Efficacy and Safety of Subcutaneous Secukinumab for Moderate to Severe Chronic Plaque-type Psoriasis for up to 1 Year (ERASURE)

A Randomized, Double-blind, Placebo Controlled, Multicenter Study of Subcutaneous Secukinumab to Demonstrate Efficacy After Twelve Weeks of Treatment, and to Assess the Safety, Tolerability and Long-term Efficacy up to One Year in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis

This study will assess the safety and efficacy of secukinumab compared to placebo 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: secukinumab 150 mg; Drug: placebo to secukinumab 150 mg

• Study Type: Interventional
• Enrollment (Actual): 738
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Mendoza, Argentina, M5502EZA
    • Novartis Investigative Site
  • Buenos Aires
    • Caba, Buenos Aires, Argentina, C1181ACH
      • Novartis Investigative Site
    • Caba, Buenos Aires, Argentina, C1122AAF
      • Novartis Investigative Site
    • Caba, Buenos Aires, Argentina, C1425AWC
      • Novartis Investigative Site
• Canada
  • New Brunswick
    • Moncton, New Brunswick, Canada, E1C 8X3
      • Novartis Investigative Site
  • Ontario
    • Hamilton, Ontario, Canada, L8N 1V6
      • Novartis Investigative Site
    • Peterborough, Ontario, Canada, K9J 5K2
      • Novartis Investigative Site
    • Waterloo, Ontario, Canada, N2J 1C4
      • Novartis Investigative Site
  • Quebec
    • Montreal, Quebec, Canada, H3H 1V4
      • Novartis Investigative Site
• Colombia
  • Barranquilla, Colombia
    • Novartis Investigative Site
  • Bogotá, Colombia
    • Novartis Investigative Site
  • Bucaramanga, Colombia
    • Novartis Investigative Site
  • Atlantico
    • Barranquilla, Atlantico, Colombia
      • Novartis Investigative Site
• Estonia
  • Tallinn, Estonia, 13419
    • Novartis Investigative Site
  • Tallinn, Estonia, 10617
    • Novartis Investigative Site
  • Tallinn, Estonia, 10138
    • Novartis Investigative Site
  • Tartu, Estonia, 51014
    • Novartis Investigative Site
• Iceland
  • Kopavogur, Iceland, IS-201
    • Novartis Investigative Site
• Israel
  • Afula, Israel, 18101
    • Novartis Investigative Site
  • Petach Tikva, Israel, 49100
    • Novartis Investigative Site
  • Ramat Gan, Israel, 52621
    • Novartis Investigative Site
• Japan
  • Kyoto, Japan, 602-8566
    • Novartis Investigative Site
  • Aichi
    • Nagoya-city, Aichi, Japan, 467-8602
      • Novartis Investigative Site
  • Fukuoka
    • Fukuoka-city, Fukuoka, Japan, 814-0180
      • Novartis Investigative Site
    • Kurume, Fukuoka, Japan, 830-0011
      • 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, 060-0063
      • Novartis Investigative Site
  • Hyogo
    • Kobe-City, Hyogo, Japan, 654-0155
      • Novartis Investigative Site
  • Ibaraki
    • Inashiki-gun, Ibaraki, Japan, 300-0395
      • Novartis Investigative Site
  • Kanagawa
    • Isehara-city, Kanagawa, Japan, 259-1193
      • Novartis Investigative Site
    • Kawasaki-city, Kanagawa, Japan, 213-8507
      • Novartis Investigative Site
    • Sagamihara-city, Kanagawa, Japan, 228-8522
      • Novartis Investigative Site
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan, 113-8655
      • Novartis Investigative Site
    • Chiyoda-ku, Tokyo, Japan, 102-8798
      • Novartis Investigative Site
    • Minato-ku, Tokyo, Japan, 105-8471
      • Novartis Investigative Site
    • Shinagawa-ku, Tokyo, Japan, 141-8625
      • Novartis Investigative Site
    • Shinjuku-ku, Tokyo, Japan, 160-0023
      • Novartis Investigative Site
    • Shinjuku-ku, Tokyo, Japan, 160-8582
      • Novartis Investigative Site
• Latvia
  • Daugavpils, Latvia, LV-5404
    • Novartis Investigative Site
  • Riga, Latvia, 1012
    • Novartis Investigative Site
  • Riga, Latvia, LV-1001
    • Novartis Investigative Site
  • Ventspils, Latvia, LV-3601
    • Novartis Investigative Site
• Lithuania
  • Kaunas, Lithuania, 50009
    • Novartis Investigative Site
  • Klaipeda, Lithuania, 92304
    • Novartis Investigative Site
  • Vilnius, Lithuania, LT-08661
    • Novartis Investigative Site
  • Vilnius, Lithuania, LT-07195
    • Novartis Investigative Site
• Mexico
  • Distrito Federal
    • México, Distrito Federal, Mexico, 14050
      • Novartis Investigative Site
    • México, Distrito Federal, Mexico, 06780
      • Novartis Investigative Site
  • Jalisco
    • Zapopan, Jalisco, Mexico, 45190
      • Novartis Investigative Site
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 64460
      • Novartis Investigative Site
• Taiwan
  • Hsin Chu, Taiwan
    • Novartis Investigative Site
  • Taichung, Taiwan, 40447
    • Novartis Investigative Site
  • Taipei, Taiwan, 10002
    • Novartis Investigative Site
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Novartis Investigative Site
    • Birmingham, Alabama, United States, 35205
      • Novartis Investigative Site
  • Arizona
    • 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
  • Colorado
    • Colorado Springs, Colorado, United States, 80915
      • Novartis Investigative Site
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Novartis Investigative Site
  • Georgia
    • Snellville, Georgia, United States, 30078
      • Novartis Investigative Site
  • Indiana
    • Evansville, Indiana, United States, 47713
      • Novartis Investigative Site
  • Kansas
    • Topeka, Kansas, United States, 66606
      • Novartis Investigative Site
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Novartis Investigative Site
    • Louisville, Kentucky, United States, 40291
      • Novartis Investigative Site
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Novartis Investigative Site
    • Ann Arbor, Michigan, United States, 48103
      • Novartis Investigative Site
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • Novartis Investigative Site
  • New York
    • New York, New York, United States, 10029
      • Novartis Investigative Site
    • Rochester, New York, United States, 14623
      • Novartis Investigative Site
  • Oregon
    • Oregon City, Oregon, United States, 97045
      • Novartis Investigative Site
    • Portland, Oregon, United States, 97210
      • Novartis Investigative Site
    • Portland, Oregon, United States, 97223
      • Novartis Investigative Site
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635
      • Novartis Investigative Site
    • Philadelphia, Pennsylvania, United States, 19104
      • Novartis Investigative Site
  • South Carolina
    • Charleston, South Carolina, United States, 29407
      • Novartis Investigative Site
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Novartis Investigative Site
  • Texas
    • Austin, Texas, United States, 78759
      • Novartis Investigative Site
    • Bryan, Texas, United States, 77802
      • Novartis Investigative Site
    • Dallas, Texas, United States, 75231
      • Novartis Investigative Site
    • Dallas, Texas, United States, 75246-1613
      • Novartis Investigative Site
    • Houston, Texas, United States, 77030
      • Novartis Investigative Site
    • San Antonio, Texas, United States, 78229
      • Novartis Investigative Site
  • Utah
    • Salt Lake City, Utah, United States, 84117
      • Novartis Investigative Site
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • 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 psoriasis disease meeting all of the following three criteria:
• Psoriasis Area and Severity Index (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.
• Subjects not willing to limit UV light exposure during the study 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

