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

Last updated: April 8, 2025
Sponsor: Hoffmann-La Roche
Overall Status: Active - Recruiting

Phase

3

Condition

Crohn's Disease

Inflammatory Bowel Disease

Treatment

Placebo

RO7790121

Clinical Study ID

NCT06589986
GA45329
2024-513014-35-00
  • Ages 16-80
  • All Genders

Study Summary

This Phase III, multicenter, double-blind, placebo-controlled, treat-through study will evaluate the efficacy and safety of 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: 400
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
September 17, 2024
Estimated Completion Date:
December 30, 2029

Connect with a study center

  • CIPREC Centro de Investigacion y Prevencion Cardiovascular

    Ciudad Autonoma Buenos Aires, C1061AAS
    Argentina

    Active - Recruiting

  • Expertia S.A- Mautalen Salud e Investigación

    Ciudad Autonoma Buenos Aires, C1128AAE
    Argentina

    Active - Recruiting

  • Royal Prince Alfred Hospital

    Sydney, New South Wales 2050
    Australia

    Active - Recruiting

  • Mater Misericordiae Limited

    South Brisbane, Queensland 4101
    Australia

    Active - Recruiting

  • Princess Alexandra Hospital

    Woolloongabba, Queensland 4102
    Australia

    Active - Recruiting

  • Lyell McEwin Hospital

    Adelaide, South Australia 5112
    Australia

    Active - Recruiting

  • Northern Hospital

    Epping, Victoria 3076
    Australia

    Active - Recruiting

  • Fiona Stanley Hospital

    Murdoch, Western Australia 6150
    Australia

    Active - Recruiting

  • Medizinische Universität Wien

    Wien, 1090
    Austria

    Active - Recruiting

  • Cliniques Universitaires St-Luc

    Bruxelles, 1200
    Belgium

    Active - Recruiting

  • AZ Maria Middelares

    Gent, 9000
    Belgium

    Active - Recruiting

  • CHC MontLégia

    Liege, 4000
    Belgium

    Active - Recruiting

  • CHU Sart-Tilman

    Liège, 4000
    Belgium

    Active - Recruiting

  • AZ Delta (Campus Rumbeke)

