Last updated 7 days ago
A Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Afimkibart (RO7790121) in Children With Moderately to Severely Active Ulcerative Colitis
100 patients around the world
Available in Brazil, United States
Hoffmann-La Roche
2Research sites
100Patients around the world
This study is for people with
Ulcerative colitis
Moderate/severe ulcerative colitis
Requirements for the patient
To 17 Years
All Gender
Medical requirements
- Bodyweight >= 10 kilogram (kg).Confirmed diagnosis of UC.Demonstrated intolerance or inadequate response (IR) to one or more of the following categories of drugs: systemic corticosteroids, immunomodulators, and/or biologic therapies as outlined in the protocol.
- Monogenic disorder pertaining to infant onset inflammatory bowel disease (IBD).Current diagnosis of Crohn's disease (CD), abdominal/intrabdominal/perianal fistula and/or abscess, indeterminant colitis, IBD-unclassified, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, or active diverticular disease.Presence of an ostomy or ileoanal pouch.Current diagnosis or suspicion of primary sclerosing cholangitis.Any major surgery within 6 weeks prior to screening or a major planned surgery during the study.Active tuberculosis (TB) infection suggested by positive TB testing, clinical symptoms, and/or chest imaging (X-ray or CT).
Sites
CECIP Jau - Centro de Estudos Clínicos do Interior Paulista Ltda
Recruiting
BR Trials - Pesquisa Clínica - Sao Paulo
Recruiting
StudyAMETRINE-PEDS
SponsorHoffmann-La Roche
Study typeInterventional
Conditions
Moderate/severe ulcerative colitis
Requirements
To 17 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07158242
