A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of RO7837195 in Participants With Moderately to Severely Active Ulcerative Colitis (UC)

Last updated: June 25, 2026
Sponsor: Genentech, Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Ulcers

Ulcerative Colitis

Crohn's Disease

Treatment

RO7837195 Matched Placebo

RO7837195

Clinical Study ID

NCT06979336
GA45977
2025-520690-39-00
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to evaluate the efficacy of RO7837195 compared with placebo in participants with moderately to severely active ulcerative colitis for whom prior treatment with conventional and/or advanced therapies has failed.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of ulcerative colitis (UC) established at least 3 months

  • Moderately to severely active UC assessed by mMS

  • Inadequate response, loss of response, or intolerance to conventional or advancedtherapies for UC

Exclusion

Exclusion Criteria:

  • Prior extensive colonic resection, subtotal or total colectomy, or planned surgeryfor UC

  • Diagnosis of Crohn's disease or indeterminate colitis

  • Treatment with an advanced therapy targeted at tumor necrosis factor-like cytokine 1A (TL1a)

  • Inadequate response, loss of response, or intolerance to treatment of UC with anadvanced therapy targeted at IL-12 and/or IL-23

Study Design

Total Participants: 224
Treatment Group(s): 2
Primary Treatment: RO7837195 Matched Placebo
Phase: 2
Study Start date:
September 29, 2025
Estimated Completion Date:
October 31, 2028

Study Description

This study consists of up to 5-week screening period, a 12-week induction phase, a 40-week active treatment extension, and a safety follow-up period following the last dose of study treatment. The induction phase will be placebo-controlled and after its completion, all participants will receive treatment with active study drug, regardless of the treatment response.

Connect with a study center

  • Mater Misericordiae Limited

    South Brisbane, Queensland 4101
    Australia

    Active - Recruiting

  • Mater Misericordiae Ltd

    South Brisbane, Queensland 4101
    Australia

    Active - Recruiting

  • HUWC - UFC - Hospital Universitrio Walter Cantdio - Universidade Federal do Cear

    Fortaleza, Ceará 60430-370
    Brazil

    Active - Recruiting

  • Chronos Pesquisa Clinica

    Brasília, Federal District 72145-450
    Brazil

    Active - Recruiting

  • L2IP ?Instituto de Pesquisas Clínicas Ltda.

    Brasília, Federal District 70200-730
    Brazil

    Active - Recruiting

  • Hospital Felicio Rocho

    Belo Horizonte, Minas Gerais 30110-934
    Brazil

    Active - Recruiting

  • Associao Paranaense de Cultura APC

    Curitiba, Paraná 80230-130
    Brazil

    Active - Recruiting

  • Centro Digestivo de Curitiba

    Curitiba, Paraná 80430-160
    Brazil

    Active - Recruiting

  • Hospital Ernesto Dornelles

    Porto Alegre, Rio Grande do Sul 90160-093
    Brazil

    Active - Recruiting

  • Hospital de Clnicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul 90035-903
    Brazil

    Active - Recruiting

  • Newdata Clinical Trials

    Aracaju, Sergipe 49075-000
    Brazil

    Active - Recruiting

  • CECIP - Centro de Estudos Clínicos do Interior Paulista

    Ja, São Paulo 17201-130
    Brazil

    Active - Recruiting

  • Pesquisare Saude

    Santo André, São Paulo 09080-110
    Brazil

    Active - Recruiting

  • CPQuali Pesquisa Clinica Ltda

    So Paulo, São Paulo 01228-000
    Brazil

    Active - Recruiting

  • Kaiser Clinica

    São José do Rio Preto, São Paulo 15015-110
    Brazil

    Active - Recruiting

  • BR Trials - Ensaios Clnicos e Consultoria

    São Paulo, São Paulo 05003-090
    Brazil

    Active - Recruiting

  • Hospital Gloria DOr - Hospitais Integrados da Gavea S/A

    Rio de Janeiro, 22211-230
    Brazil

    Active - Recruiting

  • London Digestive Disease Institute

    London, Ontario N6K 1M6
    Canada

    Active - Recruiting

  • Clinique IMD

    Montreal, Quebec H3H 1E8
    Canada

    Active - Recruiting

  • Hopital Maisonneuve-Rosemont d/b/a CIUSSS de l'Est-de-l'le-de-Montral

    Montreal, Quebec H1T 2M4
    Canada

    Active - Recruiting

  • The First Affiliated Hospital Of Fujian Medical University

    Fuzhou, Fujian 350005
    China

    Active - Recruiting

  • Zhongshan Hospital Xiamen University

    Xiamen, Fujian 361004
    China

    Active - Recruiting

  • The second Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong 510260
    China

    Active - Recruiting

  • The sixth affiliated hospital of Sun Yat-Sen University

    Guangzhou, Guangdong 510655
    China

    Active - Recruiting

  • Huizhou Municipal Central Hospital

    Huizhou, Guangdong 516001
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan 450014
    China

    Active - Recruiting

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei 430060
    China

    Active - Recruiting

  • Binzhou Medical university hospital

    Binzhou, Shandong 256603
    China

    Active - Recruiting

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan 610072
    China

    Active - Recruiting

  • The First Affiliated Hospital of Ningbo University

    Ningbo, Zhejiang 315010
    China

    Active - Recruiting

  • Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

    Hangzhou, 310018
    China

    Active - Recruiting

  • PreventaMed, s.r.o.

    Olomouc, 779 00
    Czechia

    Active - Recruiting

  • Nemocnice Slany

    Slaný, 27401
    Czechia

    Active - Recruiting

  • Groupe Hospitalier Ambroise Pare - Institut des MICI

    Neuilly, Hauts De Seine 92200
    France

    Active - Recruiting

  • CHU Saint Etienne - Hpital Nord

    Saint-Étienne-de-Montluc, Pays de la Loire Region 42055
    France

    Active - Recruiting

  • CHU Clermont Ferrand - Hôpital d'Estaing

    Clermont-Ferrand, Puy De Dome 63000
    France

    Active - Recruiting

  • Centre hospitalier Lyon Sud

    Pierre-Bénite, Rhone 69495
    France

    Active - Recruiting

  • Universitaetsklinikum Frankfurt Goethe-Universitaet

    Frankfurt am Main, Hesse 60590
    Germany

    Active - Recruiting

  • Shree Giriraj Multispeciality Hospital

    Rajkot, Gujarat 360005
    India

    Active - Recruiting

  • Kingsway Hospital

    Nagpur, Maharashtra 440010
    India

    Active - Recruiting

  • S. R. Kalla Memorial Gastro & General Hospital

    Jaipur, Rajasthan 302001J
    India

    Active - Recruiting

  • Institute of Post Graduate Medical Education And Research

    Kolkata, West Bengal 700020
    India

    Active - Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Rome, Emilia-Romagna 00168
    Italy

    Active - Recruiting

  • Fondazione Poliambulanza Istituto Ospedaliero

    Brescia, Lombardy 25124
    Italy

    Active - Recruiting

  • Ospedale San Raffaele

    Milan, Lombardy 20132
    Italy

    Active - Recruiting

  • ASST Rhodense, Rho Memorial Hospital

    Rho, Lombardy 20017
    Italy

    Active - Recruiting

  • Istituto Clinico Humanitas

    Rozzano, Lombardy 20089
    Italy

    Active - Recruiting

  • I.R.C.C.S Policlinico San Donato

    San Donato Milanese (MI), Lombardy 20097
    Italy

    Active - Recruiting

  • Ospedale Mauriziano Umberto I

    Turin, Piedmont 10128
    Italy

    Active - Recruiting

  • Ospedale Sacro Cuore Don Calabria

    Negrar, Veneto 37024
    Italy

    Active - Recruiting

  • Kokikai Tsujinaka Hospital Kashiwanoha

    Kashiwa-shi, Chiba 277-0871
    Japan

    Active - Recruiting

  • Fukuoka University Hospital

    Fukuoka, Fukuoka 814-0180
    Japan

    Active - Recruiting

  • NHO Fukuyama Medical Center

    Fukuyama-shi, Hiroshima 720-8520
    Japan

    Active - Recruiting

  • NHO Kanazawa Medical Center

    Kanazawa, Ishikawa-ken 920-8650
    Japan

    Active - Recruiting

  • Takamatsu Red Cross Hospital

    Takamatsu, Kagawa-ken 760-0017
    Japan

    Active - Recruiting

  • NHO Osaka National Hospital

    Osaka, Osaka 540-0006
    Japan

    Active - Recruiting

  • Saga University Hospital

    Saga, Saga-ken 849-8501
    Japan

    Active - Recruiting

  • Shinseikai Sai Gastroenterology, Proctology

    Fujidera-shi, 583-0027
    Japan

    Active - Recruiting

  • Kojunkai Daido Clinic

    Nagoya, 457-8511
    Japan

    Active - Recruiting

  • Centro Medico Clinico Quirurgico Especializado en Investigacion

    Tlajomulco de Zúñiga, Jalisco 45645
    Mexico

    Active - Recruiting

  • Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan

    Mérida, Yucatán 97130
    Mexico

    Active - Recruiting

  • FAICIC S de R.L. de C.V

    Veracruz, 91900
    Mexico

    Active - Recruiting

  • Centrum Medyczne "Medis"

    Bydgoszcz, 85-229
    Poland

    Active - Recruiting

  • Clinsante S.C. Osrodek Badan Klinicznych

    Bydgoszcz, 85-794
    Poland

    Active - Recruiting

  • Centrum Medyczne Lukamed Joanna Luka

    Chojnice, 89-600
    Poland

    Active - Recruiting

  • Vita Longa Sp. z o.o.

    Katowice, 40-748
    Poland

    Active - Recruiting

  • MZ Badania Slowik Zymla Sp.j.

