A Study of Guselkumab for the Treatment of Palmoplantar-non-Pustular Psoriasis

• Status: Active, not recruiting
• Trial end date: 2021-12-17
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy of guselkumab for the treatment of palmoplantar psoriasis.

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

Details

• Lead Sponsor: Janssen-Cilag Ltd.

Criteria

Inclusion Criteria:

• Should have all the following: A confirmed diagnosis of moderate-to-severe palmoplantar-non-pustular psoriasis with palm and/or sole involvement and at least one plaque at a body site other than the palms and soles for at least 6 months, to confirm a diagnosis of chronic psoriasis; psoriatic area and severity index (PASI) score greater than or equal to (>=) 3 and less than (<) 10 at screening and at baseline; Palmoplantar Investigator Global Assessment (ppIGA) score >=3 at screening and at baseline

• Should be eligible to receive biological treatments; only participants who are naive to biological treatments can be included

• A woman of childbearing potential must have a negative urine pregnancy test at screening and at Week 0

• Agree not to receive a live virus or live bacterial vaccination during the study, or within 12 weeks after the last administration of study intervention

• Agree to avoid prolonged sun exposure and agree not to use tanning booths or other ultraviolet (UV) light sources from the first administration of study intervention through 12 weeks after the final dose of study intervention (Week 56)

Exclusion Criteria:

• Currently has palmoplantar pustulosis, pustular psoriasis, or any other forms other than plaque-type psoriasis (e.g, erythrodermic, guttate), or hyperkeratotic eczema

• Has current drug-induced psoriasis (eg, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)

• Has received prior treatment with biological agents for palmoplantar-non-pustular psoriasis

• Has had prior exposure, known and reported intolerance to guselkumab or excipients, or ineligible to treatment with biological agents

• Is infected with human immunodeficiency virus (HIV, positive serology for HIV antibody)