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NCT06979336PHASE2Recruiting

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

Genentech, Inc.

Start Date

9/29/2025

Completion Date

10/31/2028

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.

Detailed 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.

Eligibility Criteria

Age Range: 18 years to No maximum

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 advanced therapies for UC Exclusion Criteria: * Prior extensive colonic resection, subtotal or total colectomy, or planned surgery for 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 an advanced therapy targeted at IL-12 and/or IL-23

Interventions

DRUG

RO7837195

DRUG

RO7837195 Matched Placebo

Interested in This Trial?

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Conditions

Ulcerative Colitis

Locations

Gastro Care Institute

Lancaster, California 93534

United States

Medical Associates Research Group, Inc.

San Diego, California 92123

United States

Peak Gastroenterology Associates

Colorado Springs, Colorado 80907

United States

Clinical Research of Osceola, LLC

Kissimmee, Florida 34741

United States

University of Chicago Medical Center

Chicago, Illinois 60637

United States

Intercity Gastroenterology

Fresh Meadows, New York 11366

United States

Monroe Biomedical Research

Monroe, North Carolina 28112

United States

University of Utah Hospitals & Clinics

Salt Lake City, Utah 84132

United States

Mater Misericordiae Limited

South Brisbane, Queensland 4101

Australia

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

Fortaleza, Ceará 60430-370

Brazil

L2IP ?Instituto de Pesquisas Clínicas Ltda.

Brasília, Federal District 70200-730

Brazil

Chronos Pesquisa Clinica

Brasília, Federal District 72145-450

Brazil

Hospital Felicio Rocho

Belo Horizonte, Minas Gerais 30110-934

Brazil

Associao Paranaense de Cultura APC

Curitiba, Paraná 80230-130

Brazil

Centro Digestivo de Curitiba

Curitiba, Paraná 80430-160

Brazil

Hospital de Clnicas de Porto Alegre

Porto Alegre, Rio Grande do Sul 90035-903

Brazil

Hospital Ernesto Dornelles

Porto Alegre, Rio Grande do Sul 90160-093

Brazil

Newdata Clinical Trials

Aracaju, Sergipe 49075-000

Brazil

CECIP - Centro de Estudos Clínicos do Interior Paulista

Ja, São Paulo 17201-130

Brazil

Pesquisare Saude

Santo André, São Paulo 09080-110

Brazil

Kaiser Clinica

São José do Rio Preto, São Paulo 15015-110

Brazil

BR Trials - Ensaios Clnicos e Consultoria

São Paulo, São Paulo 05003-090

Brazil

CPQuali Pesquisa Clinica Ltda

So Paulo, São Paulo 01228-000

Brazil

Hospital Gloria DOr - Hospitais Integrados da Gavea S/A

Rio de Janeiro, 22211-230

Brazil

London Digestive Disease Institute

London, Ontario N6K 1M6

Canada

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

Montreal, Quebec H1T 2M4

Canada

Clinique IMD

Montreal, Quebec H3H 1E8

Canada

The First Affiliated Hospital Of Fujian Medical University

Fuzhou, Fujian 350005

China

Zhongshan Hospital Xiamen University

Xiamen, Fujian 361004

China

The second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong 510260

China

The sixth affiliated hospital of Sun Yat-Sen University

Guangzhou, Guangdong 510655

China

Huizhou Municipal Central Hospital

Huizhou, Guangdong 516001

China

The Second Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan 450014

China

Renmin Hospital of Wuhan University

Wuhan, Hubei 430060

China

The First Hospital of Jilin University

Changchun, Jilin 130021

China

Binzhou Medical university hospital

Binzhou, Shandong 256603

China

Sichuan Provincial People's Hospital

Chengdu, Sichuan 610072

China

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang 315010

China

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

Hangzhou, 310018

China

PreventaMed, s.r.o.

