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

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.

Conditions

• Psoriasis

Interventions

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.

Sponsors & Collaborators

• Novartis Pharmaceuticals

  lead INDUSTRY

Principal Investigators

• PHILIPPE CELERIER · HOPITAL SAINT LOUIS - LA ROCHELLE

• MARIE-ALETH RICHARD · HOPITAL TIMONES - MARSEILLE

• SELIM ARACTINGI · HOPITAL COCHIN - PARIS

• PIERRE ANDRE BECHEREL · HOPITAL PRIVE D'ANTONY - ANTONY

• EMMANUEL MAHE · CH VICTOR DUPOUY - ARGENTEUIL

• PHILIPPE LACOUR · HOPITAL L'ARCHET - NICE

• MIREILLE RUER MULARD · CABINET BATEAU BLANC - MARTIGUES

• THIERRY BOYE · HIA SAINTE ANNE - TOULON

• ANNE DUVAL-MODESTE · HOPITAL CHARLES NICOLLE - ROUEN

• MARIE BEYLOT-BARRY · HOPITAL SAINT ANDRE - BORDEAUX

• LAURENT MISERY · HOPITAL MORVAN - BREST

• VINCENT DESCAMPS · HOPITAL BICHAT CLAUDE BERNARD - PARIS

• GUILLAUME CHABY · CHU AMIENS NORD - AMIENS

• CARLE PAUL · HOPITAL LARREY - TOULOUSE

• CHRISTOPHE BEDANE · HOPITAL DUPUYTREN - LIMOGES

• HERVÉ MAILLARD · CENTRE HOSPITALIER LE MANS - LE MANS

• JEAN-FRANCOIS CUNY · HIA LEGOUEST - METZ

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-05-20

Primary Completion

2017-02-09

Completion

2017-02-09

Countries

• France

Study Locations