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
Status: Recruiting
Location: See all (88) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
California
Gastro Care Institute
RECRUITING
Lancaster
Medical Associates Research Group, Inc.
RECRUITING
San Diego
Colorado
Peak Gastroenterology Associates
RECRUITING
Colorado Springs
Florida
Clinical Research of Osceola, LLC
RECRUITING
Kissimmee
Illinois
University of Chicago Medical Center
RECRUITING
Chicago
North Carolina
Monroe Biomedical Research
RECRUITING
Monroe
New York
Intercity Gastroenterology
RECRUITING
Fresh Meadows
Utah
University of Utah Hospitals & Clinics
RECRUITING
Salt Lake City
Other Locations
Australia
Mater Misericordiae Limited
RECRUITING
South Brisbane
Brazil
Newdata Clinical Trials
RECRUITING
Aracaju
Hospital Felicio Rocho
RECRUITING
Belo Horizonte
Chronos Pesquisa Clinica
RECRUITING
Brasília
L2IP ?Instituto de Pesquisas Clínicas Ltda.
RECRUITING
Brasília
Associao Paranaense de Cultura APC
RECRUITING
Curitiba
Centro Digestivo de Curitiba
RECRUITING
Curitiba
HUWC - UFC - Hospital Universitrio Walter Cantdio - Universidade Federal do Cear
RECRUITING
Fortaleza
CECIP - Centro de Estudos Clínicos do Interior Paulista
RECRUITING
Ja
Hospital de Clnicas de Porto Alegre
RECRUITING
Porto Alegre
Hospital Ernesto Dornelles
RECRUITING
Porto Alegre
Pesquisare Saude
RECRUITING
Santo André
Kaiser Clinica
RECRUITING
São José Do Rio Preto
BR Trials - Ensaios Clnicos e Consultoria
RECRUITING
São Paulo
CPQuali Pesquisa Clinica Ltda
RECRUITING
So Paulo
Canada
London Digestive Disease Institute
RECRUITING
London
Clinique IMD
RECRUITING
Montreal
Hopital Maisonneuve-Rosemont d/b/a CIUSSS de l'Est-de-l'le-de-Montral
RECRUITING
Montreal
China
Binzhou Medical university hospital
RECRUITING
Binzhou
Sichuan Provincial People's Hospital
RECRUITING
Chengdu
The second Affiliated Hospital of Guangzhou Medical University
RECRUITING
Guangzhou
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
RECRUITING
Hangzhou
The First Affiliated Hospital of Ningbo University
RECRUITING
Ningbo
Zhongshan Hospital Xiamen University
RECRUITING
Xiamen
The Second Affiliated Hospital of Zhengzhou University
RECRUITING
Zhengzhou
France
CHU Clermont Ferrand - Hôpital d'Estaing
RECRUITING
Clermont-ferrand
Groupe Hospitalier Ambroise Pare - Institut des MICI
RECRUITING
Neuilly
Centre hospitalier Lyon Sud
RECRUITING
Pierre-bénite
CHU Saint Etienne - Hpital Nord
RECRUITING
Saint-étienne-de-montluc
Germany
Universitaetsklinikum Frankfurt Goethe-Universitaet
RECRUITING
Frankfurt Am Main
Italy
Fondazione Poliambulanza Istituto Ospedaliero
RECRUITING
Brescia
ASST Rhodense, Rho Memorial Hospital
RECRUITING
Rho
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
RECRUITING
Rome
Istituto Clinico Humanitas
RECRUITING
Rozzano
I.R.C.C.S Policlinico San Donato
RECRUITING
San Donato Milanese (mi)
Ospedale Mauriziano Umberto I
RECRUITING
Turin
Japan
Shinseikai Sai Gastroenterology, Proctology
RECRUITING
Fujidera-shi
Fukuoka University Hospital
RECRUITING
Fukuoka
NHO Fukuyama Medical Center
RECRUITING
Fukuyama-shi
NHO Kanazawa Medical Center
RECRUITING
Kanazawa
Kokikai Tsujinaka Hospital Kashiwanoha
RECRUITING
Kashiwa-shi
Kojunkai Daido Clinic
RECRUITING
Nagoya
NHO Osaka National Hospital
RECRUITING
Osaka
Saga University Hospital
RECRUITING
Saga
Takamatsu Red Cross Hospital
RECRUITING
Takamatsu
Mexico
Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan
RECRUITING
Mérida
Centro Medico Clinico Quirurgico Especializado en Investigacion
RECRUITING
Tlajomulco De Zúñiga
FAICIC S de R.L. de C.V
RECRUITING
Veracruz
Poland
Centrum Medyczne Medis
RECRUITING
Bydgoszcz
Clinsante S.C. Osrodek Badan Klinicznych
RECRUITING
Bydgoszcz
Centrum Medyczne Lukamed Joanna Luka
RECRUITING
Chojnice
Vita Longa Sp. z o.o.
