Clinical trial NCT02752776: A Study to Evaluate Clear Skin Effect on Quality of Life in Patients With Plaque Psoriasis.
Official title: An Open-label, Prospective, Non-randomized, Multicenter Study to Evaluate Clear Skin Effect on Health Related Quality of Life Outcomes at 16 and 52 Weeks in Patients With Moderate to Severe Plaque Psoriasis Treated With Secukinumab 300 mg s.c. With or Without Previous Exposure to Systemic Therapy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Plaque Psoriasis
Keywords: secukinumab
AIN457
Moderate to severe plaque psoriasis
immune-mediated systemic disease
scaly patches
papules
plaques
itching
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2016-04-27
Enrollment: 1660
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Study of effects of secukinumab 300 mg s.c. on quality of life (QoL) in psoriasis in patients with or without prior exposure to systemic therapy.


Eligibility criteria: Inclusion Criteria:

* Men or women aged at least 18 years at time of Screening.
* Moderate to severe plaque-type psoriasis diagnosed for at least 3 months prior to Screening and candidate for systemic therapy.
* Other protocol defined inclusion criteria may apply. Please refer to the protocol.

Exclusion Criteria:

* Forms of psoriasis other than moderate to severe plaque-type psoriasis, e.g. drug-induced psoriasis at Screening.
* Patients with previous treatment with any agent targeting interleukin (IL)-17 directly or IL-17 receptor A (e.g. secukinumab, ixekizumab, or brodalumab).
* Pregnant or nursing (lactating) women
* Women of child-bearing potential unless they use effective contraception

Primary outcomes:
measure: Percentage of Participants With a Dermatology Life Quality Index 0/1 (DLQI 0/1) Response at Week 16
timeFrame: 16 weeks
Secondary outcomes:
measure: Percentage of Participants With a Dermatology Life Quality Index 0/1 (DLQI 0/1) Response at Week 52
timeFrame: 52 weeks
measure: Percentage of Participants in Each DLQI Score Category at Week 16 and Week 52
timeFrame: 52 weeks
measure: Percentage of Participants With PASI 50, PASI 75, PASI 90, PASI 100 or IGA Mod 2011 0/1 Response at Week 16 and 52
timeFrame: Week 16, Week 52
measure: Absolute Change From Baseline in EQ-5D-5L Crosswalk Index at Week 16 and Week 52
timeFrame: Week 16, Week 52
measure: Absolute Change From Baseline in EQ-5D-5L Visual Analogue Scale (VAS) at Week 16 and Week 52
timeFrame: Week 16, Week 52
measure: Absolute Change From Baseline in HAQ-DI at Week 16 and Week 52
timeFrame: Week 16 and Week 52
measure: Absolute Change From Baseline in Numeric Rating Scale (NRS) at Week 16 and Week 52
timeFrame: 16 and 52 weeks
measure: Treatment Satisfaction Questionnaire for Medication (TSQM) Scale Scores at Week 16 and Week 52
timeFrame: 16 and 52 weeks
measure: Patient Benefit Index (PBI) at Week 16 and Week 52
timeFrame: Week 16 and Week 52
Other outcomes:
Locations:
city: Geel
country: Belgium
facility: Novartis Investigative Site
state: BEL
city: Brugge
country: Belgium
facility: Novartis Investigative Site
city: Gent
country: Belgium
facility: Novartis Investigative Site
city: Seraing
country: Belgium
facility: Novartis Investigative Site
city: Pleven
country: Bulgaria
facility: Novartis Investigative Site
city: Sofia
country: Bulgaria
facility: Novartis Investigative Site
city: Sofia
country: Bulgaria
facility: Novartis Investigative Site
city: Stara Zagora
country: Bulgaria
facility: Novartis Investigative Site
city: Varna
country: Bulgaria
facility: Novartis Investigative Site
city: Usti nad Labem
country: Czechia
facility: Novartis Investigative Site
state: Czech Republic
city: Plzen
country: Czechia
facility: Novartis Investigative Site
city: Praha 5
country: Czechia
facility: Novartis Investigative Site
city: Praha
country: Czechia
facility: Novartis Investigative Site
city: Tallinn
country: Estonia
facility: Novartis Investigative Site
city: Tallinn
country: Estonia
facility: Novartis Investigative Site
city: Tartu
country: Estonia
facility: Novartis Investigative Site
city: Le Mans
country: France
facility: Novartis Investigative Site
state: Cedex 09
city: Toulon Cedex 9
country: France
facility: Novartis Investigative Site
state: Val De Marne
city: Angers cedex 09
country: France
facility: Novartis Investigative Site
city: Antony
country: France
facility: Novartis Investigative Site
city: Argenteuil
country: France
facility: Novartis Investigative Site
city: Auxerre
country: France
facility: Novartis Investigative Site
city: Bayonne
country: France
facility: Novartis Investigative Site
city: Bordeaux
country: France
facility: Novartis Investigative Site
city: Boulogne-sur-Mer
country: France
facility: Novartis Investigative Site
city: Brest
country: France
facility: Novartis Investigative Site
city: Caen
country: France
facility: Novartis Investigative Site
city: Cannes
country: France
facility: Novartis Investigative Site
city: Clermont Ferrand cedex 1
country: France
facility: Novartis Investigative Site
city: Dijon
country: France
facility: Novartis Investigative Site
city: Grenoble Cedex
country: France
facility: Novartis Investigative Site
city: La Rochelle
country: France
facility: Novartis Investigative Site
city: Lille
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: Montpellier cedex 5
country: France
facility: Novartis Investigative Site
city: Nice
country: France
facility: Novartis Investigative Site
city: Nimes
country: France
facility: Novartis Investigative Site
city: Pierre Benite Cedex
country: France
facility: Novartis Investigative Site
city: Pringy cedex
country: France
facility: Novartis Investigative Site
city: Quimper
country: France
facility: Novartis Investigative Site
city: Reims
country: France
facility: Novartis Investigative Site
city: Rouen Cedex
country: France
facility: Novartis Investigative Site
city: Saint Mande
country: France
facility: Novartis Investigative Site
city: St Priest en Jarez Cedex
country: France
facility: Novartis Investigative Site
city: Toulouse Cedex
country: France
facility: Novartis Investigative Site
city: Valence Cedex 9
country: France
facility: Novartis Investigative Site
city: Valenciennes Cedex
country: France
facility: Novartis Investigative Site
city: Vandoeuvre Les Nancy
country: France
facility: Novartis Investigative Site
city: Mannheim
country: Germany
facility: Novartis Investigative Site
state: Baden-Wuerttemberg
city: Muenchen
country: Germany
facility: Novartis Investigative Site
state: Bayern
city: Aachen
country: Germany
facility: Novartis Investigative Site
city: Andernach
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Bielefeld
country: Germany
facility: Novartis Investigative Site
city: Bonn
country: Germany
facility: Novartis Investigative Site
city: Bramsche
country: Germany
facility: Novartis Investigative Site
city: Braunschweig
country: Germany
facility: Novartis Investigative Site
city: Erlangen
country: Germany
facility: Novartis Investigative Site
city: Frankfurt
country: Germany
facility: Novartis Investigative Site
city: Freiburg
country: Germany
facility: Novartis Investigative Site
city: Friedrichshafen
country: Germany
facility: Novartis Investigative Site
city: Gelsenkirchen
country: Germany
facility: Novartis Investigative Site
city: Gera
country: Germany
facility: Novartis Investigative Site
city: Halle
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hannover
country: Germany
facility: Novartis Investigative Site
city: Heidelberg
country: Germany
facility: Novartis Investigative Site
city: Ibbenbueren
country: Germany
facility: Novartis Investigative Site
city: Kiel
country: Germany
facility: Novartis Investigative Site
city: Koeln
country: Germany
facility: Novartis Investigative Site
city: Lubeck
country: Germany
facility: Novartis Investigative Site
city: Ludwigshafen am Rhein
country: Germany
facility: Novartis Investigative Site
city: Mainz
country: Germany
facility: Novartis Investigative Site
city: Muenster
country: Germany
facility: Novartis Investigative Site
city: Osnabrueck
country: Germany
facility: Novartis Investigative Site
city: Pommelsbrunn
country: Germany
facility: Novartis Investigative Site
city: Quedlinburg
country: Germany
facility: Novartis Investigative Site
city: Recklinghausen
country: Germany
facility: Novartis Investigative Site
city: Schwerin
country: Germany
facility: Novartis Investigative Site
city: Simmern
country: Germany
facility: Novartis Investigative Site
city: Vechta
country: Germany
facility: Novartis Investigative Site
city: Wiesbaden
country: Germany
facility: Novartis Investigative Site
city: Athens
country: Greece
facility: Novartis Investigative Site
state: GR
city: Heraklion Crete
country: Greece
facility: Novartis Investigative Site
city: Patras
country: Greece
facility: Novartis Investigative Site
city: Afula
country: Israel
facility: Novartis Investigative Site
city: Be'er Sheva
country: Israel
facility: Novartis Investigative Site
city: Jerusalem
country: Israel
facility: Novartis Investigative Site
city: Kfar Saba
country: Israel
facility: Novartis Investigative Site
city: Petach Tikva
country: Israel
facility: Novartis Investigative Site
city: Arezzo
country: Italy
facility: Novartis Investigative Site
state: AR
city: Bergamo
country: Italy
facility: Novartis Investigative Site
state: BG
city: San Donato Milanese
country: Italy
facility: Novartis Investigative Site
state: MI
city: Modena
country: Italy
facility: Novartis Investigative Site
state: MO
city: Perugia
country: Italy
facility: Novartis Investigative Site
state: PG
city: Siena
country: Italy
facility: Novartis Investigative Site
state: SI
city: Varese
country: Italy
facility: Novartis Investigative Site
state: VA
city: Daugavpils
country: Latvia
facility: Novartis Investigative Site
state: LVA
city: Jelgava
country: Latvia
facility: Novartis Investigative Site
state: LVA
city: Riga
country: Latvia
facility: Novartis Investigative Site
state: LVA
city: Ventspils
country: Latvia
facility: Novartis Investigative Site
state: LVA
city: Riga
country: Latvia
facility: Novartis Investigative Site
city: Riga
country: Latvia
facility: Novartis Investigative Site
city: Kaunas
country: Lithuania
facility: Novartis Investigative Site
state: LTU
city: Klaipeda
country: Lithuania
facility: Novartis Investigative Site
state: LTU
city: Kaunas
country: Lithuania
facility: Novartis Investigative Site
city: Vilnius
country: Lithuania
facility: Novartis Investigative Site
city: Vilnius
country: Lithuania
facility: Novartis Investigative Site
city: Bydgoszcz
country: Poland
facility: Novartis Investigative Site
city: Gdansk
country: Poland
facility: Novartis Investigative Site
city: Kielce
country: Poland
facility: Novartis Investigative Site
city: Krakow
country: Poland
facility: Novartis Investigative Site
city: Krakow
country: Poland
facility: Novartis Investigative Site
city: Lodz
country: Poland
facility: Novartis Investigative Site
city: Lublin
country: Poland
facility: Novartis Investigative Site
city: Olsztyn
country: Poland
facility: Novartis Investigative Site
city: Ossy
country: Poland
facility: Novartis Investigative Site
city: Poznan
country: Poland
facility: Novartis Investigative Site
city: Warszawa
country: Poland
facility: Novartis Investigative Site
city: Warszawa
country: Poland
facility: Novartis Investigative Site
city: Wroclaw
country: Poland
facility: Novartis Investigative Site
city: Lisboa
country: Portugal
facility: Novartis Investigative Site
city: Lisboa
country: Portugal
facility: Novartis Investigative Site
city: Lisboa
country: Portugal
facility: Novartis Investigative Site
city: Lisboa
country: Portugal
facility: Novartis Investigative Site
city: Porto
country: Portugal
facility: Novartis Investigative Site
city: Porto
country: Portugal
facility: Novartis Investigative Site
city: Vila Nova de Gaia
country: Portugal
facility: Novartis Investigative Site
city: Brasov
country: Romania
facility: Novartis Investigative Site
city: Brasov
country: Romania
facility: Novartis Investigative Site
city: Bucuresti
country: Romania
facility: Novartis Investigative Site
city: Craiova
country: Romania
facility: Novartis Investigative Site
city: Iasi
country: Romania
facility: Novartis Investigative Site
city: Malacky
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Bardejov
country: Slovakia
facility: Novartis Investigative Site
state: SVK
city: Banska Bystrica
country: Slovakia
facility: Novartis Investigative Site
city: Bratislava
country: Slovakia
facility: Novartis Investigative Site
city: Kosice
country: Slovakia
facility: Novartis Investigative Site
city: Svidnik
country: Slovakia
facility: Novartis Investigative Site
city: Zilina
country: Slovakia
facility: Novartis Investigative Site
city: Ferrol
country: Spain
facility: Novartis Investigative Site
state: A Coruna
city: Vitoria
country: Spain
facility: Novartis Investigative Site
state: Alava
city: Elda
country: Spain
facility: Novartis Investigative Site
state: Alicante
city: Almeria
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Malaga
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Sevilla
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Sabadell
country: Spain
facility: Novartis Investigative Site
state: Barcelona
city: Jerez
country: Spain
facility: Novartis Investigative Site
state: Cadiz
city: Albacete
country: Spain
facility: Novartis Investigative Site
state: Castilla La Mancha
city: Guadalajara
country: Spain
facility: Novartis Investigative Site
state: Castilla La Mancha
city: Toledo
country: Spain
facility: Novartis Investigative Site
state: Castilla La Mancha
city: Avila
country: Spain
facility: Novartis Investigative Site
state: Castilla Y Leon
city: Valladolid
country: Spain
facility: Novartis Investigative Site
state: Castilla Y Leon
city: Lleida
country: Spain
facility: Novartis Investigative Site
state: Cataluna
city: Tarragona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Terrassa
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Alicante
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Alicante
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Valencia
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Valencia
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Valencia
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Zamora
country: Spain
facility: Novartis Investigative Site
state: Espana
city: La Coruna
country: Spain
facility: Novartis Investigative Site
state: Galicia
city: Lugo
country: Spain
facility: Novartis Investigative Site
state: Galicia
city: Orense
country: Spain
facility: Novartis Investigative Site
state: Galicia
city: Mostoles
country: Spain
facility: Novartis Investigative Site
state: Madrid, Communidad De
city: Alcala de Henares
country: Spain
facility: Novartis Investigative Site
state: Madrid
city: Aranjuez
country: Spain
facility: Novartis Investigative Site
state: Madrid
city: Fuenlabrada
country: Spain
facility: Novartis Investigative Site
state: Madrid
city: Getafe
country: Spain
facility: Novartis Investigative Site
state: Madrid
city: Leganes
country: Spain
facility: Novartis Investigative Site
state: Madrid
city: Torrejon de Ardoz
country: Spain
facility: Novartis Investigative Site
state: Madrid
city: Barakaldo
country: Spain
facility: Novartis Investigative Site
state: Pais Vasco
city: Bilbao
country: Spain
facility: Novartis Investigative Site
state: Pais Vasco
city: Vigo
country: Spain
facility: Novartis Investigative Site
state: Pontevedra
city: Brena Alta
country: Spain
facility: Novartis Investigative Site
state: Santa Cruz De Tenerife
city: Talavera de la Reina
country: Spain
facility: Novartis Investigative Site
state: Toledo
city: Barcelona
country: Spain
facility: Novartis Investigative Site
city: Burgos
country: Spain
facility: Novartis Investigative Site
city: Granada
country: Spain
facility: Novartis Investigative Site
city: Granollers
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Zaragoza
country: Spain
facility: Novartis Investigative Site
city: Penzance
country: United Kingdom
facility: Novartis Investigative Site
state: Cornwall
city: Harlow
country: United Kingdom
facility: Novartis Investigative Site
state: Essex
city: Rothwell
country: United Kingdom
facility: Novartis Investigative Site
state: GBR
city: Burbage
country: United Kingdom
facility: Novartis Investigative Site
state: Leicester
city: Harrow
country: United Kingdom
facility: Novartis Investigative Site
state: Middlesex
city: Bury Saint Edmonds
country: United Kingdom
facility: Novartis Investigative Site
state: Suffolk
city: Bradford
country: United Kingdom
facility: Novartis Investigative Site
state: West Yorkshire
city: Bath
country: United Kingdom
facility: Novartis Investigative Site
city: Bristol
country: United Kingdom
facility: Novartis Investigative Site
city: Chippenham
country: United Kingdom
facility: Novartis Investigative Site
city: Devon
country: United Kingdom
facility: Novartis Investigative Site
city: Durham
country: United Kingdom
facility: Novartis Investigative Site
city: East Sussex
country: United Kingdom
facility: Novartis Investigative Site
city: Exeter
country: United Kingdom
facility: Novartis Investigative Site
city: Lancaster
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: Middlesex
country: United Kingdom
facility: Novartis Investigative Site
city: Newcastle Upon Tyne
country: United Kingdom
facility: Novartis Investigative Site
city: Stoke-on-Trent
country: United Kingdom
facility: Novartis Investigative Site
city: Watford
country: United Kingdom
facility: Novartis Investigative Site
city: Wellingborough
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Merola JF, McInnes IB, Deodhar AA, Dey AK, Adamstein NH, Quebe-Fehling E, Aassi M, Peine M, Mehta NN. Effect of Secukinumab on Traditional Cardiovascular Risk Factors and Inflammatory Biomarkers: Post Hoc Analyses of Pooled Data Across Three Indications. Rheumatol Ther. 2022 Jun;9(3):935-955. doi: 10.1007/s40744-022-00434-z. Epub 2022 Mar 19.
citation: da Silva N, Sommer R, Ortmann CE, Jagiello P, Bachhuber T, Augustin M. Secukinumab effects on disease burden, patient needs and benefits, and treatment satisfaction in patients with plaque psoriasis across European regions: patient perspective data from the PROSE study. J Eur Acad Dermatol Venereol. 2021 Nov;35(11):2241-2249. doi: 10.1111/jdv.17525. Epub 2021 Jul 31.