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A Phase 3 Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Open-label Intravenous Induction Treatment Followed by Randomized Double-blind Subcutaneous Ustekinumab Maintenance in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis
Conditions
Interventions
Ustekinumab Dose Based on BSA and Body Weight
Matching Placebo
Locations
58
United States
Nemours DuPont Hospital for Children
Wilmington, Delaware, United States
Children's Center for Digestive Health Care
Atlanta, Georgia, United States
Mayo Clinic
Rochester, Minnesota, United States
Morristown Memorial Hospital
Morristown, New Jersey, United States
Levine Childrens at Atrium Health
Charlotte, North Carolina, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Start Date
March 17, 2021
Primary Completion Date
May 8, 2025
Completion Date
June 5, 2025
Last Updated
July 18, 2025
NCT05076175
NCT06359808
NCT06651281
NCT04121806
NCT06065228
NCT06892990
Lead Sponsor
Janssen Research & Development, LLC
Data Source & Attribution
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