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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-520690-39-00 | Registry Identifier | EU CT Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RO7837195 Dose Regimen 1 | Experimental | Participants will receive RO7837195 per the pre-defined dosing regimen during the 12-week induction and 40-week active treatment extension phases. |
|
| RO7837195 Dose Regimen 2 | Experimental | Participants will receive RO7837195 per the pre-defined dosing regimen during the 12-week induction and 40-week active treatment extension phases. |
|
| RO7837195 Dose Regimen 3 | Experimental | Participants will receive RO7837195 per the pre-defined dosing regimen during the 12-week induction and 40-week active treatment extension phases. |
|
| RO7837195 Dose Regimen 4 | Experimental | Participants will receive RO7837195 per the pre-defined dosing regimen during the 12-week induction and 40-week active treatment extension phases. |
|
| RO7837195 Matched Placebo/ RO7837195 | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO7837195 | Drug | RO7837195 will be administered as per the schedule specified in the protocol. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Clinical Remission at Week 12 | Clinical remission is defined as the Modified Mayo Score (mMS) of ≤ 2, including stool frequency subscore of ≤ 1, rectal bleeding subscore of 0, and endoscopy subscore of ≤ 1. | At Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Clinical Response at Week 12 | Clinical response is defined as decrease from baseline in the mMS by ≥2 and ≥ 30% reduction from baseline, with either a decrease of ≥1 in the rectal bleeding subscore or an absolute rectal bleeding subscore of ≤1. | At Week 12 |
| Percentage of Participants With Endoscopic Improvement at Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reference Study ID Number: GA45977 https://forpatients.roche.com/ No attachments to email below. | Contact | 888-662-6728 (U.S.) | global-roche-genentech-trials@gene.com | |
| Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gastro Care Institute | Recruiting | Lancaster | California | 93534 | United States | |
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| Label | URL |
|---|---|
| Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours. | View source |
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For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
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|
| RO7837195 Matched Placebo | Drug | RO7837195 matched placebo will be administered as per the schedule specified in the protocol. |
|
Endoscopic improvement is defined as a Mayo endoscopy subscore of ≤ 1. |
| At Week 12 |
| Percentage of Participants With Endoscopic Remission at Week 12 | Endoscopic remission is defined as a Mayo endoscopy subscore of 0. | At Week 12 |
| Number of Participants With Adverse Events (AEs) | Up to Weeks 65 |
| Serum Concentration of RO7837195 | Up to Weeks 65 |
| Percentage of Participants With Anti-drug Antibodies to RO7837195 | Up to Weeks 65 |
| Medical Associates Research Group, Inc. |
| Recruiting |
| San Diego |
| California |
| 92123 |
| United States |
| Peak Gastroenterology Associates | Recruiting | Colorado Springs | Colorado | 80907 | United States |
| Clinical Research of Osceola, LLC | Recruiting | Kissimmee | Florida | 34741 | United States |
| University of Chicago Medical Center | Recruiting | Chicago | Illinois | 60637 | United States |
| Intercity Gastroenterology | Recruiting | Fresh Meadows | New York | 11366 | United States |
| Monroe Biomedical Research | Recruiting | Monroe | North Carolina | 28112 | United States |
| University of Utah Hospitals & Clinics | Recruiting | Salt Lake City | Utah | 84132 | United States |
| Mater Misericordiae Limited | Recruiting | South Brisbane | Queensland | 4101 | Australia |
| HUWC - UFC - Hospital Universitrio Walter Cantdio - Universidade Federal do Cear | Recruiting | Fortaleza | Ceará | 60430-370 | Brazil |
| L2IP ?Instituto de Pesquisas Clínicas Ltda. | Recruiting | Brasília | Federal District | 70200-730 | Brazil |
