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
- Ulcerative Colitis
At a glance
- Phase
- Phase 2
- Study type
- Interventional
- Sponsor
- Genentech, Inc.
- Enrolment target
- 224
- Started
- 29 September 2025
- Main results due
- 25 August 2027
- Study sites
- 108
- Registry updated
- 28 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full 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
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(108)
Gastro Care Institute
Lancaster, California, United States
Recruiting
Medical Associates Research Group, Inc.
San Diego, California, United States
Recruiting
Peak Gastroenterology Associates
Colorado Springs, Colorado, United States
Recruiting
Clinical Research of Osceola, LLC
Kissimmee, Florida, United States
Recruiting
University of Chicago Medical Center
Chicago, Illinois, United States
Recruiting
Intercity Gastroenterology
Fresh Meadows, New York, United States
Recruiting
Monroe Biomedical Research
Monroe, North Carolina, United States
Recruiting
University of Utah Hospitals & Clinics
Salt Lake City, Utah, United States
Recruiting
Mater Misericordiae Limited
South Brisbane, Queensland, Australia
Recruiting
Royal Melbourne Hospital
Parkville VIC, Victoria, Australia
Recruiting
Fiona Stanley Hospital
Murdoch, Western Australia, Australia
Recruiting
HUWC - UFC - Hospital Universitrio Walter Cantdio - Universidade Federal do Cear
Fortaleza, Ceará, Brazil
Recruiting
L2IP ?Instituto de Pesquisas Clínicas Ltda.
Brasília, Federal District, Brazil
Recruiting
Chronos Pesquisa Clinica
Brasília, Federal District, Brazil
Recruiting
Hospital Felicio Rocho
Belo Horizonte, Minas Gerais, Brazil
Recruiting
Associao Paranaense de Cultura APC
Curitiba, Paraná, Brazil
Recruiting
Centro Digestivo de Curitiba
Curitiba, Paraná, Brazil
Recruiting
Hospital de Clnicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Recruiting
Hospital Ernesto Dornelles
Porto Alegre, Rio Grande do Sul, Brazil
Recruiting
Newdata Clinical Trials
Aracaju, Sergipe, Brazil
Recruiting
CECIP - Centro de Estudos Clínicos do Interior Paulista
Ja, São Paulo, Brazil
Recruiting
Pesquisare Saude
Santo André, São Paulo, Brazil
Recruiting
Kaiser Clinica
São José do Rio Preto, São Paulo, Brazil
Recruiting
Instituto de Assistencia Medica ao Servidor Publico Estudo Estadual
São Paulo, São Paulo, Brazil
Recruiting
BR Trials - Ensaios Clnicos e Consultoria
São Paulo, São Paulo, Brazil
Recruiting
CPQuali Pesquisa Clinica Ltda
So Paulo, São Paulo, Brazil
Recruiting
Hospital Gloria DOr - Hospitais Integrados da Gavea S/A
Rio de Janeiro, Brazil
Recruiting
London Digestive Disease Institute
London, Ontario, Canada
Recruiting
Hopital Maisonneuve-Rosemont d/b/a CIUSSS de l'Est-de-l'le-de-Montral
Montreal, Quebec, Canada
Recruiting
Clinique IMD
Montreal, Quebec, Canada
Recruiting
The First Affiliated Hospital Of Fujian Medical University
Fuzhou, Fujian, China
Recruiting
Zhongshan Hospital Xiamen University
Xiamen, Fujian, China
Recruiting
The second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Recruiting
The sixth affiliated hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China
Recruiting
Huizhou Municipal Central Hospital
Huizhou, Guangdong, China
Recruiting
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Recruiting
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
Recruiting
The First Hospital of Jilin University
Changchun, Jilin, China
Recruiting
Binzhou Medical university hospital
Binzhou, Shandong, China
Recruiting
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Recruiting
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, China
Recruiting
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Hangzhou, China
Recruiting
PreventaMed, s.r.o.
Olomouc, Czechia
Recruiting
Nemocnice Slany
Slaný, Czechia
Withdrawn
Groupe Hospitalier Ambroise Pare - Institut des MICI
Neuilly, Hauts De Seine, France
Recruiting
CHU Saint Etienne - Hpital Nord
Saint-Étienne-de-Montluc, Pays de la Loire Region, France
Recruiting
CHU Clermont Ferrand - Hôpital d'Estaing
Clermont-Ferrand, Puy De Dome, France
Recruiting
Centre hospitalier Lyon Sud
Pierre-Bénite, Rhone, France
Recruiting
Universitaetsklinikum Frankfurt Goethe-Universitaet
Frankfurt am Main, Hesse, Germany
Recruiting
Asian Institute of Gastroenterology
Hyderabad, Andhra Pradesh, India
Recruiting
Shree Giriraj Multispeciality Hospital
Rajkot, Gujarat, India
Recruiting
Kingsway Hospital
Nagpur, Maharashtra, India
Recruiting
S. R. Kalla Memorial Gastro & General Hospital
Jaipur, Rajasthan, India
Recruiting
Institute of Post Graduate Medical Education And Research
Kolkata, West Bengal, India
Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Emilia-Romagna, Italy
Recruiting
Fondazione Poliambulanza Istituto Ospedaliero
Brescia, Lombardy, Italy
Recruiting
Ospedale San Raffaele
Milan, Lombardy, Italy
Recruiting
ASST Rhodense, Rho Memorial Hospital
Rho, Lombardy, Italy
Recruiting
Istituto Clinico Humanitas
Rozzano, Lombardy, Italy
Recruiting
I.R.C.C.S Policlinico San Donato
San Donato Milanese (MI), Lombardy, Italy
Recruiting
Showing 60 of 108 sites — filter to narrow it down. 103 of the 108 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT06979336. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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