Efficacy and Safety of Subcutaneous Secukinumab (AIN457) for Moderate to Severe Chronic Plaque-type Psoriasis Assessing Different Doses and Dose Regimens (SCULPTURE)

A Randomized, Double-blind, Multicenter Study of Subcutaneous Secukinumab, Assessing Psoriasis Area and Severity Index (PASI) Response and Maintenance of Response in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis on Either a Fixed Dose Regimen or on a Retreatment at Start of Relapse Regimen

This study will assess the safety and efficacy of two different doses and two different dose regimens of subcutaneous secukinumab in patients that have moderate to severe, chronic, plaque-type psoriasis.

Study Overview

• Status: Completed
• Conditions: Moderate to Severe Plaque-type Psoriasis
• Intervention / Treatment: Drug: AIN457 150mg; Drug: AIN457 300mg

• Study Type: Interventional
• Enrollment (Actual): 967
• Phase: Phase 3

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, A-8036
    • Novartis Investigative Site
  • Linz, Austria, A-4010
    • Novartis Investigative Site
  • Vienna, Austria, A-1220
    • Novartis Investigative Site
  • Wels, Austria, 4600
    • Novartis Investigative Site
• Bulgaria
  • Pleven, Bulgaria, 5800
    • Novartis Investigative Site
  • Sofia, Bulgaria, 1431
    • Novartis Investigative Site
  • Sofia, Bulgaria, 1606
    • Novartis Investigative Site
  • Sofia, Bulgaria, 1404
    • Novartis Investigative Site
  • Sofia, Bulgaria, 1231
    • Novartis Investigative Site
  • Varna, Bulgaria, 9010
    • Novartis Investigative Site
• Canada
  • Ontario
    • Barrie, Ontario, Canada, L4M 6L2
      • Novartis Investigative Site
    • Oakville, Ontario, Canada, L6J 7W5
      • Novartis Investigative Site
    • Waterloo, Ontario, Canada, N2J 1C4
      • Novartis Investigative Site
    • Windsor, Ontario, Canada, N8W 1E6
      • Novartis Investigative Site
  • Quebec
    • Montreal, Quebec, Canada, H2K 4L5
      • Novartis Investigative Site
• Czech Republic
  • Brno - Bohunice, Czech Republic, 625 00
    • Novartis Investigative Site
  • Ceske Budejovice, Czech Republic, 370 01
    • Novartis Investigative Site
  • Novy Jicin, Czech Republic, 741 01
    • Novartis Investigative Site
  • Prague 10, Czech Republic, 100 34
    • Novartis Investigative Site
  • CZE
    • Hradec Kralove, CZE, Czech Republic, 500 05
      • Novartis Investigative Site
    • Prague 8, CZE, Czech Republic, 180 81
      • Novartis Investigative Site
• France
  • Antony, France, 92160
    • Novartis Investigative Site
  • Nice Cedex 3, France, 06202
    • Novartis Investigative Site
  • Pierre-Benite Cédex, France, F-69495
    • Novartis Investigative Site
  • Rouen, France, 76031
    • Novartis Investigative Site
  • Toulouse Cedex, France, 31059
    • Novartis Investigative Site
• Germany
  • Bad Wildbad, Germany, 75323
    • Novartis Investigative Site
  • Bochum, Germany, 44803
    • Novartis Investigative Site
  • Buchholz i. d. Nordheide, Germany, 21244
    • Novartis Investigative Site
  • Dippoldiswalde-Schmiedeberg, Germany, 01744
    • Novartis Investigative Site
  • Duisburg, Germany, 47167
    • Novartis Investigative Site
  • Düsseldorf, Germany, 40225
    • Novartis Investigative Site
  • Essen, Germany, 45147
    • Novartis Investigative Site
  • Frankfurt, Germany, 60590
    • Novartis Investigative Site
  • Freiburg, Germany, 79104
    • Novartis Investigative Site
  • Hamburg, Germany, 20246
    • Novartis Investigative Site
  • Hamburg, Germany, 22143
    • Novartis Investigative Site
  • Hamburg, Germany, 22391
    • Novartis Investigative Site
  • Hannover, Germany, 30625
    • Novartis Investigative Site
  • Kiel, Germany, 24105