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AIN457 150 mg; AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week	Drug: secukinumab 150 mg; secukinumab (AIN457) 150mg or 300mg subcutaneous; Drug: placebo to secukinumab 150 mg; Placebo to Match secukinumab (AIN457) 150mg or 300mg subcutaneous
Experimental: AIN457 300 mg; AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week	Drug: secukinumab 150 mg; secukinumab (AIN457) 150mg or 300mg subcutaneous; Drug: placebo to secukinumab 150 mg; Placebo to Match secukinumab (AIN457) 150mg or 300mg subcutaneous
Placebo Comparator: placebo; placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.	Drug: placebo to secukinumab 150 mg; Placebo to Match secukinumab (AIN457) 150mg or 300mg subcutaneous
Experimental: AIN457 150mg from Placebo; Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase because they were PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.	Drug: secukinumab 150 mg; secukinumab (AIN457) 150mg or 300mg subcutaneous; Drug: placebo to secukinumab 150 mg; Placebo to Match secukinumab (AIN457) 150mg or 300mg subcutaneous
Experimental: AIN457 300mg from Placebo; Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase. PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.	Drug: secukinumab 150 mg; secukinumab (AIN457) 150mg or 300mg subcutaneous; Drug: placebo to secukinumab 150 mg; Placebo to Match secukinumab (AIN457) 150mg or 300mg subcutaneous

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Achieved >75 or Higher (Psoriasis Area and Severity Index) PASI Score at 12 Weeks	A 75% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 75) is the current benchmark of primary endpoints for most clinical trials of psoriasis. 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).	12 weeks
Percentage of Participants Who Achieved (Investigator's Global Assessment) IGA Score of 0 or 1	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. Treatment success was defined as achievement of IGA mod 2001 score of 0 or 1. IGA score of 0 or 1 as an indicator of efficacy.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Achieved a PASI (Psoriasis Area and Severity Index) Score of 90 or Better at Week 12	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 90 was defined as participants who achievied ≥ 90% improvement from baseline.	12 weeks
Number of Participants That Maintained the Psoriasis Area and Severity Index (PASI) 75 Response at 52 Weeks of Treatment for Participants Who Were PASI 75 Responders at Week 12	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).	12 and 52 weeks
Number of Participants That Maintained the IGA Mod 2011 0 or 1 Response at 52 Weeks of Treatment for Participants Who Were IGA Mod 2011 0 or 1 Responders at Week 12	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. Treatment success was defined as achievement of IGA mod 2001 score of 0 or 1.	12 and 52 weeks
Change From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Placebo	The Psoriasis Symptom Diary©, a 16-item patient reported outcome (PRO) measure developed and validated in accordance with the FDA PRO Guidance (FDA Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims, 2009), demonstrated favorable psychometric properties and usefulness for treatment efficacy evaluation alongside other measures of disease severity in clinical trials for chronic plaque psoriasis.Weekly averages will be derived for each of the 16 questions of the Psoriasis Diary up to Week 12. A weekly average is the sum of the scored item over the course of the study week divided by the number of days on which the item was completed and will be set to missing if four or more daily assessments were missing of the corresponding question. A reduction in score from baseline shows efficacy. Each question has a score of 0 (no symptoms) up to 10 (Severe symptoms)	Week 12
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response up to 12 Weeks Induction Period	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 (max). 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 1,2,3,4,8,12,
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to Week 52	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 (max). 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 13,14,15,16,20,24,28,32,36,40,44,48,52
Mean Percent Change From Baseline in PASI Scores up to Week 12 - Induction Period	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.	Baseline, Week 1,2,3,4,8,12,
Mean Percent Change From Baseline in PASI Scores Maintenance Period After Week 12 to Week 52	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 13,14,15,16,20,24,28,32,36,40,44,48,52
Percentage of Participants in Each IGA Mod 2011 Score Category up to Week 12 - Induction Period	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 1,2,3,4,8,12,
Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52	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 13,14,15,16,20,24,28,32,36,40,44,48,52