| Chronos Pesquisa Clinica | Recruiting | Brasília | Federal District | 72145-450 | Brazil |
| Hospital Felicio Rocho | Recruiting | Belo Horizonte | Minas Gerais | 30110-934 | Brazil |
| Associao Paranaense de Cultura APC | Recruiting | Curitiba | Paraná | 80230-130 | Brazil |
| Centro Digestivo de Curitiba | Recruiting | Curitiba | Paraná | 80430-160 | Brazil |
| Hospital de Clnicas de Porto Alegre | Recruiting | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
| Hospital Ernesto Dornelles | Recruiting | Porto Alegre | Rio Grande do Sul | 90160-093 | Brazil |
| Newdata Clinical Trials | Recruiting | Aracaju | Sergipe | 49075-000 | Brazil |
| CECIP - Centro de Estudos Clínicos do Interior Paulista | Recruiting | Ja | São Paulo | 17201-130 | Brazil |
| Pesquisare Saude | Recruiting | Santo André | São Paulo | 09080-110 | Brazil |
| Kaiser Clinica | Recruiting | São José do Rio Preto | São Paulo | 15015-110 | Brazil |
| BR Trials - Ensaios Clnicos e Consultoria | Recruiting | São Paulo | São Paulo | 05003-090 | Brazil |
| CPQuali Pesquisa Clinica Ltda | Recruiting | So Paulo | São Paulo | 01228-000 | Brazil |
| Hospital Gloria DOr - Hospitais Integrados da Gavea S/A | Recruiting | Rio de Janeiro | 22211-230 | Brazil |
| London Digestive Disease Institute | Recruiting | London | Ontario | N6K 1M6 | Canada |
| Hopital Maisonneuve-Rosemont d/b/a CIUSSS de l'Est-de-l'le-de-Montral | Recruiting | Montreal | Quebec | H1T 2M4 | Canada |
| Clinique IMD | Recruiting | Montreal | Quebec | H3H 1E8 | Canada |
| The First Affiliated Hospital Of Fujian Medical University | Recruiting | Fuzhou | Fujian | 350005 | China |
| Zhongshan Hospital Xiamen University | Recruiting | Xiamen | Fujian | 361004 | China |
| The second Affiliated Hospital of Guangzhou Medical University | Recruiting | Guangzhou | Guangdong | 510260 | China |
| The sixth affiliated hospital of Sun Yat-Sen University | Recruiting | Guangzhou | Guangdong | 510655 | China |
| Huizhou Municipal Central Hospital | Recruiting | Huizhou | Guangdong | 516001 | China |
| The Second Affiliated Hospital of Zhengzhou University | Recruiting | Zhengzhou | Henan | 450014 | China |
| Renmin Hospital of Wuhan University | Recruiting | Wuhan | Hubei | 430060 | China |
| Binzhou Medical university hospital | Recruiting | Binzhou | Shandong | 256603 | China |
| Sichuan Provincial People's Hospital | Recruiting | Chengdu | Sichuan | 610072 | China |
| The First Affiliated Hospital of Ningbo University | Recruiting | Ningbo | Zhejiang | 315010 | China |
| Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University | Recruiting | Hangzhou | 310018 | China |
| PreventaMed, s.r.o. | Recruiting | Olomouc | 779 00 | Czechia |
| Nemocnice Slany | Recruiting | Slaný | 27401 | Czechia |
| Groupe Hospitalier Ambroise Pare - Institut des MICI | Recruiting | Neuilly | Hauts De Seine | 92200 | France |
| CHU Saint Etienne - Hpital Nord | Recruiting | Saint-Étienne-de-Montluc | Pays de la Loire Region | 42055 | France |
| CHU Clermont Ferrand - Hôpital d'Estaing | Recruiting | Clermont-Ferrand | Puy De Dome | 63000 | France |
| Centre hospitalier Lyon Sud | Recruiting | Pierre-Bénite | Rhone | 69495 | France |
| Universitaetsklinikum Frankfurt Goethe-Universitaet | Recruiting | Frankfurt am Main | Hesse | 60590 | Germany |
| Shree Giriraj Multispeciality Hospital | Recruiting | Rajkot | Gujarat | 360005 | India |
| Kingsway Hospital | Recruiting | Nagpur | Maharashtra | 440010 | India |
| S. R. Kalla Memorial Gastro & General Hospital | Recruiting | Jaipur | Rajasthan | 302001J | India |
| Institute of Post Graduate Medical Education And Research | Recruiting | Kolkata | West Bengal | 700020 | India |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Recruiting | Rome | Emilia-Romagna | 00168 | Italy |
| Fondazione Poliambulanza Istituto Ospedaliero | Recruiting | Brescia | Lombardy | 25124 | Italy |
| Ospedale San Raffaele | Recruiting | Milan | Lombardy | 20132 | Italy |
| ASST Rhodense, Rho Memorial Hospital | Recruiting | Rho | Lombardy | 20017 | Italy |
| Istituto Clinico Humanitas | Recruiting | Rozzano | Lombardy | 20089 | Italy |