    • Novartis Investigative Site
  • Köln, Germany, 50937
    • Novartis Investigative Site
  • Luebeck, Germany, 23538
    • Novartis Investigative Site
  • Mahlow, Germany, 15831
    • Novartis Investigative Site
  • Mainz, Germany, 55131
    • Novartis Investigative Site
  • Mannheim, Germany, 68167
    • Novartis Investigative Site
  • Muenster, Germany, 48149
    • Novartis Investigative Site
  • Pommelsbrunn, Germany, 91224
    • Novartis Investigative Site
  • Wuppertal, Germany, 42103
    • Novartis Investigative Site
• India
  • Andhra Pradesh
    • Hyderabad, Andhra Pradesh, India, 500 058
      • Novartis Investigative Site
    • Secunderabad, Andhra Pradesh, India, 500 094
      • Novartis Investigative Site
  • Karnataka
    • Bangalore, Karnataka, India, 560054
      • Novartis Investigative Site
    • Mangalore, Karnataka, India, 575 004
      • Novartis Investigative Site
  • Maharashtra
    • Mumbai, Maharashtra, India, 400 008
      • Novartis Investigative Site
    • Nagpur, Maharashtra, India
      • Novartis Investigative Site
    • Nagpur, Maharashtra, India, 440 010
      • Novartis Investigative Site
    • Nagpur, Maharashtra, India, 440013
      • Novartis Investigative Site
    • Nashik, Maharashtra, India
      • Novartis Investigative Site
• Italy
  • RM
    • Roma, RM, Italy, 00144
      • Novartis Investigative Site
    • Roma, RM, Italy, 00133
      • Novartis Investigative Site
  • SI
    • Siena, SI, Italy, 53100
      • Novartis Investigative Site
  • VR
    • Verona, VR, Italy, 37126
      • Novartis Investigative Site
• Japan
  • Aichi
    • Nagoya-city, Aichi, Japan, 467-8602
      • Novartis Investigative Site
  • Chiba
    • Kisarazu, Chiba, Japan, 292-8535
      • Novartis Investigative Site
  • Fukuoka
    • Fukuoka-city, Fukuoka, Japan, 815-8588
      • Novartis Investigative Site
    • Kitakyushu-city, Fukuoka, Japan, 800-0296
      • Novartis Investigative Site
  • Gunma
    • Maebashi-city, Gunma, Japan, 371-8511
      • Novartis Investigative Site
  • Hokkaido
    • Asahikawa-city, Hokkaido, Japan, 078-8510
      • Novartis Investigative Site
    • Sapporo-city, Hokkaido, Japan, 060-0033
      • Novartis Investigative Site
  • Osaka
    • Osaka-city, Osaka, Japan, 550-0012
      • Novartis Investigative Site
  • Tochigi
    • Shimotsuke-city, Tochigi, Japan, 329-0498
      • Novartis Investigative Site
  • Tokyo
    • Chiyoda-ku, Tokyo, Japan, 102-8798
      • Novartis Investigative Site
    • Hachioji-city, Tokyo, Japan, 193-0998
      • Novartis Investigative Site
    • Itabashi-ku, Tokyo, Japan, 173-8610
      • Novartis Investigative Site
    • Minato-ku, Tokyo, Japan, 105-8471
      • Novartis Investigative Site
    • Shinjuku-ku, Tokyo, Japan, 160-0023
      • Novartis Investigative Site
    • Shinjuku-ku, Tokyo, Japan, 160-8582
      • Novartis Investigative Site
• Poland
  • Lodz, Poland, 90-265
    • Novartis Investigative Site
  • Poznan, Poland, 60-539
    • Novartis Investigative Site
  • Wroclaw, Poland, 50-368
    • Novartis Investigative Site
• Singapore
  • Singapore, Singapore, 119074
    • Novartis Investigative Site
  • Singapore, Singapore, 308205
    • Novartis Investigative Site
• Slovakia
  • Bratislava, Slovakia, SK-81369
    • Novartis Investigative Site
  • Kosice, Slovakia, 04011
    • Novartis Investigative Site
  • Poprad, Slovakia, 05845
    • Novartis Investigative Site
  • Svidnik, Slovakia, 089 01
    • Novartis Investigative Site
  • Zilina, Slovakia, 01207
    • Novartis Investigative Site
  • Slovak Republic
    • Kosice, Slovak Republic, Slovakia, 040 15
      • Novartis Investigative Site
• Switzerland
  • Bern, Switzerland, 3010
    • Novartis Investigative Site
