Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Fresno, California and other locations
Dates
study started
estimated completion

Description

Summary

The purpose of this study is to evaluate the efficacy of guselkumab treatment versus placebo in skin of color participants with predominant moderate-to-severe body psoriasis or predominant moderate-to-severe scalp psoriasis by assessing improvements in the signs and symptoms of psoriasis.

Official Title

A Phase 3b, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of Guselkumab for the Treatment of Participants With Skin of Color Who Have Moderate-to-Severe Plaque Psoriasis and/or Moderate-to-Severe Scalp Psoriasis

Keywords

Plaque Psoriasis, Scalp Psoriasis, Psoriasis, Guselkumab, Moderate-to-severe Plaque Psoriasis, Moderate-to-severe Scalp Psoriasis

Eligibility

You can join if…

Open to people ages 18 years and up

  • Have a diagnosis of plaque psoriasis (with or without psoriatic arthritis [PsA]) for at least 6 months before the first administration of study drug
  • Self-identify as non-white or non-caucasian
  • Be a candidate for phototherapy or systemic treatment for psoriasis
  • Have an involved body surface area (BSA) greater than or equal to (>=) 10 percent (%), psoriasis area and severity index (PASI) >=12, investigator global assessment (IGA) >=3 at screening and at baseline (Cohort A), or have a scalp surface area >=30%, psoriasis scalp severity index (PSSI) >=12, scalp specific investigator global assessment (ss-IGA) >=3, and one plaque outside of the scalp at screening and at baseline (Cohort B)
  • 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 not to receive a Bacillus Calmette-Guérin (BCG) vaccination during the study, and within 12 weeks after the last administration of study intervention

You CAN'T join if...

  • Has a nonplaque form of psoriasis (example: erythrodermic, guttate, or pustular)
  • Has received ustekinumab, ixekizumab, secukinumab, or brodalumab within 12 weeks of first dose of study drug
  • 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
  • Participant has known allergies, hypersensitivity, or intolerance to guselkumab or its excipients
  • Has or has had a serious infection (example: sepsis, pneumonia or pyelonephritis), or has been hospitalized or received intravenous antibiotics for an infection during the 2 months before screening

Locations

  • Community Regional Medical Center not yet accepting patients
    Fresno California 93701 United States
  • The Regents of the University of California not yet accepting patients
    San Francisco California 94118 United States
  • Synergy Clinical Research not yet accepting patients
    San Francisco California 94132 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Janssen Research & Development, LLC
ID
NCT05272150
Phase
Phase 3 Psoriasis Research Study
Study Type
Interventional
Participants
Expecting 200 study participants
Last Updated