Clinical trial NCT02595970: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis
Keywords: Psoriasis
Secukinumab
Simplified Psoriasis Index
CAIN457A
AIN457AFR01
AIN457A
Skin condition
skin disease
itching condition
psoriasis vulgaris
relapsing/remitting psoriasis
immune-mediated systemic disease
skin lesions
red skin lesions
scaly patches
papules
plaques
itching
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2015-11-04
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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).

Primary outcomes:
measure: proSPI (s) at Week 16 Compared to Baseline
timeFrame: Week 0 (baseline) to 16 weeks
measure: Changes of saSPI (s) at Week 16 Compared to Baseline
timeFrame: Week 0 (baseline) to 16 weeks
Secondary outcomes:
measure: PASI (Psoriasis Area Severity Index) Score
timeFrame: week 0, 16, 52
measure: Correlation Between PASI and proSPI (s)
timeFrame: week 0, 16, 52
measure: proSPI (s, p and i) Over Time
timeFrame: weeks 0, 16, 52
measure: saSPI (s, p and i) Over Time
timeFrame: weeks 0, 16, 52
measure: DLQI (Dermatology Life Quality Index) Over Time
timeFrame: weeks 0, 16, 52
measure: Self-administered PASI (SA-PASI)
timeFrame: weeks 0, 16, 52
measure: Psoriasis Symptom Diary (PSD) Score
timeFrame: weeks 0, 16, 52
measure: Correlation Between proSPI (for Each Component: s, p and i) and DLQI
timeFrame: weeks 0, 16, 52
measure: Correlation Between proSPI (for Components p and i) and PASI
timeFrame: Over time (from Week 0 to Week 52)
Other outcomes:
Locations:
city: Le Mans
country: France
facility: Novartis Investigative Site
state: Cedex 09
city: Limoges cedex
country: France
facility: Novartis Investigative Site
state: Haute Vienne
city: Toulon Cedex 9
country: France
facility: Novartis Investigative Site
state: Val De Marne
city: Amiens Cedex 1
country: France
facility: Novartis Investigative Site
city: Antony
country: France
facility: Novartis Investigative Site
city: Argenteuil
country: France
facility: Novartis Investigative Site
city: Bordeaux
country: France
facility: Novartis Investigative Site
city: Brest
country: France
facility: Novartis Investigative Site
city: La Rochelle
country: France
facility: Novartis Investigative Site
city: Marseille Cedex 05
country: France
facility: Novartis Investigative Site
city: Martigues
country: France
facility: Novartis Investigative Site
city: Metz
country: France
facility: Novartis Investigative Site
city: Nice
country: France
facility: Novartis Investigative Site
city: Paris
country: France
facility: Novartis Investigative Site
city: Paris
country: France
facility: Novartis Investigative Site
city: Rouen
country: France
facility: Novartis Investigative Site
city: Toulouse Cedex
country: France
facility: Novartis Investigative Site
Study officials:
affiliation: HOPITAL SAINT LOUIS - LA ROCHELLE
name: PHILIPPE CELERIER
role: PRINCIPAL_INVESTIGATOR
affiliation: HOPITAL TIMONES - MARSEILLE
name: MARIE-ALETH RICHARD
role: PRINCIPAL_INVESTIGATOR
affiliation: HOPITAL COCHIN - PARIS
name: SELIM ARACTINGI
role: PRINCIPAL_INVESTIGATOR
affiliation: HOPITAL PRIVE D'ANTONY - ANTONY
name: PIERRE ANDRE BECHEREL
role: PRINCIPAL_INVESTIGATOR
affiliation: CH VICTOR DUPOUY - ARGENTEUIL
name: EMMANUEL MAHE
role: PRINCIPAL_INVESTIGATOR
affiliation: HOPITAL L'ARCHET - NICE
name: PHILIPPE LACOUR
role: PRINCIPAL_INVESTIGATOR
affiliation: CABINET BATEAU BLANC - MARTIGUES
name: MIREILLE RUER MULARD
role: PRINCIPAL_INVESTIGATOR
affiliation: HIA SAINTE ANNE - TOULON
name: THIERRY BOYE
role: PRINCIPAL_INVESTIGATOR
affiliation: HOPITAL CHARLES NICOLLE - ROUEN
name: ANNE DUVAL-MODESTE
role: PRINCIPAL_INVESTIGATOR
affiliation: HOPITAL SAINT ANDRE - BORDEAUX
name: MARIE BEYLOT-BARRY
role: PRINCIPAL_INVESTIGATOR
affiliation: HOPITAL MORVAN - BREST
name: LAURENT MISERY
role: PRINCIPAL_INVESTIGATOR
affiliation: HOPITAL BICHAT CLAUDE BERNARD - PARIS
name: VINCENT DESCAMPS
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU AMIENS NORD - AMIENS
name: GUILLAUME CHABY
role: PRINCIPAL_INVESTIGATOR
affiliation: HOPITAL LARREY - TOULOUSE
name: CARLE PAUL
role: PRINCIPAL_INVESTIGATOR
affiliation: HOPITAL DUPUYTREN - LIMOGES
name: CHRISTOPHE BEDANE
role: PRINCIPAL_INVESTIGATOR
affiliation: CENTRE HOSPITALIER LE MANS - LE MANS
name: HERVÉ MAILLARD
role: PRINCIPAL_INVESTIGATOR
affiliation: HIA LEGOUEST - METZ
name: JEAN-FRANCOIS CUNY
role: PRINCIPAL_INVESTIGATOR
References: