Efficacy and Safety of Intravenous and Subcutaneous Secukinumab in Moderate to Severe Chronic Plaque-type Psoriasis (STATURE)

• Efficacy of a higher dose of secukinumab than administered in CAIN457A2304 in achieving PASI 75 or IGA 0 or 1 response over time. [ Time Frame: Week 40 ] [ Designated as safety issue: No ]
• Efficacy of secukinumab treatment regimens in subjects with respect to PASI 50/75/90/100 response and IGA 0 or 1 response overtime. [ Time Frame: Week 40 ] [ Designated as safety issue: No ]
• Efficacy treatment regimens with secukinumab with respect to PASI score and IGA mod 2011 score over time. [ Time Frame: Week 40 ] [ Designated as safety issue: No ]
• Safety and tolerability of secukinumab treatment regimens as assessed by vital signs, clinical laboratory variables, ECGs and adverse events monitoring. [ Time Frame: (Vital signs, Clinical lab variables and AE monitoring) randomization, Wk 2,Wk4,Wk8,Wk12, Wk16, Wk 20, Wk 24,Wk 28,Wk 28,Wk 32,Wk 36,Wk 40,Wk 44,Wk 48 and unscheduled visits. For ECGs, randomization, Wk 8, Wk 24, Wk 40, Wk 48 and unscheduled visits. ] [ Designated as safety issue: Yes ]
• Effects of treatment regimens with secukinubab with respect to the dermatology life quality index (DLQI) 0 or 1 achievement. [ Time Frame: Randomization, Week 8, Week 16, Week 24, Week 32,up to Week 40 ] [ Designated as safety issue: No ]

The study will assess the safety and efficacy of intravenous (10mg/kg) and subcutaneous (300mg) secukinumab in moderate to severe chronic plaque-type psoriasis who are partial responders to secukinumab.

• Drug: secukinumab 150mg
  secukinumab 150mg(2 injections per dose)
• Drug: secukinumab 10mg/kg i.v. regimen
  secukinumab 10mg/kg i.v. regimen

• Experimental: secukinumab
  secukinumab 150 mg (2 injections per dose)
  Intervention: Drug: secukinumab 150mg
• Experimental: secukinumab 10mg/kg i.v. regimen
  secukinumab 10mg/kg i.v. regimen
  Intervention: Drug: secukinumab 10mg/kg i.v. regimen

Inclusion criteria:

• Written Informed Consent must be obtained before any assessment is performed,
• Subject must be able to understand and communicate with the investigator and comply with the requirements of the study.
• Subjects must have participated in the study CAIN457A2304 and have achieved a partial response after twelve weeks of treatment with no major protocol deviations.

A partial response is defined as having achieved ≥ PASI 50 but < 75 response.

Exclusion criteria

• Pregnant women or lactating women
• Forms of psoriasis other than chronic plaque -type
• Ongoing use of prohibited psoriasis treatments
• Ongoing use of other non-psoriasis prohibited treatments
• Previous exposure to any biologic drug directly targeting IL-17 or the IL-17 receptor, except secukinumab in study CAIN457A2304
• Active ongoing inflammation diseases other than psoriasis that might confound the evaluation of the benefits of secukinumab therapy
• UV therapy or excessive exposure to sunlight