Olomouc, 779 00

Czechia

Nemocnice Slany

Slaný, 27401

Czechia

Groupe Hospitalier Ambroise Pare - Institut des MICI

Neuilly, Hauts De Seine 92200

France

CHU Saint Etienne - Hpital Nord

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

France

CHU Clermont Ferrand - Hôpital d'Estaing

Clermont-Ferrand, Puy De Dome 63000

France

Centre hospitalier Lyon Sud

Pierre-Bénite, Rhone 69495

France

Universitaetsklinikum Frankfurt Goethe-Universitaet

Frankfurt am Main, Hesse 60590

Germany

Asian Institute of Gastroenterology

Hyderabad, Andhra Pradesh 500032

India

Shree Giriraj Multispeciality Hospital

Rajkot, Gujarat 360005

India

Kingsway Hospital

Nagpur, Maharashtra 440010

India

S. R. Kalla Memorial Gastro & General Hospital

Jaipur, Rajasthan 302001J

India

Institute of Post Graduate Medical Education And Research

Kolkata, West Bengal 700020

India

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Emilia-Romagna 00168

Italy

Fondazione Poliambulanza Istituto Ospedaliero

Brescia, Lombardy 25124

Italy

Ospedale San Raffaele

Milan, Lombardy 20132

Italy

ASST Rhodense, Rho Memorial Hospital

Rho, Lombardy 20017

Italy

Istituto Clinico Humanitas

Rozzano, Lombardy 20089

Italy

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

San Donato Milanese (MI), Lombardy 20097

Italy

Ospedale Mauriziano Umberto I

Turin, Piedmont 10128

Italy

Ospedale Sacro Cuore Don Calabria

Negrar, Veneto 37024

Italy

Kokikai Tsujinaka Hospital Kashiwanoha

Kashiwa-shi, Chiba 277-0871

Japan

Fukuoka University Hospital

Fukuoka, Fukuoka 814-0180

Japan

NHO Fukuyama Medical Center

Fukuyama-shi, Hiroshima 720-8520

Japan

NHO Kanazawa Medical Center

Kanazawa, Ishikawa-ken 920-8650

Japan

Takamatsu Red Cross Hospital

Takamatsu, Kagawa-ken 760-0017

Japan

NHO Osaka National Hospital

Osaka, Osaka 540-0006

Japan

Saga University Hospital

Saga, Saga-ken 849-8501

Japan

Shinseikai Sai Gastroenterology, Proctology

Fujidera-shi, 583-0027

Japan

Kojunkai Daido Clinic

Nagoya, 457-8511

Japan

Centro Medico Clinico Quirurgico Especializado en Investigacion

Tlajomulco de Zúñiga, Jalisco 45645

Mexico

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

Mérida, Yucatán 97130

Mexico

FAICIC S de R.L. de C.V

Veracruz, 91900

Mexico

Centrum Medyczne "Medis"

Bydgoszcz, 85-229

Poland

Clinsante S.C. Osrodek Badan Klinicznych

Bydgoszcz, 85-794

Poland

Centrum Medyczne Lukamed Joanna Luka

Chojnice, 89-600

Poland

Vita Longa Sp. z o.o.

Katowice, 40-748

Poland

MZ Badania Slowik Zymla Sp.j.

Knurów, 44-190

Poland

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

Nowy Targ, 34-400

Poland

SOLUMED Centrum Medyczne

Poznan, 60-529

Poland

NSZOZ Termedica Centrum Badan Klinicznych

Poznan, 60-681

Poland

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

Poznan, 61-731

Poland

Velocity Skierniewice Sp. z o.o

Skierniewice, 96-100

Poland

Twoja Przychodnia-Szczecinskie Centrum Medyczne

Szczecin, 71-434

Poland

Centrum Zdrowia MDM

Warsaw, 00-189

Poland

Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych Administracji

Warsaw, 02-507

Poland

Provita Poliklinika sp. z o.o

Warsaw, 02-647

Poland

Medon Clinical Research sp. z o.o

Warsaw, 02-679

Poland

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

Warsaw, 04-501

Poland

Przychodnia VISTAMED

Wroc?aw, 53-149

Poland

ETG Zamosc

Zamość, 22-400

Poland

Yonsei University Wonju Severance Christian Hospital

Wŏnju, Gangwon-do 26426

South Korea

Inje university Haeundae Paik Hospital

Busan, 48108

South Korea

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

Daejeon, 34943

South Korea

Chosun University Hospital

Gwangju, 61453

South Korea

Kangbuk Samsung Hospital

Seoul, 03181

South Korea

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

Seoul, 03312

South Korea

Asan Medical Center.

Seoul, 05505

South Korea

Samsung Medical Center

Seoul, 06351

South Korea

Chung-Ang University Hospital

Seoul, 06973

South Korea

Guy's Hospital

London, Greater London SE1 9RT

United Kingdom

King's College Hospital

London, Greater London SE5 9RS

United Kingdom

Royal Liverpool University Hospital

Liverpool, Merseyside L7 8YE

United Kingdom

John Radcliffe Hospital

Oxford, Oxfordshire OX3 9DU

United Kingdom

Addenbrook'es Hospital

Cambridge, CB2 0QQ

United Kingdom