    Knurów, 44-190
    Poland

    Active - Recruiting

  • Allmedica Badania Kliniczne sp. z o.o. sp.k.

    Nowy Targ, 34-400
    Poland

    Active - Recruiting

  • Clinical Research Center Spka z ograniczon odpowiedzialnoci Medic-R Sp.k.

    Poznan, 61-731
    Poland

    Active - Recruiting

  • NSZOZ Termedica Centrum Badan Klinicznych

    Poznan, 60-681
    Poland

    Active - Recruiting

  • SOLUMED Centrum Medyczne

    Poznan, 60-529
    Poland

    Active - Recruiting

  • Clinical Research Center Spka z ograniczon odpowiedzialnoci Medic-R Sp.k.

    Poznan 3088171, 61731
    Poland

    Active - Recruiting

  • NSZOZ Termedica Centrum Badan Klinicznych

    Poznan 3088171, 60-681
    Poland

    Active - Recruiting

  • Velocity Skierniewice Sp. z o.o

    Skierniewice, 96-100
    Poland

    Active - Recruiting

  • Twoja Przychodnia-Szczecinskie Centrum Medyczne

    Szczecin, 71-434
    Poland

    Active - Recruiting

  • Centrum Zdrowia MDM

    Warsaw, 00-189
    Poland

    Active - Recruiting

  • Medical Network Spka z o. o., WIP Warsaw IBD Point Profesor Kierkus

    Warsaw, 04-501
    Poland

    Active - Recruiting

  • Medon Clinical Research sp. z o.o

    Warsaw, 02-679
    Poland

    Active - Recruiting

  • Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych Administracji

    Warsaw, 02-507
    Poland

    Active - Recruiting

  • Provita Poliklinika sp. z o.o

    Warsaw, 02-647
    Poland

    Active - Recruiting

  • WIP Warsaw IBD Point Profesor Kierkus

    Warsaw, 04-501
    Poland

    Active - Recruiting

  • Centrum Zdrowia MDM

    Warsaw 756135, 00-189
    Poland

    Active - Recruiting

  • Medon Clinical Research sp. z o.o

    Warsaw 756135, 02-679
    Poland

    Active - Recruiting

  • Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych Administracji

    Warsaw 756135, 02-507
    Poland

    Active - Recruiting

  • Przychodnia VISTAMED

    Wroc?aw, 53-149
    Poland

    Active - Recruiting

  • ETG Zamosc

    Zamość, 22-400
    Poland

    Active - Recruiting

  • Yonsei University Wonju Severance Christian Hospital

    Wŏnju, Gangwon-do 26426
    South Korea

    Active - Recruiting

  • Inje university Haeundae Paik Hospital

    Busan, 48108
    South Korea

    Active - Recruiting

  • The Catholic University of Korea Daejeon ST. Mary?s Hospital

    Daejeon, 34943
    South Korea

    Active - Recruiting

  • Chosun University Hospital

    Gwangju, 61453
    South Korea

    Active - Recruiting

  • Asan Medical Center.

    Seoul, 05505
    South Korea

    Active - Recruiting

  • Chung-Ang University Hospital

    Seoul, 06973
    South Korea

    Active - Recruiting

  • Kangbuk Samsung Hospital

    Seoul, 03181
    South Korea

    Active - Recruiting

  • Samsung Medical Center

    Seoul, 06351
    South Korea

    Active - Recruiting

  • The Catholic University of Korea Eunpyeong St. Mary's Hospital

    Seoul, 03312
    South Korea

    Active - Recruiting

  • Guy's Hospital

    London, Greater London SE1 9RT
    United Kingdom

    Active - Recruiting

  • King's College Hospital

    London, Greater London SE5 9RS
    United Kingdom

    Active - Recruiting

  • Royal Liverpool University Hospital

    Liverpool, Merseyside L7 8YE
    United Kingdom

    Active - Recruiting

  • John Radcliffe Hospital

    Oxford, Oxfordshire OX3 9DU
    United Kingdom

    Active - Recruiting

  • Addenbrook'es Hospital

    Cambridge, CB2 0QQ
    United Kingdom

    Active - Recruiting

  • Gastro Care Institute

    Lancaster, California 93534
    United States

    Active - Recruiting

  • Medical Associates Research Group, Inc.

    San Diego, California 92123
    United States

    Active - Recruiting

  • Peak Gastroenterology Associates

    Colorado Springs, Colorado 80907
    United States

    Active - Recruiting

  • Clinical Research of Osceola, LLC

    Kissimmee, Florida 34741
    United States

    Active - Recruiting

  • University of Chicago Medical Center

    Chicago, Illinois 60637
    United States

    Active - Recruiting

  • Intercity Gastroenterology

    Fresh Meadows, New York 11366
    United States

    Active - Recruiting

  • Monroe Biomedical Research

    Monroe, North Carolina 28112
    United States

    Active - Recruiting

  • University of Utah Hospitals & Clinics

    Salt Lake City, Utah 84132
    United States

    Active - Recruiting

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