102
Participants
Start Date
September 29, 2014
Primary Completion Date
December 7, 2015
Study Completion Date
December 7, 2015
Secukinumab 300 mg
Secukinumab 300 mg will be provided in 1 mL prefilled syringes of 150 mg. Each dose of 300 mg secukinumab will consist of two secukinumab 150 mg injections once weekly for 5 weeks (Baseline, Weeks 1, 2, 3 and 4), followed by dosing every four weeks starting at Week 8 through Week 20 inclusive. In order to maintain the blinding, patients will receive additional placebo injections at Weeks 13, 14 and 15. The patients (or caregivers) will self-inject each dose at the study site under the supervision of site personnel when injections occur of days of study visits. The injections not occurring during a study visit will be done by the patients (or caregivers) at home.
Placebo
Placebo will be provided in 1 mL prefilled syringe. Each placebo dose will consist of two placebo injections once weekly for five weeks (Baseline, Weeks 1, 2, 3 and 4), then after four weeks at Week 8. At Week 12, PSSI responders will continue on placebo and receive their injections once weekly for five weeks (Weeks 12, 13, 14, 15 and 16), then followed by dosing after four weeks at Week 20. PSSI non-responders will be switched to receive 300 mg secukinumab at Weeks 12, 13, 14, 15 and 16, then after four weeks at Week 20. The patients (or caregivers) will self-inject each dose at the study site under the supervision of site personnel when injections occur on days of study visits. The injections not occurring during a study visit will be done by the patients (or caregivers) at home.
Novartis Investigative Site, New York
Novartis Investigative Site, New York
Novartis Investigative Site, Hershey
Novartis Investigative Site, Rockville
Novartis Investigative Site, Winston-Salem
Novartis Investigative Site, Gahanna
Novartis Investigative Site, Troy
Novartis Investigative Site, Arlington
Novartis Investigative Site, Aurora
Novartis Investigative Site, West Jordan
Novartis Investigative Site, Salt Lake City
Novartis Investigative Site, Sacramento
Novartis Investigative Site, Trumbull
Novartis Investigative Site, Andover
Novartis Investigative Site, Boston
Novartis Investigative Site, East Windsor
Novartis Investigative Site, Pittsburgh
Lead Sponsor
Novartis Pharmaceuticals
INDUSTRY