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A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of RO7837195 in Participants With Moderately to Severely Active Ulcerative Colitis (UC)
Sponsor: Genentech, Inc.
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
224
Start Date
2025-09-29
Completion Date
2028-10-31
Last Updated
2026-04-03
Healthy Volunteers
No
Conditions
Interventions
RO7837195
RO7837195 will be administered as per the schedule specified in the protocol.
RO7837195 Matched Placebo
RO7837195 matched placebo will be administered as per the schedule specified in the protocol.
Locations (64)
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
Intercity Gastroenterology
Fresh Meadows, New York, United States
Monroe Biomedical Research
Monroe, North Carolina, United States
Centro Digestivo de Curitiba
Curitiba, Paraná, Brazil
Newdata Clinical Trials
Aracaju, Sergipe, Brazil
CPQuali Pesquisa Clinica Ltda
So Paulo, São Paulo, Brazil
London Digestive Disease Institute
London, Ontario, Canada
Clinique IMD
Montreal, Quebec, Canada
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 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
Roma, Emilia-Romagna, Italy
Fondazione Poliambulanza Istituto Ospedaliero
Brescia, Lombardy, Italy
ASST Rhodense, Rho Memorial Hospital
Rho, 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
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
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