Conditions: Moderate to Severe Plaque-type Psoriasis
Keywords: Psoriasis plaque plaque-type psoriasis IL-17 blocker subcutaneous psoriatic arthritis injection AIN457 AIN457A secukinumab
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 738
Healthy volunteers: no

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

Detailed description:

Arms:
arm 1: AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week arm 2: AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week arm 3: placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48. arm 4: Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase because they were PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48. arm 5: Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase. PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.

Interventions: intervention 1: secukinumab 150 mg intervention 2: placebo to secukinumab 150 mg
Intervention descriptions: intervention 1: secukinumab (AIN457) 150mg or 300mg subcutaneous intervention 2: Placebo to Match secukinumab (AIN457) 150mg or 300mg subcutaneous

Protocol document: