Extension Study of Secukinumab Prefilled Syringes in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Completing Preceding Psoriasis Phase III Studies With Secukinumab

A Multicenter, Double-blind, Randomized Withdrawal Extension Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate Long-term Efficacy, Safety, and Tolerability up to 4 Years in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Completing Preceding Psoriasis Phase III Studies With Secukinumab

This was an extension study of secukinumab prefilled syringes in subjects with moderate to severe chronic plaque-type psoriasis completing preceding psoriasis phase III studies with secukinumab. Subjects on secukinumab at the end of treatment period in phase III studies (e.g., ongoing CAIN457A2302 and CAIN457A2303 and potentially other secukinumab phase III studies) were eligible to join this extension study. This extension study was planned to collect an additional 2 years of long-term efficacy, safety, and tolerability data of secukinumab in either continuous or interrupted therapy (randomized withdrawal period) in subjects showing at least partial response to secukinumab and completing treatment period on secukinumab in previous phase III studies. In this extension study, the prefilled syringe (PFS) liquid formulation of secukinumab were used.

Study Overview

• Status: Completed
• Conditions: Moderate to Severe Plaque-type Psoriasis
• Intervention / Treatment: Drug: Placebo; Drug: Secukinumab (AIN457)

• Study Type: Interventional
• Enrollment (Actual): 1147
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1425DKG
    • Novartis Investigative Site
  • Mendoza, Argentina, M5502EZA
    • Novartis Investigative Site
  • Buenos Aires
    • Caba, Buenos Aires, Argentina, C1181ACH
      • Novartis Investigative Site
    • Caba, Buenos Aires, Argentina, C1062ABK
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    • Caba, Buenos Aires, Argentina, C1122AAF
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    • Caba, Buenos Aires, Argentina, C1425BEI
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• Australia
  • New South Wales
    • Kogarah, New South Wales, Australia, 2217
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  • Queensland
    • Woolloongabba, Queensland, Australia, 4102
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  • Victoria
    • Carlton, Victoria, Australia, 3053
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    • East Melbourne, Victoria, Australia, 3002
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• Belgium
  • Bruxelles, Belgium, 1200
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  • Gent, Belgium, 9000
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  • Liege, Belgium, 4000
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• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T5K 1X3
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  • British Columbia
    • Surrey, British Columbia, Canada, V3V 0C6
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    • Vancouver, British Columbia, Canada, V5Z 4E8
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  • New Brunswick
    • Moncton, New Brunswick, Canada, E1C 8X3
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  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 1Z2
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  • Ontario
    • Hamilton, Ontario, Canada, L8N 1V6
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    • Markham, Ontario, Canada, L3P 1A8
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    • Peterborough, Ontario, Canada, K9J 5K2
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    • Richmond Hil, Ontario, Canada, L4B 1A5
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    • Waterloo, Ontario, Canada, N2J 1C4
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  • Quebec
    • Montreal, Quebec, Canada, H3H 1V4
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    • Sainte-Foy, Quebec, Canada, G1V 4X7
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• Colombia
  • Barranquilla, Colombia
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  • Bogota, Colombia, 110221
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  • Atlantico
    • Barranquilla, Atlantico, Colombia
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• Estonia
  • Tallinn, Estonia, 13419
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  • Tallinn, Estonia, 10138
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  • Tartu, Estonia, 51014
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• Finland
  • Helsinki, Finland, 00250
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• France
  • Bordeaux Cedex, France, 33075
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  • Marseille Cedex 9, France, 13913
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  • Martigues, France, 13500
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  • Nice Cedex 3, France, 06202
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  • Reims, France, 51090
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  • Toulouse Cedex, France, 31400
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  • Cedex 10
    • Paris Cedex 10, Cedex 10, France, 75475
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• Germany
  • Augsburg, Germany, 86179
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  • Berlin, Germany, 10117
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  • Berlin, Germany, 10789
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  • Berlin, Germany, 13187
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  • Bielefeld, Germany, 33647
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  • Bochum, Germany, 44791
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  • Bochum, Germany, 44793
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  • Bonn, Germany, 53105
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  • Darmstadt, Germany, 64283
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  • Dresden, Germany, 01307
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  • Erfurt, Germany, 99089
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  • Erlangen, Germany, 91054
