Study of Guselkumab Versus Placebo for the Treatment of Low Body Surface Area Moderate Plaque Psoriasis

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT06039189
Phase
PHASE3
Status
Completed

Conditions

  • Moderate Plaque Psoriasis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Guselkumab — DRUG
    Guselkumab will be administered as subcutaneous injection.
  • Placebo — DRUG
    Placebo will be administered as subcutaneous injection.

Study Details

The purpose of this study is to evaluate the efficacy of guselkumab compared to an inactive drug in participants with low body surface area moderate plaque psoriasis and special site involvement.

Key Dates

Start date
Aug 24, 2023
Status verified
Apr 2026
Primary completion
Apr 14, 2025
Completion
Apr 14, 2025

Study Design

Enrollment
338 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1: Guselkumab
    Participants will receive guselkumab by subcutaneous injection with placebo as needed to maintain the blind.
  • Placebo Comparator: Group 2: Placebo
    Participants will receive placebo by subcutaneous injection then receive guselkumab by subcutaneous injection.

Primary Outcome Measure

Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16 [ Time Frame: Week 16 ]

Locations (45)

FacilityCityStateZIPSite coordinators
Cahaba Research IncBirminghamAlabama35244-
Total DermatologyBirminghamAlabama35203-
California Dermatology & Clinical Research InstituteEncinitasCalifornia92024-
First OC DermatologyFountain ValleyCalifornia92708-
Practice WangRiversideCalifornia92505-
Therapeutics Clinical ResearchSan DiegoCalifornia92123-
Rehlen, Bartlow, Goodman and Baron Dermatology GroupSanta AnaCalifornia92701-
Clinical Science InstituteSanta MonicaCalifornia90404-
University of Conn Health CenterFarmingtonConnecticut06030-
TrueBlue Clinical ResearchBrandonFlorida33511-
Florida Academic Dermatology CentersCoral GablesFlorida33134-
Revival ResearchDoralFlorida33122-
Glick Research InstituteMargateFlorida33063-
Miami VA Healthcare SystemMiamiFlorida33124-
Tory P Sullivan M D PANorth Miami BeachFlorida33162-
Atlanta Biomedical Clinical ResearchAtlantaGeorgia303331-
Kindred Hair and Skin CenterColumbiaMaryland21045-
DermAssociates, PCRockvilleMaryland20850-
Lawrence J Green MD LLCRockvilleMaryland20850-
Metro Boston Clinical PartnersBrightonMassachusetts02135-
DermCare, LLCQuincyMassachusetts02169-
Henry Ford Medical CenterWest BloomfieldMichigan48322-
Icahn School of Medicine at Mount SinaiNew YorkNew York10003-
Markowitz Medical OptiSkinNew YorkNew York10128-
Accellacare Research of CaryCaryNorth Carolina27511-
Darst DermatologyCharlotteNorth Carolina28277-
Piedmont Plastic Surgery and DermatologyHuntersvilleNorth Carolina28078-
Bexley dermatology researchBexleyOhio43209-
Remington Davis IncColumbusOhio43215-
Apex Dermatology Mayfield HeightsMayfield HeightsOhio44124-
Dermatology and Laser Center of CharlestonCharlestonSouth Carolina29414-
Palmetto Clinical Trial Services, LLCFountain InnSouth Carolina29644-
Nashville Skin: Comprehensive Dermatology CenterNashvilleTennessee37212-
Tennessee Clinical Research CenterNashvilleTennessee37215-
Arlington Center for DermatologyArlingtonTexas76011-
Bellair DermatologyBellaireTexas77401-
Bare DermatologyDallasTexas75235-
Menter Dermatology Research InstituteDallasTexas75246-
Modern Research Associates PLLCDallasTexas75231-
Center for Clinical StudiesHoustonTexas77004-
Suzanne Bruce and Associates - The Center for Skin ResearchHoustonTexas77056-4132-
Progressive Clinical ResearchSan AntonioTexas78229-
Texas Dermatology and Laser SpecialistsSan AntonioTexas78218-
Acclaim DermatologySugar LandTexas77479-
Frontier Derm Partners CRO, LLCMill CreekWashington98102-

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