A Study to Assess the Efficacy and Safety of Induction Therapy With RO7790121 in Participants With Moderately to Severely Active Ulcerative Colitis

Last updated: April 9, 2025
Sponsor: Hoffmann-La Roche
Overall Status: Active - Recruiting

Phase

3

Condition

Crohn's Disease

Inflammatory Bowel Disease

Treatment

Placebo

RO7790121

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 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): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
December 11, 2024
Estimated Completion Date:
December 30, 2029

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

    Active - Recruiting

  • Coral Sea Clinical Research Institute

    Mackay, Queensland 4740
    Australia

    Active - Recruiting

  • Footscray Hospital

    Footscray, Victoria 3011
    Australia

    Active - Recruiting

  • Royal Melbourne Hospital

    Parkville, Victoria 3050
    Australia

    Active - Recruiting

  • Ordensklinikum Linz Barmherzige Schwestern

    Linz, 4010
    Austria

    Active - Recruiting

  • Klinikum Wels-Grieskirchen

    Wels, 4600
    Austria

    Active - Recruiting

  • AZORG Campus Aalst-Moorselbaan

    Aalst, 9300
    Belgium

    Active - Recruiting

  • CHU St Pierre (St Pierre)

    Brussels, 1000
    Belgium

    Active - Recruiting

  • Cliniques Universitaires St-Luc

    Bruxelles, 1200
    Belgium

    Active - Recruiting

  • London Health Sciences Centre Uni Campus

    London, Ontario N6A 5A5
    Canada

    Active - Recruiting

  • Centro de Investigación Clínica UC-CICUC

    Santiago, 8330034
    Chile

    Active - Recruiting

  • Third Xiangya Hospital Centrel South University

    Changsha, 410013
    China

    Active - Recruiting

  • West China Hospital of Sichuan University

    Chengdu City, 610041
    China

    Active - Recruiting

  • Guangzhou First People's Hospital

    Guangzhou, 510180
    China

    Active - Recruiting

  • The second Affiliated Hospital of Guangzhou Medical University

    Guangzhou City, 510260
    China

    Active - Recruiting

  • Sir Run Run Shaw Hospital Zhejiang University

    Hangzhou City, 310016
    China

    Active - Recruiting

  • Huizhou Central People's Hospital

    Huizhou, 516001
    China

    Active - Recruiting

  • The First Affilliated Hospital of Kunming Medical University

    Kunming, 650032
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Nanchang University

    Nanchang City, 330008
    China

    Active - Recruiting

  • The First Affiliate Hospital of Guangxi Medical University

    Nanning, 530021
    China

    Active - Recruiting

  • The First Affiliated Hospital of Ningbo University

    Ningbo City, 315000
    China

    Active - Recruiting

  • The Affiliated Hospital of Medical College Qingdao University

    Qingdao, 266000
    China

    Active - Recruiting

  • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, 200092
    China

    Active - Recruiting

  • Ruijin Hospital Shanghai Jiaotong University School of Medicine

    Shanghai City, 200025
    China

    Active - Recruiting

  • Shengjing Hospital of China Medical University

    ShenYang, 110004
    China

    Active - Recruiting

  • First Affiliated Hospital of Soochow University

    Suzhou, 215006
    China

    Active - Recruiting

  • The First Affiliated Hospital of Xiamen University

    Xiamen, 361003
    China

    Active - Recruiting

  • Zhongshan Hospital Xiamen University

    Xiamen, 361004
    China

    Active - Recruiting

  • Fakultni nemocnice Ostrava

    Ostrava - Poruba, 708 52
    Czechia

    Active - Recruiting

  • Ålborg Universitets Hospital

    Ålborg, 9000
    Denmark

    Active - Recruiting

  • CHU Tours - Hôpital Trousseau

    Chambray les Tours, 37170
    France

    Active - Recruiting

  • CHU Clermont Ferrand - Hôtel Dieu

    Clermont-Ferrand, 63000
    France

    Active - Recruiting

  • Hôpital Henri Mondor

    Créteil, 94000
    France

    Active - Recruiting

  • Polyclinique Grand Sud

    Nimes, 30900
    France

    Active - Recruiting

  • Hôpital de Brabois Adultes

    Vandoeuvre-les-nancy, 54511
    France

    Active - Recruiting

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120
    Germany

    Active - Recruiting

  • Medizinisches Zentrum Klinikum Lueneburg

    Lueneburg, 21339
    Germany

    Active - Recruiting

  • Észak-Pesti Centrumkórház-Honvédkórház

    Budapest, 1062
    Hungary

    Active - Recruiting

  • Vasutegeszsegugyi Kft. - Debreceni Egeszsegugyi Kozpont

    Debrecen, 4025
    Hungary

    Active - Recruiting

  • Vas-Oxy Egeszsegugyi Kft

    Szombathely, 9700
    Hungary

    Active - Recruiting

  • Fejer Varmegyei Szent György Egyetemi Oktatokorhaz

    Székesfehérvár, 8000
    Hungary

    Active - Recruiting

  • Ospedale Isola Tiberina Gemelli

    Roma, Lazio 00186
    Italy

    Active - Recruiting

  • Policlinico Universitario Campus Biomedico Di Roma

    Roma, Lazio 00128
    Italy

    Active - Recruiting

  • FAICIC S de R.L. de C.V

    Veracruz, 91900
    Mexico

    Active - Recruiting

  • ETZ Elisabeth

    Tilburg, 5022 GC
    Netherlands

    Active - Recruiting

  • Medical Center Kermed

    Bydgoszcz, 85-231
    Poland

    Active - Recruiting

  • MZ Badania Slowik Zymla Sp.j.

