Efficacy, Safety, and Withdrawal and Retreatment With Brodalumab in Moderate to Severe Plaque Psoriasis Subjects

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Bausch Health Americas, Inc.
Study ID
NCT01708590
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 subcutaneous (SC)
  • 140 mg brodalumab — DRUG
    140 mg brodalumab administered subcutaneous (SC)
  • placebo — DRUG
    Placebo administered subcutaneous (SC)

Study Details

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

Key Dates

Start date
Aug 31, 2012
Status verified
Dec 2019
Primary completion
May 31, 2014
Completion
Aug 31, 2015

Study Design

Enrollment
661 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 placebo or continued treatment. Participants are retreated at return of disease.
  • Experimental: 140 mg brodalumab
    Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to placebo or continued treatment. Participants are retreated at return of disease.
  • Placebo Comparator: placebo
    Administered by SC injection until week 12. At week 12 particpants are assigned to 210 mg brodalumab.

Primary Outcome Measure

Percentage of Participants With Psoriasis Area and Severity Index (PASI) 75 at Week 12 [ Time Frame: 0-12 weeks ]

Locations (33)

FacilityCityStateZIPSite coordinators
Research SitePhoenixArizona85023-
Research SiteBakersfieldCalifornia93301-
Research SiteEncinoCalifornia91436-
Research SiteLos AngelesCalifornia90045-
Research SiteSan DiegoCalifornia92123-
Research SiteSan FranciscoCalifornia94118-
Research SiteSan RamonCalifornia94583-
Research SiteSanta MonicaCalifornia90404-
Research SiteAlpharettaGeorgia30022-
Research SiteWest DundeeIllinois60118-
Research SiteRichmondKentucky40475-
Research SiteColumbiaMaryland21045-
Research SiteBostonMassachusetts02111-
Research SiteFort GratiotMichigan48059-
Research SiteSt LouisMissouri63104-
Research SiteSt LouisMissouri63117-
Research SiteSt LouisMissouri63141-
Research SiteOmahaNebraska68131-
Research SiteBuffaloNew York14221-
Research SiteForest HillsNew York11375-
Research SiteRochesterNew York14618-
Research SiteStony BrookNew York11790-
Research SiteWilmingtonNorth Carolina28401-
Research SiteClevelandOhio44106-
Research SitePortlandOregon97223-
Research SiteRapid CitySouth Dakota57702-
Research SiteGoodlettsvilleTennessee37072-
Research SiteNashvilleTennessee37215-
Research SiteArlingtonTexas76011-
Research SiteAustinTexas78759-
Research SiteDallasTexas75231-
Research SiteHoustonTexas77030-
Research SiteSan AntonioTexas78229-

Find similar trials in Phoenix, AZ

By condition
Psoriasis
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
Research Site· Phoenix, AZResearch Site· Bakersfield, CAResearch Site· Encino, CAResearch Site· Los Angeles, CAResearch Site· San Diego, CAResearch Site· San Francisco, CA

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