A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (Also Known as RO7790121) in Participants With Moderately to Severely Active Ulcerative Colitis

Last updated: July 1, 2026
Sponsor: Hoffmann-La Roche
Overall Status: Active - Recruiting

Phase

3

Condition

Inflammatory Bowel Disease

Crohn's Disease

Treatment

RO7790121

Afimkibart

Placebo

Clinical Study ID

NCT06588855
GA45330
2024-513015-27-00
  • Ages 16-80
  • All Genders

Study Summary

This Phase III, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of induction therapy with Afimkibart (RO7790121) compared with placebo in participants with moderately to severely active ulcerative colitis (UC).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Confirmed diagnosis of UC

  • Moderately to severely active UC assessed by mMS

  • Bodyweight >= 40 kilogram (kg)

  • Up to date with colorectal cancer (CRC) screening performed according to localstandards

  • Demonstrated inadequate response, loss of response and/or intolerance to at leastone protocol-specified conventional or advanced UC therapy

  • Males and females of childbearing potential must meet protocol criteria forcontraception requirements

Exclusion

Exclusion Criteria:

  • Currently known complications of UC (e.g. fulminant colitis, toxic megacolon)

  • Current diagnosis of Crohn's disease (CD) or indeterminate colitis, microscopiccolitis, ischemic colitis, infectious colitis, radiation colitis

  • Presence of an ostomy or ileoanal pouch

  • Current diagnosis or suspicion of primary sclerosing cholangitis

  • Pregnancy or breastfeeding, or intention of becoming pregnant during the study

  • Past or current evidence of definite low-grade or high-grade colonic dysplasia oradenomas or neoplasia not completely removed

  • History of malignancy within 5 years, with the exception of malignancies adequatelytreated with resection for non-metastatic basal cell or squamous cell cancer or insitu cervical cancer

  • Evidence of infection with Clostridioides difficile (C. difficile; formerly known asClostridium difficile), cytomegalovirus (CMV), human immunodeficiency virus (HIV),Hepatitis B (HBV), Hepatitis C (HCV)

  • Has evidence of active tuberculosis (TB), latent TB not successfully treated (perlocal guidance) or inadequately treated TB

  • Has received protocol-specified prohibited medicines, including known exposure toany type of anti-TL1A therapy

Study Design

Total Participants: 350
Treatment Group(s): 3
Primary Treatment: RO7790121
Phase: 3
Study Start date:
December 11, 2024
Estimated Completion Date:
January 30, 2031

Connect with a study center

  • Hospital Britanico

    Ciudad Autonoma Bs As, C1280AEB
    Argentina

    Active - Recruiting

  • Instituto Medico CER

    Quilmes, B1878DVB
    Argentina

    Active - Recruiting

  • Macquarie University Hospital

    Macquarie Park, New South Wales 2109
    Australia

    Site Not Available

  • Coral Sea Clinical Research Institute

    Mackay, Queensland 4740
    Australia

    Site Not Available

  • Footscray Hospital

    Footscray, Victoria 3011
    Australia

    Site Not Available

  • Royal Melbourne Hospital

    Parkville, Victoria 3050
    Australia

    Site Not Available

  • Ordensklinikum Linz Barmherzige Schwestern

    Linz, 4010
    Austria

    Site Not Available

  • Klinikum Wels-Grieskirchen

    Wels, 4600
    Austria

    Site Not Available

  • AZORG Campus Aalst-Moorselbaan

    Aalst, 9300
    Belgium

    Site Not Available

  • CHU St Pierre (St Pierre)

    Brussels, 1000
    Belgium

    Site Not Available

  • Cliniques Universitaires St-Luc

    Brussels, 1200
    Belgium

    Site Not Available

  • Cliniques Universitaires St-Luc

    Brussels 2800866, 1200
    Belgium

    Active - Recruiting

  • AZ Oostende

    Ostend, 8400
    Belgium

    Site Not Available

  • Hospital Moinhos de Vento

    Porto Alegre, Rio Grande do Sul 90035-000
    Brazil

    Active - Recruiting

  • Instituto Lobus Unimed Volta Redonda

    Volta Redonda, Rio de Janeiro 27258-000
    Brazil

    Active - Recruiting

  • Newdata Clinical Trials

    Aracaju, Sergipe 49055-000
    Brazil

    Active - Recruiting

  • CECIP - Centro de Estudos Clínicos do Interior Paulista

    Jaú, São Paulo 17210-190
    Brazil

    Active - Recruiting

  • Centro Paulista de Investigacao Clinica - CEPIC

    São Paulo, São Paulo 04266-010
    Brazil

    Active - Recruiting

  • Hospital Sírio-Libanês

    São Paulo, São Paulo 01308-050
    Brazil

    Active - Recruiting

  • Centro Paulista de Investigacao Clinica - CEPIC

    São Paulo 3448439, São Paulo 3448433 04266-010
    Brazil

    Active - Recruiting

  • Second Multiprofile Hospital For Active Treatment-Sofia

    Sofia Town, Sofia 1202
    Bulgaria

    Site Not Available

  • MC " Sveti Ivan Rilski Chudotvorets- 2010

    Plovdiv, 4003
    Bulgaria

    Active - Recruiting

  • "City Clinic UMHAC" EOOD

    Sofia, 1407
    Bulgaria

    Active - Recruiting

  • Barrie GI Associates

    Barrie, Ontario L4M 7G1
    Canada

    Active - Recruiting

  • GNRR Digestive Clinics and Research Center Inc.

    Brampton, Ontario L6S 0E2
    Canada

    Site Not Available

  • LDDI Clinical Trials Inc.

    London, Ontario N6K 1M6
    Canada

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  • London Health Sciences Centre Uni Campus

    London, Ontario N6A 5A5
    Canada

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  • TIDHI Innovation Inc.

    Toronto, Ontario M6A 3B4
    Canada

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  • CIUSSS-de-l?Est-de-l?Île-de-Montréal

    Montreal, Quebec H1T 2M4
    Canada

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  • Centro de Investigación Clínica UC-CICUC

    Santiago, 8330034
    Chile

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  • Beijing No.6 Hospital

    Beijing, Beijing Municipality 100007
    China

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  • The First Affilliated Hospital of Kunming Medical University

    Kunming, Yunnan 650032
    China

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  • Third Xiangya Hospital Centrel South University

    Changsha, 410013
    China

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  • West China Hospital of Sichuan University

    Chengdu, 610041
    China

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  • Guangzhou First People's Hospital

    Guangzhou, 510180
    China

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  • The second Affiliated Hospital of Guangzhou Medical University

    Guangzhou, 510260
    China

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  • Guangzhou First People's Hospital

    Guangzhou 1809858, 510180
    China

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  • Sir Run Run Shaw Hospital Zhejiang University

    Hangzhou, 310016
    China

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    Huizhou, 516001
    China

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  • The Second Affiliated Hospital of Nanchang University

    Nanchang, 330008
    China

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  • The First Affiliate Hospital of Guangxi Medical University

    Nanning, 530021
    China

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    Ningbo, 315000
    China

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    Qingdao, 266000
    China

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    Shanghai, 200025
    China

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    Shanghai, 200092
    China

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    Shanghai 1796236, 200025
    China

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    Shenyang, 110004
    China

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  • First Affiliated Hospital of Soochow University

    Suzhou, 215006
    China

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    Xiamen, 361003
    China

    Site Not Available

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    Xiamen, 361004
    China

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  • The First Affiliated Hospital of Xiamen University

    Xiamen 1790645, 361003
    China

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  • Borzan Polyclinic

    Osijek, 31000
    Croatia

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  • Clinical Hospital Center Sestre Milosrdnice

    Zagreb, 10000
    Croatia

    Site Not Available

  • Hepato-Gastroenterologie HK, s.r.o.

