Last updated 9 days ago
A Study to Assess the Efficacy and Safety of RO7790121 for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis
400 patients around the world
Available in Chile
Hoffmann-La Roche
1Research sites
400Patients around the world
This study is for people with
Ulcerative colitis
Moderate/severe ulcerative colitis
Requirements for the patient
To 80 Years
All Gender
Medical requirements
- 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.
- 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.
Sites
Clínica Universidad de los Andes
Recruiting
StudyAmetrine-1
SponsorHoffmann-La Roche
Conditions
Moderate/severe ulcerative colitis
Requirements
To 80 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06589986
