Status:
COMPLETED
A Study of Guselkumab in the Treatment of Participants With Moderate to Severe Plaque-Type Psoriasis With Randomized Withdrawal and Retreatment
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, safety, and tolerability of guselkumab (CNTO 1959) in the treatment of participants with moderate to severe plaque-type psoriasis (scaly skin ras...
Detailed Description
This is a randomized (assignment of study drug by chance), double-blind (neither the participant or study staff will know the identity of study drugs), placebo- (inactive substance identical in appear...
Eligibility Criteria
Inclusion
- Have a diagnosis of plaque-type psoriasis (with or without psoriatic arthritis) at least 6 months before the first administration of study agent
- 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) score \>=3 at Screening and at Baseline
- Have an involved body surface area (BSA) \>=10 percent (%) at Screening and at Baseline
- Must be a candidate for either systemic therapy or phototherapy for psoriasis
Exclusion
- Participants with nonplaque forms of psoriasis (for example, erythrodermic, guttate, or pustular) or with current drug-induced psoriasis (for example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
- Participants who have ever received guselkumab or adalimumab
- 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 any condition that, in the opinion of the investigator, would make participation not be in the best interest (for example, compromise the well-being) of the participant or that could prevent, limit, or confound the protocol-specified assessments
- Is pregnant, nursing, or planning a pregnancy (both men and women) within 5 months following the last administration of study drug
Key Trial Info
Start Date :
November 3 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2020
Estimated Enrollment :
992 Patients enrolled
Trial Details
Trial ID
NCT02207244
Start Date
November 3 2014
End Date
July 1 2020
Last Update
July 22 2021
Active Locations (93)
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Birmingham, Alabama, United States
2
Bakersfield, California, United States
3
Los Angeles, California, United States
4
San Diego, California, United States