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