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  • Essen, Germany, 45122
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  • Frankfurt, Germany, 60590
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  • Gera, Germany, 07548
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  • Goettingen, Germany, 37075
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  • Greifswald, Germany, 17475
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  • Hamburg, Germany, 20354
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  • Hamburg, Germany, 22143
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  • Hamburg, Germany, 22391
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  • Hanau, Germany, 63450
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  • Heidelberg, Germany, 69115
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  • Kiel, Germany, 24105
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  • Krefeld, Germany, 47805
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  • Muenchen, Germany, 80802
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  • Muenster, Germany, 48149
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  • Osnabrueck, Germany, 49074
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  • Plauen, Germany, 08529
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  • Recklinghausen, Germany, 45657
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  • Schwerin, Germany, 19055
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  • Tuebingen, Germany, 72076
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  • Wuppertal, Germany, 42275
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  • Nordrhein-Westfalen
    • Koeln, Nordrhein-Westfalen, Germany, 50937
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• Guatemala
  • Guatemala City, Guatemala, 01010
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  • Guatemala City, Guatemala, 01015
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• Hungary
  • Budapest, Hungary, 1134
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  • Debrecen, Hungary, 4032
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  • Kaposvar, Hungary, 7400
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  • Miskolc, Hungary, 3529
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  • Szeged, Hungary, H-6725
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  • Szombathely, Hungary, 9700
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• Iceland
  • Kopavogur, Iceland, 201
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• Israel
  • Afula, Israel, 1834111
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  • Petach Tikva, Israel, 49100
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  • Ramat Gan, Israel, 5265601
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• Italy
  • CT
    • Catania, CT, Italy, 95123
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  • MO
    • Modena, MO, Italy, 41124
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• Japan
  • Aichi
    • Nagoya-city, Aichi, Japan, 467-8602
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  • Fukuoka
    • Fukuoka-city, Fukuoka, Japan, 814-0180
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    • Kurume city, Fukuoka, Japan, 830-0011
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  • Gunma
    • Maebashi city, Gunma, Japan, 371 8511
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  • Hokkaido
    • Asahikawa-city, Hokkaido, Japan, 078-8510
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    • Sapporo-city, Hokkaido, Japan, 060-0063
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  • Hyogo
    • Kobe-City, Hyogo, Japan, 654-0155
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  • Ibaraki
    • Inashiki-gun, Ibaraki, Japan, 300-0395
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  • Kanagawa
    • Isehara-city, Kanagawa, Japan, 259-1193
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    • Kawasaki-city, Kanagawa, Japan, 213-8507
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    • Sagamihara-city, Kanagawa, Japan, 228-8522
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  • Kyoto
    • Kyoto-city, Kyoto, Japan, 602-8566
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  • Tokyo
    • Bunkyo ku, Tokyo, Japan, 113 8655
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    • Chiyoda-ku, Tokyo, Japan, 102-8798
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    • Minato-ku, Tokyo, Japan, 105-8471
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    • Shinagawa-ku, Tokyo, Japan, 141 8625
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    • Shinjuku-ku, Tokyo, Japan, 160-0023
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    • Shinjuku-ku, Tokyo, Japan, 160-8582
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• Korea, Republic of
  • Busan, Korea, Republic of, 49241
    • Novartis Investigative Site
  • Gwangju, Korea, Republic of, 61469
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  • Seoul, Korea, Republic of, 03722
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  • Seoul, Korea, Republic of, 156-755
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  • Seoul, Korea, Republic of, 05030
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  • Korea
    • Daejeon, Korea, Korea, Republic of, 35015
      • Novartis Investigative Site
    • Seoul, Korea, Korea, Republic of, 05505
      • Novartis Investigative Site
    • Seoul, Korea, Korea, Republic of, 06351
      • Novartis Investigative Site
  • Seocho-gu
    • Seoul, Seocho-gu, Korea, Republic of, 06591
      • Novartis Investigative Site
• Latvia
  • Riga, Latvia, 1012
    • Novartis Investigative Site
  • Riga, Latvia, LV-1001
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  • LVA
    • Daugavpils, LVA, Latvia, LV-5404
      • Novartis Investigative Site
    • Ventspils, LVA, Latvia, LV-3601
      • Novartis Investigative Site
• Lithuania
  • Vilnius, Lithuania, LT-08661
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  • Vilnius, Lithuania, LT-07195
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  • LTU
    • Kaunas, LTU, Lithuania, LT-50161
