RECRUITING

A Study to Assess the Efficacy and Safety of Afimkibart (Also Known as 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 Afimkibart (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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Related Conditions:

Moderately to Severely Active Ulcerative Colitis

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 Afimkibart (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 Afimkibart (Also Known as 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 of the Southeast (Gastroenterology Associates of Dothan) - Dothan, Dothan, Alabama, United States, 36305

Sun City

Arizona Digestive Health, P.C (ADH), Sun City, Arizona, United States, 85351

Inglewood

310 Clinical Research, Inglewood, California, United States, 90301

Lancaster

Om Research LLC, Lancaster, California, United States, 93534

Orange

University of California Irvine, Orange, California, United States, 92868

San Diego

Acclaim Clinical Research, Inc., San Diego, California, United States, 92120

San Francisco

UCSF/Medical Center at Mount Zion, San Francisco, California, United States, 94115

Santa Clarita

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

Colorado Springs

Peak Gastroenterology Associates, Colorado Springs, Colorado, United States, 80907

Lone Tree

Peak Gastroenterology Surgery Center, Lone Tree, Colorado, United States, 80124

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)
  • * Up to date with colorectal cancer (CRC) screening performed according to local standards
  • * 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