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

NCT06979336 · tracked via the Priya Life Science UK tracker

Sponsor

Genentech, Inc.

Phase

Phase 2

Started

2025-09-29

Last updated

2026-08-27

Condition(s) studied

Ulcerative Colitis

Investigational drug(s) / intervention(s)

RO7837195RO7837195 Matched Placebo

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

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

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Percentage of Participants With Clinical Remission at Week 12 — 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.

Trial sites (106)

Facility	City	Region	Status
Gastro Care Institute	Lancaster	California	Recruiting
Medical Associates Research Group, Inc.	San Diego	California	Recruiting
Peak Gastroenterology Associates	Colorado Springs	Colorado	Recruiting
Clinical Research of Osceola, LLC	Kissimmee	Florida	Recruiting
University of Chicago Medical Center	Chicago	Illinois	Recruiting
Intercity Gastroenterology	Fresh Meadows	New York	Recruiting
Monroe Biomedical Research	Monroe	North Carolina	Recruiting
University of Utah Hospitals & Clinics	Salt Lake City	Utah	Recruiting
Mater Misericordiae Limited	South Brisbane	Queensland	Recruiting
Royal Melbourne Hospital	Parkville VIC	Victoria	Recruiting
Fiona Stanley Hospital	Murdoch	Western Australia	Recruiting
HUWC - UFC - Hospital Universitrio Walter Cantdio - Universidade Federal do Cear	Fortaleza	Ceará	Recruiting
L2IP ?Instituto de Pesquisas Clínicas Ltda.	Brasília	Federal District	Recruiting
Chronos Pesquisa Clinica	Brasília	Federal District	Recruiting
Hospital Felicio Rocho	Belo Horizonte	Minas Gerais	Recruiting
Associao Paranaense de Cultura APC	Curitiba	Paraná	Recruiting
Centro Digestivo de Curitiba	Curitiba	Paraná	Recruiting
Hospital de Clnicas de Porto Alegre	Porto Alegre	Rio Grande do Sul	Recruiting
Hospital Ernesto Dornelles	Porto Alegre	Rio Grande do Sul	Recruiting
Newdata Clinical Trials	Aracaju	Sergipe	Recruiting
CECIP - Centro de Estudos Clínicos do Interior Paulista	Ja	São Paulo	Recruiting
Pesquisare Saude	Santo André	São Paulo	Recruiting
Kaiser Clinica	São José do Rio Preto	São Paulo	Recruiting
Instituto de Assistencia Medica ao Servidor Publico Estudo Estadual	São Paulo	São Paulo	Recruiting
BR Trials - Ensaios Clnicos e Consultoria	São Paulo	São Paulo	Recruiting
CPQuali Pesquisa Clinica Ltda	So Paulo	São Paulo	Recruiting
Hospital Gloria DOr - Hospitais Integrados da Gavea S/A	Rio de Janeiro	Brazil	Recruiting
London Digestive Disease Institute	London	Ontario	Recruiting
Hopital Maisonneuve-Rosemont d/b/a CIUSSS de l'Est-de-l'le-de-Montral	Montreal	Quebec	Recruiting
Clinique IMD	Montreal	Quebec	Recruiting
The First Affiliated Hospital Of Fujian Medical University	Fuzhou	Fujian	Recruiting
Zhongshan Hospital Xiamen University	Xiamen	Fujian	Recruiting
The second Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong	Recruiting
The sixth affiliated hospital of Sun Yat-Sen University	Guangzhou	Guangdong	Recruiting
Huizhou Municipal Central Hospital	Huizhou	Guangdong	Recruiting
The Second Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan	Recruiting
Renmin Hospital of Wuhan University	Wuhan	Hubei	Recruiting
The First Hospital of Jilin University	Changchun	Jilin	Recruiting
Binzhou Medical university hospital	Binzhou	Shandong	Recruiting
Sichuan Provincial People's Hospital	Chengdu	Sichuan	Recruiting

+ 66 more sites — see the full list on the official registry below.

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Other trials for the same condition

A Study to Investigate the Efficacy and Safety of SAR442970 in Adult Participants With Ulcerative Colitis Recruiting

A Study to Evaluate Efficacy and Safety of MK-8690 in Participants With Moderately to Severely Active Ulcerative Colitis (MK-8690-002) Recruiting

Mirikizumab Administered at the Same Time as Tirzepatide in Adult Participants With Moderately to Severely Active Ulcerative Colitis and Obesity or Overweight: Phase 3b Study Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06979336 on ClinicalTrials.gov ↗ ← All trials in the UK