A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (Also Known as RO7790121) in Participants With Moderately to Severely Active Ulcerative Colitis

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Moderately to Severely Active Ulcerative Colitis

In brief

This Phase III, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of induction therapy with Afimkibart (RO7790121) compared with placebo in participants with moderately to severely active ulcerative colitis (UC).

Key facts

Study ID

NCT06588855

Run by

Hoffmann-La Roche

People needed

350

Starts

2024-12-11

Expected to finish

2031-01-30

Last updated by the study team

2026-08-05

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

• Mayo Clinic Hospital — Scottsdale, Arizona, United States (enrolling)
• Digestive Health Specialists of the Southeast (Gastroenterology Associates of Dothan) - Dothan — Dothan, Alabama, United States (enrolling)
• Om Research LLC — Apple Valley, California, United States (enrolling)
• Valley View Internal Medicine — Garden Grove, California, United States (enrolling)
• Gastro Care Associates — Lancaster, California, United States (enrolling)
• Arizona Digestive Health, P.C (ADH) — Sun City, Arizona, United States (enrolling)
• Hoag Memorial Hospital Presbyterian;Hoag Center for Research and Education — Newport Beach, California, United States (enrolling)
• Stanford Medicine Outpatient Center — Redwood City, California, United States (enrolling)
• Peak Gastroenterology Associates — Colorado Springs, Colorado, United States (enrolling)
• Hi Tech and Global Research, LLC — Coral Gables, Florida, United States (enrolling)
• The Sister Life Research — Hialeah, Florida, United States (enrolling)
• LCC Medical Research Institute, LLC — Miami, Florida, United States (enrolling)
• Allied Biomedical Research Institute — Miami, Florida, United States (enrolling)
• University of Southern California — Los Angeles, California, United States (enrolling)
• Integrity Trials LLC — Orlando, Florida, United States (enrolling)
• Digestive and Liver Center of Florida — Orlando, Florida, United States (enrolling)
• Advanced Medical Research Center — Port Orange, Florida, United States (enrolling)
• University of South Florida School of Medicine Morsani Center for Advanced Health Care — Tampa, Florida, United States (enrolling)
• Guardian Angel Research Center, LLC — Tampa, Florida, United States (enrolling)
• Santos Research Center, CORP — Tampa, Florida, United States (enrolling)
• Cleveland Clinic Florida — Weston, Florida, United States (enrolling)
• Randomize Now, LLC — Atlanta, Georgia, United States (enrolling)
• Atlanta Gastroenterology Associates — Atlanta, Georgia, United States (enrolling)
• Gastroenterology Associates of Central Georgia — Macon, Georgia, United States (enrolling)
• Grand Teton Research Group, PLLC — Idaho Falls, Idaho, United States (enrolling)

Full record on ClinicalTrials.gov

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