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

Description

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

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

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

Condition
Moderately to Severely Active Ulcerative Colitis
Intervention / Treatment

-

Contacts and Locations

Miami

Ambert Medical Research, Miami, Florida, United States, 33176

Orlando

Digestive and Liver Center of Florida, Orlando, Florida, United States, 32825

Tampa

Guardian Angel Research Center, LLC, Tampa, Florida, United States, 33614

Southaven

Delta Gastroenterology & Endoscopy Center, Southaven, Mississippi, United States, 38671

Brooklyn

Ellipsis Research Group, Brooklyn, New York, United States, 11215

Rochester

Gastroenterology Group of Rochester under CTNx, Rochester, New York, United States, 14618

Georgetown

Amel Med LLC, Georgetown, Texas, United States, 78628

Harlingen

Cano Medical Center, Harlingen, Texas, United States, 78550

Harlingen

Texas Digestive Specialists, Harlingen, Texas, United States, 78550

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