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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01365455
First received: June 1, 2011
Last updated: May 7, 2015
Last verified: May 2015

June 1, 2011
May 7, 2015
June 2011
April 2013   (final data collection date for primary outcome measure)
  • Percentage of Participants Who Achieved >75 or Higher (Psoriasis Area and Severity Index) PASI Score at 12 Weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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).
  • Percentage of Participants Who Achieved (Investigator's Global Assessment) IGA Score of 0 or 1 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.
Efficacy of secukinumab in subjects with moderate to severe chronic plaque-type psoriasis [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Measure: PASI and IGA
Complete list of historical versions of study NCT01365455 on ClinicalTrials.gov Archive Site
  • Percentage of Participants Who Achieved a PASI (Psoriasis Area and Severity Index) Score of 90 or Better at Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.
  • 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 [ Time Frame: 12 and 52 weeks ] [ Designated as safety issue: Yes ]
    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).
  • 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 [ Time Frame: 12 and 52 weeks ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Placebo [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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)
  • Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response up to 12 Weeks Induction Period [ Time Frame: Week 1,2,3,4,8,12, ] [ Designated as safety issue: No ]
    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.
  • Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to Week 52 [ Time Frame: Week 13,14,15,16,20,24,28,32,36,40,44,48,52 ] [ Designated as safety issue: No ]
    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.
  • Mean Percent Change From Baseline in PASI Scores up to Week 12 - Induction Period [ Time Frame: Baseline, Week 1,2,3,4,8,12, ] [ Designated as safety issue: No ]
    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.
  • Mean Percent Change From Baseline in PASI Scores Maintenance Period After Week 12 to Week 52 [ Time Frame: Week 13,14,15,16,20,24,28,32,36,40,44,48,52 ] [ Designated as safety issue: No ]
    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.
  • Percentage of Participants in Each IGA Mod 2011 Score Category up to Week 12 - Induction Period [ Time Frame: Baseline, Week 1,2,3,4,8,12, ] [ Designated as safety issue: No ]
    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.
  • Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52 [ Time Frame: Week 13,14,15,16,20,24,28,32,36,40,44,48,52 ] [ Designated as safety issue: No ]
    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.
  • Time to PASI 75 Response up to 12 Weeks [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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.
  • Mean Percent Change From Baseline in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment (From 0 to 100) Induction Period [ Time Frame: Baseline, Week 4,8, 12 ] [ Designated as safety issue: No ]
    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.
  • Mean Percent Change From Baseline in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment (From 0 to 100) Maintenance Period [ Time Frame: Week 12, 24, 36, 52 ] [ Designated as safety issue: No ]
    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.
  • Percentage Changes in the Dermatology Life Quality Index (DLQI) During Induction Period [ Time Frame: Baseline, Week 4, 8 & 12 ] [ Designated as safety issue: No ]
    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.
  • Percentage Changes in the Dermatology Life Quality Index (DLQI) During Maintenance Period [ Time Frame: Week 12,24, 36 & 52 ] [ Designated as safety issue: No ]
    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.
  • Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) of 0 or 1 During Induction Period [ Time Frame: Week 4, 8, 12 ] [ Designated as safety issue: No ]
    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.
  • Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) of 0 or 1 During Maintenance Period [ Time Frame: Week 12,24,36, & 52 ] [ Designated as safety issue: No ]
    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.
  • 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 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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
  • Number of Participants Who Developed Anti-secukinumab Antibodies [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    The development of anti-secunimubab anti-bodies would decrease a participant's ability to respond to secukinumab treatment.
  • Efficacy of secukinumab in subjects with moderate to severe chronic plaque-type psoriasis [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Measure: PASI and IGA
  • Clinical safety and tolerability of secukinumab [ Time Frame: 12 and 52 weeks ] [ Designated as safety issue: Yes ]
    Measure: vital signs, clinical laboratory variables, ECGs, adverse events
  • Quality of life assessments [ Time Frame: 12 and 52 weeks ] [ Designated as safety issue: No ]
    Measure: Patient reported outcome questionnaires
Not Provided
Not Provided
 
Efficacy and Safety of Subcutaneous Secukinumab for Moderate to Severe Chronic Plaque-type Psoriasis for up to 1 Year
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Moderate to Severe Plaque-type Psoriasis
  • 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 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
    Interventions:
    • Drug: secukinumab 150 mg
    • Drug: placebo to secukinumab 150 mg
  • 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
    Interventions:
    • Drug: secukinumab 150 mg
    • Drug: placebo to secukinumab 150 mg
  • 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.
    Intervention: Drug: placebo to secukinumab 150 mg
  • 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.
    Interventions:
    • Drug: secukinumab 150 mg
    • Drug: placebo to secukinumab 150 mg
  • 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.
    Interventions:
    • Drug: secukinumab 150 mg
    • Drug: placebo to secukinumab 150 mg

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
739
April 2013
April 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Canada,   Colombia,   Estonia,   Iceland,   Israel,   Japan,   Latvia,   Lithuania,   Mexico,   Taiwan
 
NCT01365455
CAIN457A2302, 2010-023512-13
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Study Director: Novartis Pharmceuticals Novartis Pharmaceuticals
Novartis
May 2015

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