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A Study to Assess the Pharmacokinetics, Effectiveness and Safety of Afimkibart for Induction and Maintenance Therapy in Children With Moderately to Severely Active Crohn's Disease
Sponsor: Hoffmann-La Roche
Summary
This phase III, double-blind, multi-center treat-through study will evaluate the efficacy and safety of Afimkibart (also known as RO7790121) in children with moderately to severely active Crohn's Disease (CD).
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 Crohn's Disease
Key Details
Gender
All
Age Range
2 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2026-08-18
Completion Date
2031-05-30
Last Updated
2026-10-06
Healthy Volunteers
No
Interventions
Afimkibart
Afimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection.
Locations (17)
NYU Langone Health
New York, New York, United States
Mater Hospital Brisbane
South Brisbane, Queensland, Australia
Royal Children's Hospital
Parkville, Victoria, Australia
Perth Children's Hospital
Nedlands, Western Australia, Australia
Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
CECIP - Centro de Estudos Clínicos do Interior Paulista
Jaú, São Paulo, Brazil
BR Trials - Pesquisa Clínica
São Paulo, São Paulo, Brazil
Centro de Investigación Clínica Acelerada, S.C
Mexico City, Mexico CITY (federal District), Mexico
FAICIC Clinical Research
Veracruz, Mexico
Emmed Research
Pretoria, Gauteng, South Africa
IATROS International
Bloemfontein, South Africa
National Taiwan University Hospital
Taipei, Taiwan
Chulalongkorn University
Bangkok, Thailand
Siriraj Hospital
Bangkok, Thailand
Ramathibodi Hospital
Bangkok, Thailand
King's College Hospital
London, United Kingdom
Sheffield Childrens Hospital
Sheffield, United Kingdom