A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of RO7837195 in Participants With Moderately to Severely Active Ulcerative Colitis (UC)
Recruiting · NCT06979336 · Interventional (participants receive a specific treatment) · Lead sponsor: Genentech, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
RO7837195RO7837195 Matched Placebo
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
60 locations listed across 7 US states.
- Gastro Care Institute - Lancaster, California, United States
- Medical Associates Research Group, Inc. - San Diego, California, United States
- Peak Gastroenterology Associates - Colorado Springs, Colorado, United States
- Clinical Research of Osceola, LLC - Kissimmee, Florida, United States
- University of Chicago Medical Center - Chicago, Illinois, United States
- Intercity Gastroenterology - Fresh Meadows, New York, United States
- Monroe Biomedical Research - Monroe, North Carolina, United States
- University of Utah Hospitals & Clinics - Salt Lake City, Utah, United States
- Inje university Haeundae Paik Hospital - Busan, South Korea
- Centrum Medyczne "Medis" - Bydgoszcz, Poland
- Clinsante S.C. Osrodek Badan Klinicznych - Bydgoszcz, Poland
- Addenbrook'es Hospital - Cambridge, United Kingdom
- Centrum Medyczne Lukamed Joanna Luka - Chojnice, Poland
- The Catholic University of Korea Daejeon ST. Mary?s Hospital - Daejeon, South Korea
- Shinseikai Sai Gastroenterology, Proctology - Fujidera-shi, Japan
- Chosun University Hospital - Gwangju, South Korea
- Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University - Hangzhou, China
- Vita Longa Sp. z o.o. - Katowice, Poland
- MZ Badania Slowik Zymla Sp.j. - Knurów, Poland
- Kojunkai Daido Clinic - Nagoya, Japan
- Allmedica Badania Kliniczne sp. z o.o. sp.k. - Nowy Targ, Poland
- PreventaMed, s.r.o. - Olomouc, Czechia
- SOLUMED Centrum Medyczne - Poznan, Poland
- NSZOZ Termedica Centrum Badan Klinicznych - Poznan, Poland
- Clinical Research Center Spka z ograniczon odpowiedzialnoci Medic-R Sp.k. - Poznan, Poland
- Hospital Gloria DOr - Hospitais Integrados da Gavea S/A - Rio de Janeiro, Brazil
- Kangbuk Samsung Hospital - Seoul, South Korea
- The Catholic University of Korea Eunpyeong St. Mary's Hospital - Seoul, South Korea
- Asan Medical Center. - Seoul, South Korea
- Samsung Medical Center - Seoul, South Korea
- Chung-Ang University Hospital - Seoul, South Korea
- Velocity Skierniewice Sp. z o.o - Skierniewice, Poland
- Nemocnice Slany - Slaný, Czechia
- Twoja Przychodnia-Szczecinskie Centrum Medyczne - Szczecin, Poland
- FAICIC S de R.L. de C.V - Veracruz, Mexico
- Centrum Zdrowia MDM - Warsaw, Poland
- Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych Administracji - Warsaw, Poland
- Provita Poliklinika sp. z o.o - Warsaw, Poland
- Medon Clinical Research sp. z o.o - Warsaw, Poland
- Medical Network Spka z o. o., WIP Warsaw IBD Point Profesor Kierkus - Warsaw, Poland
- Przychodnia VISTAMED - Wroc?aw, Poland
- ETG Zamosc - Zamość, Poland
- Asian Institute of Gastroenterology - Hyderabad, Andhra Pradesh, India
- HUWC - UFC - Hospital Universitrio Walter Cantdio - Universidade Federal do Cear - Fortaleza, Ceará, Brazil
- Kokikai Tsujinaka Hospital Kashiwanoha - Kashiwa-shi, Chiba, Japan
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Rome, Emilia-Romagna, Italy
- L2IP ?Instituto de Pesquisas Clínicas Ltda. - Brasília, Federal District, Brazil
- Chronos Pesquisa Clinica - Brasília, Federal District, Brazil
- The First Affiliated Hospital Of Fujian Medical University - Fuzhou, Fujian, China
- Zhongshan Hospital Xiamen University - Xiamen, Fujian, China
- Fukuoka University Hospital - Fukuoka, Fukuoka, Japan
- Yonsei University Wonju Severance Christian Hospital - Wŏnju, Gangwon-do, South Korea
- Guy's Hospital - London, Greater London, United Kingdom
- King's College Hospital - London, Greater London, United Kingdom
- The second Affiliated Hospital of Guangzhou Medical University - Guangzhou, Guangdong, China
- The sixth affiliated hospital of Sun Yat-Sen University - Guangzhou, Guangdong, China
- Huizhou Municipal Central Hospital - Huizhou, Guangdong, China
- Shree Giriraj Multispeciality Hospital - Rajkot, Gujarat, India
- Groupe Hospitalier Ambroise Pare - Institut des MICI - Neuilly, Hauts De Seine, France
- The Second Affiliated Hospital of Zhengzhou University - Zhengzhou, Henan, China
Showing 60 of 106 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →