Efficacy and Safety of Subcutaneous Secukinumab in Adults With Moderate to Severe Scalp Psoriasis

PHASE3CompletedINTERVENTIONAL
Enrollment

102

Participants

Timeline

Start Date

September 29, 2014

Primary Completion Date

December 7, 2015

Study Completion Date

December 7, 2015

Conditions
Chronic Scalp Psoriasis
Interventions
BIOLOGICAL

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.

BIOLOGICAL

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.

Trial Locations (17)

10025

Novartis Investigative Site, New York

10075

Novartis Investigative Site, New York

17033

Novartis Investigative Site, Hershey

20850

Novartis Investigative Site, Rockville

27157

Novartis Investigative Site, Winston-Salem

43230

Novartis Investigative Site, Gahanna

48084

Novartis Investigative Site, Troy

76011

Novartis Investigative Site, Arlington

80045

Novartis Investigative Site, Aurora

84088

Novartis Investigative Site, West Jordan

84132

Novartis Investigative Site, Salt Lake City

95819

Novartis Investigative Site, Sacramento

06611

Novartis Investigative Site, Trumbull

01810

Novartis Investigative Site, Andover

02114

Novartis Investigative Site, Boston

08520

Novartis Investigative Site, East Windsor

15213-3403

Novartis Investigative Site, Pittsburgh

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY