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Evaluating a new treatment for active ulcerative colitis

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

Phase 3 Interventional Hoffmann-La Roche · NCT06588855

This study is testing a new drug called RO7790121 to see if it can help people with moderate to severe ulcerative colitis who haven't found relief with other treatments.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment350 (estimated)
Ages16 Years to 80 Years
SexAll
SponsorHoffmann-La Roche Industry-sponsored
Drugs / interventionsradiation
Locations199 sites (Dothan, Alabama and 198 other locations)
Trial IDNCT06588855 on ClinicalTrials.gov

What this trial studies

This Phase III, multicenter, double-blind, placebo-controlled study aims to assess the efficacy and safety of RO7790121 as an induction therapy for participants suffering from moderately to severely active ulcerative colitis. Participants will be randomly assigned to receive either the investigational drug or a placebo, allowing for a rigorous comparison of outcomes. The study will include individuals who have not adequately responded to previous treatments for their condition. The primary focus is to determine if RO7790121 can provide significant relief and improvement in symptoms compared to placebo.

Who should consider this trial

Good fit: Ideal candidates are individuals diagnosed with moderately to severely active ulcerative colitis who have not responded to other therapies.

Not a fit: Patients with complications from ulcerative colitis or other forms of colitis may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new effective option for patients with difficult-to-treat ulcerative colitis.

How similar studies have performed: Other studies have shown promise with similar therapeutic approaches, but the specific efficacy of RO7790121 is being evaluated for the first time in this context.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Dothan, Alabama and 198 other locations

+149 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Moderately to Severely Active Ulcerative Colitis
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.