    Knurów, 44-190
    Poland

    Active - Recruiting

  • Centrum Medyczne Promed

    Kraków, 31-513
    Poland

    Active - Recruiting

  • Medrise sp z o.o

    Lublin, 20-582
    Poland

    Active - Recruiting

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

    Pozna?, 61-731
    Poland

    Active - Recruiting

  • EMC Instytut Medyczny SA

    Pozna?, 60-309
    Poland

    Active - Recruiting

  • Gabinety Lekarskie Rivermed

    Pozna?, 61-441
    Poland

    Active - Recruiting

  • Endoskopia Sp. z o.o.

    Sopot, 81-756
    Poland

    Active - Recruiting

  • Sonomed Sp. z o.o.

    Szczecin, 71-685
    Poland

    Active - Recruiting

  • Centrum Zdrowia-MDM

    Warszawa, 00-189
    Poland

    Active - Recruiting

  • Medon Clinical Research sp. z o.o

    Warszawa, 02-679
    Poland

    Active - Recruiting

  • PlanetMed sp. z o.o.

    Wroc?aw, 52-210
    Poland

    Active - Recruiting

  • Hospital de Braga

    Braga, 4710-243
    Portugal

    Active - Recruiting

  • Hospital da Luz Lisboa

    Lisboa, 1500-650
    Portugal

    Active - Recruiting

  • Centro Hospitalar do Algarve - Hospital de Portimao

    Portimao, 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

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, Madrid 28222
    Spain

    Active - Recruiting

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

    Chiang Mai, 50200
    Thailand

    Active - Recruiting

  • Burapha University Hospital

    Chonburi, 20131
    Thailand

    Active - Recruiting

  • 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

    Active - Recruiting

  • Stepping Hill Hospital

    Stockport, SK2 7JE
    United Kingdom

    Active - Recruiting

  • New Cross Hospital

    Wolverhampton, WV10 0QP
    United Kingdom

    Active - Recruiting

  • Om Research LLC

    Apple Valley, California 92307
    United States

    Active - Recruiting

  • Valley View Internal Medicine

    Garden Grove, California 92845
    United States

    Active - Recruiting

  • Gastro Care Associates

    Lancaster, California 93534
    United States

    Active - Recruiting

  • Hi Tech and Global Research, LLC

    Coral Gables, Florida 33134
    United States

    Active - Recruiting

  • Ambert Medical Research

    Miami, Florida 33176
    United States

    Active - Recruiting

  • LCC Medical Research Institute, LLC

    Miami, Florida 33126
    United States

    Active - Recruiting

  • Digestive and Liver Center of Florida

    Orlando, Florida 32825
    United States

    Active - Recruiting

  • Gastroenterology Institute of Orlando

    Orlando, Florida 32807
    United States

    Active - Recruiting

  • Guardian Angel Research Center, LLC

    Tampa, Florida 33614
    United States

    Active - Recruiting

  • Santos Research Center, CORP

    Tampa, Florida 33615
    United States

    Active - Recruiting

  • Atlanta Gastroenterology Associates

    Atlanta, Georgia 30342
    United States

    Active - Recruiting

  • Illinois Gastroenterology Group-Glenview powered by GI Alliance

    Glenview, Illinois 60026
    United States

    Active - Recruiting

  • GI Alliance - Gurnee

    Gurnee, Illinois 60031
    United States

    Active - Recruiting

  • Kansas Gastroenterology, LLC under Clinical Trials Network

    Wichita, Kansas 67226-8119
    United States

    Active - Recruiting

  • Delta Gastroenterology & Endoscopy Center

    Southaven, Mississippi 38671
    United States

    Active - Recruiting

  • Ellipsis Research Group

    Brooklyn, New York 11215
    United States

    Active - Recruiting

  • DiGiovanna Inst for Med Ed&Res

    North Massapequa, New York 11758
    United States

    Active - Recruiting

  • Queens Village Medical Care

    Queens Village, New York 11428
    United States

    Active - Recruiting

  • Gastroenterology Group of Rochester under CTNx

    Rochester, New York 14618
    United States

    Active - Recruiting

  • Charlotte Gastroenterology and Hepatology, P.L.L.C

    Charlotte, North Carolina 28207
    United States

    Active - Recruiting

  • Omega Research North Carolina, LLC

    Fuquay-Varina, North Carolina 27526
    United States

    Active - Recruiting

  • Dayton Gastroenterology, Inc.

    Beavercreek, Ohio 45440
    United States

    Active - Recruiting

  • University of Cincinnati Hospital

    Cincinnati, Ohio 45267
    United States

    Active - Recruiting

  • Ohio State University

    Hilliard, Ohio 43026
    United States

    Active - Recruiting

  • Frontier Clinical Re search, LLC

    Uniontown, Pennsylvania 15401
    United States

    Active - Recruiting

  • Gastroenterology Associates, PA PA of Greenville

    Greenville, South Carolina 29607
    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

  • Emeritas Research Group

    Lansdowne Town Center, Virginia 20176
    United States

    Active - Recruiting

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