiting
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
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SeoulSouth KoreaRecruiting
Kangbuk Samsung Hospital
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SeoulSouth KoreaRecruiting
Samsung Medical Center
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SeoulSouth KoreaRecruiting
Kyung Hee University Hospital
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SeoulSouth KoreaNot yet recruiting
Wonju Severance Christian Hospital
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WŏnjuSouth KoreaRecruiting
Hospital of Lithuanian University of Health Sciences Kauno Klinikos
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KaunasLithuaniaRecruiting
Klaipeda University hospital
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KlaipėdaLithuaniaNot yet recruiting
Viesoji Istaiga Klaipedos Miesto Poliklinika
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KlaipėdaLithuaniaRecruiting
VCA poliklīnika Aura
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RigaLatviaNot yet recruiting
Pauls Stradins Clinical Univeristy Hospital
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RigaLatviaRecruiting
Scientia Investigacion Clinica S.C.
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Chihuahua CityMexicoRecruiting
Scientia Investigacion Clinica Tj
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Ciudad de TijuanaMexicoRecruiting
Clinica de Investigacion en Reumatologia y Obesidad S. C.
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GuadalajaraMexicoRecruiting
Private Practice - Dr. Adriana Sánchez
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GuadalajaraMexicoNot yet recruiting
Proactive CR México SA de CV
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IrapuatoMexicoNot yet recruiting
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
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Mexico CityMexicoNot yet recruiting
Hospital Juarez de Mexico
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Mexico CityMexicoNot yet recruiting
Centro de Investigacion Clinica Chapultepec
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Mexico CityMexicoNot yet recruiting
Centro de Investigacion y Gastroenterologia, S.C.
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Mexico CityMexicoNot yet recruiting
Keystone Clinical Trials
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Mexico CityMexicoNot yet recruiting
Servicios de Oncología Médica Integral - Monterrey
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MonterreyMexicoNot yet recruiting
Centro de Investigacion Clinica Chapultepec
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QuerétaroMexicoNot yet recruiting
M2M Med
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ChorzówPolandRecruiting
Gyncentrum sp. z o.o. NZOZ Holsamed - oddział Libero
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KatowicePolandRecruiting
Polimedica PTG Kielce
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KielcePolandRecruiting
Centrum Medyczne Oslomed
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KrakowPolandRecruiting
Santa Familia Ptg Lodz
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LodzPolandRecruiting
Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. z o. o
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MalborkPolandNot yet recruiting
Allmedica
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Nowy TargPolandRecruiting
Twoja Przychodnia PCM
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PoznanPolandRecruiting
ETG Siedlce
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SiedlcePolandRecruiting
Sonomed Sp. z o.o.
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SzczecinPolandRecruiting
Twoja Przychodnia SCM
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SzczecinPolandRecruiting
H-T Centrum Medyczne Endoterapia
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TychyPolandRecruiting
Clinical Best Solutions
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WarsawPolandNot yet recruiting
Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś
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WarsawPolandRecruiting
ETG Zamosc
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ZamośćPolandRecruiting
Pan American Center for Oncology Trials - Ciudadela
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San JuanPuerto RicoRecruiting
Adult University Hospital
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San JuanPuerto RicoRecruiting
2Ca Braga
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BragaPortugalRecruiting
Hospital da Luz Lisboa
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LisbonPortugalRecruiting
Centro Hospitalar Universitário Lisboa Norte, E.P.E. - Hospital de Santa Maria
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LisbonPortugalRecruiting
Unidade Local de Saúde Entre o Douro e Voga
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Santa Maria da FeiraPortugalRecruiting
MSB General Hospital
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BelgradeSerbiaNot yet recruiting
Leskovac General Hospital
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LeskovacSerbiaNot yet recruiting
Sremska Mitrovica Health Centre
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Sremska MitrovicaSerbiaNot yet recruiting
General Hospital - Djordje Joanovic
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ZrenjaninSerbiaNot yet recruiting
Cliniq s.r.o.
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BratislavaSlovakiaRecruiting
Gastroentero s.r.o.
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BratislavaSlovakiaRecruiting
GASTRO I., s.r.o.
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PrešovSlovakiaRecruiting
Vseobecna nemocnica Rimavska Sobota
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Rimavská SobotaSlovakiaRecruiting
Accout Center
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ŠahySlovakiaRecruiting
Changhua Christian Hospital
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ChanghuaTaiwanRecruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
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Kaohsiung CityTaiwanRecruiting
China Medical University Hospital
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TaichungTaiwanRecruiting
Tri-Service General Hospital
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TaipeiTaiwanRecruiting
National Taiwan University Hospital
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TaipeiTaiwanRecruiting
Chernivtsi Regional Clinical Hospital
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ChernivtsiUkraineRecruiting
Medical Center of Limited Liability Company "Medical Center "Consilium Medical"
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KievUkraineRecruiting
Municipal Nonprofit Enterprise of Kyiv Region Council "Kyiv Regional Clinical Hospital"
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KyivUkraineRecruiting
Medbud Clinic
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KyivUkraineRecruiting
Center of Family Medicine Plus
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KyivUkraineRecruiting
Edelweiss Medics
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KyivUkraineRecruiting
Medical Center OK!Clinic+
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KyivUkraineRecruiting
Progastro Clinic
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LvivUkraineRecruiting
Transcarpathian Regional Hospital im.Andriya Novak
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UzhhorodUkraineRecruiting
Communal Non-Commercial Enterprise Vinnytsia City Clinical Hospital 1
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VinnytsiaUkraineRecruiting
Clinnova Research
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AnaheimUnited StatesRecruiting
Treasure Valley Medical Research
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BoiseUnited StatesRecruiting
Medical University of South Carolina
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CharlestonUnited StatesNot yet recruiting
Rush University Medical Center
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ChicagoUnited StatesNot yet recruiting
Northwestern University
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ChicagoUnited StatesNot yet recruiting
Peak Gastroenterology Associates
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Colorado SpringsUnited StatesRecruiting
K2 Medical Research - Daytona Beach
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Daytona BeachUnited StatesRecruiting
Advanced Research Institute - Denver
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DenverUnited StatesSuspended
Midwest Digestive Health & Nutrition
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Des PlainesUnited StatesRecruiting
GMC Clinical Research
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FolsomUnited StatesRecruiting
GI Alliance - Fort Worth
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Fort WorthUnited StatesRecruiting
GI Alliance - Garland
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GarlandUnited StatesRecruiting
Carolina Digestive Diseases and Endoscopy Center
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GreenvilleUnited StatesRecruiting
Medical Research Center of Connecticut
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HamdenUnited StatesNot yet recruiting
Ohio State University
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HilliardUnited StatesNot yet recruiting
Integrity Advanced Therapeutics
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HoustonUnited StatesRecruiting
Grand Teton Research Group
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Idaho FallsUnited StatesRecruiting
Skyline Gastroenterology of West Tennessee
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JacksonUnited StatesRecruiting
Clinical Research of Osceola
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KissimmeeUnited StatesRecruiting
Rocky Mountain Gastroenterology Associates - Lakewood
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LakewoodUnited StatesRecruiting
Florida Research Institute
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Lakewood RchUnited StatesRecruiting
Digestive Disease Specialists - Las Vegas - Crimson Canyon Drive
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Las VegasUnited StatesRecruiting
Gastroenterology Health Partners
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LouisvilleUnited StatesRecruiting
GI Alliance - Gastro Group and Endocenter - Mandeville
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MandevilleUnited StatesRecruiting
GI Alliance - Mansfield
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MansfieldUnited StatesRecruiting
Virtua Health & Wellness Center - Moorestown
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MoorestownUnited StatesNot yet recruiting
Gastroenterology Health Partners
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New AlbanyUnited StatesRecruiting
Saint Peter's University Hospital
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New BrunswickUnited StatesRecruiting
Eximia Research-VA, LLC
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NorfolkUnited StatesRecruiting
AdventHealth Orlando
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OrlandoUnited StatesNot yet recruiting
Valleywise Health Medical Center
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PhoenixUnited StatesRecruiting
The Oregon Clinic
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PortlandUnited StatesRecruiting
Mayo Clinic in Rochester, Minnesota
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RochesterUnited StatesNot yet recruiting
Southern Star Research Institute
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San AntonioUnited StatesRecruiting
GI Alliance - San Marcos
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San MarcosUnited StatesRecruiting
One of a Kind Clinical Research Center
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ScottsdaleUnited StatesRecruiting
Swedish Medical Center
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SeattleUnited StatesNot yet recruiting
Sanford USD Medical Center
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Sioux FallsUnited StatesRecruiting
Principle Research Solutions
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SpokaneUnited StatesRecruiting
Providence Sacred Heart Medical Center & Children's Hospital
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SpokaneUnited StatesRecruiting
DSI Research, LLC d/b/a ObjectiveHealth Clinical Research - Springboro
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SpringboroUnited StatesRecruiting
Springfield Clinic - First
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SpringfieldUnited StatesRecruiting
KAD Clinical Research
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St LouisUnited StatesRecruiting
Specialists in Gastroenterology
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St LouisUnited StatesRecruiting
Stony Brook University
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Stony BrookUnited StatesNot yet recruiting
Washington Gastroenterology - Tacoma
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TacomaUnited StatesRecruiting
Om Research LLC
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Temple CityUnited StatesRecruiting
Tyler Research Institute
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TylerUnited StatesRecruiting
Om Research, LLC
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VictorvilleUnited StatesRecruiting
Gastro Intestinal Research Institute of Northern Ohio, LLC
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WestlakeUnited StatesRecruiting
Wilmington Health, PLLC
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WilmingtonUnited StatesRecruiting
Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center
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WyomingUnited StatesRecruiting
IATROS International
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BloemfonteinSouth AfricaNot yet recruiting
Mediclinic Panorama
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Cape TownSouth AfricaNot yet recruiting
Spoke Research
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Cape TownSouth AfricaNot yet recruiting
Lenasia Clinical Trial Centre - Johannesburg
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JohannesburgSouth AfricaNot yet recruiting
Clinresco Centres
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Kempton ParkSouth AfricaNot yet recruiting
Bakent University, Adana Clinic & Research Ctr.
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AdanaTurkey (Türkiye)Not yet recruiting
Hacettepe Universite Hastaneleri
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AnkaraTurkey (Türkiye)Not yet recruiting
Antalya Egitim ve Arastırma Hastanesi
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AntalyaTurkey (Türkiye)Not yet recruiting
Ege Universitesi Hastanesi
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BornovaTurkey (Türkiye)Not yet recruiting
Mustafa Kemal Universitesi
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HatayTurkey (Türkiye)Recruiting
Bezmialem Vakf Üniversitesi
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IstanbulTurkey (Türkiye)Recruiting
Kocaeli University Medical Faculty Hospital
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İzmitTurkey (Türkiye)Recruiting
Mersin University
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MersinTurkey (Türkiye)Recruiting

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