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 (IPSI-PSO)

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

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: Secukinumab

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

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Amiens Cedex 1, France, 80054
    • Novartis Investigative Site
  • Antony, France, 92160
    • Novartis Investigative Site
  • Argenteuil, France, 95107
    • Novartis Investigative Site
  • Bordeaux, France, 33076
    • Novartis Investigative Site
  • Brest, France, 29609
    • Novartis Investigative Site
  • La Rochelle, France, 17019
    • Novartis Investigative Site
  • Marseille Cedex 05, France, 13885
    • Novartis Investigative Site
  • Martigues, France, 13500
    • Novartis Investigative Site
  • Metz, France, 57077
    • Novartis Investigative Site
  • Nice, France, 06202
    • Novartis Investigative Site
  • Paris, France, 75014
    • Novartis Investigative Site
  • Paris, France, 75877
    • Novartis Investigative Site
  • Rouen, France, 76031
    • Novartis Investigative Site
  • Toulouse Cedex, France, 31400
    • Novartis Investigative Site
  • Cedex 09
    • Le Mans, Cedex 09, France, 72037
      • Novartis Investigative Site
  • Haute Vienne
    • Limoges cedex, Haute Vienne, France, 87000
      • Novartis Investigative Site
  • Val De Marne
    • Toulon Cedex 9, Val De Marne, France, 83800
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Secukinumab; 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; weekly sub cutaneous injections of 300 mg during the first month and then monthly until week 52 plus extension until 03/11/2016.; 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)

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Principal Investigator: SELIM ARACTINGI, HOPITAL COCHIN - PARIS; Principal Investigator: PHILIPPE CELERIER, HOPITAL SAINT LOUIS - LA ROCHELLE; Principal Investigator: MARIE-ALETH RICHARD, HOPITAL TIMONES - MARSEILLE; Principal Investigator: PIERRE ANDRE BECHEREL, HOPITAL PRIVE D'ANTONY - ANTONY; Principal Investigator: EMMANUEL MAHE, CH VICTOR DUPOUY - ARGENTEUIL; Principal Investigator: PHILIPPE LACOUR, HOPITAL L'ARCHET - NICE; Principal Investigator: MIREILLE RUER MULARD, CABINET BATEAU BLANC - MARTIGUES; Principal Investigator: THIERRY BOYE, HIA Sainte Anne - Toulon; Principal Investigator: ANNE DUVAL-MODESTE, HOPITAL CHARLES NICOLLE - ROUEN; Principal Investigator: MARIE BEYLOT-BARRY, Hôpital Saint André - Bordeaux; Principal Investigator: LAURENT MISERY, Hôpital Morvan - Brest; Principal Investigator: VINCENT DESCAMPS, HOPITAL BICHAT CLAUDE BERNARD - PARIS; Principal Investigator: GUILLAUME CHABY, CHU AMIENS NORD - AMIENS; Principal Investigator: CARLE PAUL, HOPITAL LARREY - TOULOUSE; Principal Investigator: CHRISTOPHE BEDANE, Hôpital Dupuytren - Limoges; Principal Investigator: HERVÉ MAILLARD, CENTRE HOSPITALIER LE MANS - LE MANS; Principal Investigator: JEAN-FRANCOIS CUNY, HIA LEGOUEST - METZ

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2015
• Primary Completion (Actual): February 9, 2017
• Study Completion (Actual): February 9, 2017

Study Registration Dates

• First Submitted: February 25, 2015
• First Submitted That Met QC Criteria: November 2, 2015
• First Posted (Estimate): November 4, 2015

Study Record Updates

• Last Update Posted (Actual): April 17, 2019
• Last Update Submitted That Met QC Criteria: April 15, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Psoriasis; plaques; skin disease; Secukinumab; itching; psoriasis vulgaris; immune-mediated systemic disease; skin lesions; scaly patches; papules; Skin condition; AIN457A; itching condition; relapsing/remitting psoriasis; red skin lesions; Simplified Psoriasis Index; CAIN457A; AIN457AFR01
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: CAIN457AFR01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No