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 — DRUGPlacebo to Match secukinumab (AIN457) 150mg or 300mg or Placebo to match etanercept
- secukinumab (AIN457) — DRUGsecukinumab (AIN457) 150mg or 300mg subcutaneous
- etanercept — DRUGetanercept 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 150mgAIN457 150mg
- Experimental: AIN457 300mgAIN457 300mg
- Placebo Comparator: PlaceboPlacebo
- Active Comparator: EtanerceptEtanercept
- Experimental: AIN457 150mg from PlaceboPatients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase
- Experimental: AIN457 300mg from PlaceboPatients 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)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Novartis Investigative Site | Birmingham | Alabama | 35205 | - |
| Novartis Investigative Site | Phoenix | Arizona | 85013 | - |
| Novartis Investigative Site | San Diego | California | 92103 | - |
| Novartis Investigative Site | San Diego | California | 92123 | - |
| Novartis Investigative Site | Indianapolis | Indiana | 46256 | - |
| Novartis Investigative Site | High Point | North Carolina | 27262 | - |
| Novartis Investigative Site | Warren | Ohio | 44483 | - |
| Novartis Investigative Site | Portland | Oregon | 97210 | - |
| Novartis Investigative Site | Johnston | Rhode Island | 02919 | - |
| Novartis Investigative Site | Charleston | South Carolina | 29407 | - |
| Novartis Investigative Site | Kingsport | Tennessee | 37660 | - |
| Novartis Investigative Site | San Antonio | Texas | 78229 | - |
| Novartis Investigative Site | Norfolk | Virginia | 23507 | - |