A Study to Evaluate Clear Skin Effect on Quality of Life in Patients With Plaque Psoriasis. (PROSE)

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 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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 1660
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Brugge, Belgium, 8000
    • Novartis Investigative Site
  • Gent, Belgium, 9000
    • Novartis Investigative Site
  • Seraing, Belgium, 4100
    • Novartis Investigative Site
  • BEL
    • Geel, BEL, Belgium, 2440
      • Novartis Investigative Site
• Bulgaria
  • Pleven, Bulgaria, 5800
    • Novartis Investigative Site
  • Sofia, Bulgaria, 1431
    • Novartis Investigative Site
  • Sofia, Bulgaria, 1407
    • Novartis Investigative Site
  • Stara Zagora, Bulgaria, 6000
    • Novartis Investigative Site
  • Varna, Bulgaria, 9010
    • Novartis Investigative Site
• Czechia
  • Plzen, Czechia, 30460
    • Novartis Investigative Site
  • Praha, Czechia, 12808
    • Novartis Investigative Site
  • Praha 5, Czechia, 150 06
    • Novartis Investigative Site
  • Czech Republic
    • Usti nad Labem, Czech Republic, Czechia, 400 11
      • Novartis Investigative Site
• Estonia
  • Tallinn, Estonia, 13419
    • Novartis Investigative Site
  • Tallinn, Estonia, 10138
    • Novartis Investigative Site
  • Tartu, Estonia, 51014
    • Novartis Investigative Site
• France
  • Angers cedex 09, France, 49933
    • Novartis Investigative Site
  • Antony, France, 92160
    • Novartis Investigative Site
  • Argenteuil, France, 95107
    • Novartis Investigative Site
  • Auxerre, France, 89000
    • Novartis Investigative Site
  • Bayonne, France, 64109
    • Novartis Investigative Site
  • Bordeaux, France, 33076
    • Novartis Investigative Site
  • Boulogne-sur-Mer, France, 62321
    • Novartis Investigative Site
  • Brest, France, 29609
    • Novartis Investigative Site
  • Caen, France, 14033
    • Novartis Investigative Site
  • Cannes, France, 06400
    • Novartis Investigative Site
  • Clermont Ferrand cedex 1, France, 63003
    • Novartis Investigative Site
  • Dijon, France, 21000
    • Novartis Investigative Site
  • Grenoble Cedex, France
    • Novartis Investigative Site
  • La Rochelle, France, 17019
    • Novartis Investigative Site
  • Lille, France, 59000
    • Novartis Investigative Site
  • Marseille cedex 05, France, 13385
    • Novartis Investigative Site
  • Martigues, France, 13500
    • Novartis Investigative Site
  • Montpellier cedex 5, France, 34295
    • Novartis Investigative Site
  • Nice, France, 06202
    • Novartis Investigative Site
  • Nimes, France, 30029
    • Novartis Investigative Site
  • Pierre Benite Cedex, France, 69495
    • Novartis Investigative Site
  • Pringy cedex, France, 74374
    • Novartis Investigative Site
  • Quimper, France, 29000
    • Novartis Investigative Site
  • Reims, France, 51100
    • Novartis Investigative Site
  • Rouen Cedex, France, 76031
    • Novartis Investigative Site
  • Saint Mande, France, 94163
    • Novartis Investigative Site
  • St Priest en Jarez Cedex, France, 42277
    • Novartis Investigative Site
  • Toulouse Cedex, France, 31400
    • Novartis Investigative Site
  • Valence Cedex 9, France, 26953
    • Novartis Investigative Site
  • Valenciennes Cedex, France, 59322
    • Novartis Investigative Site
  • Vandoeuvre Les Nancy, France, 54511
    • Novartis Investigative Site
  • Cedex 09
    • Le Mans, Cedex 09, France, 72037
      • Novartis Investigative Site
  • Val De Marne
    • Toulon Cedex 9, Val De Marne, France, 83800
      • Novartis Investigative Site
• Germany
  • Aachen, Germany, 52074
    • Novartis Investigative Site
  • Andernach, Germany, 56626
    • Novartis Investigative Site
  • Berlin, Germany, 13353
    • Novartis Investigative Site
  • Berlin, Germany, 10789
    • Novartis Investigative Site
  • Berlin, Germany, 13507
    • Novartis Investigative Site
  • Berlin, Germany, 13187
    • Novartis Investigative Site
  • Berlin, Germany, 13597
    • Novartis Investigative Site
  • Berlin, Germany, 15831
    • Novartis Investigative Site
  • Bielefeld, Germany, 33647
    • Novartis Investigative Site
  • Bonn, Germany, 53105
    • Novartis Investigative Site
  • Bramsche, Germany, 49565
    • Novartis Investigative Site
  • Braunschweig, Germany, 38114
    • Novartis Investigative Site
  • Erlangen, Germany, 91054
    • Novartis Investigative Site
  • Frankfurt, Germany, 60590
    • Novartis Investigative Site
  • Freiburg, Germany, 79106
    • Novartis Investigative Site
  • Friedrichshafen, Germany, 88045
    • Novartis Investigative Site
  • Gelsenkirchen, Germany, 45883
    • Novartis Investigative Site
  • Gera, Germany, 07548
    • Novartis Investigative Site
  • Halle, Germany, 06108
    • Novartis Investigative Site
  • Hamburg, Germany, 20354
    • Novartis Investigative Site
  • Hamburg, Germany, 20246
    • Novartis Investigative Site
  • Hamburg, Germany, 22391
    • Novartis Investigative Site
  • Hamburg, Germany, 22303
    • Novartis Investigative Site
  • Hannover, Germany, 30625
    • Novartis Investigative Site
  • Heidelberg, Germany, 69120
    • Novartis Investigative Site
  • Ibbenbueren, Germany, 49477
    • Novartis Investigative Site
  • Kiel, Germany, 24105
    • Novartis Investigative Site
  • Koeln, Germany, 50937
    • Novartis Investigative Site
  • Lubeck, Germany, 23538
    • Novartis Investigative Site
  • Ludwigshafen am Rhein, Germany, 67063
    • Novartis Investigative Site
  • Mainz, Germany, 55131
    • Novartis Investigative Site
  • Muenster, Germany, 48149
    • Novartis Investigative Site
  • Osnabrueck, Germany, 49074
    • Novartis Investigative Site
  • Pommelsbrunn, Germany, 91224
    • Novartis Investigative Site
  • Quedlinburg, Germany, 06484
    • Novartis Investigative Site
  • Recklinghausen, Germany, 45657
    • Novartis Investigative Site
  • Schwerin, Germany, 19055
    • Novartis Investigative Site
  • Simmern, Germany, 55469
    • Novartis Investigative Site
  • Vechta, Germany, 49377
    • Novartis Investigative Site
  • Wiesbaden, Germany, 65203
    • Novartis Investigative Site
  • Baden-Wuerttemberg
    • Mannheim, Baden-Wuerttemberg, Germany, 68305
      • Novartis Investigative Site
  • Bayern
    • Muenchen, Bayern, Germany, 81675
      • Novartis Investigative Site
• Greece
  • Heraklion Crete, Greece, 711 10
    • Novartis Investigative Site
  • Patras, Greece, 265 00
    • Novartis Investigative Site
  • GR
    • Athens, GR, Greece, 115 25
      • Novartis Investigative Site
• Israel
  • Afula, Israel, 1834111
    • Novartis Investigative Site
  • Be'er Sheva, Israel, 84101
    • Novartis Investigative Site
  • Jerusalem, Israel, 91120
    • Novartis Investigative Site
  • Kfar Saba, Israel, 4428164
    • Novartis Investigative Site
  • Petach Tikva, Israel, 4941492
    • Novartis Investigative Site
• Italy
  • AR
    • Arezzo, AR, Italy, 52100
      • Novartis Investigative Site
  • BG
    • Bergamo, BG, Italy, 24127
      • Novartis Investigative Site
  • MI
    • San Donato Milanese, MI, Italy, 20097
      • Novartis Investigative Site
  • MO
    • Modena, MO, Italy, 41124
      • Novartis Investigative Site
  • PG
    • Perugia, PG, Italy, 06100
      • Novartis Investigative Site
  • SI
    • Siena, SI, Italy, 53100
      • Novartis Investigative Site
  • VA
    • Varese, VA, Italy, 21100
      • Novartis Investigative Site
• Latvia
  • Riga, Latvia, 1012
    • Novartis Investigative Site
  • Riga, Latvia, LV-1001
    • Novartis Investigative Site
  • LVA
    • Daugavpils, LVA, Latvia, LV-5404
      • Novartis Investigative Site
    • Jelgava, LVA, Latvia, LV-3001
      • Novartis Investigative Site
    • Riga, LVA, Latvia, LV-1003
      • Novartis Investigative Site
    • Ventspils, LVA, Latvia, LV-3601
      • Novartis Investigative Site
• Lithuania
  • Kaunas, Lithuania, 47144
    • Novartis Investigative Site
  • Vilnius, Lithuania, LT-08661
    • Novartis Investigative Site
  • Vilnius, Lithuania, LT-07195
    • Novartis Investigative Site
  • LTU
    • Kaunas, LTU, Lithuania, LT 50161
      • Novartis Investigative Site
    • Klaipeda, LTU, Lithuania, 92304
      • Novartis Investigative Site
• Poland
  • Bydgoszcz, Poland, 85-094
    • Novartis Investigative Site
  • Gdansk, Poland, 80-546
    • Novartis Investigative Site
  • Kielce, Poland, 25-317
    • Novartis Investigative Site
  • Krakow, Poland, 31-530
    • Novartis Investigative Site
  • Krakow, Poland, 31-913
    • Novartis Investigative Site
  • Lodz, Poland, 90-436
    • Novartis Investigative Site
  • Lublin, Poland, 20-079
    • Novartis Investigative Site
  • Olsztyn, Poland, 10-045
    • Novartis Investigative Site
  • Ossy, Poland, 42 624
    • Novartis Investigative Site
  • Poznan, Poland, 60 529
    • Novartis Investigative Site
  • Warszawa, Poland, 02-507
    • Novartis Investigative Site
  • Warszawa, Poland, 04141
    • Novartis Investigative Site
  • Wroclaw, Poland, 50-368
    • Novartis Investigative Site
• Portugal
  • Lisboa, Portugal, 1649-035
    • Novartis Investigative Site
  • Lisboa, Portugal, 1400-038
    • Novartis Investigative Site
  • Lisboa, Portugal, 1998-018
    • Novartis Investigative Site
  • Lisboa, Portugal, 1300-000
    • Novartis Investigative Site
  • Porto, Portugal, 4099-001
    • Novartis Investigative Site
  • Porto, Portugal, 4200 319
    • Novartis Investigative Site
  • Vila Nova de Gaia, Portugal, 4434 502
    • Novartis Investigative Site
• Romania
  • Brasov, Romania, 500283
    • Novartis Investigative Site
  • Brasov, Romania, 500366
    • Novartis Investigative Site
  • Bucuresti, Romania, 010825
    • Novartis Investigative Site
  • Craiova, Romania, 200642
    • Novartis Investigative Site
  • Iasi, Romania, 700381
    • Novartis Investigative Site
• Slovakia
  • Banska Bystrica, Slovakia, 974 01
    • Novartis Investigative Site
