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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2041240200

Enrollment

400

Registered

2025-03-11

Start date

2025-04-18

Completion date

Unknown

Last updated

2026-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis

Interventions

RO7790121: RO7790121/Placebo will be administered as IV infusion. RO7790121/Placebo will be administered as SC injection.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
efficacy -Percentage of Participants with Clinical Remission at Week 12 -Percentage of Participants with Clinical Remission at Week 52	—

Secondary

Measure	Time frame
safety, efficacy -Percentage of Participants with Clinical Response -Percentage of Participants with Maintenance of Remission -Percentage of Participants with Clinical remission: Among Biomarker-Defined Subgroups of Participants -Change in Health-Related Quality of Life -Overall Change in UC Symptoms	—

Countries

Australia, Belgium, Bulgaria, Canada, Chile, China, Czechia, Denmark, France, Germany, Hungary, Japan, Netherlands, Poland, Portugal, Serbia, Spain, Thailand, United Kingdom, United States

Contacts

Public ContactClinical trials information

Chugai Pharmaceutical Co., Ltd.

clinical-trials@chugai-pharm.co.jp+81-120189706

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: May 30, 2026