StudyFinder



Search Results

Here are the studies that match your search criteria. If you are interested in participating, please reach out to the contact listed for the study. If no contact is listed, contact us and we'll help you find the right person.

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.

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.

Marc Schaefer
Erica Miller - at emiller25@pennstatehealth.psu.edu or 717-531-5656
 

All
Younger than 18 years old
This study is NOT accepting healthy volunteers
NCT04630028
STUDY00016342
Show full eligibility criteria
Hide eligibility criteria
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
I'm interested
Share via email
See this study on ClinicalTrials.gov
Show 1 location

Study Locations

Hide all locations
Location Contacts
Hershey, PA ,