Study to Evaluate Psoriasis Severity and Its Psychosocial Impact Using the Simplified Psoriasis Index (SPI), as Well as Long-term Safety, Tolerability and Efficacy of Secukinumab Administered Subcutaneously in Patients With Moderate to Severe Psoriasis

Study Overview
=================
Brief Summary
-----------------
Evaluate psoriasis severity and its psychosocial impact using a novel Patient Reported Outcome (the Simplified Psoriasis Index SPI) at 16 weeks, as well as long-term safety, tolerability and efficacy of secukinumab administered subcutaneously during 52 weeks (plus extension) in patients with moderate to severe psoriasis.

Detailed Description
-----------------
Study to Evaluate Psoriasis Severity and Its Psychosocial Impact Using the Simplified Psoriasis Index (SPI), as Well as Long-term Safety, Tolerability and Efficacy of Secukinumab Administered Subcutaneously in Patients With Moderate to Severe Psoriasis

Official Title
-----------------
A 52-week (Plus Extension Until Commercialization), Single-arm Study to Evaluate Psoriasis Severity and Its Psychosocial Impact Using the Simplified Psoriasis Index (SPI) at 16 Weeks, as Well as Long-term Safety, Tolerability and Efficacy of Secukinumab Administered Subcutaneously in Participants Suffering From Moderate to Severe Psoriasis

Conditions
-----------------
Psoriasis

Intervention / Treatment
-----------------
* Drug: Secukinumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with a history of chronic, moderate to severe plaque psoriasis (PASI ≥12; BSA (body surface area) ≥10 and IGA mod 2011 (Investigator's Global Assessment) ≥3) for at least 6 months patient candidates for systemic therapy. informed consent. Exclusion Criteria: previous treatment with agent targeting IL-17 (interleukine-17) or IL-17 receptor. recent treatment with topical treatment (2 weeks), systemic agents (4 weeks for methotrexate, Ciclosporine A; systemic retinoids and other systemic treatment), TNF (tumor necrosis factor) inhibitors (3 months) or IL-12/23 inhibitors (6 months).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Secukinumab<br>Weekly sub cutaneous injections of 300 mg during the first month and then Monthly until Week 52 plus extension until 03/11/2016. | Drug: Secukinumab<br>* weekly sub cutaneous injections of 300 mg during the first month and then monthly until week 52 plus extension until 03/11/2016.<br>* Other names: open label, no other intervention;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proSPI (s) at Week 16 Compared to Baseline | The primary efficacy outcome of this study evaluates the benefit of secukinumab on the severity of psoriasis based on the SPI. This index comprises 3 components: severity (SPIs), psychosocial (SPIp) and intervention (SPIi) and were evaluated by both health care professional (professional, proSPI) and the patient (self-administered: saSPI). Only the severity components were evaluated for the primary objective: proSPI (s) and saSPI (s). Changes at Week 16 compared to Baseline in patients suffering from moderate to severe plaque psoriasis were analyzed for the purpose of this study. | Week 0 (baseline) to 16 weeks | 
| Changes of saSPI (s) at Week 16 Compared to Baseline | The primary efficacy objective of the study was to evaluate the benefit of secukinumab on the severity of psoriasis based on the SPI. This index comprises 3 components: severity (SPIs), psychosocial (SPIp) and intervention (SPIi) and were evaluated by both health care professional (professional, proSPI) and the patient (self-administered: saSPI). Only the severity components were evaluated for the primary objective: proSPI (s) and saSPI (s). Changes at Week 16 compared to Baseline in patients suffering from moderate to severe plaque psoriasis were analyzed. proSPI (s) score range is 0 to 50. Higher score means worse condition | Week 0 (baseline) to 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PASI (Psoriasis Area Severity Index) Score | PASI administered by a professional score range: 0 (no disease) to 72 (maximal disease) | week 0, 16, 52 | 
| Correlation Between PASI and proSPI (s) | Psoriasis Area Severity Index vs Professional Version of Simplified Psoraisis Index (proSPI) score | week 0, 16, 52 | 
| proSPI (s, p and i) Over Time | Professional Version of Simplified Psoriasis Index (proSPI) SPI for Simplified Psoriasis Index. SPI is composed of 3 domains : s for the severity, min =0 and max=50 p for the psychosocial, min=0 and max=10 i for the intervention, min = 0 and max = 10 For each domain, high values represented a worse outcome The 3 subscales cannot be combined Please use sore on a scale for the unit of measure | weeks 0, 16, 52 | 
| saSPI (s, p and i) Over Time | Self-administered Simplified Psoriasis Index (saSPI) SPI for Simplified Psoriasis Index. SPI is composed of 3 domains : s for the severity, min =0 and max=50 p for the psychosocial, min=0 and max=10 i for the intervention, min = 0 and max = 10 For each domain, high values represented a worse outcome The 3 subscales cannot be combined Please use sore on a scale for the unit of measure | weeks 0, 16, 52 | 
| DLQI (Dermatology Life Quality Index) Over Time | DLQI score has a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired MEANING OF DLQI SCORES 0 - 1 no effect on patient's life 2 - 5 small effect on patient's life 6 - 10 moderate effect on patient's life 11 - 20 very large effect on patient's life 21 - 30 extremely large effect on patient's life | weeks 0, 16, 52 | 
| Self-administered PASI (SA-PASI) | self-administered PASI (SA-PASI) score | weeks 0, 16, 52 | 
| Psoriasis Symptom Diary (PSD) Score | assessment of pain, itching and scaling using the Psoriasis Symptom Diary questionnaire over time PSD scores range from 0 to 10, with higher scores indicating a worse condition for each assessment: pain, itching and scaling | weeks 0, 16, 52 | 
| Correlation Between proSPI (for Each Component: s, p and i) and DLQI | Correlation between proSPI (for each component: s, p and i) and DLQI is summarized in table below | weeks 0, 16, 52 | 
| Correlation Between proSPI (for Components p and i) and PASI | Correlation between proSPI (p, i) and PASI score by visit (Full Analysis Set (observed)) is summarized in table below | Over time (from Week 0 to Week 52) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
itching condition, immune-mediated systemic disease, skin lesions, red skin lesions, scaly patches, papules, plaques, itching, Psoriasis, Secukinumab, Simplified Psoriasis Index, CAIN457A, AIN457AFR01, AIN457A, Skin condition, skin disease, psoriasis vulgaris, relapsing/remitting psoriasis