RecruitingRecruiting
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of RO7837195 in Participants With Moderately to Severely Active Ulcerative Colitis (UC)
NCT06979336 · Genentech, Inc.
In plain English
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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
About this study
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
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
Study design
Enrollment target: 224 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2025-09-29
Estimated completion: 2028-10-31
Last updated: 2026-06-01
Interventions
Drug: RO7837195Drug: RO7837195 Matched Placebo
Primary outcomes
- • Percentage of Participants With Clinical Remission at Week 12 (At Week 12)
Sponsor
Genentech, Inc. · industry
Contacts & investigators
ContactReference Study ID Number: GA45977 https://forpatients.roche.com/ · contact · global-roche-genentech-trials@gene.com · 888-662-6728 (U.S.)
ContactFastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry · contact
InvestigatorClinical Trials · study_director, Genentech, Inc.
All locations (90)
Gastro Care InstituteRecruiting
Lancaster, California, United States
Medical Associates Research Group, Inc.Recruiting
San Diego, California, United States
Peak Gastroenterology AssociatesRecruiting
Colorado Springs, Colorado, United States
Clinical Research of Osceola, LLCRecruiting
Kissimmee, Florida, United States
University of Chicago Medical CenterRecruiting
Chicago, Illinois, United States
Intercity GastroenterologyRecruiting
Fresh Meadows, New York, United States
Monroe Biomedical ResearchRecruiting
Monroe, North Carolina, United States
University of Utah Hospitals & ClinicsRecruiting
Salt Lake City, Utah, United States
Mater Misericordiae LimitedRecruiting
South Brisbane, Queensland, Australia
HUWC - UFC - Hospital Universitrio Walter Cantdio - Universidade Federal do CearRecruiting
Fortaleza, Ceará, Brazil
L2IP ?Instituto de Pesquisas Clínicas Ltda.Recruiting
Brasília, Federal District, Brazil
Chronos Pesquisa ClinicaRecruiting
Brasília, Federal District, Brazil
Hospital Felicio RochoRecruiting
Belo Horizonte, Minas Gerais, Brazil
Associao Paranaense de Cultura APCRecruiting
Curitiba, Paraná, Brazil
Centro Digestivo de CuritibaRecruiting
Curitiba, Paraná, Brazil
Hospital de Clnicas de Porto AlegreRecruiting
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Ernesto DornellesRecruiting
Porto Alegre, Rio Grande do Sul, Brazil
Newdata Clinical TrialsRecruiting
Aracaju, Sergipe, Brazil
CECIP - Centro de Estudos Clínicos do Interior PaulistaRecruiting
Ja, São Paulo, Brazil
Pesquisare SaudeRecruiting
Santo André, São Paulo, Brazil
Kaiser ClinicaRecruiting
São José do Rio Preto, São Paulo, Brazil
BR Trials - Ensaios Clnicos e ConsultoriaRecruiting
São Paulo, São Paulo, Brazil
CPQuali Pesquisa Clinica LtdaRecruiting
So Paulo, São Paulo, Brazil
London Digestive Disease InstituteRecruiting
London, Ontario, Canada
Hopital Maisonneuve-Rosemont d/b/a CIUSSS de l'Est-de-l'le-de-MontralRecruiting
Montreal, Quebec, Canada
Clinique IMDRecruiting
Montreal, Quebec, Canada
Zhongshan Hospital Xiamen UniversityRecruiting
Xiamen, Fujian, China
The second Affiliated Hospital of Guangzhou Medical UniversityRecruiting
Guangzhou, Guangdong, China
The Second Affiliated Hospital of Zhengzhou UniversityRecruiting
Zhengzhou, Henan, China
Binzhou Medical university hospitalRecruiting
Binzhou, Shandong, China
Sichuan Provincial People's HospitalRecruiting
Chengdu, Sichuan, China
The First Affiliated Hospital of Ningbo UniversityRecruiting
Ningbo, Zhejiang, China
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang UniversityRecruiting
Hangzhou, China
PreventaMed, s.r.o.Recruiting
Olomouc, Czechia
Nemocnice SlanyRecruiting
Slaný, Czechia
Groupe Hospitalier Ambroise Pare - Institut des MICIRecruiting
Neuilly, Hauts De Seine, France
CHU Saint Etienne - Hpital NordRecruiting
Saint-Étienne-de-Montluc, Pays de la Loire Region, France
CHU Clermont Ferrand - Hôpital d'EstaingRecruiting
Clermont-Ferrand, Puy De Dome, France
Centre hospitalier Lyon SudRecruiting
Pierre-Bénite, Rhone, France
Universitaetsklinikum Frankfurt Goethe-UniversitaetRecruiting
Frankfurt am Main, Hesse, Germany
Fondazione Policlinico Universitario Agostino Gemelli IRCCSRecruiting
Rome, Emilia-Romagna, Italy
Fondazione Poliambulanza Istituto OspedalieroRecruiting
Brescia, Lombardy, Italy
ASST Rhodense, Rho Memorial HospitalRecruiting
Rho, Lombardy, Italy
Istituto Clinico HumanitasRecruiting
Rozzano, Lombardy, Italy
I.R.C.C.S Policlinico San DonatoRecruiting
San Donato Milanese (MI), Lombardy, Italy
Ospedale Mauriziano Umberto IRecruiting
Turin, Piedmont, Italy
Kokikai Tsujinaka Hospital KashiwanohaRecruiting
Kashiwa-shi, Chiba, Japan
Fukuoka University HospitalRecruiting
Fukuoka, Fukuoka, Japan
NHO Fukuyama Medical CenterRecruiting
Fukuyama-shi, Hiroshima, Japan
NHO Kanazawa Medical CenterRecruiting
Kanazawa, Ishikawa-ken, Japan
Takamatsu Red Cross HospitalRecruiting
Takamatsu, Kagawa-ken, Japan
NHO Osaka National HospitalRecruiting
Osaka, Osaka, Japan
Saga University HospitalRecruiting
Saga, Saga-ken, Japan
Shinseikai Sai Gastroenterology, ProctologyRecruiting
Fujidera-shi, Japan
Kojunkai Daido ClinicRecruiting
Nagoya, Japan
Centro Medico Clinico Quirurgico Especializado en InvestigacionRecruiting
Tlajomulco de Zúñiga, Jalisco, Mexico
Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en YucatanRecruiting
Mérida, Yucatán, Mexico
FAICIC S de R.L. de C.VRecruiting
Veracruz, Mexico
Centrum Medyczne "Medis"Recruiting
Bydgoszcz, Poland
Clinsante S.C. Osrodek Badan KlinicznychRecruiting
Bydgoszcz, Poland
Centrum Medyczne Lukamed Joanna LukaRecruiting
Chojnice, Poland
Vita Longa Sp. z o.o.Recruiting
Katowice, Poland
MZ Badania Slowik Zymla Sp.j.Recruiting
Knurów, Poland
Allmedica Badania Kliniczne sp. z o.o. sp.k.Recruiting
Nowy Targ, Poland
SOLUMED Centrum MedyczneRecruiting
Poznan, Poland
NSZOZ Termedica Centrum Badan KlinicznychRecruiting
Poznan, Poland
Clinical Research Center Spka z ograniczon odpowiedzialnoci Medic-R Sp.k.Recruiting
Poznan, Poland
Velocity Skierniewice Sp. z o.oRecruiting
Skierniewice, Poland
Twoja Przychodnia-Szczecinskie Centrum MedyczneRecruiting
Szczecin, Poland
Centrum Zdrowia MDMRecruiting
Warsaw, Poland
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych AdministracjiRecruiting
Warsaw, Poland
Provita Poliklinika sp. z o.oRecruiting
Warsaw, Poland
Medon Clinical Research sp. z o.oRecruiting
Warsaw, Poland
Medical Network Spka z o. o., WIP Warsaw IBD Point Profesor KierkusRecruiting
Warsaw, Poland
Przychodnia VISTAMEDRecruiting
Wroc?aw, Poland
ETG ZamoscRecruiting
Zamość, Poland
Yonsei University Wonju Severance Christian HospitalRecruiting
Wŏnju, Gangwon-do, South Korea
Inje university Haeundae Paik HospitalRecruiting
Busan, South Korea
The Catholic University of Korea Daejeon ST. Mary?s HospitalRecruiting
Daejeon, South Korea
Chosun University HospitalRecruiting
Gwangju, South Korea
Kangbuk Samsung HospitalRecruiting
Seoul, South Korea
The Catholic University of Korea Eunpyeong St. Mary's HospitalRecruiting
Seoul, South Korea
Asan Medical Center.Recruiting
Seoul, South Korea
Samsung Medical CenterRecruiting
Seoul, South Korea
Chung-Ang University HospitalRecruiting
Seoul, South Korea
Guy's HospitalRecruiting
London, Greater London, United Kingdom
King's College HospitalRecruiting
London, Greater London, United Kingdom
Royal Liverpool University HospitalRecruiting
Liverpool, Merseyside, United Kingdom
John Radcliffe HospitalRecruiting
Oxford, Oxfordshire, United Kingdom
Addenbrook'es HospitalRecruiting
Cambridge, United Kingdom