    Roeselare, 8800
    Belgium

    Active - Recruiting

  • Vitaz

    Sint Niklaas, 9100
    Belgium

    Active - Recruiting

  • MHAT St. Ivan Rilski

    Gorna Oryahovitsa, 5100
    Bulgaria

    Active - Recruiting

  • MHAT Kaspela

    Plovdiv, 4002
    Bulgaria

    Active - Recruiting

  • South Edmonton Gastroenterology

    Edmonton, Alberta T6K 4B2
    Canada

    Active - Recruiting

  • TDDA Specialty Research

    Woodbridge, Ontario L4L 4Y7
    Canada

    Active - Recruiting

  • Hospital Guillermo Grant Benavente

    Concepcion, 4030000
    Chile

    Active - Recruiting

  • Clinica Universidad de Los Andes

    Santiago,
    Chile

    Active - Recruiting

  • Medwal

    Santiago,
    Chile

    Active - Recruiting

  • Binzhou Medical university hospital

    Binzhou, DUMMY_VALUE
    China

    Active - Recruiting

  • the First Hospital of Jilin University

    Changchun, 130021
    China

    Active - Recruiting

  • Sichuan Provincial People's Hospital

    Chengdu, 610072
    China

    Active - Recruiting

  • The First Affiliated Hospital Of Fujian Medical University

    Fuzhou City, 350005
    China

    Active - Recruiting

  • The First Affiliated Hospital of Sun Yat-sen University

    Guangzhou City, 510080
    China

    Active - Recruiting

  • The sixth affiliated hospital of Sun Yat-Sen University

    Guangzhou City, 510655
    China

    Active - Recruiting

  • Anhui Provincial Hospital

    Hefei, 230001
    China

    Active - Recruiting

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, 230022
    China

    Active - Recruiting

  • Huizhou First Hospital

    Huizhou,
    China

    Active - Recruiting

  • Jinhua municipal central hospital

    Jinhua,
    China

    Active - Recruiting

  • The 1st Affiliated Hospital of Nanchang Unversity

    Nanchang City, 330006
    China

    Active - Recruiting

  • Nanjing 1st Hospital

    Nanjing, 210006
    China

    Active - Recruiting

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

    Shanghai, 200127
    China

    Active - Recruiting

  • Peking University Shenzhen Hospital

    Shenzhen, 518036
    China

    Active - Recruiting

  • Hebei Medical University - The Second Hospital

    Shijiazhuang City, 050004
    China

    Active - Recruiting

  • The First Hospital of Shanxi Medical University

    Taiyuan, 030001
    China

    Active - Recruiting

  • Tianjin Medical University General Hospital

    Tianjin, 300052
    China

    Active - Recruiting

  • Ren Min Hospital Affiliated Wu Han University

    Wuhan, 430060
    China

    Active - Recruiting

  • Wuhan Union Hospital Tongji Medical College, Huazhong University of Science and Technology

    Wuhan City, 430022
    China

    Active - Recruiting

  • Wuxi People's Hospital

    Wuxi, 214023
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Xi'an Jiao Tong University

    Xi'an City, 710004
    China

    Active - Recruiting

  • Zhuzhou Central Hospital

    Zhuzhou,
    China

    Active - Recruiting

  • SurGal Clinic s.r.o.

    Brno, 602 00
    Czechia

    Active - Recruiting

  • Gastroenterologie s.r.o.

    Hradec Kralove, 500 02
    Czechia

    Active - Recruiting

  • Herlev Hospital

    Herlev, 2730
    Denmark

    Active - Recruiting

  • Sjaellands Universitetshospital, Køge

    Køge, 4600
    Denmark

    Active - Recruiting

  • Sjællands Universitetshospital, Køge

    Køge, 4600
    Denmark

    Active - Recruiting

  • CHU Amiens - Hopital Sud

    Amiens, 80054
    France

    Active - Recruiting

  • CHU Dijon Bourgogne Hôpital François Mitterand

    Dijon, 21000
    France

    Active - Recruiting

  • CH Dptal Les Oudairies

    La Roche Sur Yon, 85925
    France

    Active - Recruiting

  • CHRU de Lille - Hopital Claude Huriez

    Lille, 59037
    France

    Active - Recruiting

  • Hopital Nord

    Marseille, 13015
    France

    Active - Recruiting

  • Institut des MICI, Clinique Ambroise Paré

    Neuilly sur Seine, 92200
    France

    Active - Recruiting

  • CHU Nice - Hopital de l'Archet 2

    Nice, 06202
    France

    Active - Recruiting

  • CHU Bordeaux - Hôpital Haut-Lévêque

    Pessac, 33604
    France

    Active - Recruiting

  • Centre Hospitalier Lyon Sud

    Pierre-Benite, 69495
    France

    Active - Recruiting

  • Hopital Robert Debre

    Reims, 51092
    France

    Active - Recruiting

  • CHU de Rennes - Hopital de Pontchaillo

    Rennes, 35033
    France

    Active - Recruiting

  • CHU Saint Etienne - Hôpital Nord

    Saint Etienne, 42055
    France

    Active - Recruiting

  • Hôpital de Rangueil

    Toulouse, 31400
    France

    Active - Recruiting

  • Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin

    Berlin, 12200
    Germany

    Active - Recruiting

  • Klinik Johann Wolfgang von Goethe Uni

    Frankfurt, 60590
    Germany

    Active - Recruiting

  • Universitaetsklinikum Halle (Saale)

    Halle, 06120
    Germany

    Active - Recruiting

  • Universitaetsklinikum Jena

    Jena, 77430
    Germany

    Active - Recruiting

  • Klinikum Mannheim GmbH Universitätsklinikum

    Mannheim, 68167
    Germany

    Active - Recruiting

  • Universitätsklinikum Ulm

    Ulm, 89081
    Germany

    Active - Recruiting

  • Clinexpert Kft.

    Budapest, 1033
    Hungary

    Active - Recruiting

  • Obudai Egeszsegugyi Centrum Kft.

    Budapest, 1036
    Hungary

    Active - Recruiting

  • Pannonia Maganorvosi Centrum

    Budapest, 1136
    Hungary

    Active - Recruiting

  • Semmelweis Egyetem

    Budapest, 1088
    Hungary

    Active - Recruiting

  • Bekes Varmegyei Kozponti Korhaz, dr Rethy Pal Tagkorhaz

    Békéscsaba, 5600
    Hungary

    Active - Recruiting

  • Heves County Markhot Ferenc Teaching Hospital

    Eger, 3300
    Hungary

    Active - Recruiting

  • Gyöngyösi Bugát Pál Kórház

    Gyöngyös, 3200
    Hungary

    Active - Recruiting

  • Clinfan Szolgaltato Kft.

    Szekszard, 7100
    Hungary

    Active - Recruiting

  • Jávorszky Ödön Kórház

    Vác, 2600
    Hungary

    Active - Recruiting

  • Ospedale Madonna delle Grazie

    Matera, Basilicata 75100
    Italy

    Active - Recruiting

  • Universita'degli Studi di Napoli Federico II

    Napoli, Campania 80131
    Italy

    Active - Recruiting

  • Policlinico Universitario Agostino Gemelli

    Roma, Lazio 00168
    Italy

    Active - Recruiting

  • ASST Rhodense - Ospedale di Rho

    Rho, Lombardia 20017
    Italy

    Active - Recruiting

  • IRCCS Ospedale Casa Sollievo della Soffenza

    San Giovanni Rotondo, Lombardia 71013
    Italy

    Active - Recruiting

  • Azienda Ospedaliera di Padova

    Padova, Veneto 35128
    Italy

    Active - Recruiting

  • Tsujinaka Hospital Kashiwanoha

    Chiba, 277-0871
    Japan

    Active - Recruiting

  • Japanese Red Cross Takayama Hospital

    Gifu, 506-8550
    Japan

    Active - Recruiting

  • Universitair Medisch Centrum Utrecht

    Utrecht, 3584 CX
    Netherlands

    Active - Recruiting

  • Clinical Trials UMED Sp. z o. o.

    ?ód?, 92-213
    Poland

    Active - Recruiting

  • Centrum Medyczne "Medis"

    Bydgoszcz, 85-229
    Poland

    Active - Recruiting

  • Centrum Medyczne Lukamed Joanna Luka-Wendrowska

    Chojnice, 89-600
    Poland

    Active - Recruiting

  • Endo-Med Sp. z o.o.

    Karczew, 05-480
    Poland

    Active - Recruiting

  • Allmedica Badania Kliniczne Sp z o.o. Sp K.

    Nowy Targ, 34-400
    Poland

    Active - Recruiting

  • Wojewodzki Specjalistyczny Szpital w Olsztynie

    Olsztyn, 10-561
    Poland

    Active - Recruiting

  • NZOZ Eskulap Pabianice

    Pabianice, 92-500
    Poland

    Active - Recruiting

  • Trialmed CRS

    Piotrków Trybunalski, 97-300
    Poland

    Active - Recruiting

  • SOLUMED Centrum Medyczne

    Pozna?, 60-529
    Poland

    Active - Recruiting

  • Centrum Medyczne "MEDYK"

    Rzeszów, 35-326
    Poland

    Active - Recruiting

  • Kiepury Clinic

    Sosnowiec, 41-200
    Poland

    Active - Recruiting

  • Gastromed Kopon Zmudzinski i Wspolnicy Sp.j.Specjalistyczne Centrum Gastrologii i Endoskopii Specj

    Toru?, 87-100
    Poland

    Active - Recruiting

  • WIP Warsaw IBD Point Profesor Kierkus

    Warsaw, 04-501
    Poland

    Active - Recruiting

  • Centralny Szpital Kliniczny MSW w Warszawie

    Warszawa, 02-507
    Poland

    Active - Recruiting

  • Melita Medical

    Wroc?aw, 50-449
    Poland

    Active - Recruiting

  • Przychodnia EuroMediCare

    Wroc?aw, 50-220
    Poland

    Active - Recruiting

  • Vistamed & Vertigo Spó?Ka Z Ograniczon? Odpowiedzialno?Ci?

