A Study to Compare the Efficacy of Guselkumab to Fumaric Acid Esters for the Treatment of Participants With Moderate to Severe Plaque Psoriasis

• Status: Completed
• Trial end date: 2019-02-06
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to compare the efficacy of Guselkumab with commercially available active comparator Fumaderm initial/Fumaderm tablets for the treatment of adult participants with moderate to severe plaque-type psoriasis who have not yet received any systemic therapy.

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

Details

• Lead Sponsor: Janssen-Cilag G.m.b.H
• Treatments: Dimethyl Fumarate

Criteria

Inclusion Criteria:

• Have a diagnosis of plaque-type psoriasis for at least 6 months before the first administration of study drug

• Have a Psoriasis Area and Severity Index (PASI) greater than (>)10 or Body Surface Area (BSA) >10 at screening and at baseline

• Have a Dermatology Life Quality Index (DLQI) >10 at screening and at baseline

• Agree not to receive a live virus or live bacterial vaccination during the study, or within 3 months after the last administration of study drug; for information on Bacille Calmette-Guérin (BCG) vaccination, agree not to receive a BCG vaccination during the study, or within 12 months after the last administration of study drug

• No dipstick detection of proteins or glucose in urine. If there are signs of proteins and/or glucose on urine test strip, the urine sample must be analyzed centrally. Here, protein and glucose levels must not exceed trace levels, example, <=(+); one re-test (central urine analysis) is allowed

Exclusion Criteria:

• Has a history or current signs or symptoms of severe, progressive, or uncontrolled liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances

• 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)

• Known allergies, hypersensitivity, or intolerance to Guselkumab or its excipients

• Is pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 12 weeks after the last dose of study drug

• Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments