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.
You will be asked to complete patient diary and questionnaires, provide blood, stool samples and urine samples, receive at least 3 endoscopy with biopsies, chest x-rays. If you pass screening, you will receive an IV dose of the study medication and then be randomized to receive a subcutaneous injection of study medication every 8weeks or every 12 weeks.
Must have Ulcerative Colitis diagnosed prior to screening
Must have moderately to severely active Ulcerative Colitis
Have Ulcerative Colitis limited to the rectum only
Presence of a stoma
Presence or history of a fistula