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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
Sponsor: Hoffmann-La Roche
Summary
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).
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
Key Details
Gender
All
Age Range
2 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2026-04-15
Completion Date
2031-03-31
Last Updated
2026-05-22
Healthy Volunteers
No
Interventions
Afimkibart
Afimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection.
Locations (12)
Children's Healthcare of Atlanta
Atlanta, Georgia, United States
NYU Langone Health
New York, New York, United States
Royal Children's Hospital
Parkville, Victoria, Australia
Perth Children's Hospital
Nedlands, Western Australia, Australia
Children's Hospital ZheJiang University School of Medicine
Hangzhou, Zhejiang, China
National Taiwan University Hospital
Taipei, Taiwan
Chulalongkorn University
Bangkok, Thailand
Siriraj Hospital
Bangkok, Thailand
Ramathibodi Hospital
Bangkok, Thailand
Birmingham Children's Hospital
Birmingham, United Kingdom
Addenbrooke's Hospital
Cambridge, United Kingdom
Sheffield Childrens Hospital
Sheffield, United Kingdom