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1 Study Matches

A Phase 3 Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Openlabel Intravenous Induction Treatment Followed by Randomized Double-blind Subcutaneous (SC) Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis (UC)

The primary objective and primary endpoint in this study is to assess clinical remission. participants who were in clinical response in induction.  To evaluate the safety profile of ustekinumab (study drug). Participants who meet inclusion criteria will receive ustekinumab through and IntraVenous infusion during the induction period. And then will be randomized either every 8weeks or 12weeks to receive ustekinumab through a SubCutaneous injection.
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
NCT04630028
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Inclusion Criteria:
Ages 2 to 18years at the time of the first administration of study drug
Must have Ulcerative Colitis diagnosed prior to screening
Must have moderately to severely active Ulcerative Colitis
Exclusion Criteria:
Have severe extensive colitis
Have Ulcerative Colitis limited to the rectum only
Presence of a stoma
Presence or history of a fistula
Digestive Systems & Liver Disease
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Study Locations

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Location
Hershey, PA