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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

NCT ID: NCT02595970

Last Updated: 2019-04-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-20

Study Completion Date

2017-02-09

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Psoriasis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

This was an open label single-arm study; therefore treatment blinding was not necessary.

Study Groups

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Secukinumab

Weekly sub cutaneous injections of 300 mg during the first month and then Monthly until Week 52 plus extension until 03/11/2016.

Group Type EXPERIMENTAL

Secukinumab

Intervention Type DRUG

weekly sub cutaneous injections of 300 mg during the first month and then monthly until week 52 plus extension until 03/11/2016.

Interventions

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Secukinumab

weekly sub cutaneous injections of 300 mg during the first month and then monthly until week 52 plus extension until 03/11/2016.

Intervention Type DRUG

Other Intervention Names

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open label, no other intervention

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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PHILIPPE CELERIER

Role: PRINCIPAL_INVESTIGATOR

HOPITAL SAINT LOUIS - LA ROCHELLE

MARIE-ALETH RICHARD

Role: PRINCIPAL_INVESTIGATOR

HOPITAL TIMONES - MARSEILLE

SELIM ARACTINGI

Role: PRINCIPAL_INVESTIGATOR

HOPITAL COCHIN - PARIS

PIERRE ANDRE BECHEREL

Role: PRINCIPAL_INVESTIGATOR

HOPITAL PRIVE D'ANTONY - ANTONY

EMMANUEL MAHE

Role: PRINCIPAL_INVESTIGATOR

CH VICTOR DUPOUY - ARGENTEUIL

PHILIPPE LACOUR

Role: PRINCIPAL_INVESTIGATOR

HOPITAL L'ARCHET - NICE

MIREILLE RUER MULARD

Role: PRINCIPAL_INVESTIGATOR

CABINET BATEAU BLANC - MARTIGUES

THIERRY BOYE

Role: PRINCIPAL_INVESTIGATOR

HIA SAINTE ANNE - TOULON

ANNE DUVAL-MODESTE

Role: PRINCIPAL_INVESTIGATOR

HOPITAL CHARLES NICOLLE - ROUEN

MARIE BEYLOT-BARRY

Role: PRINCIPAL_INVESTIGATOR

HOPITAL SAINT ANDRE - BORDEAUX

LAURENT MISERY

Role: PRINCIPAL_INVESTIGATOR

HOPITAL MORVAN - BREST

VINCENT DESCAMPS

Role: PRINCIPAL_INVESTIGATOR

HOPITAL BICHAT CLAUDE BERNARD - PARIS

GUILLAUME CHABY

Role: PRINCIPAL_INVESTIGATOR

CHU AMIENS NORD - AMIENS

CARLE PAUL

Role: PRINCIPAL_INVESTIGATOR

HOPITAL LARREY - TOULOUSE

CHRISTOPHE BEDANE

Role: PRINCIPAL_INVESTIGATOR

HOPITAL DUPUYTREN - LIMOGES

HERVÉ MAILLARD

Role: PRINCIPAL_INVESTIGATOR

CENTRE HOSPITALIER LE MANS - LE MANS

JEAN-FRANCOIS CUNY

Role: PRINCIPAL_INVESTIGATOR

HIA LEGOUEST - METZ

Locations

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Novartis Investigative Site

Le Mans, Cedex 09, France

Site Status

Novartis Investigative Site

Limoges, Haute Vienne, France

Site Status

Novartis Investigative Site

Toulon, Val De Marne, France

Site Status

Novartis Investigative Site

Amiens, , France

Site Status

Novartis Investigative Site

Antony, , France

Site Status

Novartis Investigative Site

Argenteuil, , France

Site Status

Novartis Investigative Site

Bordeaux, , France

Site Status

Novartis Investigative Site

Brest, , France

Site Status

Novartis Investigative Site

La Rochelle, , France

Site Status

Novartis Investigative Site

Marseille, , France

Site Status

Novartis Investigative Site

Martigues, , France

Site Status

Novartis Investigative Site

Metz, , France

Site Status

Novartis Investigative Site

Nice, , France

Site Status

Novartis Investigative Site

Paris, , France

Site Status

Novartis Investigative Site

Paris, , France

Site Status

Novartis Investigative Site

Rouen, , France

Site Status

Novartis Investigative Site

Toulouse, , France

Site Status

Countries

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France

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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CAIN457AFR01

Identifier Type: -

Identifier Source: org_study_id

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