NCT06979336RecruitingPhase 2
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of RO7837195 in Participants With Moderately to Severely Active Ulcerative Colitis (UC)
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
Source: ClinicalTrials.gov · Last updated 27 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 224 (estimated)
- First submitted
- 15 May 2025
- Start date
- 29 Sept 2025
- Primary completion date
- 25 Aug 2027
- Lead sponsor
- Genentech, Inc.
- Diseases
- Ulcerative colitis
- NCT number
- NCT06979336
- EU CT number
- 2025-520690-39-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 224
- From 29 Sept 2025 to the primary completion date, 25 Aug 2027
- 118 sites in 15 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior extensive colonic resection, subtotal or total colectomy, or planned surgery for UC
- 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
Other illness
- Diagnosis of Crohn's disease or indeterminate colitis
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (118)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Royal Prince Alfred Hospital Coordinator of this site? Confirm its status | Camperdown | Australia | Recruiting |
| Fiona Stanley Hospital Coordinator of this site? Confirm its status | Murdoch | Australia | Recruiting |
| Royal Melbourne Hospital Coordinator of this site? Confirm its status | Parkville VIC | Australia | Recruiting |
| Mater Misericordiae Limited Coordinator of this site? Confirm its status | South Brisbane | Australia | Recruiting |
| Newdata Clinical Trials Coordinator of this site? Confirm its status | Aracaju | Brazil | Recruiting |
| Hospital Felicio Rocho Coordinator of this site? Confirm its status | Belo Horizonte | Brazil | Recruiting |
| L2IP - Instituto de Pesquisas Clínicas Ltda Coordinator of this site? Confirm its status | Brasília | Brazil | Recruiting |
| Chronos Pesquisa Clínica Coordinator of this site? Confirm its status | Brasília | Brazil | Recruiting |
| Centro Digestivo de Curitiba Coordinator of this site? Confirm its status | Curitiba | Brazil | Recruiting |
| Associao Paranaense de Cultura APC Coordinator of this site? Confirm its status | Curitiba | Brazil | Recruiting |
| HUWC - UFC - Hospital Universitrio Walter Cantdio - Universidade Federal do Cear Coordinator of this site? Confirm its status | Fortaleza | Brazil | Recruiting |
| CECIP - Centro de Estudos Clínicos do Interior Paulista Coordinator of this site? Confirm its status | Ja | Brazil | Recruiting |
| Hospital de Clnicas de Porto Alegre Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Recruiting |
| Hospital Ernesto Dornelles Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Recruiting |
| Hospital Gloria DOr - Hospitais Integrados da Gavea S/A Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Recruiting |
| Pesquisare Saude Coordinator of this site? Confirm its status | Santo André | Brazil | Recruiting |
| Kaiser Clinica Coordinator of this site? Confirm its status | São Jose Do Rio Preto | Brazil | Recruiting |
| Instituto de Assistencia Medica ao Servidor Publico Estudo Estadual Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
| BR Trials - Ensaios Clnicos e Consultoria Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
| CPQuali Pesquisa Clinica Ltda Coordinator of this site? Confirm its status | So Paulo | Brazil | Recruiting |
| London Digestive Disease Institute Coordinator of this site? Confirm its status | London | Canada | Recruiting |
| Hopital Maisonneuve-Rosemont d/b/a CIUSSS de l'Est-de-l'le-de-Montral Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| Clinique IMD Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| Binzhou Medical University Hospital Coordinator of this site? Confirm its status | Binzhou | China | Recruiting |
| The First Hospital of Jilin University Coordinator of this site? Confirm its status | Changchun | China | Recruiting |
| Sichuan Provincial People's Hospital Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
| The First Affiliated Hospital of Fujian Medical University Coordinator of this site? Confirm its status | Fuzhou | China | Recruiting |
| The second Affiliated Hospital of Guangzhou Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| The Sixth Affiliated Hospital of Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| Huizhou Municipal Central Hospital Coordinator of this site? Confirm its status | Huizhou | China | Recruiting |
| The First Affiliated Hospital of Ningbo University Coordinator of this site? Confirm its status | Ningbo | China | Recruiting |
| Renmin Hospital of Wuhan University Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
