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

NCT07158242 · Hoffmann-La Roche
In plain English

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Official title
A Phase III Randomized Double-Blind Multi-Center Treat-Through Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Induction and Maintenance Therapy With Afimkibart (RO7790121) in Children Aged 2 - 17 Years With Moderately to Severely Active Ulcerative Colitis
About this study
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
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)
Study design
Enrollment target: 100 participants
Allocation: randomized
Masking: quadruple
Age groups: child
Timeline
Starts: 2026-04-15
Estimated completion: 2031-03-31
Last updated: 2026-04-13
Interventions
Drug: Afimkibart
Primary outcomes
  • Percentage of Participants with Clinical Remission at Week 12 (At Week 12)
  • Percentage of Participants with Clinical Remission at Week 52 (At Week 52)
Sponsor
Hoffmann-La Roche · industry
Contacts & investigators
ContactReference Study ID Number: CA45905 https://forpatients.roche.com/ · contact · global-roche-genentech-trials@gene.com · 888-662-6728 (U.S. and Canada)
InvestigatorClinical Trials · study_director, Hoffmann-La Roche
All locations (6)
Children's Healthcare of AtlantaRecruiting
Atlanta, Georgia, United States
NYU School of MedicineRecruiting
New York, New York, United States
National Taiwan University HospitalRecruiting
Taipei, Taiwan
Birmingham Children's HospitalRecruiting
Birmingham, United Kingdom
Addenbrooke's HospitalRecruiting
Cambridge, United Kingdom
Sheffield Childrens HospitalRecruiting
Sheffield, United Kingdom
A Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Afimkibart (RO7790121) in Children With Moderately to Severely Active Ulcerative Colitis · TrialPath