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

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 Overview

• Status: Recruiting
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Drug: RO7837195; Drug: RO7837195 Matched Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 224
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Reference Study ID Number: GA45977 https://forpatients.roche.com/; Phone Number: 888-662-6728 (U.S.); Email: global-roche-genentech-trials@gene.com
• Study Contact Backup: Name: Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry

Study Locations

• Australia
  • Queensland
    • South Brisbane, Queensland, Australia, 4101
      • Recruiting
      • Mater Misericordiae Limited
• Brazil
  • Ceará
    • Fortaleza, Ceará, Brazil, 60430-370
      • Recruiting
      • HUWC - UFC - Hospital Universitrio Walter Cantdio - Universidade Federal do Cear
  • Federal District
    • Brasília, Federal District, Brazil, 70200-730
      • Recruiting
      • L2IP ?Instituto de Pesquisas Clínicas Ltda.
    • Brasília, Federal District, Brazil, 72145-450
      • Recruiting
      • Chronos Pesquisa Clinica
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30110-934
      • Recruiting
      • Hospital Felicio Rocho
  • Paraná
    • Curitiba, Paraná, Brazil, 80430-160
      • Recruiting
      • Centro Digestivo de Curitiba
    • Curitiba, Paraná, Brazil, 80230-130
      • Recruiting
      • Associao Paranaense de Cultura APC
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90160-093
      • Recruiting
      • Hospital Ernesto Dornelles
    • Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
      • Recruiting
      • Hospital de Clnicas de Porto Alegre
  • Sergipe
    • Aracaju, Sergipe, Brazil, 49075-000
      • Recruiting
      • Newdata Clinical Trials
  • São Paulo
    • Ja, São Paulo, Brazil, 17201-130
      • Recruiting
      • CECIP - Centro de Estudos Clínicos do Interior Paulista
    • Santo André, São Paulo, Brazil, 09080-110
      • Recruiting
      • Pesquisare Saude
    • So Paulo, São Paulo, Brazil, 01228-000
      • Recruiting
      • CPQuali Pesquisa Clínica Ltda
    • São José do Rio Preto, São Paulo, Brazil, 15015-110
      • Recruiting
      • Kaiser Clinica
    • São Paulo, São Paulo, Brazil, 05003-090
      • Recruiting
      • BR Trials - Ensaios Clnicos e Consultoria
• Canada
  • Ontario
    • London, Ontario, Canada, N6K 1M6
      • Recruiting
      • London Digestive Disease Institute
  • Quebec
    • Montreal, Quebec, Canada, H1T 2M4
      • Recruiting
      • Hopital Maisonneuve-Rosemont d/b/a CIUSSS de l'Est-de-l'le-de-Montral
    • Montreal, Quebec, Canada, H3H 1E8
      • Recruiting
      • Clinique IMD
• China
  • Hangzhou, China, 310018
    • Recruiting
    • Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
  • Fujian
    • Xiamen, Fujian, China, 361004
      • Recruiting
      • Zhongshan Hospital Xiamen University
  • Guangdong
    • Guangzhou, Guangdong, China, 510260
      • Recruiting
      • The Second Affiliated Hospital of Guangzhou Medical University
  • Henan
    • Zhengzhou, Henan, China, 450014
      • Recruiting
      • The Second Affiliated Hospital of Zhengzhou University
  • Shandong
    • Binzhou, Shandong, China, 256603
      • Recruiting
      • Binzhou Medical University Hospital
  • Sichuan
    • Chengdu, Sichuan, China, 610072
      • Recruiting
      • Sichuan Provincial People's Hospital
  • Zhejiang
    • Ningbo, Zhejiang, China, 315010
      • Recruiting
      • The First Affiliated Hospital of Ningbo University
• Czechia
  • Olomouc, Czechia, 779 00
    • Recruiting
    • PreventaMed, s.r.o.
  • Slaný, Czechia, 27401
    • Recruiting
    • Nemocnice Slany
• France
  • Hauts De Seine
    • Neuilly, Hauts De Seine, France, 92200
      • Recruiting
      • Groupe Hospitalier Ambroise Pare - Institut des MICI
  • Pays de la Loire Region
    • Saint-Étienne-de-Montluc, Pays de la Loire Region, France, 42055
      • Recruiting
      • CHU Saint Etienne - Hpital Nord
  • Puy De Dome
    • Clermont-Ferrand, Puy De Dome, France, 63000
      • Recruiting
      • CHU Clermont Ferrand - Hôpital d'Estaing
  • Rhone