| Zhongshan Hospital Xiamen University Coordinator of this site? Confirm its status | Xiamen | China | Recruiting |
| The Second Affiliated Hospital of Zhengzhou University Coordinator of this site? Confirm its status | Zhengzhou | China | Recruiting |
| PreventaMed, s.r.o. Coordinator of this site? Confirm its status | Olomouc | Czechia | Recruiting |
| Goethe University Frankfurt Coordinator of this site? Confirm its status | Frankfurt Am Main | Germany | Recruiting |
| Universitaetsklinikum Regensburg AöR Coordinator of this site? Confirm its status | Regensburg | Germany | Recruiting |
| University Hospital Of Clermont-Ferrand Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Recruiting |
| Centre Medico Chirurgical Ambroise Pare Hartmann Coordinator of this site? Confirm its status | Neuilly-Sur-Seine | France | Recruiting |
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Pierre-Bénite | France | Recruiting |
| Centre Hospitalier Universitaire de Saint Etienne Coordinator of this site? Confirm its status | Saint-Priest-en-Jarez | France | Recruiting |
| Addenbrook'es Hospital Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Recruiting |
| Royal Liverpool University Hospital Coordinator of this site? Confirm its status | Liverpool | United Kingdom | Recruiting |
| Guy's Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| King's College Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| John Radcliffe Hospital Coordinator of this site? Confirm its status | Oxford | United Kingdom | Recruiting |
| Asian Institute Of Gastroenterology Coordinator of this site? Confirm its status | Hyderabad | India | Recruiting |
| S.R.Kalla Memorial Gastro & General Hospital Coordinator of this site? Confirm its status | Jaipur | India | Recruiting |
| Institute of Post-Graduate Medical Education and Research Coordinator of this site? Confirm its status | Kolkata | India | Recruiting |
| Kingsway Hospital Coordinator of this site? Confirm its status | Nagpur | India | Recruiting |
| Shree Giriraj Multispeciality Hospital Coordinator of this site? Confirm its status | Rajkot | India | Recruiting |
| Fondazione Poliambulanza Coordinator of this site? Confirm its status | Brescia | Italy | Recruiting |
| Ospedale San Raffaele S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| IRCCS Ospedale Sacro Cuore Don Calabria Coordinator of this site? Confirm its status | Negrar | Italy | Recruiting |
| Fondazione IRCCS Policlinico San Matteo Coordinator of this site? Confirm its status | Pavia | Italy | Recruiting |
| Azienda Socio Sanitaria Territoriale Rhodense Coordinator of this site? Confirm its status | Rho | Italy | Recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Humanitas Mirasole S.p.A. Coordinator of this site? Confirm its status | Rozzano | Italy | Recruiting |
| Policlinico San Donato S.p.A. Coordinator of this site? Confirm its status | San Donato Milanese | Italy | Recruiting |
| Azienda Ospedaliera Ordine Mauriziano di Torino Coordinator of this site? Confirm its status | Turin | Italy | Recruiting |
| Shinseikai Sai Gastroenterology, Proctology Coordinator of this site? Confirm its status | Fujidera-shi | Japan | Recruiting |
| Fukuoka University Hospital Coordinator of this site? Confirm its status | Fukuoka | Japan | Recruiting |
| NHO Fukuyama Medical Center Coordinator of this site? Confirm its status | Fukuyama-shi | Japan | Recruiting |
| NHO Kanazawa Medical Center Coordinator of this site? Confirm its status | Kanazawa | Japan | Recruiting |
| Kokikai Tsujinaka Hospital Kashiwanoha Coordinator of this site? Confirm its status | Kashiwa-shi | Japan | Recruiting |
| Kojunkai Daido Clinic Coordinator of this site? Confirm its status | Nagoya | Japan | Recruiting |
| NHO Osaka National Hospital Coordinator of this site? Confirm its status | Osaka | Japan | Recruiting |
| Saga University Hospital Coordinator of this site? Confirm its status | Saga | Japan | Recruiting |
| Takamatsu Red Cross Hospital Coordinator of this site? Confirm its status | Takamatsu | Japan | Recruiting |
| Inje University Haeundae Paik Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Recruiting |
| The Catholic University of Korea, Daejeon ST.Mary's Hospital Coordinator of this site? Confirm its status | Daejeon | South Korea | Recruiting |
| Chosun University Hospital Coordinator of this site? Confirm its status | Gwangju | South Korea | Recruiting |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| The Catholic University of Korea, Eunpyeong St. Mary's Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Chung ang University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Kangbuk Samsung Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Yonsei University Wonju Severance Christian Hospital Coordinator of this site? Confirm its status | Wŏnju | South Korea | Recruiting |
