Evaluating RO7790121 for treating active ulcerative colitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase III, multicenter, double-blind, placebo-controlled study aims to assess the efficacy and safety of RO7790121 in patients with moderately to severely active ulcerative colitis. Participants will receive either the investigational drug or a placebo, and their responses will be monitored throughout the treatment period. The study will focus on individuals who have not adequately responded to previous therapies for ulcerative colitis. The goal is to determine if RO7790121 can provide a more effective treatment option for these patients.

Why it matters

Who can join: the full rules

Inclusion 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

Exclusion Criteria:

* 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

Where it's running

• Digestive Health Specialists of the Southeast (Gastroenterology Associates of Dothan) - Dothan
  Dothan, Alabama, United States Recruiting
• Arizona Digestive Health, P.C (ADH)
  Sun City, Arizona, United States Recruiting
• University of California Irvine
  Orange, California, United States Recruiting
• UCSF/Medical Center at Mount Zion
  San Francisco, California, United States Recruiting
• Amicis Research Center
  Santa Clarita, California, United States Recruiting
• Peak Gastroenterology Associates
  Colorado Springs, Colorado, United States Recruiting

+160 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Reference Study ID Number: GA45329 https://forpatients.roche.com/
• Email: global-roche-genentech-trials@gene.com
• Phone: 888-662-6728 (U.S. and Canada)

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.