Safety and Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe, Chronic Plaque-Type Psoriasis

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT01358578
Phase
PHASE3
Status
Completed

Conditions

  • Chronic Plaque Psoriasis

Eligibility Criteria

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

Interventions

  • Placebo — DRUG
    Placebo to Match secukinumab (AIN457) 150mg or 300mg or Placebo to match etanercept
  • secukinumab (AIN457) — DRUG
    secukinumab (AIN457) 150mg or 300mg subcutaneous
  • etanercept — DRUG
    etanercept 50mg subcutaneous

Study Details

This study will assess the safety and efficacy of secukinumab compared to placebo and etanercept in patients that have moderate to severe, chronic, plaque-type psoriasis.

Key Dates

Start date
Jun 30, 2011
Status verified
Mar 2019
Primary completion
Jul 31, 2013
Completion
Jul 31, 2013

Study Design

Enrollment
1,306 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: AIN457 150mg
    AIN457 150mg
  • Experimental: AIN457 300mg
    AIN457 300mg
  • Placebo Comparator: Placebo
    Placebo
  • Active Comparator: Etanercept
    Etanercept
  • Experimental: AIN457 150mg from Placebo
    Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase
  • Experimental: AIN457 300mg from Placebo
    Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase

Primary Outcome Measure

Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 75 (Psoriasis Area and Severity Index) . [ Time Frame: 12 wks ]

Locations (13)

FacilityCityStateZIPSite coordinators
Novartis Investigative SiteBirminghamAlabama35205-
Novartis Investigative SitePhoenixArizona85013-
Novartis Investigative SiteSan DiegoCalifornia92103-
Novartis Investigative SiteSan DiegoCalifornia92123-
Novartis Investigative SiteIndianapolisIndiana46256-
Novartis Investigative SiteHigh PointNorth Carolina27262-
Novartis Investigative SiteWarrenOhio44483-
Novartis Investigative SitePortlandOregon97210-
Novartis Investigative SiteJohnstonRhode Island02919-
Novartis Investigative SiteCharlestonSouth Carolina29407-
Novartis Investigative SiteKingsportTennessee37660-
Novartis Investigative SiteSan AntonioTexas78229-
Novartis Investigative SiteNorfolkVirginia23507-

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