Tapinarof for the Treatment of Plaque Psoriasis in Adults (3001)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Organon and Co
Study ID
NCT03956355
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
May 21, 2019
Status verified
Sep 2022
Primary completion
May 26, 2020
Completion
May 26, 2020

Study Design

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

Arms

  • Experimental: Tapinarof (DMVT-505)
    Tapinarof (DMVT-505) Cream Group
  • Placebo Comparator: Vehicle Cream
    Vehicle Cream Group

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 (44)

FacilityCityStateZIPSite coordinators
Dermavant Investigative SiteBirminghamAlabama35205-
Dermavant Investigative SitePhoenixArizona85032-
Dermavant Investigative SiteHot SpringsArkansas71913-
Dermavant Investigative SiteRogersArkansas72758-
Dermavant Investigative SiteAnaheim HillsCalifornia92807-
Dermavant Investigative SiteFresnoCalifornia93720-
Dermavant Investigative SiteLos AngelesCalifornia90033-
Dermavant Investigative SiteNorthridgeCalifornia91324-
Dermavant Investigative SiteSan DiegoCalifornia92123-
Dermavant Investigative SiteSanta AnaCalifornia92701-
Dermavant Investigative SiteCromwellConnecticut06416-
Dermavant Investigative SiteBoca RatonFlorida33431-
Dermavant Investigative SiteBrandonFlorida33511-
Dermavant Investigative SiteHialeahFlorida33016-
Dermavant Investigative SiteMiramarFlorida33027-
Dermavant Investigative SiteMariettaGeorgia30060-
Dermavant Investigative SiteEvansvilleIndiana47714-
Dermavant Investigative SiteIndianapolisIndiana46250-
Dermavant Investigative SiteNew AlbanyIndiana47150-
Dermavant Investigative SiteLouisvilleKentucky40202-
Dermavant Investigative SiteOwensboroKentucky42301-
Dermavant Investigative SiteBaton RougeLouisiana70809-
Dermavant Investigative SiteNew OrleansLouisiana70112-
Dermavant Investigative SiteNew OrleansLouisiana70115-
Dermavant Investigative SiteBostonMassachusetts02115-
Dermavant Investigative SiteClarkstonMichigan48346-
Dermavant Investigative SiteWarrenMichigan48088-
Dermavant Investigative SiteSaint JosephMissouri64506-
Dermavant Investigative SiteVeronaNew Jersey07044-
Dermavant Investigative SiteKew GardensNew York11374-
Dermavant Investigative SiteNew YorkNew York10029-
Dermavant Investigative SiteRochesterNew York14623-
Dermavant Investigative SiteCaryNorth Carolina27518-
Dermavant Investigative SiteHigh PointNorth Carolina27262-
Dermavant Investigative SiteNormanOklahoma73071-
Dermavant Investigative SitePortlandOregon97210-
Dermavant Investigative SitePittsburghPennsylvania15213-
Dermavant Investigative SiteJohnstonRhode Island02919-
Dermavant Investigative SiteArlingtonTexas76011-
Dermavant Investigative SiteCollege StationTexas77802-
Dermavant Investigative SiteDripping SpringsTexas78620-
Dermavant Investigative SiteHoustonTexas77004-
Dermavant Investigative SiteSan AntonioTexas78213-
Dermavant Investigative SiteWest JordanUtah84088-

Find similar trials in Birmingham, AL

By condition
Psoriasis
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
Dermavant Investigative Site· Birmingham, ALDermavant Investigative Site· Phoenix, AZDermavant Investigative Site· Hot Springs, ARDermavant Investigative Site· Rogers, ARDermavant Investigative Site· Anaheim Hills, CADermavant Investigative Site· Fresno, CA

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