    Wroc?aw, 53-149
    Poland

    Active - Recruiting

  • ETG Zamosc

    Zamo??, 22-400
    Poland

    Active - Recruiting

  • ETG Zamosc

    Zamosc, 22-400
    Poland

    Site Not Available

  • 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

  • Colentina Clinical Hospital

    Bucharest, 020125
    Romania

    Active - Recruiting

  • University Hospital Center Dr Dragisa Misovic - Dedinje

    Belgrade, 11040
    Serbia

    Active - Recruiting

  • University Hospital Medical Center Zvezdara

    Belgrade, 11120
    Serbia

    Active - Recruiting

  • University Hospital Medical Center Bezanijska Kosa

    Beograd, 11080
    Serbia

    Active - Recruiting

  • Clinical Center of Vojvodina

    Novi Sad, 21137
    Serbia

    Active - Recruiting

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria 39008
    Spain

    Active - Recruiting

  • Hospital Universitario La Paz

    Madrid, 28046
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen del Rocio

    Sevilla, 41013
    Spain

    Active - Recruiting

  • Division of Gastroenterology, Depart of Internal Med, Siriraj H, Mahidol Uni

    Bangkok, 10700
    Thailand

    Active - Recruiting

  • Division of Gastroenterology, Depart of Medicine, Fac of Med., Chulalongkorn University

    Bangkok, 10330
    Thailand

    Active - Recruiting

  • Liver Research Unit, Srinagarind Hospital

    Khon Kaen, 40002
    Thailand

    Active - Recruiting

  • Thammasat University Hospital

    Pathumthani, 12120
    Thailand

    Active - Recruiting

  • Division of Gastroenterology, Depart of Medicine, Fac. of Med, Songklanagarind University

    Songkhla, 90110
    Thailand

    Active - Recruiting

  • Surin hospital

    Surin, 32000
    Thailand

    Active - Recruiting

  • Royal Liverpool University Hospital

    Liverpool, L7 8XP
    United Kingdom

    Active - Recruiting

  • Digestive Health Specialists

    Dothan, Alabama 36301
    United States

    Active - Recruiting

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

    Dothan, Alabama 36305
    United States

    Active - Recruiting

  • Arizona Digestive Health, P.C (ADH)

    Sun City, Arizona 85351
    United States

    Active - Recruiting

  • University of California Irvine

    Irvine, California 92697
    United States

    Site Not Available

  • University of California Irvine

    Orange, California 92868
    United States

    Active - Recruiting

  • UCSF/Medical Center at Mount Zion

    San Francisco, California 94115
    United States

    Active - Recruiting

  • Amicis Research Center

    Santa Clarita, California 91355
    United States

    Active - Recruiting

  • Peak Gastroenterology Associates

    Colorado Springs, Colorado 80907
    United States

    Active - Recruiting

  • Peak Gastroenterology Surgery Center

    Lone Tree, Colorado 80124
    United States

    Active - Recruiting

  • Access Research Institute

    Brooksville, Florida 34613
    United States

    Active - Recruiting

  • Gastro Florida

    Clearwater, Florida 33756
    United States

    Active - Recruiting

  • J&A Clinical Research

    Doral, Florida 33126
    United States

    Active - Recruiting

  • Homestead Associates in Research, Inc.

    Homestead, Florida 33033
    United States

    Site Not Available

  • Clinical Research of Osceola, LLC

    Kissimmee, Florida 34741
    United States

    Active - Recruiting

  • Auzmer Research

    Lakeland, Florida 33813
    United States

    Active - Recruiting

  • Allied Biomedical Research Institute, Inc

    Miami, Florida 33155
    United States

    Active - Recruiting

  • Homestead Associates in Research, Inc.

    Miami, Florida 33033
    United States

    Active - Recruiting

  • Miami Beach Clinical Research Center

    Miami Beach, Florida 33141
    United States

    Active - Recruiting

  • Eminat Research Group

    Miramar, Florida 33027
    United States

    Active - Recruiting

  • Nodal Medical Center, LLC

    Tampa, Florida 33607
    United States

    Active - Recruiting

  • Theia Clinical Research Centers, LLC

    Tampa, Florida 33613
    United States

    Active - Recruiting

  • Florida Medical Clinic

    Zephyrhills, Florida 33542
    United States

    Active - Recruiting

  • Gastroenterology Associates of Central Georgia

    Macon, Georgia 31201
    United States

    Active - Recruiting

  • Grand Teton Research Group, PLLC

    Idaho Falls, Idaho 83404
    United States

    Active - Recruiting

  • The University of Chicago

    Chicago, Illinois 60637
    United States

    Active - Recruiting

  • Indiana University Health University Hospital

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

  • Gastroenterology Health Partners, PLLC

    New Albany, Indiana 47150
    United States

    Active - Recruiting

  • Tri-State Gastroenterology Associates

    Crestview Hills, Kentucky 41017-3409
    United States

    Active - Recruiting

  • Gastroenterology Health Partners, PLLC

    Louisville, Kentucky 40218
    United States

    Active - Recruiting

  • Louisiana Research Center - GastroIntestinal Associates

    Shreveport, Louisiana 71105
    United States

    Active - Recruiting

  • Boston University

    Boston, Massachusetts 02118
    United States

    Active - Recruiting

  • Brigham & Womens Hosp

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • Michigan Center of Medical Research