  • Bratislava, Slovakia, 825 56
    • Novartis Investigative Site
  • Kosice, Slovakia, 04011
    • Novartis Investigative Site
  • Svidnik, Slovakia, 08901
    • Novartis Investigative Site
  • Zilina, Slovakia, 01207
    • Novartis Investigative Site
  • SVK
    • Bardejov, SVK, Slovakia, 085 01
      • Novartis Investigative Site
  • Slovak Republic
    • Malacky, Slovak Republic, Slovakia, 90101
      • Novartis Investigative Site
• Spain
  • Barcelona, Spain, 08029
    • Novartis Investigative Site
  • Burgos, Spain, 09006
    • Novartis Investigative Site
  • Granada, Spain, 18016
    • Novartis Investigative Site
  • Granollers, Spain, 08402
    • Novartis Investigative Site
  • Madrid, Spain, 28034
    • Novartis Investigative Site
  • Madrid, Spain, 28006
    • Novartis Investigative Site
  • Madrid, Spain, 28040
    • Novartis Investigative Site
  • Zaragoza, Spain, 50009
    • Novartis Investigative Site
  • A Coruna
    • Ferrol, A Coruna, Spain, 15405
      • Novartis Investigative Site
  • Alava
    • Vitoria, Alava, Spain, 01009
      • Novartis Investigative Site
  • Alicante
    • Elda, Alicante, Spain, 03600
      • Novartis Investigative Site
  • Andalucia
    • Almeria, Andalucia, Spain, 04009
      • Novartis Investigative Site
    • Malaga, Andalucia, Spain, 29010
      • Novartis Investigative Site
    • Sevilla, Andalucia, Spain, 41009
      • Novartis Investigative Site
  • Barcelona
    • Sabadell, Barcelona, Spain, 08208
      • Novartis Investigative Site
  • Cadiz
    • Jerez, Cadiz, Spain, 11407
      • Novartis Investigative Site
  • Castilla La Mancha
    • Albacete, Castilla La Mancha, Spain, 02006
      • Novartis Investigative Site
    • Guadalajara, Castilla La Mancha, Spain, 19002
      • Novartis Investigative Site
    • Toledo, Castilla La Mancha, Spain, 45071
      • Novartis Investigative Site
  • Castilla Y Leon
    • Avila, Castilla Y Leon, Spain, 05004
      • Novartis Investigative Site
    • Valladolid, Castilla Y Leon, Spain, 47011
      • Novartis Investigative Site
  • Cataluna
    • Lleida, Cataluna, Spain, 25198
      • Novartis Investigative Site
  • Catalunya
    • Tarragona, Catalunya, Spain, 43005
      • Novartis Investigative Site
    • Terrassa, Catalunya, Spain, 08221
      • Novartis Investigative Site
  • Comunidad Valenciana
    • Alicante, Comunidad Valenciana, Spain, 03010
      • Novartis Investigative Site
    • Alicante, Comunidad Valenciana, Spain, 03550
      • Novartis Investigative Site
    • Valencia, Comunidad Valenciana, Spain, 46026
      • Novartis Investigative Site
    • Valencia, Comunidad Valenciana, Spain, 46010
      • Novartis Investigative Site
    • Valencia, Comunidad Valenciana, Spain, 46017
      • Novartis Investigative Site
  • Espana
    • Zamora, Espana, Spain, 49022
      • Novartis Investigative Site
  • Galicia
    • La Coruna, Galicia, Spain, 15006
      • Novartis Investigative Site
    • Lugo, Galicia, Spain, 27003
      • Novartis Investigative Site
    • Orense, Galicia, Spain, 32005
      • Novartis Investigative Site
  • Madrid
    • Alcala de Henares, Madrid, Spain, 28805
      • Novartis Investigative Site
    • Aranjuez, Madrid, Spain, 28300
      • Novartis Investigative Site
    • Fuenlabrada, Madrid, Spain, 28942
      • Novartis Investigative Site
