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RECRUITINGPhase 2INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

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.

Locations (20)

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
Intercity Gastroenterology
Fresh Meadows, New York, United States
Monroe Biomedical Research
Monroe, North Carolina, United States
Centro Digestivo de Curitiba
Curitiba, Paraná, Brazil
Newdata Clinical Trials
Aracaju, Sergipe, Brazil
CPQuali Pesquisa Clinica Ltda
So Paulo, São Paulo, Brazil
London Digestive Disease Institute
London, Ontario, Canada
Clinique IMD
Montreal, Quebec, Canada
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Hangzhou, China
PreventaMed, s.r.o.
Olomouc, Czechia
Nemocnice Slany
Slaný, Czechia
Groupe Hospitalier Ambroise Pare - Institut des MICI
Neuilly, Hauts De Seine, France
CHU Saint Etienne - Hpital Nord
Saint-Étienne-de-Montluc, Pays de la Loire Region, France
CHU Clermont Ferrand - Hôpital d'Estaing
Clermont-Ferrand, Puy De Dome, France
Centre hospitalier Lyon Sud
Pierre-Bénite, Rhone, France