P3 Study Brodalumab in Treatment of Moderate to Severe Plaque Psoriasis

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Bausch Health Americas, Inc.
Study ID
NCT01708603
Phase
PHASE3
Status
Terminated

Conditions

  • Moderate to Severe Plaque Psoriasis

Eligibility Criteria

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

Interventions

  • 210 mg brodalumab — DRUG
    210 mg brodalumab administered SC
  • 140 mg brodalumab — DRUG
    140 mg brodalumab administered SC
  • ustekinumab — DRUG
    45 mg or 90 mg ustekinumab administered SC per the labeled dosing regimen.
  • placebo — DRUG
    Placebo administered SC

Study Details

The purpose of this study is to assess the safety and efficacy of brodalumab at two different doses

Key Dates

Start date
Aug 31, 2012
Status verified
Jan 2020
Primary completion
Sep 30, 2014
Completion
Oct 31, 2015

Study Design

Enrollment
1,831 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 210 mg brodalumab
    Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.
  • Experimental: 140 mg brodalumab
    Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.
  • Active Comparator: ustekinumab
    Administered by subcutaneous (SC) injection per the labeled dosing regimen.
  • Placebo Comparator: Placebo
    Administered by subcutaneous (SC) injection until week 12. At week 12 participants are assigned to 210 mg brodalumab.

Primary Outcome Measure

Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12 [ Time Frame: 12 weeks ]

Locations (67)

FacilityCityStateZIPSite coordinators
Research SiteBirminghamAlabama35233-
Research SiteTucsonArizona85710-
Research SiteHot SpringsArkansas71913-
Research SiteBakersfieldCalifornia93309-
Research SiteBeverly HillsCalifornia90211-
Research SiteIrvineCalifornia92697-
Research SiteLos AngelesCalifornia90027-
Research SiteLos AngelesCalifornia90045-
Research SiteSacramentoCalifornia95816-
Research SiteSan DiegoCalifornia92103-
Research SiteSan DiegoCalifornia92123-
Research SiteVistaCalifornia92083-
Research SiteDenverColorado80209-
Research SiteDenverColorado80210-
Research SiteDenverColorado80239-
Research SiteNew HavenConnecticut06511-
Research SiteAventuraFlorida33180-
Research SiteJacksonvilleFlorida32216-
Research SiteMiamiFlorida33136-
Research SitePembroke PinesFlorida33028-
Research SiteTampaFlorida33612-
Research SiteAtlantaGeorgia30342-
Research SiteNewnanGeorgia30263-
Research SiteSnellvilleGeorgia30078-
Research SiteChicagoIllinois60611-
Research SiteChicagoIllinois60654-
Research SiteSkokieIllinois60077-
Research SiteCarmelIndiana46032-
Research SitePlainfieldIndiana46168-
Research SiteSouth BendIndiana46617-
Research SiteLouisvilleKentucky40202-
Research SiteLake CharlesLouisiana70601-
Research SiteLake CharlesLouisiana70605-
Research SiteNew OrleansLouisiana70112-
Research SiteRockvilleMaryland20850-
Research SiteSilver SpringMaryland20902-
Research SiteBostonMassachusetts02114-
Research SiteBostonMassachusetts02115-
Research SiteNorth AndoverMassachusetts01845-
Research SiteAnn ArborMichigan48109-
Research SiteFridleyMinnesota55432-
Research SiteOmahaNebraska68144-
Research SiteHendersonNevada89074-
Research SiteBrooklynNew York11209-
Research SiteNew YorkNew York10029-
Research SiteRochesterNew York14625-
Research SiteCharlotteNorth Carolina28210-
Research SiteDurhamNorth Carolina27710-
Research SiteRaleighNorth Carolina27612-
Research SiteWinston-SalemNorth Carolina27103-
Research SiteBeachwoodOhio44122-
Research SiteColumbusOhio43212-
Research SiteGahannaOhio43230-
Research SiteSouth EuclidOhio44118-
Research SitePortlandOregon97239-
Research SitePittsburghPennsylvania15213-
Research SiteAndersonSouth Carolina29621-
Research SiteMt. PleasantSouth Carolina29464-
Research SiteAustinTexas78759-
Research SiteDallasTexas75246-
Research SiteHoustonTexas77065-
Research SiteSan AntonioTexas78229-
Research SiteSan AntonioTexas78249-
Research SiteWest JordanUtah84088-
Research SiteNorfolkVirginia23502-
Research SiteRoanokeVirginia24016-
Research SiteSeattleWashington98101-

Find similar trials in Birmingham, AL

By research site
Research Site· Birmingham, ALResearch Site· Tucson, AZResearch Site· Hot Springs, ARResearch Site· Bakersfield, CAResearch Site· Beverly Hills, CAResearch Site· Irvine, CA

Related Studies