Last updated 11 days ago
A Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With RO7790121 in Participants With Moderately to Severely Active Crohn's Disease
600 patients around the world
Available in Puerto Rico, Chile, United States, Mexico
Hoffmann-La Roche
1Research sites
600Patients around the world
This study is for people with
Crohn's disease
Moderate to severe crohn's disease
Requirements for the patient
To 80 Years
All Gender
Medical requirements
- Confirmed diagnosis of CD.Moderately to severely active CD.Bodyweight >= 40 kilogram (kg).Demonstrated inadequate response, loss of response and/or intolerance to at least one protocol-specified conventional or advanced CD therapy.Males and females of childbearing potential must meet protocol criteria for contraception requirements.
- Current diagnosis of ulcerative colitis (UC) or indeterminate colitis, ischemic colitis, infectious colitis, radiation colitis, microscopic colitis.Participant with a history of >= 3 bowel resections (> 2 missing segments of the 5 following segments: terminal ilelium, right colon, transverse colon, sigmoid and left colon, and rectum).Diagnosis of short gut or short bowel syndrome.Presence of an ileostomy, colostomy or ileoanal pouch.Participants with symptomatic bowel strictures, fulminant colitis, or toxic megacolon.Presence of abdominal or perianal abscess.Presence of rectovaginal fistulas or perianal fistulas with >3 openings.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
Medical Care & Research SA de CV
Recruiting
StudySIBERITE-1
SponsorHoffmann-La Roche
Study typeInterventional
Conditions
Moderate to severe crohn's disease
Requirements
To 80 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06819878
