Tapinarof for the Treatment of Plaque Psoriasis in Adults (3002)

Part of paid clinical trials in Fort Smith, Arkansas.

Sponsor
Organon and Co
Study ID
NCT03983980
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Tapinarof — DRUG
    Tapinarof cream, 1%, applied once daily
  • Vehicle Cream — DRUG
    Vehicle cream applied once daily

Study Details

This is a randomized double-blind vehicle-controlled Phase 3 study to evaluate the efficacy and safety of topical tapinarof cream, 1% once daily for the treatment of plaque psoriasis in adults. Approximately 500 adult subjects with plaque psoriasis will be randomized 2:1 to receive either tapinarof cream, 1% or matching vehicle cream once daily for 12 weeks.

Key Dates

Start date
Jun 6, 2019
Status verified
Sep 2022
Primary completion
May 13, 2020
Completion
May 29, 2020

Study Design

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

Arms

  • Experimental: Tapinarof (DMVT-505) Cream Group
    Tapinarof cream, 1%, applied once daily
  • Placebo Comparator: Vehicle Cream Group
    Vehicle cream applied once daily

Primary Outcome Measure

Percent of Subjects Who Achieve a Physician Global Assessment (PGA) Score of Clear (0) or Almost Clear (1) With a Minimum 2-grade Improvement From Baseline at Week 12. Analyses Were Done Using Multiple Imputation [ Time Frame: Baseline to Week 12 ]

Locations (42)

FacilityCityStateZIPSite coordinators
Dermavant Investigative SiteFort SmithArkansas72916-
Dermavant Investigative SiteFountain ValleyCalifornia92708-
Dermavant Investigative SiteFremontCalifornia94538-
Dermavant Investigative SiteLos AngelesCalifornia90045-
Dermavant Investigative SiteOceansideCalifornia92056-
Dermavant Investigative SiteSan DiegoCalifornia92123-
Dermavant Investigative SiteSanta MonicaCalifornia90404-
Dermavant Investigative SiteDenverColorado80210-
Dermavant Investigative SiteBoynton BeachFlorida33437-
Dermavant Investigative SiteMargateFlorida33414-
Dermavant Investigative SiteMiamiFlorida33144-
Dermavant Investigative SiteBoiseIdaho83713-
Dermavant Investigative SiteRolling MeadowsIllinois60008-
Dermavant Investigative SitePlainfieldIndiana46168-
Dermavant Investigative SiteOverland ParkKansas66215-
Dermavant Investigative SiteLouisvilleKentucky40217-
Dermavant Investigative SiteOwensboroKentucky42301-
Dermavant Investigative SiteMetairieLouisiana70006-
Dermavant Investigative SiteBostonMassachusetts02215-
Dermavant Investigative SiteBay CityMichigan48706-
Dermavant Investigative SiteDetroitMichigan48202-
Dermavant Investigative SiteFort GratiotMichigan48059-
Dermavant Investigative SiteFridleyMinnesota55432-
Dermavant Investigative SiteOmahaNebraska68144-
Dermavant Investigative SiteLas VegasNevada89148-
Dermavant Investigative SiteEast WindsorNew Jersey08520-
Dermavant Investigative SiteHackensackNew Jersey07601-
Dermavant Investigative SiteStony BrookNew York11790-
Dermavant Investigative SiteWilmingtonNorth Carolina28405-
Dermavant Investigative SiteWinston-SalemNorth Carolina27157-
Dermavant Investigative SiteBeachwoodOhio44122-
Dermavant Investigative SiteBexleyOhio43209-
Dermavant Investigative SitePortlandOregon97223-
Dermavant Investigative SiteCharlestonSouth Carolina29414-
Dermavant Investigative SiteNashvilleTennessee37215-
Dermavant Investigative SiteHoustonTexas77056-
Dermavant Investigative SitePflugervilleTexas78660-
Dermavant Investigative SitePlanoTexas75024-
Dermavant Investigative SiteSan AntonioTexas78229-
Dermavant Investigative SiteWebsterTexas77598-
Dermavant Investigative SiteNorfolkVirginia23502-
Dermavant Investigative SiteSpokaneWashington99202-

Find similar trials in Fort Smith, AR

By condition
Psoriasis
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
Dermavant Investigative Site· Fort Smith, ARDermavant Investigative Site· Fountain Valley, CADermavant Investigative Site· Fremont, CADermavant Investigative Site· Los Angeles, CADermavant Investigative Site· Oceanside, CADermavant Investigative Site· San Diego, CA

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