Time to PASI 75 Response up to 12 Weeks	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 (max). 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 75 was defined as participants achieving ≥ 75% improvement from baseline.	Week 12
Mean Percent Change From Baseline in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment (From 0 to 100) Induction Period	The EQ-5D is an instrument used to assess a participant's health status. The instrument includes a descriptive profile and a visual analog scale (VAS). The descriptive profile includes 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension had 3 response levels: no problems, some problems and severe problems. The VAS is a vertical scale that assesses the health status from 0 (worst possible health state) to 100 (best possible health state). This outcome measures the percent change in VAS score. Positive mean percent changes indicate improvement.	Baseline, Week 4,8, 12
Mean Percent Change From Baseline in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment (From 0 to 100) Maintenance Period	The EQ-5D is an instrument used to assess a participant's health status. The instrument includes a descriptive profile and a visual analog scale (VAS). The descriptive profile includes 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension had 3 response levels: no problems, some problems and severe problems. The VAS is a vertical scale that assesses the health status from 0 (worst possible health state) to 100 (best possible health state). This outcome measures the percent change in VAS score. Positive mean percent changes indicate improvement.	Week 12, 24, 36, 52
Percentage Changes in the Dermatology Life Quality Index (DLQI) During Induction Period	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. A negative mean percentage change from baseline indicates improvement.	Baseline, Week 4, 8 & 12
Percentage Changes in the Dermatology Life Quality Index (DLQI) During Maintenance Period	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. A negative mean percentage change from baseline indicates improvement.	Week 12,24, 36 & 52
Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) of 0 or 1 During Induction Period	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. A negative mean percentage change from baseline indicates improvement.	Week 4, 8, 12
Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) of 0 or 1 During Maintenance Period	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. A negative mean percentage change from baseline indicates improvement.	Week 12,24,36, & 52
Percentage of Participants Achieving PASI 75, PASI 90 and IGA Mod 2011 0 or 1 Response at Week 12 by Previous Exposure to Biologic Systemic Therapy or Anti-TNF-α Therapy and Failed to Respond to a Previous Biologic or Anti-TNF-α Therapy Psoriasis Therapy	PASI is an assessment of lesion severity & affected area into a single score:0(no disease)to 72(max. disease).Body is divided into 4 areas for scoring(head,arms,trunk,legs)each area is scored separately & then added for final PASI.For each area, % 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(max). 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 75, 90 is patients achieving≥75%or90% improvement from baseline.The IGA mod 2011 scale is static, exclusively to the patients disease at assessment,& not with any of the patient's previous disease states at other visits.The scores are:0=clear,1=almost clear,2= mild,3=moderate&4=severe.Response variables PASI 75,90, IGA mod 2011 0 or 1 response at wk 12 was scored versus previous psoriasis systemic therapy & response to previous biologic systemic therapy by treatment	Week 12
Number of Participants Who Developed Anti-secukinumab Antibodies	The development of anti-secunimubab anti-bodies would decrease a participant's ability to respond to secukinumab treatment.	Week 12

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.
• Houghton K, Patil D, Gomez B, Feldman SR. Correlation Between Change in Psoriasis Area and Severity Index and Dermatology Life Quality Index in Patients with Psoriasis: Pooled Analysis from Four Phase 3 Clinical Trials of Secukinumab. Dermatol Ther (Heidelb). 2021 Aug;11(4):1373-1384. doi: 10.1007/s13555-021-00564-2. Epub 2021 Jun 10.
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Helpful Links

• Plain Language Trial Summaries available on novartisclinicaltrials.com

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: June 1, 2011
• First Submitted That Met QC Criteria: June 2, 2011
• First Posted (Estimate): June 3, 2011

Study Record Updates

• Last Update Posted (Actual): January 5, 2021
• Last Update Submitted That Met QC Criteria: December 9, 2020
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Psoriasis; subcutaneous; psoriatic arthritis; plaque; AIN457; secukinumab; injection; AIN457A; plaque-type psoriasis; IL-17 blocker
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Immunologic Factors; Antibodies, Monoclonal
• Other Study ID Numbers: CAIN457A2302; 2010-023512-13 (EudraCT Number)