Trial Radar
Sign in

NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

NCT07158242

RecruitingPhase 3

Sponsor: Hoffmann-La Roche

Conditions: Moderately to Severely Active Ulcerative Colitis

Interventions: Afimkibart

Countries: United States, Australia, China, South Africa, Taiwan, Thailand, United Kingdom

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 overview

Sex: ALL

Age: 2 Years to 17 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)
Locations (15)
  • Tampa, Florida, United States
  • Atlanta, Georgia, United States
  • New York, New York, United States
  • South Brisbane, Queensland, Australia
  • Parkville, Victoria, Australia
  • Nedlands, Western Australia, Australia
  • Hangzhou, Zhejiang, China
  • Pretoria, South Africa
  • Taipei, Taiwan
  • Bangkok, Thailand
  • Bangkok, Thailand
  • Bangkok, Thailand
  • Birmingham, United Kingdom
  • Cambridge, United Kingdom
  • Sheffield, United Kingdom