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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
2026-08-14
Healthy Volunteers
No
Interventions
Afimkibart
Afimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection.
Locations (22)
Children's Hospital Colorado
Aurora, Colorado, United States
University of South Florida
Tampa, Florida, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, United States
Northwell Health
Lake Success, New York, United States
NYU Langone Health
New York, New York, United States
Mater Hospital Brisbane
South Brisbane, Queensland, Australia
Royal Childrens Hospital
Parkville, Victoria, Australia
Perth Children's Hospital
Nedlands, Western Australia, Australia
CECIP - Centro de Estudos Clínicos do Interior Paulista
Jaú, São Paulo, Brazil
BR Trials - Pesquisa Clínica
São Paulo, São Paulo, Brazil
Hospital For Sick Children
Toronto, Ontario, Canada
Children's Hospital ZheJiang University School of Medicine
Hangzhou, Zhejiang, China
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai, China
IATROS International
Bloemfontein, South Africa
Emmed Research
Pretoria, South Africa
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