    Farmington Hills, Michigan 48334
    United States

    Active - Recruiting

  • Allied Gastrointestinal Associates, PA

    Flowood, Mississippi 39232
    United States

    Active - Recruiting

  • Gastroenterology Associates and Endoscopy Center of North Mississippi

    Oxford, Mississippi 38655
    United States

    Active - Recruiting

  • BVL Clinical Research

    Liberty, Missouri 64068
    United States

    Active - Recruiting

  • Intercity Gastroenterology

    Fresh Meadows, New York 11366
    United States

    Active - Recruiting

  • New York-Presbyterian Hospital-Columbia University Medical Center

    New York, New York 10032
    United States

    Active - Recruiting

  • Pioneer Clinical Research NY

    New York, New York 10016
    United States

    Active - Recruiting

  • Digestive Health Partners, PA

    Asheville, North Carolina 28801
    United States

    Active - Recruiting

  • Peters Medical Research (PMR), LLC

    High Point, North Carolina 27260
    United States

    Active - Recruiting

  • Monroe Biomedical Research

    Monroe, North Carolina 28112
    United States

    Active - Recruiting

  • Digestive Disease Consultants

    Brunswick, Ohio 44212
    United States

    Active - Recruiting

  • Ohio Gastroenterology Group

    Columbus, Ohio 43202
    United States

    Active - Recruiting

  • Great Lakes Gastroenterology Research, LLC

    Mentor, Ohio 44060
    United States

    Active - Recruiting

  • Gastro Intestinal Research Institute of Northern Ohio

    Westlake, Ohio 44145
    United States

    Active - Recruiting

  • Central Sooner Research

    Norman, Oklahoma 73071
    United States

    Active - Recruiting

  • University Gastroenterology

    Providence, Rhode Island 02904
    United States

    Active - Recruiting

  • Gastro One

    Cordova, Tennessee 38018
    United States

    Active - Recruiting

  • Gastro One

    Germantown, Tennessee 38138
    United States

    Site Not Available

  • Gastrointestinal Associates of Northeast Tennessee

    Johnson City, Tennessee 37604
    United States

    Active - Recruiting

  • Quality Medical Research

    Nashville, Tennessee 37211
    United States

    Active - Recruiting

  • Texas Clinical Research Institute, LLC

    Arlington, Texas 76012
    United States

    Active - Recruiting

  • Texas Digestive Disease Consultants - Cedar Park

    Cedar Park, Texas 78613
    United States

    Active - Recruiting

  • Proactive El Paso,LLC

    El Paso, Texas 79902
    United States

    Active - Recruiting

  • GI Alliance

    Garland, Texas 75044
    United States

    Active - Recruiting

  • GI Alliance - Mansfield

    Mansfield, Texas 76063
    United States

    Active - Recruiting

  • TDDC dba GI Alliance Research

    Mansfield, Texas 76063
    United States

    Active - Recruiting

  • Digestive System Healthcare - Biopharma Informatic, LLC

    Pasadena, Texas 77505-3950
    United States

    Active - Recruiting

  • Carta - Clinical Associates In Research Therapeutics Of America;LLC

    San Antonio, Texas 78212
    United States

    Active - Recruiting

  • Southern Star Research Institute, LLC.

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • GI Alliance - Southlake

    Southlake, Texas 76092
    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

  • Tidewater Gastroenterology Pllc T/A Gastro. Assoc. of Tidewater

    Chesapeake, Virginia 23320
    United States

    Active - Recruiting

  • Gastroenterology Consultants and Endoscopy Center of Southwest Virginia

    Roanoke, Virginia 24014
    United States

    Active - Recruiting

  • Marshall Health

    Huntington, West Virginia 25701
    United States

    Active - Recruiting

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