A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of RO7837195 in Participants With Moderately to Severely Active Ulcerative Colitis (UC)

NCT06979336 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: GA459772025-520690-39-00
• Study Type: interventional
• Target: 224
• Locations: 14 countries
• Sites: 82

Brief Summary

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.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Percentage of Participants With Clinical Response at Week 12

  At Week 12

• Percentage of Participants With Endoscopic Improvement at Week 12

  At Week 12

• Percentage of Participants With Endoscopic Remission at Week 12

  At Week 12

• Number of Participants With Adverse Events (AEs)

  Up to Weeks 65

• Serum Concentration of RO7837195

  Up to Weeks 65

Study Arms (5)

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.

Drug: RO7837195

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.

Drug: RO7837195

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.

Drug: RO7837195

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.

Drug: RO7837195

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.

Drug: RO7837195; Drug: RO7837195 Matched Placebo

Interventions

RO7837195 DRUG

RO7837195 will be administered as per the schedule specified in the protocol.

RO7837195 Dose Regimen 1; RO7837195 Dose Regimen 2; RO7837195 Dose Regimen 3; RO7837195 Dose Regimen 4; RO7837195 Matched Placebo/ RO7837195

RO7837195 Matched Placebo DRUG

RO7837195 matched placebo will be administered as per the schedule specified in the protocol.

RO7837195 Matched Placebo/ RO7837195

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (82)

Gastro Care Institute

Lancaster, California, 93534, United States

RECRUITING

Medical Associates Research Group, Inc.

San Diego, California, 92123, United States

RECRUITING

Peak Gastroenterology Associates

Colorado Springs, Colorado, 80907, United States

RECRUITING

Clinical Research of Osceola, LLC

Kissimmee, Florida, 34741, United States

RECRUITING

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

RECRUITING

Intercity Gastroenterology

Fresh Meadows, New York, 11366, United States

RECRUITING

Monroe Biomedical Research

Monroe, North Carolina, 28112, United States

RECRUITING

Mater Misericordiae Ltd

South Brisbane, Queensland, 4101, Australia

RECRUITING

Chronos Pesquisa Clinica

Brasília, Federal District, 72145-450, Brazil

RECRUITING

Hospital Felicio Rocho

Belo Horizonte, Minas Gerais, 30110-934, Brazil

RECRUITING

Associao Paranaense de Cultura APC

Curitiba, Paraná, 80230-130, Brazil

RECRUITING

Centro Digestivo de Curitiba

Curitiba, Paraná, 80430-160, Brazil

RECRUITING

Hospital de Clnicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

RECRUITING

Hospital Ernesto Dornelles

Porto Alegre, Rio Grande do Sul, 90160-093, Brazil

RECRUITING

Newdata Clinical Trials

Aracaju, Sergipe, 49075-000, Brazil

RECRUITING

Pesquisare Saude

Santo André, São Paulo, 09080-110, Brazil

RECRUITING

CPQuali Pesquisa Clinica Ltda

So Paulo, São Paulo, 01228-000, Brazil

RECRUITING

London Digestive Disease Institute

London, Ontario, N6K 1M6, Canada

RECRUITING

Hopital Maisonneuve-Rosemont d/b/a CIUSSS de l'Est-de-l'le-de-Montral

Montreal, Quebec, H1T 2M4, Canada

RECRUITING

Clinique IMD

Montreal, Quebec, H3H 1E8, Canada

RECRUITING

Zhongshan Hospital Xiamen University

Xiamen, Fujian, 361004, China

RECRUITING

The Second Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450014, China

RECRUITING

Binzhou Medical university hospital

Binzhou, Shandong, 256603, China

RECRUITING

Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610072, China

RECRUITING

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, 315010, China

RECRUITING

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

Hangzhou, 310018, China

RECRUITING

PreventaMed, s.r.o.

Olomouc, 779 00, Czechia

RECRUITING

Nemocnice Slany

Slaný, 27401, Czechia

RECRUITING

Groupe Hospitalier Ambroise Pare - Institut des MICI

Neuilly, Hauts De Seine, 92200, France

RECRUITING

CHU Saint Etienne - Hpital Nord

Saint-Étienne-de-Montluc, Pays de la Loire Region, 42055, France

RECRUITING

CHU Clermont Ferrand - Hôpital d'Estaing

Clermont-Ferrand, Puy De Dome, 63000, France

RECRUITING

Centre hospitalier Lyon Sud

Pierre-Bénite, Rhone, 69495, France

RECRUITING

Universitaetsklinikum Frankfurt Goethe-Universitaet

Frankfurt am Main, Hesse, 60590, Germany

RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Emilia-Romagna, 00168, Italy

RECRUITING

Fondazione Poliambulanza Istituto Ospedaliero

Brescia, Lombardy, 25124, Italy

RECRUITING

ASST Rhodense, Rho Memorial Hospital

Rho, Lombardy, 20017, Italy

RECRUITING

Istituto Clinico Humanitas

Rozzano, Lombardy, 20089, Italy

RECRUITING

I.R.C.C.S Policlinico San Donato

San Donato Milanese (MI), Lombardy, 20097, Italy

RECRUITING

Ospedale Mauriziano Umberto I

Turin, Piedmont, 10128, Italy

RECRUITING

Kokikai Tsujinaka Hospital Kashiwanoha

Kashiwa-shi, Chiba, 277-0871, Japan

RECRUITING

Fukuoka University Hospital

Fukuoka, Fukuoka, 814-0180, Japan

RECRUITING

NHO Fukuyama Medical Center

Fukuyama-shi, Hiroshima, 720-8520, Japan

RECRUITING

NHO Kanazawa Medical Center

Kanazawa, Ishikawa-ken, 920-8650, Japan

RECRUITING

Takamatsu Red Cross Hospital

Takamatsu, Kagawa-ken, 760-0017, Japan

RECRUITING

NHO Osaka National Hospital

Osaka, Osaka, 540-0006, Japan

RECRUITING

Saga University Hospital

Saga, Saga-ken, 849-8501, Japan

RECRUITING

Shinseikai Sai Gastroenterology, Proctology

Fujidera-shi, 583-0027, Japan

RECRUITING

Kojunkai Daido Clinic

Nagoya, 457-8511, Japan

RECRUITING

Centro Medico Clinico Quirurgico Especializado en Investigacion

Tlajomulco de Zúñiga, Jalisco, 45645, Mexico

RECRUITING

Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan

Mérida, Yucatán, 97130, Mexico

RECRUITING

Centrum Medyczne "Medis"

Bydgoszcz, 85-229, Poland

RECRUITING

Clinsante S.C. Osrodek Badan Klinicznych

Bydgoszcz, 85-794, Poland

RECRUITING

Centrum Medyczne Lukamed Joanna Luka

Chojnice, 89-600, Poland

RECRUITING

Vita Longa Sp. z o.o.

Katowice, 40-748, Poland

RECRUITING

MZ Badania Slowik Zymla Sp.j.

Knurów, 44-190, Poland

RECRUITING

Allmedica Badania Kliniczne sp. z o.o. sp.k.

Nowy Targ, 34-400, Poland

RECRUITING

SOLUMED Centrum Medyczne

Poznan, 60-529, Poland

RECRUITING

NSZOZ Termedica Centrum Badan Klinicznych

Poznan, 60-681, Poland

RECRUITING

Clinical Research Center Spka z ograniczon odpowiedzialnoci Medic-R Sp.k.

Poznan, 61-731, Poland

RECRUITING

Velocity Skierniewice Sp. z o.o

Skierniewice, 96-100, Poland

RECRUITING

Twoja Przychodnia-Szczecinskie Centrum Medyczne

Szczecin, 71-434, Poland

RECRUITING

Centrum Zdrowia MDM

Warsaw, 00-189, Poland

RECRUITING

Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych Administracji

Warsaw, 02-507, Poland

RECRUITING

Provita Poliklinika sp. z o.o

Warsaw, 02-647, Poland

RECRUITING

Medon Clinical Research sp. z o.o

Warsaw, 02-679, Poland

RECRUITING

Medical Network Spka z o. o., WIP Warsaw IBD Point Profesor Kierkus

Warsaw, 04-501, Poland

RECRUITING

Przychodnia VISTAMED

Wroc?aw, 53-149, Poland

RECRUITING

ETG Zamosc

Zamość, 22-400, Poland

RECRUITING

Yonsei University Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, 26426, South Korea

RECRUITING

Inje university Haeundae Paik Hospital

Busan, 48108, South Korea

RECRUITING

The Catholic University of Korea Daejeon ST. Mary?s Hospital

Daejeon, 34943, South Korea

RECRUITING

Chosun University Hospital

Gwangju, 61453, South Korea

RECRUITING

Kangbuk Samsung Hospital

Seoul, 03181, South Korea

RECRUITING

The Catholic University of Korea Eunpyeong St. Mary's Hospital

Seoul, 03312, South Korea

RECRUITING

Asan Medical Center.

Seoul, 05505, South Korea

RECRUITING

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

Chung-Ang University Hospital

Seoul, 06973, South Korea

RECRUITING

Guy's Hospital

London, Greater London, SE1 9RT, United Kingdom

RECRUITING

King's College Hospital

London, Greater London, SE5 9RS, United Kingdom

RECRUITING

Royal Liverpool University Hospital

Liverpool, Merseyside, L7 8YE, United Kingdom

RECRUITING

John Radcliffe Hospital

Oxford, Oxfordshire, OX3 9DU, United Kingdom

RECRUITING

Addenbrook'es Hospital

Cambridge, CB2 0QQ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Clinical Trials

  Genentech, Inc.

  STUDY DIRECTOR

Central Study Contacts

Reference Study ID Number: GA45977 https://forpatients.roche.com/

CONTACT

888-662-6728 (U.S.); global-roche-genentech-trials@gene.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: May 18, 2025
• Study Start: September 29, 2025
• Primary Completion (Estimated): August 25, 2027
• Study Completion (Estimated): October 31, 2028
• Last Updated: May 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

CN (6); CA (3); BR (9); AU (1); ME (2); DE (1); FR (4); PL (18); IT (6); GB (5); CZ (2); JP (9); US (7); KR (9)