RecruitingPhase 2NCT06979336

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

A Phase IIb, Multicenter, Double-blind, Placebo-controlled Induction Study With an Active Treatment Extension to Assess the Efficacy, Safety, and Pharmacokinetics of RO7837195 in Patients With Moderately to Severely Active Ulcerative Colitis

Sponsor

Genentech, Inc.

Enrollment

224 participants

Start Date

Sep 29, 2025

Study Type

INTERVENTIONAL

Conditions

Ulcerative Colitis

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called RO7837195 for people with moderate to severe ulcerative colitis (UC) — a type of inflammatory bowel disease — who have not responded to or cannot tolerate standard and advanced treatments. Ulcerative colitis causes inflammation and sores in the large intestine. **You may be eligible if...** - You have been diagnosed with ulcerative colitis for at least 3 months - Your UC is currently moderately to severely active - You have previously tried conventional therapies or other advanced treatments (like biologics) and they have not worked or stopped working **You may NOT be eligible if...** - You have had major bowel surgery or are planning surgery for UC - You have Crohn's disease or indeterminate colitis - You have previously been treated with a drug targeting the TL1a protein - You have failed treatment with an IL-12/23 inhibitor (like ustekinumab or risankizumab) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRO7837195

RO7837195 will be administered as per the schedule specified in the protocol.

DRUGRO7837195 Matched Placebo

RO7837195 matched placebo will be administered as per the schedule specified in the protocol.

Locations(82)

Gastro Care Institute

Lancaster, California, United States

Medical Associates Research Group, Inc.

San Diego, California, United States

Peak Gastroenterology Associates

Colorado Springs, Colorado, United States

Clinical Research of Osceola, LLC

Kissimmee, Florida, United States

University of Chicago Medical Center

Chicago, Illinois, United States

Intercity Gastroenterology

Fresh Meadows, New York, United States

Monroe Biomedical Research

Monroe, North Carolina, United States

Mater Misericordiae Ltd

South Brisbane, Queensland, Australia

Chronos Pesquisa Clinica

Brasília, Federal District, Brazil

Hospital Felicio Rocho

Belo Horizonte, Minas Gerais, Brazil

Associao Paranaense de Cultura APC

Curitiba, Paraná, Brazil

Centro Digestivo de Curitiba

Curitiba, Paraná, Brazil

Hospital de Clnicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Hospital Ernesto Dornelles

Porto Alegre, Rio Grande do Sul, Brazil

Newdata Clinical Trials

Aracaju, Sergipe, Brazil

Pesquisare Saude

Santo André, São Paulo, Brazil

CPQuali Pesquisa Clinica Ltda

So Paulo, São Paulo, Brazil

London Digestive Disease Institute

London, Ontario, Canada

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

Montreal, Quebec, Canada

Clinique IMD

Montreal, Quebec, Canada

Zhongshan Hospital Xiamen University

Xiamen, Fujian, China

The Second Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Binzhou Medical university hospital

Binzhou, Shandong, China

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, China

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

Hangzhou, China

PreventaMed, s.r.o.

Olomouc, Czechia

Nemocnice Slany

Slaný, Czechia

Groupe Hospitalier Ambroise Pare - Institut des MICI

Neuilly, Hauts De Seine, France

CHU Saint Etienne - Hpital Nord

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

CHU Clermont Ferrand - Hôpital d'Estaing

Clermont-Ferrand, Puy De Dome, France

Centre hospitalier Lyon Sud

Pierre-Bénite, Rhone, France

Universitaetsklinikum Frankfurt Goethe-Universitaet

Frankfurt am Main, Hesse, Germany

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Emilia-Romagna, Italy

Fondazione Poliambulanza Istituto Ospedaliero

Brescia, Lombardy, Italy

ASST Rhodense, Rho Memorial Hospital

Rho, Lombardy, Italy

Istituto Clinico Humanitas

Rozzano, Lombardy, Italy

I.R.C.C.S Policlinico San Donato

San Donato Milanese (MI), Lombardy, Italy

Ospedale Mauriziano Umberto I

Turin, Piedmont, Italy

Kokikai Tsujinaka Hospital Kashiwanoha

Kashiwa-shi, Chiba, Japan

Fukuoka University Hospital

Fukuoka, Fukuoka, Japan

NHO Fukuyama Medical Center

Fukuyama-shi, Hiroshima, Japan

NHO Kanazawa Medical Center

Kanazawa, Ishikawa-ken, Japan

Takamatsu Red Cross Hospital

Takamatsu, Kagawa-ken, Japan

NHO Osaka National Hospital

Osaka, Osaka, Japan

Saga University Hospital

Saga, Saga-ken, Japan

Shinseikai Sai Gastroenterology, Proctology

Fujidera-shi, Japan

Kojunkai Daido Clinic

Nagoya, Japan

Centro Medico Clinico Quirurgico Especializado en Investigacion

Tlajomulco de Zúñiga, Jalisco, Mexico

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

Mérida, Yucatán, Mexico

Centrum Medyczne "Medis"

Bydgoszcz, Poland

Clinsante S.C. Osrodek Badan Klinicznych

Bydgoszcz, Poland

Centrum Medyczne Lukamed Joanna Luka

Chojnice, Poland

Vita Longa Sp. z o.o.

Katowice, Poland

MZ Badania Slowik Zymla Sp.j.

Knurów, Poland

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

Nowy Targ, Poland

SOLUMED Centrum Medyczne

Poznan, Poland

NSZOZ Termedica Centrum Badan Klinicznych

Poznan, Poland

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

Poznan, Poland

Velocity Skierniewice Sp. z o.o

Skierniewice, Poland

Twoja Przychodnia-Szczecinskie Centrum Medyczne

Szczecin, Poland

Centrum Zdrowia MDM

Warsaw, Poland

Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych Administracji

Warsaw, Poland

Provita Poliklinika sp. z o.o

Warsaw, Poland

Medon Clinical Research sp. z o.o

Warsaw, Poland

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

Warsaw, Poland

Przychodnia VISTAMED

Wroc?aw, Poland

ETG Zamosc

Zamość, Poland

Yonsei University Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, South Korea

Inje university Haeundae Paik Hospital

Busan, South Korea

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

Daejeon, South Korea

Chosun University Hospital

Gwangju, South Korea

Kangbuk Samsung Hospital

Seoul, South Korea

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

Seoul, South Korea

Asan Medical Center.

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Chung-Ang University Hospital

Seoul, South Korea

Guy's Hospital

London, Greater London, United Kingdom

King's College Hospital

London, Greater London, United Kingdom

Royal Liverpool University Hospital

Liverpool, Merseyside, United Kingdom

John Radcliffe Hospital

Oxford, Oxfordshire, United Kingdom

Addenbrook'es Hospital

Cambridge, United Kingdom

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NCT06979336

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