Efficacy and Safety of Brodalumab Compared With Placebo and Ustekinumab in Moderate to Severe Plaque Psoriasis Subjects

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Bausch Health Americas, Inc.
Study ID
NCT01708629
Phase
PHASE3
Status
Terminated

Conditions

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 compared with placebo in participants with moderate to severe plaque psoriasis. A second purpose of this study is to assess the safety and efficacy brodalumab at two different doses compared with ustekinumab in participants with moderate to severe plaque psoriasis. A third purpose of this study is to assess the safety and efficacy of 4 maintenance regimens of brodalumab.

Key Dates

Start date
Sep 30, 2012
Status verified
Dec 2019
Primary completion
Aug 31, 2014
Completion
Oct 31, 2015

Study Design

Enrollment
1,881 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 SC injection until week 12. At week 12 participants are assigned to 210 mg brodalumab.

Primary Outcome Measure

Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12 [ Time Frame: 12 weeks ]

Locations (74)

FacilityCityStateZIPSite coordinators
Research SiteBirminghamAlabama35205-
Research SiteMobileAlabama36608-
Research SitePhoenixArizona85023-
Research SiteBeverly HillsCalifornia90212-
Research SiteBurbankCalifornia91505-
Research SiteEncinoCalifornia91436-
Research SiteFremontCalifornia94538-
Research SiteFullertonCalifornia92835-
Research SiteIrvineCalifornia92614-
Research SiteLos AngelesCalifornia90036-
Research SiteRiversideCalifornia92505-
Research SiteSacramentoCalifornia95819-
Research SiteSan DiegoCalifornia92103-
Research SiteSan DiegoCalifornia92123-
Research SiteSan FranciscoCalifornia94118-
Research SiteDenverColorado80220-
Research SiteFarmingtonConnecticut06030-
Research SiteTrumbullConnecticut06611-
Research SiteBoca RatonFlorida33486-
Research SiteCoral GablesFlorida33134-
Research SiteHollywoodFlorida33021-
Research SiteJacksonvilleFlorida32204-
Research SiteMiamiFlorida33144-
Research SiteOcalaFlorida34471-
Research SiteTamaracFlorida33321-
Research SiteAlpharettaGeorgia30022-
Research SiteAtlantaGeorgia30327-
Research SiteMaconGeorgia31217-
Research SiteBoiseIdaho83704-
Research SiteArlington HeightsIllinois60005-
Research SiteChampaignIllinois61820-
Research SiteMaywoodIllinois60153-
Research SiteNormalIllinois61761-
Research SiteWheatonIllinois60189-
Research SiteIndianapolisIndiana46256-
Research SiteNew AlbanyIndiana47150-
Research SiteOverland ParkKansas66202-
Research SiteOverland ParkKansas66215-
Research SiteLouisvilleKentucky40217-
Research SiteOwensboroKentucky42303-
Research SiteWorcesterMassachusetts01605-
Research SiteAnn ArborMichigan48103-
Research SiteClarkstonMichigan48346-
Research SiteClinton TownshipMichigan48038-
Research SiteHendersonNevada89074-
Research SiteLas VegasNevada89144-
Research SiteEast WindsorNew Jersey08520-
Research SiteHobokenNew Jersey07030-
Research SiteVeronaNew Jersey07044-
Research SiteNew YorkNew York10016-
Research SiteRochesterNew York14623-
Research SiteThe BronxNew York10467-
Research SiteHigh PointNorth Carolina27262-
Research SiteCincinnatiOhio45249-
Research SiteClevelandOhio44106-
Research SiteLake OswegoOregon97035-
Research SitePortlandOregon97210-
Research SiteExtonPennsylvania19341-
Research SiteJohnstonRhode Island02919-
Research SiteGreerSouth Carolina29650-
Research SiteBartlettTennessee38134-
Research SiteNashvilleTennessee37205-
Research SiteBellaireTexas77401-
Research SiteDallasTexas75230-
Research SiteDallasTexas75231-
Research SiteHoustonTexas77004-
Research SiteHoustonTexas77030-
Research SiteHoustonTexas77082-
Research SiteWebsterTexas77598-
Research SiteSalt Lake CityUtah84132-
Research SiteNorfolkVirginia23507-
Research SiteRichmondVirginia23294-
Research SiteSpokaneWashington99204-
Research SiteClarksburgWest Virginia26301-

Find similar trials in Birmingham, AL

By condition
Psoriasis
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
Research Site· Birmingham, ALResearch Site· Mobile, ALResearch Site· Phoenix, AZResearch Site· Beverly Hills, CAResearch Site· Burbank, CAResearch Site· Encino, CA

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