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A Phase 3 Open-label Study to Assess the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Ustekinumab in the Treatment of Moderate to Severe Chronic Plaque Psoriasis in Pediatric Subjects Greater Than or Equal to 6 to Less Than 12 Years of Age
The purpose of this study is to evaluate the efficacy and safety of ustekinumab in pediatric participants aged greater than or equal to (\>=) 6 through less than (\<) 12 years with moderate to severe chronic plaque psoriasis
This is an open label (identity of study drug will be known to participant and study staff) and multicenter (when more than one hospital or medical school team work on a medical research study) study. The participant population will be comprised of boys and girls who have had a diagnosis of plaque psoriasis for at least 6 months prior to first study drug administration and who have moderate to severe disease defined by Psoriasis Area and Severity Index score (PASI) \>=12, Physician's Global Assessment (PGA) \>=3, and Body Surface Area (BSA) \>=10 percent (%). The study consists of Screening Phase (up to 10 weeks before administration of the study drug), Treatment Period (Week 0 up to Week 52) and Safety follow up (Week 56). Participants will be primarily evaluated for efficacy, pharmacokinetics (PK) and safety. Following completion of the Week 52 visit, participants who have had a beneficial response from ustekinumab treatment as determined by the investigator, and who have not yet reached the age of 12 years or older in countries where marketing authorization for ustekinumab has been granted for the treatment of psoriasis in adolescent participants (12-17 years), and are willing to continue ustekinumab treatment, may enter the long-term extension period (from Week 56 through Week 264) of the study.
Age
6 - 11 years
Sex
ALL
Healthy Volunteers
No
San Diego, California, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
St Louis, Missouri, United States
Arlington, Texas, United States
Dallas, Texas, United States
Norfolk, Virginia, United States
Brussels, Belgium
Ghent, Belgium
Liège, Belgium
Start Date
May 1, 2016
Primary Completion Date
December 1, 2017
Completion Date
October 1, 2020
Last Updated
November 1, 2021
44
ACTUAL participants
Ustekinumab 0.75 mg/kg
DRUG
Ustekinumab 45 mg
DRUG
Ustekinumab 90 mg
DRUG
Lead Sponsor
Janssen Research & Development, LLC
NCT07449234
NCT07116967
NCT07250802
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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