A Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Afimkibart (RO7790121) in Children With Moderately to Severely Active Ulcerative Colitis

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age2-17
SponsorHoffmann-La Roche

About this trial

This Phase III, randomized, double-blind, multicenter, induction and maintenance study will evaluate the safety and efficacy of Afimkibart (RO7790121) in pediatric participants with moderate to severe active ulcerative colitis (UC).

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Afimkibart

Treatment groups

100 Participants
are divided into 2 treatment groups

Sponsors and collaborators