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    • Klaipeda, LTU, Lithuania, 92304
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• Poland
  • Lodz, Poland, 90-265
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  • Lodz, Poland, 90-436
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  • Poznan, Poland, 60 529
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  • Wroclaw, Poland, 50-368
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• Romania
  • Bucuresti, Romania, 041335
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• Singapore
  • Singapore, Singapore, 119074
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• Spain
  • Barcelona, Spain, 08041
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  • Madrid, Spain, 28041
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  • Madrid, Spain, 28031
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  • Barcelona
    • Sabadell, Barcelona, Spain, 08208
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  • Cataluña
    • Santa Coloma De Gramanet, Cataluña, Spain, 08923
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  • Comunidad Valenciana
    • Valencia, Comunidad Valenciana, Spain, 46014
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• Sweden
  • Malmo, Sweden, SE-205 02
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  • Uppsala, Sweden, 751 85
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• Taiwan
  • Hsin Chu, Taiwan
    • Novartis Investigative Site
  • Taichung, Taiwan, 40447
    • Novartis Investigative Site
  • Taipei, Taiwan, 10002
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• United Kingdom
  • Harrogate, United Kingdom, HG2 7SX
    • Novartis Investigative Site
  • Nuneaton, United Kingdom, CV10 7DJ
    • Novartis Investigative Site
  • Devon
    • Plymouth, Devon, United Kingdom, PL6 8DH
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  • England
    • London, England, United Kingdom, E11 1NR
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  • Manchester
    • Salford, Manchester, United Kingdom, M6 8HD
      • Novartis Investigative Site
  • Somerset
    • Yeovil, Somerset, United Kingdom, BA21 4AT
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  • West Midlands
    • Dudley, West Midlands, United Kingdom, DY1 2HQ
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• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Novartis Investigative Site
    • Birmingham, Alabama, United States, 35205
      • Novartis Investigative Site
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • Novartis Investigative Site
    • Phoenix, Arizona, United States, 85032
      • Novartis Investigative Site
  • California
    • Los Angeles, California, United States, 90045
      • Novartis Investigative Site
    • Oceanside, California, United States, 92056
      • Novartis Investigative Site
    • Pasadena, California, United States, 91105
      • Novartis Investigative Site
    • San Diego, California, United States, 92123
      • Novartis Investigative Site
    • San Diego, California, United States, 92103
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  • Colorado
    • Colorado Springs, Colorado, United States, 80915
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  • Georgia
    • Snellville, Georgia, United States, 30078
      • Novartis Investigative Site
  • Indiana
    • Indianapolis, Indiana, United States, 46256
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  • Kansas
    • Topeka, Kansas, United States, 66606
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  • Kentucky
    • Louisville, Kentucky, United States, 40241
      • Novartis Investigative Site
    • Louisville, Kentucky, United States, 40291
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  • Michigan
    • Ann Arbor, Michigan, United States, 48109
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  • Nebraska
    • Omaha, Nebraska, United States, 68144
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  • New York
    • New York, New York, United States, 10029
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    • Rochester, New York, United States, 14623
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  • North Carolina
    • High Point, North Carolina, United States, 27262
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  • Ohio
    • Warren, Ohio, United States, 44483
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  • Oregon
    • Oregon City, Oregon, United States, 97045
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    • Portland, Oregon, United States, 97210
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    • Portland, Oregon, United States, 97223
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  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635
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    • Philadelphia, Pennsylvania, United States, 19104
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  • Rhode Island
    • Johnston, Rhode Island, United States, 02919
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  • South Carolina
    • Charleston, South Carolina, United States, 29407
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  • Tennessee
    • Kingsport, Tennessee, United States, 37660
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    • Nashville, Tennessee, United States, 37203
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  • Texas
    • Austin, Texas, United States, 78759
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    • Dallas, Texas, United States, 75231
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    • Dallas, Texas, United States, 75246-1613
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    • Houston, Texas, United States, 77030
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    • San Antonio, Texas, United States, 78229
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  • Utah
    • Salt Lake City, Utah, United States, 84117
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  • Virginia
    • Norfolk, Virginia, United States, 23507
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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