    Hradec Králové, 500 12
    Czechia

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  • Fakultni nemocnice Ostrava

    Ostrava - Poruba, 708 52
    Czechia

    Site Not Available

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    Prague, 170 04
    Czechia

    Active - Recruiting

  • Ålborg Universitets Hospital

    Aalborg, 9000
    Denmark

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    Chambray-lès-Tours, 37170
    France

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    Clermont-Ferrand, 63000
    France

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    Créteil, 94000
    France

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  • Polyclinique Grand Sud

    Nîmes, 30900
    France

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  • Hôpital de Brabois Adultes

    Vandœuvre-lès-Nancy, 54511
    France

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  • Universitätsklinikum Heidelberg

    Heidelberg, 69120
    Germany

    Site Not Available

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    Lüneburg, 21339
    Germany

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    Potsdam, 14467
    Germany

    Site Not Available

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    Budapest, 1082
    Hungary

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    Budapest, 1062
    Hungary

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    Budapest 3054643, 1082
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    Debrecen, 4025
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  • Vas-Oxy Egeszsegugyi Kft

    Szombathely, 9700
    Hungary

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  • Fejer Varmegyei Szent György Egyetemi Oktatokorhaz

    Székesfehérvár, 8000
    Hungary

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  • Gujarat Gastro and Vascular Hospital

    Surat, Gujarat 395009
    India

    Active - Recruiting

  • Surat Institute of Digestive Sciences Hospitals

    Surat, Gujarat 395002
    India

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  • Gujarat Gastro and Vascular Hospital

    Surat 1255364, Gujarat 1270770 395009
    India

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  • Kingsway Hospital

    Nagpur (urban), Maharashtra 440001
    India

    Completed

  • MIDAS Multispeciality Hospital

    Nagpur (urban), Maharashtra 440018
    India

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  • Sahyadri Super Speciality Hospital

    Nashik, Maharashtra 422001
    India

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  • SMS Superspeciality Hospital

    Jaipur, Rajasthan 302007
    India

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  • SR Kalla Memorial Gastro & General Hospital

    Jaipur, Rajasthan 302006
    India

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  • SR Kalla Memorial Gastro & General Hospital

    Jaipur 1269515, Rajasthan 1258899 302006
    India

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  • AIG Hospitals

    Gachibowli, Telangana 500032
    India

    Site Not Available

  • Yashoda Hospitals

    Secunderabad, Telangana 500003
    India

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  • Soroka Medical Center

    Beersheba, 8410101
    Israel

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  • The Chaim Sheba Medical Center

    Ramat Gan, 5265601
    Israel

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  • Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi-Via Massarenti

    Bologna, Emilia-Romagna 40138
    Italy

    Site Not Available

  • Ospedale Isola Tiberina Gemelli

    Roma, Lazio 00186
    Italy

    Active - Recruiting

  • Ospedale Isola Tiberina Gemelli

    Rome, Lazio 00186
    Italy

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  • Policlinico Universitario Campus Biomedico Di Roma

    Rome, Lazio 00128
    Italy

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  • Policlinico Universitario Campus Biomedico Di Roma

    Rome 3169070, Lazio 3174976 00128
    Italy

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  • Asst Degli Spedali Civili Di Brescia

    Brescia, Lombardy 25123
    Italy

    Active - Recruiting

  • IRCCS Ospedale San Raffaele

    Milan, Lombardy 20132
    Italy

    Active - Recruiting

  • Azienda Ospedaliera San Gerardo di Monza

    Monza MI, Lombardy 20900
    Italy

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  • Istituto Clinico Humanitas

    Rozzano (MI), Lombardy 20089
    Italy

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  • IRCCS Ospedale Sacro Cuore Don Calabria

    Negrar, Veneto 37024
    Italy

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  • Boca Clinical Trials Mexico S.C. (Cd. Mexico)

    Miguel Hidalgo, Mexico CITY (federal District) 01120
    Mexico

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  • FAICIC S de R.L. de C.V

    Veracruz, 91900
    Mexico

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  • ETZ Elisabeth

    Tilburg, 5022 GC
    Netherlands

    Site Not Available

  • Szpital Zakonu Bonifratrow Sw. Jana Bozego w Lodzi sp. z o.o.

    ?ód?, 93-357
    Poland

    Site Not Available

  • Gastromed Kralisz, Romatowski, Stachurska sp.j.

