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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Moderately to Severely Active Ulcerative Colitis

In brief

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).

Key facts

Study ID

NCT06589986

Run by

Hoffmann-La Roche

People needed

400

Starts

2024-09-17

Expected to finish

2031-01-30

Last updated by the study team

2026-06-18

Who can join

Age: 16 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• Om Research LLC — Lancaster, California, United States
• University of California Irvine — Orange, California, United States
• Amicis Research Center — Santa Clarita, California, United States
• Peak Gastroenterology Associates — Colorado Springs, Colorado, United States
• Access Research Institute — Brooksville, Florida, United States
• Gastro Florida — Clearwater, Florida, United States
• J&A Clinical Research — Doral, Florida, United States
• Clinical Research of Osceola, LLC — Kissimmee, Florida, United States
• Auzmer Research — Lakeland, Florida, United States
• Florida Research Institute - Lakewood — Lakewood Rch, Florida, United States
• Homestead Associates in Research, Inc. — Miami, Florida, United States
• Allied Biomedical Research Institute, Inc — Miami, Florida, United States
• Miami Beach Clinical Research Center — Miami Beach, Florida, United States
• Eminat Research Group — Miramar, Florida, United States
• Nodal Medical Center, LLC — Tampa, Florida, United States
• Theia Clinical Research Centers, LLC — Tampa, Florida, United States
• Florida Medical Clinic — Zephyrhills, Florida, United States
• Gastroenterology Associates of Central Georgia — Macon, Georgia, United States
• Grand Teton Research Group, PLLC — Idaho Falls, Idaho, United States
• The University of Chicago — Chicago, Illinois, United States
• Indiana University Health University Hospital — Indianapolis, Indiana, United States
• Gastroenterology Health Partners, PLLC — New Albany, Indiana, United States
• Tri-State Gastroenterology Associates — Crestview Hills, Kentucky, United States
• Robley Rex VA Medical Center — Louisville, Kentucky, United States
• Digestive Health Specialists of the Southeast (Gastroenterology Associates of Dothan) - Dothan — Dothan, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.