A Study to Assess the Efficacy and Safety of RO7790121 for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis

Description

This Phase III, multicenter, double-blind, placebo-controlled, treat-through study will evaluate the efficacy and safety of RO7790121 compared with placebo in participants with moderately to severely active ulcerative colitis (UC).

Conditions

Moderately to Severely Active Ulcerative Colitis

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Study Overview

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Study Details

Study overview

This Phase III, multicenter, double-blind, placebo-controlled, treat-through study will evaluate the efficacy and safety of RO7790121 compared with placebo in participants with moderately to severely active ulcerative colitis (UC).

A Phase III, Multicenter, Double-Blind, Placebo-Controlled, Treat-Through Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With RO7790121 in Patients With Moderately to Severely Active Ulcerative Colitis

A Study to Assess the Efficacy and Safety of RO7790121 for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis

Condition
Moderately to Severely Active Ulcerative Colitis
Intervention / Treatment

-

Contacts and Locations

Dothan

Digestive Health Specialists, Dothan, Alabama, United States, 36301

Santa Clarita

Amicis Research Center, Santa Clarita, California, United States, 91355

Homestead

Homestead Associates in Research, Inc., Homestead, Florida, United States, 33033

Kissimmee

Clinical Research of Osceola, LLC, Kissimmee, Florida, United States, 34741

Miami Beach

Miami Beach Clinical Research Center, Miami Beach, Florida, United States, 33141

Zephyrhills

Florida Medical Clinic, Zephyrhills, Florida, United States, 33542

Macon

Gastroenterology Associates of Central Georgia, Macon, Georgia, United States, 31201

Idaho Falls

Grand Teton Research Group, PLLC, Idaho Falls, Idaho, United States, 83404

New Albany

Gastroenterology Health Partners, PLLC, New Albany, Indiana, United States, 47150

Crestview Hills

Tri-State Gastroenterology Associates, Crestview Hills, Kentucky, United States, 41017

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Confirmed diagnosis of UC
  • * Moderately to severely active UC assessed by mMS
  • * Bodyweight \>= 40 kilogram (kg)
  • * Demonstrated inadequate response, loss of response and/or intolerance to at least one protocol-specified conventional or advanced UC therapy
  • * Males and females of childbearing potential must meet protocol criteria for contraception requirements
  • * Currently known complications of UC (e.g. fulminant colitis, toxic megacolon)
  • * Current diagnosis of Crohn's disease (CD) or indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis
  • * Presence of an ostomy or ileoanal pouch
  • * Current diagnosis or suspicion of primary sclerosing cholangitis
  • * Pregnancy or breastfeeding, or intention of becoming pregnant during the study
  • * Past or current evidence of definite low-grade or high-grade colonic dysplasia or adenomas or neoplasia not completely removed
  • * History of malignancy within 5 years, with the exception of malignancies adequately treated with resection for non-metastatic basal cell or squamous cell cancer or in situ cervical cancer
  • * Evidence of infection with Clostridioides difficile (C. difficile; formerly known as Clostridium difficile), cytomegalovirus (CMV), human immunodeficiency virus (HIV), Hepatitis B (HBV), Hepatitis C (HCV)
  • * Has evidence of active tuberculosis (TB), latent TB not successfully treated (per local guidance) or inadequately treated TB
  • * Has received protocol-specified prohibited medicines, including known exposure to any type of anti-TL1A therapy

Ages Eligible for Study

16 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Hoffmann-La Roche,

Clinical Trials, STUDY_DIRECTOR, Hoffmann-La Roche

Study Record Dates

2029-12-30