Key Inclusion Criteria:

Completed the full study treatment period of 52 weeks in preceding phase III studies, and have been receiving secukinumab treatment during the maintenance phase of the preceding phase III studies, and show at least a partial response (PASI 50 or better) at Week 52 of the preceding phase III studies.

Written informed consent form.

Key Exclusion Criteria:

A protocol deviation in either of the preceding phase III studies which according to the investigator prevented the meaningful analysis of the extension study for the individual subject.

Ongoing use of prohibited psoriasis or non-psoriasis treatments.

Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (>10 mIU/mL).

Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unwilling to use effective contraception during the study and for 16 weeks after stopping treatment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: PASI 75 Responders; PASI 75 responders participated in "randomized withdrawal". Subjects who were PASI 75 responders at Week 52 visit of the core studies (e.g.CAIN457A2302 or CAIN457A2303) and have been on secukinumab s.c. 150 mg or 300 mg in core studies were randomized to continue same s.c. doses of secukinumab in PFS or receive placebo every 4 weeks up to Week 152 or until relapse. Participants on first full relapse received loading dose followed by routine dosing with secukinumab s.c. 150 mg or 300 mg regimen.	Drug: Placebo; Placebo; Drug: Secukinumab (AIN457); Secukinumab is a new type of psoriasis medication called a human monoclonal antibody. Monoclonal antibodies are proteins that recognize and bind to unique proteins that your body produces. Secukinumab binds and reduces the activity of a cytokine (a "messenger" protein in the body) called Interleukin 17 (IL-17). IL-17 is believed to be partly responsible for inflammation (pain, swelling, redness). Researchers believe that IL-17 causes symptoms of plaque-type psoriasis like plaques and scales. A product that targets IL-17 therefore may help to relieve these symptoms and conditions.
Experimental: Partial responders; Partial responders were not randomized. Subjects who were partial responders at Week 52 visit in core studies (e.g.CAIN457A2302 or CAIN457A2303) and have been on secukinumab s.c. 150 mg or 300 mg in core studies did not participate in the randomized withdrawal. These subjects continued same treatment s.c. dose in PFS (secukinumab s.c. 150 mg or 300 mg) as they were receiving at the time of completing the maintenance period (Week 52) in the core studies.	Drug: Secukinumab (AIN457); Secukinumab is a new type of psoriasis medication called a human monoclonal antibody. Monoclonal antibodies are proteins that recognize and bind to unique proteins that your body produces. Secukinumab binds and reduces the activity of a cytokine (a "messenger" protein in the body) called Interleukin 17 (IL-17). IL-17 is believed to be partly responsible for inflammation (pain, swelling, redness). Researchers believe that IL-17 causes symptoms of plaque-type psoriasis like plaques and scales. A product that targets IL-17 therefore may help to relieve these symptoms and conditions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of Participants With Loss of Psoriasis Area and Severity Index (PASI) 75 Response up to Week 68	The primary variable was the cumulative rate of patients who lost PASI 75 response up to Week 68 (time=0 being defined as Week 52). Loss of PASI 75 response was analyzed by means of a survival analysis defining "loss of PASI 75 response" as "failure". The term cumulative rate corresponded to 1 minus the survival function within this survival analysis, and the cumulative rate and the survival functions were dependent on time t. PASI 75 response: patients achieving ≥ 75% improvement (reduction) in PASI score compared to baseline of the core study were defined as PASI 75 responders.	At week 68 (16 weeks after week 52)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period	Psoriasis Area and Severity Index (PASI) 75 responder at week 52. Patients in the placebo groups were not evaluable after re-treatment with Secukinumab. PASI 75 Responders: patients with a PASI 75 response (patients achieving ≥75% improvement [reduction] in PASI score compared to baseline of the core study). PASI 50 response: patients achieving ≥ 50% improvement (reduction) in PASI score compared to baseline of the core study were defined as PASI 50 responders. PASI 90 response: patients achieving ≥ 90% improvement (reduction) in PASI score compared to baseline of the core study were defined as PASI 90 responders. PASI 100 response/remission: complete clearing of psoriasis (PASI=0)	Week 52, 104, and 156