    • Pierre-Bénite, Rhone, France, 69495
      • Recruiting
      • Centre Hospitalier Lyon Sud
• Germany
  • Hesse
    • Frankfurt am Main, Hesse, Germany, 60590
      • Recruiting
      • Universitaetsklinikum Frankfurt Goethe-Universitaet
• Italy
  • Emilia-Romagna
    • Rome, Emilia-Romagna, Italy, 00168
      • Recruiting
      • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  • Lombardy
    • Brescia, Lombardy, Italy, 25124
      • Recruiting
      • Fondazione Poliambulanza Istituto Ospedaliero
    • Rho, Lombardy, Italy, 20017
      • Recruiting
      • ASST Rhodense, Rho Memorial Hospital
    • Rozzano, Lombardy, Italy, 20089
      • Recruiting
      • Istituto Clinico Humanitas
    • San Donato Milanese (MI), Lombardy, Italy, 20097
      • Recruiting
      • I.R.C.C.S Policlinico San Donato
  • Piedmont
    • Turin, Piedmont, Italy, 10128
      • Recruiting
      • Ospedale Mauriziano Umberto I
• Japan
  • Fujidera-shi, Japan, 583-0027
    • Recruiting
    • Shinseikai Sai Gastroenterology, Proctology
  • Nagoya, Japan, 457-8511
    • Recruiting
    • Kojunkai Daido Clinic
  • Chiba
    • Kashiwa-shi, Chiba, Japan, 277-0871
      • Recruiting
      • Kokikai Tsujinaka Hospital Kashiwanoha
  • Fukuoka
    • Fukuoka, Fukuoka, Japan, 814-0180
      • Recruiting
      • Fukuoka University Hospital
  • Hiroshima
    • Fukuyama-shi, Hiroshima, Japan, 720-8520
      • Recruiting
      • NHO Fukuyama Medical Center
  • Ishikawa-ken
    • Kanazawa, Ishikawa-ken, Japan, 920-8650
      • Recruiting
      • NHO Kanazawa Medical Center
  • Kagawa-ken
    • Takamatsu, Kagawa-ken, Japan, 760-0017
      • Recruiting
      • Takamatsu Red Cross Hospital
  • Osaka
    • Osaka, Osaka, Japan, 540-0006
      • Recruiting
      • NHO Osaka National Hospital
  • Saga-ken
    • Saga, Saga-ken, Japan, 849-8501
      • Recruiting
      • Saga University Hospital
• Mexico
  • Veracruz, Mexico, 91900
    • Recruiting
    • FAICIC S de R.L. de C.V
  • Jalisco
    • Tlajomulco de Zúñiga, Jalisco, Mexico, 45645
      • Recruiting
      • Centro Medico Clinico Quirurgico Especializado en Investigacion
  • Yucatán
    • Mérida, Yucatán, Mexico, 97130
      • Recruiting
      • Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan
• Poland
  • Bydgoszcz, Poland, 85-229
    • Recruiting
    • Centrum Medyczne "Medis"
  • Bydgoszcz, Poland, 85-794
    • Recruiting
    • Clinsante S.C. Osrodek Badan Klinicznych
  • Chojnice, Poland, 89-600
    • Recruiting
    • Centrum Medyczne Lukamed Joanna Luka
  • Katowice, Poland, 40-748
    • Recruiting
    • Vita Longa Sp. z o.o.
  • Knurów, Poland, 44-190
    • Recruiting
    • MZ Badania Slowik Zymla Sp.j.
  • Nowy Targ, Poland, 34-400
    • Recruiting
    • Allmedica Badania Kliniczne sp. z o.o. sp.k.
  • Poznan, Poland, 60-529
    • Recruiting
    • Solumed Centrum Medyczne
  • Poznan, Poland, 60-681
    • Recruiting
    • NSZOZ Termedica Centrum Badan Klinicznych
  • Poznan, Poland, 61-731
    • Recruiting
    • Clinical Research Center Spka z ograniczon odpowiedzialnoci Medic-R Sp.k.
  • Skierniewice, Poland, 96-100
    • Recruiting
    • Velocity Skierniewice Sp. z o.o
  • Szczecin, Poland, 71-434
    • Recruiting
    • Twoja Przychodnia-Szczecinskie Centrum Medyczne
  • Warsaw, Poland, 00-189
    • Recruiting
    • Centrum Zdrowia MDM
  • Warsaw, Poland, 02-679
    • Recruiting
    • Medon Clinical Research sp. z o.o
  • Warsaw, Poland, 02-507
    • Recruiting
    • Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych Administracji
  • Warsaw, Poland, 02-647
    • Recruiting
    • Provita Poliklinika sp. z o.o
  • Warsaw, Poland, 04-501
    • Recruiting
    • Medical Network Spka z o. o., WIP Warsaw IBD Point Profesor Kierkus
  • Wroc?aw, Poland, 53-149
    • Recruiting
    • Przychodnia Vistamed
  • Zamość, Poland, 22-400
    • Recruiting
    • ETG Zamosc
• South Korea
  • Busan, South Korea, 48108
    • Recruiting
    • Inje University Haeundae Paik Hospital
  • Daejeon, South Korea, 34943
    • Recruiting
    • The Catholic University of Korea Daejeon ST. Mary?s Hospital
  • Gwangju, South Korea, 61453
    • Recruiting
    • Chosun university hospital
  • Seoul, South Korea, 06351
