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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
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Younger than 18 years old
This study is NOT accepting healthy volunteers
NCT04673357
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Inclusion Criteria:
Ages 2 to 18years at the time of the first administration of study drug
Must have been diagnosed with moderately to severely active Crohn's Disease prior to screening
Exclusion Criteria:
Has had any kind of bowel resection within 6months
Currently has or is suspected to have an abscess
Digestive Systems & Liver Disease
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Location
Hershey, PA