  • Lausanne, Switzerland, 1011
    • Novartis Investigative Site
  • Zuerich, Switzerland, 8091
    • Novartis Investigative Site
• United Kingdom
  • Birmingham, United Kingdom, B15 2TH
    • Novartis Investigative Site
  • Blackpool, United Kingdom, FY3 7EN
    • Novartis Investigative Site
  • Leicester, United Kingdom, LE7 5WW
    • Novartis Investigative Site
  • Poole, United Kingdom, BH15 2JB
    • Novartis Investigative Site
  • England
    • London, England, United Kingdom, E11 1NR
      • Novartis Investigative Site
• United States
  • California
    • Fresno, California, United States, 93710
      • Novartis Investigative Site
    • Pasadena, California, United States, 91105
      • Novartis Investigative Site
    • Sacramento, California, United States, 95817
      • Novartis Investigative Site
    • San Francisco, California, United States, 94118
      • Novartis Investigative Site
  • Florida
    • Jacksonville, Florida, United States, 32204
      • Novartis Investigative Site
    • Jacksonville, Florida, United States, 32216
      • Novartis Investigative Site
    • Miami, Florida, United States, 33136
      • Novartis Investigative Site
    • Naples, Florida, United States, 34119
      • Novartis Investigative Site
    • South Miami, Florida, United States, 33143
      • Novartis Investigative Site
    • West Palm Beach, Florida, United States, 33409
      • Novartis Investigative Site
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Novartis Investigative Site
  • Illinois
    • Champaign, Illinois, United States, 61820
      • Novartis Investigative Site
    • Skokie, Illinois, United States, 60077
      • Novartis Investigative Site
    • Springfield, Illinois, United States, 62703
      • Novartis Investigative Site
  • Indiana
    • Indianapolis, Indiana, United States, 46256
      • Novartis Investigative Site
  • Kansas
    • Overland Park, Kansas, United States, 66215
      • Novartis Investigative Site
  • Kentucky
    • Owensboro, Kentucky, United States, 42301
      • Novartis Investigative Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Novartis Investigative Site
  • Minnesota
    • Fridley, Minnesota, United States, 55432
      • Novartis Investigative Site
  • Missouri
    • St. Louis, Missouri, United States, 63117
      • Novartis Investigative Site
  • Nevada
    • Henderson, Nevada, United States, 89052
      • Novartis Investigative Site
    • Las Vegas, Nevada, United States, 89119
      • Novartis Investigative Site
  • New Jersey
    • Verona, New Jersey, United States, 07044
      • Novartis Investigative Site
  • North Carolina
    • Greensboro, North Carolina, United States, 27401
      • Novartis Investigative Site
    • High Point, North Carolina, United States, 27262
      • Novartis Investigative Site
    • Winston-Salem, North Carolina, United States, 27103
      • Novartis Investigative Site
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • Novartis Investigative Site
    • Greer, South Carolina, United States, 29651
      • Novartis Investigative Site
  • Tennessee
    • Goodlettsville, Tennessee, United States, 37072-2301
      • Novartis Investigative Site
  • Texas
    • Dallas, Texas, United States, 75230
      • Novartis Investigative Site
    • Dallas, Texas, United States, 75231
      • Novartis Investigative Site
    • San Antonio, Texas, United States, 78229
      • Novartis Investigative Site
  • Utah
    • Salt Lake City, Utah, United States, 84124
      • Novartis Investigative Site
• Vietnam
  • Hanoi, Vietnam, 1000
    • Novartis Investigative Site
  • Ho Chi Minh, Vietnam, 7000
    • 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:

• Moderate and severe plaque-type psoriasis diagnosed for at least 6 months.

Severity of disease meeting all of the following three criteria:

• PASI score of 12 or greater,
• Investigator's Global Assessment (IGA) score of 3 or greater
• Total body surface area (BSA) affected of 10% or greater.
• Inadequate control by prior use of topical treatment, phototherapy and/or systemic therapy.

Exclusion criteria:

• Current forms of psoriasis other than chronic plaque-type psoriasis (for example, pustular, erythrodermic, guttate).
• Current drug-induced psoriasis.
• Previous use of secukinumab or any drug that targets IL-17 or IL-17 receptor.
• Significant medical problems such as uncontrolled hypertension, congestive heart failure or a condition that significantly immunocompromises the subject.
• Hematological abnormalities.
• History of an ongoing, chronic or recurrent infectious disease, or evidence of untreated tuberculosis.
• History of lymphoproliferative disease or history of malignancy of any organ system within the past 5 years.
• Pregnant or nursing (lactating) women.
• Other protocol-defined inclusion/exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AIN457150 mg- Induction period Only(IPO); secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)	Drug: AIN457 150mg; (1 injection per dose) and placebo to secukinumab 150 mg; Other Names: secukinumab 150 mg
Experimental: AIN457 300 mg - IPO; secukinumab- 2 x 150mg injections per dose	Drug: AIN457 300mg; secukinumab 150 mg (2 injections per dose); Other Names: secukinumab
Experimental: AIN457 150 mg - Fixed Interval (FI); 1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection	Drug: AIN457 150mg; (1 injection per dose) and placebo to secukinumab 150 mg; Other Names: secukinumab 150 mg
Experimental: AIN457 300 mg FI; 2 s.c. secukinumab 150 mg injections	Drug: AIN457 300mg; secukinumab 150 mg (2 injections per dose); Other Names: secukinumab
Experimental: AIN457 150 mg- Start of relapse (SoR); 1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection	Drug: AIN457 150mg; (1 injection per dose) and placebo to secukinumab 150 mg; Other Names: secukinumab 150 mg
Experimental: AIN457 300 mg- SoR; 2 s.c. secukinumab 150 mg injections	Drug: AIN457 300mg; secukinumab 150 mg (2 injections per dose); Other Names: secukinumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
For the Fixed Interval Group and the Start of Relapse (SoR) Group, the Percentage of Participants (Who Responded to Treatment at Week 12) Maintaining a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 52	PASI: Combined assessment of lesion severity and 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 and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and 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)	Week 40 , week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute Change From Baseline for PASI 50 / 75 / 90 / 100 and IGA 2011 Score of 0 or 1 at Week 2, 4, 6, 8, 12	PASI: Combined assessment of lesion severity and 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 and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section(head:01, arms:0.2 body:0.3 legs:0.4)	Baseline, week 2, 3 , 4, 8, 12
Absolute Change From Baseline for PASI 50 / 75 / 90 / 100 and IGA 2011 Score of 0 or 1 at Week at Week 16, 20, 24,28,32,36,40,44,48,and Week 52	PASI: Combined assessment of lesion severity and 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 and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section(head:01, arms:0.2 body:0.3 legs:0.4)	Baseline, week 12,16,20,24,28,32,36,40,44,48 and week 52
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Induction)	PASI is a combined assessment of lesion severity and 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 and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and 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 and 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	Baseline, week 2, 4, 6, 8, 12
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Maintenance Period))	The IGA mod 2011 is a static scale, i.e., it refers exclusively to the participant's disease state at the time of the assessments and does not attempt a comparison to any of the participant's previous disease states at prior visits. The score ranges from 0 (clear) to 4 (severe. The score 0 is clear, 1 is almost clear, 2 is mild, 3 is moderate, and 4 is severe	Baseline, week 16,20,24,28,32,36,40,44,48, and Week 52
Change From Baseline in EQ-5D at Each Visit, up to Week 52, (Induction)	ED-5Q: Participant rated questionnaire to assess health related quality of life in terms of a single utility score. Five domains are assessed mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each with three possible score: 1 indicates no problems, better state of health; 3 indicates worst state of health (example "confined to bed") A visual analog scale (VAS) assesses the health status from 0 (worst possible health state) to 100 (best possible health state)	Baseline to week 2, 4, 8, 12
