Status:
COMPLETED
A Study of Guselkumab in Participants With Moderate to Severe Plaque-type Psoriasis and an Inadequate Response to Ustekinumab
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Psoriasis
Eligibility:
All Genders
18-99 years
Phase:
PHASE3
Brief Summary
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 inad...
Detailed Description
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 gusel...
Eligibility Criteria
Inclusion
- Have a diagnosis of plaque-type psoriasis (with or without psoriatic arthritis for at least 6 months before the first administration of study drug
- Have a Psoriasis Area and Severity Index (PASI) greater than or equal to (\>=) 12 at Screening and at Baseline
- Have an Investigator's Global Assessment (IGA) \>=3 at Screening and at Baseline
- Have an involved body surface area (BSA) \>= 10 percent (%) at Screening and at Baseline
- Be a candidate for phototherapy or systemic treatment for psoriasis (either naïve or history of previous treatment)
Exclusion
- Has a history or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
- Has unstable cardiovascular disease, defined as a recent clinical deterioration (example \[eg\], unstable angina, rapid atrial fibrillation) in the last 3 months or a cardiac hospitalization within the last 3 months
- Currently has a malignancy or has a history of malignancy within 5 years before Screening (with the exception of a nonmelanoma skin cancer that has been adequately treated with no evidence of recurrence for at least 3 months before the first study drug administration, or cervical carcinoma in situ that has been treated with no evidence of recurrence for at least 3 months before the first study drug administration)
- Has previously received guselkumab or ustekinumab
Key Trial Info
Start Date :
October 7 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 24 2016
Estimated Enrollment :
872 Patients enrolled
Trial Details
Trial ID
NCT02203032
Start Date
October 7 2014
End Date
May 24 2016
Last Update
September 12 2017
Active Locations (85)
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Birmingham, Alabama, United States
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Bakersfield, California, United States
3
Los Angeles, California, United States
4
Santa Monica, California, United States