Number of Participants With PASI 50, PASI 75, PASI 90, and PASI 100 (Observed Data) - Entire Study Period	Psoriasis Area and Severity Index (PASI) scoring system: The average degree of severity of each sign in each of the four body regions was assigned a score of 0-4. The area covered by lesions on each body region was estimated as a percentage of the total area of that particular body region.	Week 52, Week 104, Week 156, week 208, week 260
Percent Change From Baseline for PASI Score Over Time (Observed Data) - Randomized Withdrawal Period	The improvement (decrease from baseline) in PASI total scores observed at Week 52. Perc. change = 100 x Abs. change /Base. (Abs. change = Post - Base) For each post-baseline visit only patients with a value at both baseline and the respective post-baseline visit are included.	Week 52, 104, and 156
Percent Change From Baseline for PASI Score Over Time (Observed Data) - Entire Study Period	Perc. change = 100 x Abs. change /Base. (Abs. change = Post - Base) For each post-baseline visit only patients with a value at both baseline and the respective post-baseline visit are included.	Week 52, Week 104, Week 156, week 208, week 260
Number of Participants in Each IGA Mod 2011 Category (Observed Data)- Randomized Withdrawal Period	Investigator Global Assessment (IGA) mod 2011; scale from 0 - 4. Score 0: Clear (No signs of psoriasis. Post-inflammatory hyperpigmentation could be Present). Score 1: Almost clear (Normal to pink coloration of lesions; no thickening; no to minimal focal scaling), Score 2: Mild (Pink to light red coloration; just detectable to mild thickening; predominantly fine scaling). Score 3: Moderate (Dull bright red, clearly distinguishable erythema; clearly distinguishable to moderate thickening; moderate scaling). Score 4: Severe (Bright to deep dark red coloration; severe thickening with hard edges; severe /coarse scaling covering almost all or all lesions). Patients in the placebo groups were not evaluable after re-treatment with Secukinumab	Week 52 (baseline), 104, and 156
Number of Participants in Each IGA Mod 2011 Category (Observed Data) - Entire Study Period	Investigator's Global Assessment (IGA) mod 2011; scale from 0 - 4. Score 0= clear (no signs of psoriasis) Score 1 = almost clear no to minimal local scaling) Score 2 = mild (predominantly fine scaling) Score 3 = moderate (moderate scaling) Score 4 = severe (severe/coarse scaling covering almost all or all lesions)	Week 52, Week 104, Week 156, week 208, week 260
Number of Participants With IGA Mod 2011 0/1 Response (Observed Data) - Entire Study Period	Investigator's Global Assessment (IGA) mod 2011 0/1. Score 0= clear (no signs of psoriasis) Score 1 = almost clear no to minimal local scaling) Score 2 = mild (predominantly fine scaling) Score 3 = moderate (moderate scaling) Score 4 = severe (severe/coarse scaling covering almost all or all lesions) Based on this scale, a patient was considered as IGA mod 2011 0/1 responder if the patient achieved a score of 0 or 1 and improved by at least 2 points on the IGA scale compared to baseline.	Week 52, Week 104, Week 156, week 208, week 260
Percent of Participants With Loss of IGA Mod 2011 0 or 1 Response Over Time for Subjects With IGA Mod 2011 0 or 1 Response at Week 52 - Randomized Withdrawal Period	Summary for loss of IGA mod 2011 0 or 1 response over time for patients with response at Week 52. time = 0 refers to Week 52	Week 68
Percent of Participants With PASI 75 Response - Treatment Period for Re-treated After Relapse	PASI 75 response since reinitiating treatment after relapse. time = 0 refers to Week 52	up to week 260
Percent of Participants With IGA Mod 0 or 1 Response - Treatment Period for Re-treated After Relapse	IGA mod 2011 0 or 1 response since reinitiating treatment after relapse for subjects with IGA 0 or 1 response at week 52 and not have IGA 0 or 1 response at relapse. time = 0 refers to Week 52	up to week 260
Percent pf Participants With Relapse Over Time - Randomized Withdrawal Period	Time 0 = week 52	up to week 156
Percent of Participants With Relapse After Last Injection	Relapse: when the achieved maximal PASI improvement from baseline of core study was reduced by >50%. Time 0 = week 52	up to week 16
