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A Phase 3, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Guselkumab for the Treatment of Subjects With Moderate to Severe Plaque-type Psoriasis and an Inadequate Response to Ustekinumab
The purpose of this study is to evaluate the efficacy and safety of guselkumab (CNTO 1959) in the treatment of participants with moderate to severe plaque-type psoriasis (scaly skin rash) who had inadequate response to ustekinumab.
This is a randomized (assignment of study drug by chance), double-blind (participants nor study staff will know the identity of study drugs), multicenter study to evaluate efficacy and safety of guselkumab for the treatment of participants with moderate to severe plaque-type psoriasis who had an inadequate response to ustekinumab. The study will consist of a screening period, open-label and double-blind treatment periods, and a follow-up period. The treatment period will have 2 phases: an open-label treatment phase during which all participants will receive ustekinumab at Weeks 0 and 4 and a blinded treatment phase during which participants with an inadequate Investigator's Global Assessment response (IGA≥2) to ustekinumab at Week 16 will be randomized to receive either guselkumab or ustekinumab through Week 44. Participants with an IGA response of 0 or 1 (cleared or minimal disease) at Week 16 will continue to receive open-label treatment with ustekinumab every 12 weeks through Week 40. All participants will complete a follow-up phase through Week 52 for efficacy and through Week 60 for safety evaluations. The total duration of the study will be approximately 64 weeks (includes a 4-week screening period). Participants' safety will be monitored throughout the study.
Age
18 - 99 years
Sex
ALL
Healthy Volunteers
No
Birmingham, Alabama, United States
Bakersfield, California, United States
Los Angeles, California, United States
Santa Monica, California, United States
Coral Gables, Florida, United States
Ocala, Florida, United States
Alpharetta, Georgia, United States
Atlanta, Georgia, United States
Arlington Heights, Illinois, United States
Chicago, Illinois, United States
Start Date
October 7, 2014
Primary Completion Date
December 25, 2015
Completion Date
May 24, 2016
Last Updated
September 12, 2017
872
ACTUAL participants
Ustekinumab
DRUG
Guselkumab
DRUG
Placebo for ustekinumab
DRUG
Placebo for guselkumab
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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