    • Getafe, Madrid, Spain, 28905
      • Novartis Investigative Site
    • Leganes, Madrid, Spain, 28911
      • Novartis Investigative Site
    • Torrejon de Ardoz, Madrid, Spain, 28850
      • Novartis Investigative Site
  • Madrid, Communidad De
    • Mostoles, Madrid, Communidad De, Spain, 28933
      • Novartis Investigative Site
  • Pais Vasco
    • Barakaldo, Pais Vasco, Spain, 48903
      • Novartis Investigative Site
    • Bilbao, Pais Vasco, Spain, 48013
      • Novartis Investigative Site
  • Pontevedra
    • Vigo, Pontevedra, Spain, 36200
      • Novartis Investigative Site
  • Santa Cruz De Tenerife
    • Brena Alta, Santa Cruz De Tenerife, Spain, 38712
      • Novartis Investigative Site
  • Toledo
    • Talavera de la Reina, Toledo, Spain, 45600
      • Novartis Investigative Site
• United Kingdom
  • Bath, United Kingdom, BA2 3HT
    • Novartis Investigative Site
  • Bristol, United Kingdom, BS48 1BZ
    • Novartis Investigative Site
  • Chippenham, United Kingdom, SN14 6GT
    • Novartis Investigative Site
  • Devon, United Kingdom, EX8 2JF
    • Novartis Investigative Site
  • Durham, United Kingdom, DH1 5TW
    • Novartis Investigative Site
  • East Sussex, United Kingdom, BN2 5BE
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  • Exeter, United Kingdom, EX2 5DW
    • Novartis Investigative Site
  • Lancaster, United Kingdom, LA1 4RP
    • Novartis Investigative Site
  • London, United Kingdom, SE1 9RT
    • Novartis Investigative Site
  • Middlesex, United Kingdom, TW7 6AF
    • Novartis Investigative Site
  • Newcastle Upon Tyne, United Kingdom, NE1 4LP
    • Novartis Investigative Site
  • Stoke-on-Trent, United Kingdom, ST4 6QG
    • Novartis Investigative Site
  • Watford, United Kingdom, WD25 7NL
    • Novartis Investigative Site
  • Wellingborough, United Kingdom, NN8 4RW
    • Novartis Investigative Site
  • Cornwall
    • Penzance, Cornwall, United Kingdom, TR19 7HX
      • Novartis Investigative Site
  • Essex
    • Harlow, Essex, United Kingdom, CM20 1QX
      • Novartis Investigative Site
  • GBR
    • Rothwell, GBR, United Kingdom, NN14 6JQ
      • Novartis Investigative Site
  • Leicester
    • Burbage, Leicester, United Kingdom, LE10 2SE
      • Novartis Investigative Site
  • Middlesex
    • Harrow, Middlesex, United Kingdom, HA1 3UJ
      • Novartis Investigative Site
  • Suffolk
    • Bury Saint Edmonds, Suffolk, United Kingdom, IP33 2QZ
      • Novartis Investigative Site
  • West Yorkshire
    • Bradford, West Yorkshire, United Kingdom, BD5 0NA
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• 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; All patients are received s.c. injections of secukinumab 300 mg at Week 0, 1, 2 and 3 during the first 4 weeks followed by monthly maintenance dosing of 300 mg secukinumab starting at Week 4 until Week 48. Consideration was given to discontinuing treatment in patients who showed no response up to 16 weeks of treatment (e.g. patients who did not achieve a PASI 50 response). If discontinued, patients completed the end of study visit assessments. Some patients with an initially partial response (e.g. patients who achieved a PASI 50 response but not a PASI 75 response) subsequently improved with continued treatment beyond 16 weeks.

