A Study to Evaluate the Comparative Efficacy of CNTO 1959 (Guselkumab) and Secukinumab for the Treatment of Moderate to Severe Plaque-type Psoriasis

• Status: Completed
• Trial end date: 2018-09-20
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy of guselkumab compared with secukinumab for 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: Antibodies, Monoclonal

Criteria

Inclusion Criteria:

• Have a diagnosis of plaque-type psoriasis (with or without [Psoriatic Arthritis]PsA) for at least 6 months before the first administration of study drug

• A woman of childbearing potential must have a negative urine pregnancy test at screening and at Week 0 and agree to urine pregnancy testing before receiving injections

• 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

• Agree not to receive a Bacille Calmette-Guérin (BCG) vaccination during the study, or within 12 months after the last administration of study drug

• Agree to avoid prolonged sun exposure and avoid use of tanning booths or other ultraviolet light sources during study

Exclusion Criteria:

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

• Has previously received guselkumab or secukinumab

• Has a history of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection (example bronchiectasis), recurrent urinary tract infection (recurrent pyelonephritis or chronic nonremitting cystitis), fungal infection (mucocutaneous candidiasis), or open, draining, or infected skin wounds or ulcers

• Has a history of lymphoproliferative disease, including lymphoma; a history of monoclonal gammopathy of undetermined significance; or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy or splenomegaly

• Is unable or unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access to veins