    Bia?ystok, 15-322
    Poland

    Site Not Available

  • Medical Center Kermed

    Bydgoszcz, 85-231
    Poland

    Active - Recruiting

  • Szpital Miejski sw. Jana Paw?a II w Elblagu

    Elblag, 82-300
    Poland

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  • Centrum Medyczne CLW-med Aneta Cichomska , Joanna Luka -Wendrowska

    Grudzadz, 86-300
    Poland

    Site Not Available

  • Osrodek Badan Klinicznych Bd Research

    I?awa, 14-200
    Poland

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  • MZ Badania Slowik Zymla Sp.j.

    Knurów, 44-190
    Poland

    Site Not Available

  • Centrum Medyczne Promed

    Krakow, 31-513
    Poland

    Site Not Available

  • Medrise sp z o.o

    Lublin, 20-582
    Poland

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  • Clinical Research Center Sp. z o.o. MEDIC-R Spó?ka Komandytowa

    Pozna?, 61-731
    Poland

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  • Gabinety Lekarskie Rivermed

    Pozna?, 61-441
    Poland

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  • Clinical Research Center Sp. z o.o. MEDIC-R Spó?ka Komandytowa

    Poznan, 61-731
    Poland

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  • EMC Instytut Medyczny SA

    Późna, 60-309
    Poland

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  • Gabinety Lekarskie Rivermed

    Późna, 61-441
    Poland

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  • Clinical Research Center Sp. z o.o. MEDIC-R Spó?ka Komandytowa

    Późna 7534652, 61-731
    Poland

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  • Gabinety Lekarskie Rivermed

    Późna 7534652, 61-441
    Poland

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  • Endoskopia Sp. z o.o.

    Sopot, 81-756
    Poland

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  • Sonomed Sp. z o.o.

    Szczecin, 71-685
    Poland

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  • Centrum Zdrowia-MDM

    Warsaw, 00-189
    Poland

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  • Medon Clinical Research sp. z o.o

    Warsaw, 02-679
    Poland

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  • Vivamed Spolka Z Ograniczona Odpowiedzialnoscia

    Warsaw, 03-580
    Poland

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  • Medon Clinical Research sp. z o.o

    Warsaw 756135, 02-679
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  • Vivamed Spolka Z Ograniczona Odpowiedzialnoscia

    Warsaw 756135, 03-580
    Poland

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  • Centrum Zdrowia-MDM

    Warszawa, 00-189
    Poland

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  • Medon Clinical Research sp. z o.o

    Warszawa, 02-679
    Poland

    Active - Recruiting

  • PlanetMed sp. z o.o.

    Wroc?aw, 52-210
    Poland

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  • Centrum Medyczne Oporow

    Wroclaw, 52-416
    Poland

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  • Hospital de Braga

    Braga, 4710-243
    Portugal

    Active - Recruiting

  • Hospital da Luz Lisboa

    Lisbon, 1500-650
    Portugal

    Active - Recruiting

  • Centro Hospitalar do Algarve - Hospital de Portimao

    Portimão, 8500-338
    Portugal

    Active - Recruiting

  • Hospital de Sao Joao

    Porto, 4202-451
    Portugal

    Active - Recruiting

  • Centro Hospitalar de Entre Douro e Vouga - H. São Sebastião

    Santa Maria da Feira, 4520-211
    Portugal

    Active - Recruiting

  • Hospital Sao Teotonio

    Viseu, 3504-509
    Portugal

    Active - Recruiting

  • Klinical Investigations Group LLC

    San Juan, 00909
    Puerto Rico

    Active - Recruiting

  • General Hospital "Djordje Joanovic"

    Zrenjanin, 23000
    Serbia

    Active - Recruiting

  • KM Management spol. s r.o.

    Nitra, 949 01
    Slovakia

    Site Not Available

  • Accout Center s.r.o.