RECRUITING
Katowice
MZ Badania Slowik Zymla Sp.j.
RECRUITING
Knurów
Allmedica Badania Kliniczne sp. z o.o. sp.k.
RECRUITING
Nowy Targ
Clinical Research Center Spka z ograniczon odpowiedzialnoci Medic-R Sp.k.
RECRUITING
Poznan
NSZOZ Termedica Centrum Badan Klinicznych
RECRUITING
Poznan
SOLUMED Centrum Medyczne
RECRUITING
Poznan
Velocity Skierniewice Sp. z o.o
RECRUITING
Skierniewice
Twoja Przychodnia-Szczecinskie Centrum Medyczne
RECRUITING
Szczecin
Centrum Zdrowia MDM
RECRUITING
Warsaw
Medical Network Spka z o. o., WIP Warsaw IBD Point Profesor Kierkus
RECRUITING
Warsaw
Medon Clinical Research sp. z o.o
RECRUITING
Warsaw
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych Administracji
RECRUITING
Warsaw
Provita Poliklinika sp. z o.o
RECRUITING
Warsaw
Przychodnia VISTAMED
RECRUITING
Wroc?aw
ETG Zamosc
RECRUITING
Zamość
Republic of Korea
Inje university Haeundae Paik Hospital
RECRUITING
Busan
The Catholic University of Korea Daejeon ST. Mary?s Hospital
RECRUITING
Daejeon
Chosun University Hospital
RECRUITING
Gwangju
Asan Medical Center.
RECRUITING
Seoul
Chung-Ang University Hospital
RECRUITING
Seoul
Kangbuk Samsung Hospital
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
The Catholic University of Korea Eunpyeong St. Mary's Hospital
RECRUITING
Seoul
Yonsei University Wonju Severance Christian Hospital
RECRUITING
Wŏnju
United Kingdom
Addenbrook'es Hospital
RECRUITING
Cambridge
Royal Liverpool University Hospital
RECRUITING
Liverpool
Guy's Hospital
RECRUITING
London
King's College Hospital
RECRUITING
London
John Radcliffe Hospital
RECRUITING
Oxford
Contact Information
Primary
Reference Study ID Number: GA45977 https://forpatients.roche.com/
global-roche-genentech-trials@gene.com
888-662-6728 (U.S.)
Backup
Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry
Time Frame
Start Date: 2025-09-29
Estimated Completion Date: 2028-10-31
Participants
Target number of participants: 224
Treatments
Experimental: RO7837195 Dose Regimen 1
Participants will receive RO7837195 per the pre-defined dosing regimen during the 12-week induction and 40-week active treatment extension phases.
Experimental: RO7837195 Dose Regimen 2
Participants will receive RO7837195 per the pre-defined dosing regimen during the 12-week induction and 40-week active treatment extension phases.
Experimental: RO7837195 Dose Regimen 3
Participants will receive RO7837195 per the pre-defined dosing regimen during the 12-week induction and 40-week active treatment extension phases.
Experimental: RO7837195 Dose Regimen 4
Participants will receive RO7837195 per the pre-defined dosing regimen during the 12-week induction and 40-week active treatment extension phases.
Experimental: RO7837195 Matched Placebo/ RO7837195
Participants will receive RO7837195 matched placebo and RO7837195 per the pre-defined dosing regimen during the 12-week induction and 40-week active treatment extension phases, respectively.
Related Therapeutic Areas
Sponsors
Leads: Genentech, Inc.