Change From Baseline in EQ-5D at Each Visit, up to Week 52, (Maintenance)	ED-5Q: Participant rated questionnaire to assess health related quality of life in terms of a single utility score. Five domains are assessed mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each with three possible score: 1 indicates no problems, better state of health; 3 indicates worst state of health (example "confined to bed") A visual analog scale (VAS) assesses the health status from 0 (worst possible health state) to 100 (best possible health state)	Baseline to week 16, 20, 24, 28, 32, 36, 40, 44, 48, and Week 52.
Change From Baseline in Dermatology Life Quality Index (DLQI) Score. up to Week 52, (Induction)	The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions	Baseline to week 2, 4, 8, 12
Change From Baseline in Dermatology Life Quality Index (DLQI) Score. up to Week 52, (Maintenance)	The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions	Baseline to week 16, 20, 24, 28, 32, 36, 40, 44, 48, and Week 52.
% of Participants Achieving a DLQI Score of 0 or 1 at Each Visit up to Week 52, (Induction)	The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions	Baseline to week 2, 4, 6, 8, 12
% of Participants Achieving a DLQI Score of 0 or 1 at Each Visit up to Week 52, (Maintenance).	The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions	Baseline to week 16, 20, 24, 28, 32, 36, 40, 44, 48, and Week 52
Median Time to Relapse (Weeks) From Week 12.	Median time to relapse (weeks) from week 12. Relapse is defined as greater than 50% loss of the maximal PASI improvement from baseline. PASI is a combined assessment of lesion severity and 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 and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and 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). A negative mean percentage change indicates improvement	Week 12 to week 16, 20, 24, 28, 32, 36, 40, 44, 48, and Week 52.
Percent of Responders With PASI Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100 and Percent of Responders With IGA Score of 0 or 1 Who Failed to Respond to a Previous Biologic Psoriasis Therapy	PASI is a combined assessment of lesion severity and 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 and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and 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 and 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 12
Percent of Responders With PASI Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100 and Percent of Responders With IGA Score of 0 or 1 Who Failed to Respond to a Previous Biologic Psoriasis Therapy	PASI is a combined assessment of lesion severity and 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 and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and 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 and 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 52
Number of Visits With PASI 50, 75, 90, 100 Score and IGA Mod 2011 0 or 1	PASI is a combined assessment of lesion severity and 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 and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and 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 and 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, 20, 24,28,32,36,40,44,48,and Week 52
Number of Secukinumab Injections Needed to Regain PASI 75 Response From Start of Relapse After Week 12	The number of secukinumab injections needed for participants to regain PASI 75 response from the start of relapse after week 12	week 16, 20, 24,28,32,36,40,44,48,and Week 52
Number of Participants Developing Anti-secukinumab Antibodies	The development of anti-secunimubab anti-bodies will decrease a participant's ability to respond to secukinumab treatment. The number of participants developing anti-secukinumab anti-bodies was measured from Baseline to week 12, 24, 52 and 8 weeks after treatment at week 60	Baseline, weeks 12, 24, 52 and 60

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.
• Dehlin M, Fasth AER, Reinhardt M, Jacobsson LTH. Impact of psoriasis disease activity and other risk factors on serum urate levels in patients with psoriasis and psoriatic arthritis-a post-hoc analysis of pooled data from three phase 3 trials with secukinumab. Rheumatol Adv Pract. 2021 Feb 18;5(1):rkab009. doi: 10.1093/rap/rkab009. eCollection 2021.

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: July 12, 2011
• First Submitted That Met QC Criteria: July 29, 2011
• First Posted (Estimate): August 1, 2011

Study Record Updates

• Last Update Posted (Estimate): May 19, 2015
• Last Update Submitted That Met QC Criteria: April 30, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Psoriasis; plaque; AIN457; scaly patches; secukinumab; inflammatory skin disease; Moderate to Severe Plaque-type Psoriasis
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Immunologic Factors; Antibodies, Monoclonal
• Other Study ID Numbers: CAIN457A2304; 2011-000767-27 (EudraCT Number)