    Šahy, 936 01
    Slovakia

    Site Not Available

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, Madrid 28222
    Spain

    Site Not Available

  • Hospital Clinico Univ. Lozano Blesa

    Zaragoza, 50009
    Spain

    Site Not Available

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009
    Spain

    Site Not Available

  • Hospital Universitario Miguel Servet

    Zaragoza 3104324, 50009
    Spain

    Active - Recruiting

  • China Medical University Hospital

    Taichung, 40447
    Taiwan

    Active - Recruiting

  • Division of Gastroenterology, Depart of Internal Med., Fac of Med., Chiang Mai University

    Chiang Mai, 50200
    Thailand

    Active - Recruiting

  • Burapha University Hospital

    Chon Buri, 20131
    Thailand

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  • Sunpasitthiprasong Hospital

    Ubonratchathani, 34000
    Thailand

    Active - Recruiting

  • Leicester General Hospital

    Leicester, LE5 4PW
    United Kingdom

    Active - Recruiting

  • Bronglais General Hospital

    Llanrhystud, SY23 1ER
    United Kingdom

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  • King College Hospital NHS Foundation Trust

    London, SE5 9RS
    United Kingdom

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  • Peterborough City Hospital

    Peterborough, PE 3 9GZ
    United Kingdom

    Site Not Available

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    Stockport, SK2 7JE
    United Kingdom

    Active - Recruiting

  • New Cross Hospital

    Wolverhampton, WV10 0QP
    United Kingdom

    Active - Recruiting

  • Digestive Health Specialists of the Southeast (Gastroenterology Associates of Dothan) - Dothan

    Dothan, Alabama 36305
    United States

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  • Mayo Clinic Hospital

    Scottsdale, Arizona 85259
    United States

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  • Arizona Digestive Health, P.C (ADH)

    Sun City, Arizona 85351
    United States

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  • Om Research LLC

    Apple Valley, California 92307
    United States

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  • Valley View Internal Medicine

    Garden Grove, California 92845
    United States

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  • Gastro Care Associates

    Lancaster, California 93534
    United States

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  • University of Southern California

    Los Angeles, California 90033-1057
    United States

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  • Hoag Memorial Hospital Presbyterian;Hoag Center for Research and Education

    Newport Beach, California 92663
    United States

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    Redwood City, California 94063
    United States

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  • Peak Gastroenterology Associates

    Colorado Springs, Colorado 80907
    United States

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    Coral Gables, Florida 33134
    United States

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    Hialeah, Florida 33013
    United States

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    Miami, Florida 33155
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    Miami, Florida 33176
    United States

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    Miami, Florida 33126
    United States

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    Orlando, Florida 32825
    United States

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    Orlando, Florida 32807
    United States

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    Orlando, Florida 32807
    United States

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    Port Orange, Florida 32127
    United States

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    Tampa, Florida 33614
    United States

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    Tampa, Florida 33615
    United States

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    Tampa, Florida 33612
    United States

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    Weston, Florida 33331
    United States

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  • LCC Medical Research Institute, LLC

    Miami 4164138, Florida 4155751 33126
    United States

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  • Gastroenterology Institute of Orlando

    Orlando 4167147, Florida 4155751 32807
    United States

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  • Guardian Angel Research Center, LLC

    Tampa 4174757, Florida 4155751 33614
    United States

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  • Santos Research Center, CORP

    Tampa 4174757, Florida 4155751 33615
    United States

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  • Atlanta Gastroenterology Associates

    Atlanta, Georgia 30342
    United States

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    Atlanta, Georgia 30308
    United States

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  • Gastroenterology Associates of Central Georgia

    Macon, Georgia 31201
    United States

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  • Atlanta Gastroenterology Associates

    Atlanta 4180439, Georgia 4197000 30342
    United States

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  • Grand Teton Research Group, PLLC

    Idaho Falls, Idaho 83404
    United States

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  • Illinois Gastroenterology Group-Glenview powered by GI Alliance

    Glenview, Illinois 60026
    United States

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    Gurnee, Illinois 60031
    United States

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    New Albany, Indiana 47150
    United States

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  • Kansas Gastroenterology, LLC under Clinical Trials Network

    Wichita, Kansas 67226
    United States

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  • One GI: GHP - Gastroenterology Health Partners Louisville

    Louisville, Kentucky 40218
    United States

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  • Louisiana Research Center - GastroIntestinal Associates

    Shreveport, Louisiana 71105
    United States

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  • Allied Gastrointestinal Associates, PA

    Flowood, Mississippi 39232
    United States

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  • Delta Gastroenterology & Endoscopy Center

