A Study of Guselkumab in the Treatment of Participants With Moderate to Severe Plaque-Type Psoriasis

• Status: Completed
• Trial end date: 2020-06-17
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Treatments: Adalimumab; Antibodies, Monoclonal

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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