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.
Participants who meet inclusion criteria will receive ustekinumab through an IntraVenous infusion during the induction period. And then will be randomized either every 8weeks or 12weeks to receive ustekinumab through a SubCutaneous injection.
Must have been diagnosed with moderately to severely active Crohn's Disease prior to screening
Currently has or is suspected to have an abscess