Phase 3b Safety and Efficacy Study of Apremilast to Treat Moderate to Severe Plaque-plaque Psoriasis

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Amgen
Study ID
NCT01690299
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Apremilast — DRUG
    Apremilast 30 mg tablet orally BID
  • Etanercept — DRUG
    Etanercept 50 mg evaluator/subject-blinded SC QW injection
  • Placebo tablet — DRUG
    Placebo tablets BID
  • Placebo injection — DRUG
    Once weekly evaluator/subject-blinded SC placebo (1 mL x 2 injections SC)

Study Details

This study will test the clinical effectiveness and safety of apremilast compared with placebo as well as etanercept compared with placebo in the same group of patients with moderate to severe plaque psoriasis.

Key Dates

First listed
Sep 21, 2012
Start date
Oct 1, 2012
Status verified
Apr 2020
Primary completion
Jul 3, 2014
Completion
Apr 4, 2016

Study Design

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

Arms

  • Experimental: Apremilast 30 mg plus placebo injection
    Apremilast 30 mg tablets orally twice a day (BID) plus once weekly (QW) evaluator/subject-blinded subcutaneous (SC) saline (placebo) injections
  • Experimental: Etanercept 50 mg plus placebo tablet
    Etanercept 50 mg evaluator/subject-blinded SC QW injections plus placebo tablets orally BID
  • Placebo Comparator: Oral placebo tablets plus SC placebo injections
    Identically matching placebo tablets and evaluator/subject-blinded SC injections

Primary Outcome Measure

Percentage of Participants Who Achieved a 75% Improvement (Response) in the Psoriasis Area Severity Index (PASI-75) for the Comparison Between Apremilast and Placebo at Week 16 From Baseline [ Time Frame: Baseline to Week 16 ]

Locations (31)

FacilityCityStateZIPSite coordinators
Arizona Research CenterPhoenixArizona85023-
Bakersfield Dermatology and Skin Cancer Medical GroupBakersfieldCalifornia93309-
University of California Irvine-Department of DermatologyIrvineCalifornia92697-
University of California San Diego Medical CenterSan DiegoCalifornia92122-
Horizons Clinical ResearchDenverColorado80220-
George Washington UniversityWashington D.C.District of Columbia20037-
Florida Center for Dermatology, PAJacksonvilleFlorida32204-
Florida Academic Dermatology CenterMiamiFlorida33136-
International Dermatology ResearchMiamiFlorida33144-
Renstar Medical ResearchOcalaFlorida34471-
Atlanta Dermatology, Vein and Research Center, PCAlpharettaGeorgia30022-
NorthShore University HealthSystemSkokieIllinois60077-
Southern Illinois University School of MedicineSpringfieldIllinois62702-
Dawes Fretzin Clinical Research Group, LLCIndianapolisIndiana46256-
Dermatology and Advanced AestheticsLake CharlesLouisiana70605-
Lawrence Green, MD, LLCRockvilleMaryland20850-
Dartmouth Hitchcock Medical CenterLebanonNew Hampshire03756-
Robert Wood Johnson Medical SchoolSomersetNew Jersey08873-
Forest Hills Dermatology GroupForest HillsNew York11375-
NYU Department of DermatologyNew YorkNew York10016-
University of North CarolinaChapel HillNorth Carolina27516-
Duke University Medical CenterDurhamNorth Carolina27710-
Wake Forest University Health SciencesWinston-SalemNorth Carolina27104-
University Hospitals Case Medical CenterClevelandOhio44106-
Ohio State University Medical CenterColumbusOhio43230-
University of Pittsburgh Medical CenterPittsburghPennsylvania15213-
Tennesse Clinical Research CenterNashvilleTennessee37215-
Teckton ResearchAustinTexas78745-
The Education and Research FoundationLynchburgVirginia24501-
Virginia Clinical Research IncNorfolkVirginia23507-
Dermatology Associates of SeattleSeattleWashington98101-

Find similar trials in Phoenix, AZ

By condition
PsoriasisPsoriatic arthritis
By specialty
DermatologyRheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
Arizona Research Center· Phoenix, AZBakersfield Dermatology and Skin Cancer Medical Group· Bakersfield, CAUniversity of California Irvine-Department of Dermatology· Irvine, CAUniversity of California San Diego Medical Center· San Diego, CAHorizons Clinical Research· Denver, COGeorge Washington University· Washington D.C., DC

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