Drug: Secukinumab; Secukinumab was used as commercially available PFS of 150 mg. Patients received PFS at the site and were instructed to administer Secukinumab as needed (300 mg each application).; Other Names: AIN457

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With a Dermatology Life Quality Index 0/1 (DLQI 0/1) Response at Week 16	The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment.	16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With a Dermatology Life Quality Index 0/1 (DLQI 0/1) Response at Week 52	The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment.	52 weeks
Percentage of Participants in Each DLQI Score Category at Week 16 and Week 52	The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment.	52 weeks
Percentage of Participants With PASI 50, PASI 75, PASI 90, PASI 100 or IGA Mod 2011 0/1 Response at Week 16 and 52	PASI is a combined assessment of lesion severity & affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself & scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), & severity is estimated by clinical signs, erythema, induration & desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 & 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline. The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.	Week 16, Week 52
Absolute Change From Baseline in EQ-5D-5L Crosswalk Index at Week 16 and Week 52	The EQ-5D descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort & anxiety/depression. The 5 dimensions have 5 response levels scored from 1 (best) to 5 (worst). The first 3 dimensions have the response levels lasting from no problems, slight problems, moderate problems, severe problems to unable; the last 2 dimensions have the 5 response levels lasting from no, slight, moderate, severe to extreme. From these 5 dimensions the Crosswalk-index is calculated by concatenating the responses & choosing the corresponding country specific index value from the EQ-5D-5L_Crosswalk_Index_Value_Calculator.v2 excel file (https://euroqol.org/eq-5d-instruments/eq-5d-5labout/valuation-standard-value-sets/crosswalk-index-value-calculator/). This calculated participant-level index scores from -0.654 (worst health) to 1.0 (best health).	Week 16, Week 52
Absolute Change From Baseline in EQ-5D-5L Visual Analogue Scale (VAS) at Week 16 and Week 52	A visual analogue scale (VAS) was used within the EQ-5D. This scale recorded the respondent's self-rated health on a vertical 20-cm VAS where the endpoints were labeled "best imaginable health state" and "worst imaginable health state." This resulted in a numeric value set ranging from 0 (="worst imaginable health state") up to 100 (="best imaginable health state").	Week 16, Week 52
Absolute Change From Baseline in HAQ-DI at Week 16 and Week 52	The HAQ-DI (Health Assessment Questionnaire - Disability Index) assesses a patient's level of functional ability & includes questions on fine movements of the upper extremity, locomotor activities of the lower extremity & activities that involve both upper & lower extremities. There are 20 items in 8 categories of functioning including dressing & grooming, arising, eating, walking, hygiene, reach, grip & usual activities. The stem of each item asks over the past week, "Are you able to..." perform a particular task. Each item is scored on a 4-point scale from 0 to 3, representing normal, no difficulty (0), some difficulty (1), much difficulty (2) & unable to do (3). The HAQ-DI also includes questions about the use of 'aids or devices' & aid from other people to supplement the answers given to the 20 items. Total scores were calculated by averaging all scores and ranging from 0 (best) to 3 (worst). Subtracting the baseline value from the week 16 or 52 values results in the change.	Week 16 and Week 52
Absolute Change From Baseline in Numeric Rating Scale (NRS) at Week 16 and Week 52	Selfadministered 11-point numeric rating scales (NRS, 0-10) were used to evaluate the patients' assessment of their current pain, itching & scaling. Respondents answered the following questions for the assessment: Pain: Overall, how severe was your psoriasis-related pain over the past 24 hours?; Itching: Overall, how severe was your psoriasis-related itch over the past 24 hours?; & Scaling: Overall, how severe was your psoriasis related scaling over the past 24 hours? Patients had to rate their pain, itching, & scaling from 0 to 10 (11-point scale), with the understanding that the 0 represents the absence or null end of the pain, itching, or scale intensity (i.e. no pain, itching or scaling) & the 10 represents the other extreme of pain, itching, or scaling intensity (i.e. pain, itching or scaling as bad as it could be). The number that the patient selected represents his or her intensity score in the respective category.	16 and 52 weeks
Treatment Satisfaction Questionnaire for Medication (TSQM) Scale Scores at Week 16 and Week 52	Treatment Satisfaction Questionnaire for Medication (TSQM) is general measure for treatment satisfaction. Each scale score was calculated by summing individual items and then transformed to a 0-100 scale. Higher summary scores indicate better satisfaction with study drug.	16 and 52 weeks
Patient Benefit Index (PBI) at Week 16 and Week 52	The questionnaire includes 23 items on patient-relevant therapy needs & benefits. The first part of the instrument, the 'Patient Needs Questionnaire' (PNQ), is filled in by the patient before therapy. A 5-step Likert scale (0='not important at all' to 4='very important') records the individual relevance of the different items to the patients. The second part, the PBQ, is filled in by the patient during or after therapy. It comprises the same items as the PNQ, but in contrast, the patients evaluate the extent to which the treatment needs have been fulfilled by therapy (scaled from 0='treatment did not help at all' to 4='treatment helped a lot'). In addition, the Likert scale contains the option 'does not apply to me' in the PNQ & the option 'did not apply to me' in the PBQ. The needs prior to treatment (PNQ) & the benefits achieved by treatment (PBQ) are converted to a weighted index value, the PBI in the narrower sense. PBI can have a value from 0='no benefit' to 4='maximal benefit'.	Week 16 and Week 52

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2016
• Primary Completion (Actual): March 28, 2018
• Study Completion (Actual): March 28, 2018

Study Registration Dates

• First Submitted: February 10, 2016
• First Submitted That Met QC Criteria: April 22, 2016
• First Posted (Estimate): April 27, 2016

Study Record Updates

• Last Update Posted (Actual): September 25, 2019
• Last Update Submitted That Met QC Criteria: August 29, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: plaques; AIN457; itching; immune-mediated systemic disease; scaly patches; papules; secukinumab; Moderate to severe plaque psoriasis
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: CAIN457A3401; 2015-003701-42 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

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

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

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