Percent of Participants With Rebound After Last Injection	Rebound: PASI increases to > 125% of baseline (where baseline is the PASI at the randomization of the core study) or presence of new pustular psoriasis, new erythrodermic psoriasis or more inflammatory psoriasis occurring within 8 Weeks of stopping therapy (after the last dose of study treatment received). Rebound like event (RLE) was defined as increase of PASI of > 125% from baseline value or occurrence of new pustular, new erythrodermic or more inflammatory psoriasis any time after stopping therapy (last treatment administered) up to Week 68. Rebound was evaluated for the patients randomized to the placebo groups in the extension study; hence these patients received the last dose of secukinumab during the core studies.	up to week 68
Number of Participants With Dermatology Life Quality Index Response (DLQI 0 or 1) - Randomized Withdrawal Period (Observed Data)	Dermatology Life Quality Index (DLQI) scores range from 0 to 30. Lower absolute scores on DLQI indicate better/improved health-related quality-of life impairment.	Week 52 (baseline), 64, 76, 88, 104, 116, 128, 140, and 156
Number of Participants With Dermatology Life Quality Index Response (DLQI 0 or 1) - Entire Treatment Period	Dermatology Life Quality Index (DLQI) scores range from 0 to 30. Lower absolute scores on DLQI indicate better/improved health-related quality-of life impairment.	Week 52 (baseline), 64, 76, 88, 104, 116, 128, 140, and 156
EQ-5D Health State Assessment (Observed Value) - Randomized Withdrawal Period	EQ-5D: EuroQOL 5-Dimension Health Status Questionnaire. The EQ-5D© is a generic instrument to assess each patient's health status. It provides a simple descriptive profile and a single index value for health status. The EQ visual analog scale records the respondent's self-rated health on a vertical scale where the endpoints are labeled 'Best imaginable health state' and 'Worst imaginable health state'. This information can be used as a quantitative measure of health outcome as judged by the individual respondents.	Week 52 (baseline), 64, 76, 88, 104, 116, 128, 140, and 156
EQ-5D Health State Assessment (Observed Value) - Entire Study Period	EQ-5D: EuroQOL 5-Dimension Health Status Questionnaire. The EQ-5D© is a generic instrument to assess each patient's health status. It provides a simple descriptive profile and a single index value for health status. The EQ visual analog scale records the respondent's self-rated health on a vertical scale where the endpoints are labeled 'Best imaginable health state' and 'Worst imaginable health state'. This information can be used as a quantitative measure of health outcome as judged by the individual respondents.	week 64, 76, 88, 104, 116, 128, 140, and 156
Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period	CTCAE: common terminology criteria for adverse events. A subject with multiple variable measurements is counted only once under the worst condition. LLN = lower limit of normal. IR=incidence rate per 100 subject years	Week 52-156
Clinical Laboratory Evaluation: Number of Participants With Clinically CTCAE - Entire Study Period	CTCAE: common terminology criteria for adverse events. A subject with multiple variable measurements is counted only once under the worst condition. LLN = lower limit of normal.	approximately 4 years
Electrocardiogram: Incidence of Participants With ECG Test Results - Randomized Withdrawal Period	QTcB: QT interval corrected using Bazett's formula QTcF: QT interval corrected using Fridericia's formula A patient with multiple variable measurements is counted only once under the worst condition. IR=incidence rate per 100 subject years.	Week 52 - 156
Electrocardiogram: Number of Participants With ECG Test Results - Entire Treatment Period	QTcB: QT interval corrected using Bazett's formula QTcF: QT interval corrected using Fridericia's formula A patient with multiple variable measurements is counted only once under the worst condition.	Approximately 4 years

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2012
• Primary Completion (Actual): June 26, 2017
• Study Completion (Actual): June 26, 2017

Study Registration Dates

• First Submitted: February 28, 2012
• First Submitted That Met QC Criteria: February 29, 2012
• First Posted (Estimate): March 6, 2012

Study Record Updates

• Last Update Posted (Actual): December 20, 2018
• Last Update Submitted That Met QC Criteria: November 27, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: scaly patches; secukinumab (AIN457); Psoriasis, inflammatory skin disease; Psoriasis Area and Severity Index (PASI); Investigator Global Assessment (IGA) mod 2011
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: CAIN457A2302E1; 2012-000533-39

Plan for Individual participant data (IPD)

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

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

Drug and device information, study documents

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