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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(SC) Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Crohn’s Disease
The primary objective and primary endpoint in this study is to assess clinical remission.
To evaluate the efficacy of ustekinumab dosing in maintaining clinical remission among participants who were in clinical response in induction.
To evaluate the safety profile of ustekinumab.
To evaluate ustekinumab exposure (pharmacokinetics [PK]).
To evaluate the efficacy of IV ustekinumab during the induction period.
To evaluate the efficacy of SC ustekinumab during the maintenance period among participants who were in clinical response in induction.
Erica Miller at emiller25@pennstatehealth.psu.edu or 717-531-5656
All
Younger than 18 years old
NCT04673357
Digestive Systems & Liver Disease