    Southaven, Mississippi 38671
    United States

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  • Dartmouth-Hitchcock Medical Center-Norris Cotton Cancer Center

    Lebanon, New Hampshire 03756
    United States

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  • Ellipsis Research Group

    Brooklyn, New York 11215
    United States

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  • NYU Inflammatory Bowel Disease Center

    New York, New York 10016
    United States

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  • Weill Cornell Medical College

    New York, New York 10021
    United States

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  • DiGiovanna Inst for Med Ed&Res

    North Massapequa, New York 11758
    United States

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  • Queens Village Medical Care

    Queens Village, New York 11428
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  • Gastroenterology Group Of Rochester, LLP

    Rochester, New York 14618
    United States

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  • James J Peters Veterans Administration Medical Center - NAVREF

    The Bronx, New York 10468
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    Rochester 5134086, New York 5128638 14618
    United States

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    Charlotte, North Carolina 28207
    United States

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  • Omega Research North Carolina, LLC

    Fuquay-Varina, North Carolina 27526
    United States

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  • Peters Medical Research (PMR), LLC

    High Point, North Carolina 27260
    United States

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  • Dayton Gastroenterology, Inc.

    Beavercreek, Ohio 45440
    United States

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  • University of Cincinnati Hospital

    Cincinnati, Ohio 45267
    United States

    Active - Recruiting

  • Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • Ohio Gastroenterology Group

    Columbus, Ohio 43202
    United States

    Active - Recruiting

  • Ohio State University

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • Gastro Intestinal Research Institute of Northern Ohio

    Westlake, Ohio 44145
    United States

    Active - Recruiting

  • Frontier Clinical Re search, LLC

    Uniontown, Pennsylvania 15401
    United States

    Active - Recruiting

  • University Gastroenterology

    Providence, Rhode Island 02904
    United States

    Active - Recruiting

  • Gastroenterology Associates

    Greenville, South Carolina 29607
    United States

    Active - Recruiting

  • Gastroenterology Associates, PA PA of Greenville

    Greenville 4580543, South Carolina 4597040 29607
    United States

    Active - Recruiting

  • Gastro One

    Cordova, Tennessee 38018
    United States

    Active - Recruiting

  • Uni of Texas Medical Branch

    Galveston, Texas 77555
    United States

    Active - Recruiting

  • GI Alliance

    Garland, Texas 75044
    United States

    Active - Recruiting

  • Amel Med LLC

    Georgetown, Texas 78628
    United States

    Active - Recruiting

  • Cano Medical Center

    Harlingen, Texas 78550
    United States

    Active - Recruiting

  • Texas Digestive Specialists

    Harlingen, Texas 78550
    United States

    Active - Recruiting

  • Integrity Advanced Therapeutics PLLC

    Houston, Texas 77090
    United States

    Site Not Available

  • GI Alliance - Bay Area Gastroenterology

    Lubbock, Texas 79410
    United States

    Active - Recruiting

  • TDDC dba GI Alliance Research

    Mansfield, Texas 76063
    United States

    Active - Recruiting

  • Southern Star Research Institute, LLC.

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • Baylor Scott and White Medical Center

    Temple, Texas 76508
    United States

    Active - Recruiting

  • Tyler Research Institute, LLC

    Tyler, Texas 75701
    United States

    Active - Recruiting

  • University of Texas Health Center at Tyler

    Tyler, Texas 75708
    United States

    Active - Recruiting

  • TDDC GI Alliance research Webster

    Webster, Texas 77598
    United States

    Active - Recruiting

  • Cano Medical Center

    Harlingen 4696233, Texas 4736286 78550
    United States

    Active - Recruiting

  • Tyler Research Institute, LLC

    Tyler 4738214, Texas 4736286 75701
    United States

    Active - Recruiting

  • Gastroenterology Associates of Tidewater

    Chesapeake, Virginia 23320
    United States

    Active - Recruiting

  • Emeritas Research Group

    Lansdowne Town Center, Virginia 20176
    United States

    Active - Recruiting

  • Gastroenterology Consultants of SWVA

    Roanoke, Virginia 24018
    United States

    Active - Recruiting

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