    • Recruiting
    • Samsung Medical Center
  • Seoul, South Korea, 03181
    • Recruiting
    • Kangbuk Samsung Hospital
  • Seoul, South Korea, 06973
    • Recruiting
    • Chung-Ang University Hospital
  • Seoul, South Korea, 03312
    • Recruiting
    • The Catholic University of Korea Eunpyeong St. Mary's Hospital
  • Seoul, South Korea, 05505
    • Recruiting
    • Asan Medical Center.
  • Gangwon-do
    • Wŏnju, Gangwon-do, South Korea, 26426
      • Recruiting
      • Yonsei University Wonju Severance Christian Hospital
• United Kingdom
  • Cambridge, United Kingdom, CB2 0QQ
    • Recruiting
    • Addenbrook'es Hospital
  • Greater London
    • London, Greater London, United Kingdom, SE5 9RS
      • Recruiting
      • King's College Hospital
    • London, Greater London, United Kingdom, SE1 9RT
      • Recruiting
      • Guy's Hospital
  • Merseyside
    • Liverpool, Merseyside, United Kingdom, L7 8YE
      • Recruiting
      • Royal Liverpool University Hospital
  • Oxfordshire
    • Oxford, Oxfordshire, United Kingdom, OX3 9DU
      • Recruiting
      • John Radcliffe Hospital
• United States
  • California
    • Lancaster, California, United States, 93534
      • Recruiting
      • Gastro Care Institute
    • San Diego, California, United States, 92123
      • Recruiting
      • Medical Associates Research Group, Inc.
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Recruiting
      • Peak Gastroenterology Associates
  • Florida
    • Kissimmee, Florida, United States, 34741
      • Recruiting
      • Clinical Research of Osceola, LLC
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Recruiting
      • University of Chicago Medical Center
  • New York
    • Fresh Meadows, New York, United States, 11366
      • Recruiting
      • Intercity Gastroenterology
  • North Carolina
    • Monroe, North Carolina, United States, 28112
      • Recruiting
      • Monroe Biomedical Research
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • Recruiting
      • University of Utah Hospitals & Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RO7837195 Dose Regimen 1; Participants will receive RO7837195 per the pre-defined dosing regimen during the 12-week induction and 40-week active treatment extension phases.	Drug: RO7837195; RO7837195 will be administered as per the schedule specified in the protocol.
Experimental: RO7837195 Dose Regimen 2; Participants will receive RO7837195 per the pre-defined dosing regimen during the 12-week induction and 40-week active treatment extension phases.	Drug: RO7837195; RO7837195 will be administered as per the schedule specified in the protocol.
Experimental: RO7837195 Dose Regimen 3; Participants will receive RO7837195 per the pre-defined dosing regimen during the 12-week induction and 40-week active treatment extension phases.	Drug: RO7837195; RO7837195 will be administered as per the schedule specified in the protocol.
Experimental: RO7837195 Dose Regimen 4; Participants will receive RO7837195 per the pre-defined dosing regimen during the 12-week induction and 40-week active treatment extension phases.	Drug: RO7837195; RO7837195 will be administered as per the schedule specified in the protocol.
Experimental: RO7837195 Matched Placebo/ RO7837195; 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.	Drug: RO7837195; RO7837195 will be administered as per the schedule specified in the protocol.; Drug: RO7837195 Matched Placebo; RO7837195 matched placebo will be administered as per the schedule specified in the protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Genentech, Inc.
• Investigators: Study Director: Clinical Trials, Genentech, Inc.

Publications and helpful links

Helpful Links

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2025
• Primary Completion (Estimated): August 25, 2027
• Study Completion (Estimated): October 31, 2028

Study Registration Dates

• First Submitted: May 15, 2025
• First Submitted That Met QC Criteria: May 16, 2025
• First Posted (Actual): May 18, 2025

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: GA45977; 2025-520690-39-00 (Registry Identifier: EU CT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No