| I.R.C.C.S Policlinico San Donato | Recruiting | San Donato Milanese (MI) | Lombardy | 20097 | Italy |
| Ospedale Mauriziano Umberto I | Recruiting | Turin | Piedmont | 10128 | Italy |
| Ospedale Sacro Cuore Don Calabria | Recruiting | Negrar | Veneto | 37024 | Italy |
| Kokikai Tsujinaka Hospital Kashiwanoha | Recruiting | Kashiwa-shi | Chiba | 277-0871 | Japan |
| Fukuoka University Hospital | Recruiting | Fukuoka | Fukuoka | 814-0180 | Japan |
| NHO Fukuyama Medical Center | Recruiting | Fukuyama-shi | Hiroshima | 720-8520 | Japan |
| NHO Kanazawa Medical Center | Recruiting | Kanazawa | Ishikawa-ken | 920-8650 | Japan |
| Takamatsu Red Cross Hospital | Recruiting | Takamatsu | Kagawa-ken | 760-0017 | Japan |
| NHO Osaka National Hospital | Recruiting | Osaka | Osaka | 540-0006 | Japan |
| Saga University Hospital | Recruiting | Saga | Saga-ken | 849-8501 | Japan |
| Shinseikai Sai Gastroenterology, Proctology | Recruiting | Fujidera-shi | 583-0027 | Japan |
| Kojunkai Daido Clinic | Recruiting | Nagoya | 457-8511 | Japan |
| Centro Medico Clinico Quirurgico Especializado en Investigacion | Recruiting | Tlajomulco de Zúñiga | Jalisco | 45645 | Mexico |
| Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan | Recruiting | Mérida | Yucatán | 97130 | Mexico |
| FAICIC S de R.L. de C.V | Recruiting | Veracruz | 91900 | Mexico |
| Centrum Medyczne "Medis" | Recruiting | Bydgoszcz | 85-229 | Poland |
| Clinsante S.C. Osrodek Badan Klinicznych | Recruiting | Bydgoszcz | 85-794 | Poland |
| Centrum Medyczne Lukamed Joanna Luka | Recruiting | Chojnice | 89-600 | Poland |
| Vita Longa Sp. z o.o. | Recruiting | Katowice | 40-748 | Poland |
| MZ Badania Slowik Zymla Sp.j. | Recruiting | Knurów | 44-190 | Poland |
| Allmedica Badania Kliniczne sp. z o.o. sp.k. | Recruiting | Nowy Targ | 34-400 | Poland |
| SOLUMED Centrum Medyczne | Recruiting | Poznan | 60-529 | Poland |
| NSZOZ Termedica Centrum Badan Klinicznych | Recruiting | Poznan | 60-681 | Poland |
| Clinical Research Center Spka z ograniczon odpowiedzialnoci Medic-R Sp.k. | Recruiting | Poznan | 61-731 | Poland |
| Velocity Skierniewice Sp. z o.o | Recruiting | Skierniewice | 96-100 | Poland |
| Twoja Przychodnia-Szczecinskie Centrum Medyczne | Recruiting | Szczecin | 71-434 | Poland |
| Centrum Zdrowia MDM | Recruiting | Warsaw | 00-189 | Poland |
| Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych Administracji | Recruiting | Warsaw | 02-507 | Poland |
| Provita Poliklinika sp. z o.o | Recruiting | Warsaw | 02-647 | Poland |
| Medon Clinical Research sp. z o.o | Recruiting | Warsaw | 02-679 | Poland |
| Medical Network Spka z o. o., WIP Warsaw IBD Point Profesor Kierkus | Recruiting | Warsaw | 04-501 | Poland |
| Przychodnia VISTAMED | Recruiting | Wroc?aw | 53-149 | Poland |
| ETG Zamosc | Recruiting | Zamość | 22-400 | Poland |
| Yonsei University Wonju Severance Christian Hospital | Recruiting | Wŏnju | Gangwon-do | 26426 | South Korea |
| Inje university Haeundae Paik Hospital | Recruiting | Busan | 48108 | South Korea |
| The Catholic University of Korea Daejeon ST. Mary?s Hospital | Recruiting | Daejeon | 34943 | South Korea |
| Chosun University Hospital | Recruiting | Gwangju | 61453 | South Korea |
| Kangbuk Samsung Hospital | Recruiting | Seoul | 03181 | South Korea |
| The Catholic University of Korea Eunpyeong St. Mary's Hospital | Recruiting | Seoul | 03312 | South Korea |
| Asan Medical Center. | Recruiting | Seoul | 05505 | South Korea |
| Samsung Medical Center | Recruiting | Seoul | 06351 | South Korea |
| Chung-Ang University Hospital | Recruiting | Seoul | 06973 | South Korea |
| Guy's Hospital | Recruiting | London | Greater London | SE1 9RT | United Kingdom |
| King's College Hospital | Recruiting | London | Greater London | SE5 9RS | United Kingdom |
| Royal Liverpool University Hospital | Recruiting | Liverpool | Merseyside | L7 8YE | United Kingdom |
| John Radcliffe Hospital | Recruiting | Oxford | Oxfordshire | OX3 9DU | United Kingdom |
| Addenbrook'es Hospital | Recruiting | Cambridge | CB2 0QQ | United Kingdom |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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