| Clinica de Investigacion en Reumatologia y Obesidad S. C. Coordinator of this site? Confirm its status | Guadalajara | Mexico | Recruiting |
| Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan ( Coordinator of this site? Confirm its status | Mérida | Mexico | Recruiting |
| Centro de Alta Especialidad en Reumatologia e Investigación del Potosi,S.C Coordinator of this site? Confirm its status | San Luis Potosí City | Mexico | Recruiting |
| Centro Medico Clinico Quirurgico Especializado en Investigacion Coordinator of this site? Confirm its status | Tlajomulco de Zúñiga | Mexico | Recruiting |
| FAICIC S. de R.L. de C.V. Coordinator of this site? Confirm its status | Veracruz | Mexico | Recruiting |
| Manermed Sp. z o.o. Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Recruiting |
| Osrodek Badan Klinicznych Clinsante S.C. Ewa Galczak-Nowak Malgorzata Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Recruiting |
| Centrum Medyczne LukaMed Joanna Łuka Coordinator of this site? Confirm its status | Chojnice | Poland | Recruiting |
| Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k. Coordinator of this site? Confirm its status | Cracow | Poland | Recruiting |
| Centrum Medyczne Clw-Med Aneta Cichomska I Joanna Luka-Wendrowska Sp. j. Coordinator of this site? Confirm its status | Grudziadz | Poland | Recruiting |
| Vita Longa Sp. Z o.o. Coordinator of this site? Confirm its status | Katowice | Poland | Recruiting |
| MZ Badania Slowik Zymla Sp.j. Coordinator of this site? Confirm its status | Knurów | Poland | Recruiting |
| Allmedica Badania Kliniczne Sp z o.o. Sp K. Coordinator of this site? Confirm its status | Nowy Targ | Poland | Recruiting |
| Twoja Przychodnia Opolskie Centrum Medyczne Coordinator of this site? Confirm its status | Opole | Poland | Recruiting |
| Clinical Research Center Sp z o o Medic R Sp k Coordinator of this site? Confirm its status | Poznan | Poland | Recruiting |
| Twoja Przychodnia Poznanskie Centrum Medyczne Sp. z o.o. Coordinator of this site? Confirm its status | Poznan | Poland | Recruiting |
| Solumed Centrum Medyczne Sp. z o.o. Coordinator of this site? Confirm its status | Poznan | Poland | Recruiting |
| Termedia Sp. z o.o. Coordinator of this site? Confirm its status | Poznan | Poland | Recruiting |
| EMC Instytut Medyczny S.A. Coordinator of this site? Confirm its status | Poznan | Poland | Recruiting |
| Velocity Skierniewice Sp. z o.o. Coordinator of this site? Confirm its status | Skierniewice | Poland | Recruiting |
| Twoja Przychodnia-Szczecinskie Centrum Medyczne Sp. z o. o. Coordinator of this site? Confirm its status | Szczecin | Poland | Recruiting |
| Wsd Medi Clinical Sp. z o.o. Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Medical Network Sp z o o Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Eb Group Sp. z o.o. Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Provita Poliklinika sp. z o.o Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Medon Clinical Research Sp. z o.o. Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Vistamed & Vertigo Sp Z O O Coordinator of this site? Confirm its status | Wroclaw | Poland | Recruiting |
| Centrum Medyczne Oporow Coordinator of this site? Confirm its status | Wroclaw | Poland | Recruiting |
| Etg Zamosc Sp. z o.o. Coordinator of this site? Confirm its status | Zamość | Poland | Recruiting |
| University of Chicago Medical Center Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| Peak Gastroenterology Associates Coordinator of this site? Confirm its status | Colorado Springs | United States | Recruiting |
| Intercity Gastroenterology Coordinator of this site? Confirm its status | Fresh Meadows | United States | Recruiting |
| Clinical Research of Osceola, LLC Coordinator of this site? Confirm its status | Kissimmee | United States | Recruiting |
| Gastro Care Institute Coordinator of this site? Confirm its status | Lancaster | United States | Recruiting |
| Monroe Biomedical Research Coordinator of this site? Confirm its status | Monroe | United States | Recruiting |
| University of Rochester - PARENT Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
| University of Utah Hospitals & Clinics Coordinator of this site? Confirm its status | Salt Lake City | United States | Recruiting |
| Medical Associates Research Group, Inc. Coordinator of this site? Confirm its status | San Diego | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.