Digestive Health Clinical Trials
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 (Ametrine-2)
Learn MoreWhat is the purpose of this study?
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).
Eligibility
- 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
- 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 can I participate?
More about this Clinical TrialWhat is the full name of this Clinical Trial?
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
- Disease Type/ConditionModerately to Severely Active Ulcerative Colitis
- Principal InvestigatorCaroline Hwang, MD
- Co-InvestigatorsRashmi Kumar, MD, Monica McCawley, NP
- Age GroupChild, Adult, Older Adult
- PhaseIII
- ClinicalTrials.gov IDNCT06588855
- Key Eligibilityclinicaltrials.gov
- How do I learn more about this study?Laurie Hendricks, MSN, RN, OCN
laurie.hendricks@hoag.org
Hoag Digestive Health Institute
Hoag Digestive Health Institute provides advanced, comprehensive care for the full spectrum of digestive conditions, with access to world-class specialists, diagnostics and imaging, advanced interventional therapeutics, and clinical trials. Patients benefit from a research-driven approach that connects leading-edge treatment options with personalized care across gastroenterology and GI surgery.
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