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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01358578
Registration number
NCT01358578
Ethics application status
Date submitted
20/05/2011
Date registered
23/05/2011
Date last updated
5/01/2021
Titles & IDs
Public title
Safety and Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe, Chronic Plaque-Type Psoriasis
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Scientific title
A Randomized, Double-blind, Double-dummy, Placebo Controlled, Multicenter Study of Subcutaneous Secukinumab to Demonstrate Efficacy After Twelve Weeks of Treatment, Compared to Placebo and Etanercept, and to Assess the Safety, Tolerability and Long-term Efficacy up to One Year in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis
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Secondary ID [1]
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2010-022228-66
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Secondary ID [2]
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CAIN457A2303
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Universal Trial Number (UTN)
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Trial acronym
FIXTURE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Plaque Psoriasis
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Condition category
Condition code
Skin
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0
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0
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Dermatological conditions
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Skin
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0
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0
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Other skin conditions
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - secukinumab (AIN457)
Treatment: Drugs - etanercept
Experimental: AIN457 150mg - AIN457 150mg
Experimental: AIN457 300mg - AIN457 300mg
Placebo Comparator: Placebo - Placebo
Active Comparator: Etanercept - Etanercept
Experimental: AIN457 150mg from Placebo - Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase
Experimental: AIN457 300mg from Placebo - Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase
Treatment: Drugs: Placebo
Placebo to Match secukinumab (AIN457) 150mg or 300mg or Placebo to match etanercept
Treatment: Drugs: secukinumab (AIN457)
secukinumab (AIN457) 150mg or 300mg subcutaneous
Treatment: Drugs: etanercept
etanercept 50mg subcutaneous
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 75 (Psoriasis Area and Severity Index) .
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Assessment method [1]
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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
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Timepoint [1]
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12 wks
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Primary outcome [2]
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Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure:IGA (Investigator's Global Assessment) Mod 2011 With a 0 or 1 Response at Week 12
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Assessment method [2]
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The IGA mod 2011 scale has been developed based on a previous version of the scale used in secukinumab phase II studies in collaboration with health authorities, in particular the FDA. The explanations/descriptions of the points on the scale have been improved to ensure appropriate differentiation between the points. The IGA mod 2011 used in this study is static, i.e. it refers exclusively to the subject's disease state at the time of the assessments, and does not attempt a comparison with any of the subject's previous disease states, whether at baseline or at a previous visit.IGA mod 2011 has a scale of 0-4 with the lower scores correlating to better performance. A score of 0= clear skin, 1= almost clear skin, 2=mild, 3=moderate,4=severe.
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Timepoint [2]
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12 wks
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Secondary outcome [1]
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Efficacy of Secukinumab Compared to Etanercept and Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 90 at Week 12
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Assessment method [1]
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A 90% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 90) is above current benchmark of primary endpoints for most clinical trials of psoriasis
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Timepoint [1]
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12 wks
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Secondary outcome [2]
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Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 75 at Week 12
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Assessment method [2]
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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
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Timepoint [2]
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12 wks
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Secondary outcome [3]
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Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: :IGA (Investigator's Global Assessment) Mod 2011 With a 0 or 1 Response at Week 12
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Assessment method [3]
0
0
The IGA mod 2011 scale has been developed based on a previous version of the scale used in secukinumab phase II studies in collaboration with health authorities, in particular the FDA. The explanations/descriptions of the points on the scale have been improved to ensure appropriate differentiation between the points. The IGA mod 2011 used in this study is static, i.e. it refers exclusively to the subject's disease state at the time of the assessments, and does not attempt a comparison with any of the subject's previous disease states, whether at baseline or at a previous visit.IGA mod 2011 has a scale of 0-4 with the lower scores correlating to better performance. A score of 0= clear skin, 1= almost clear skin, 2=mild, 3=moderate,4=severe.
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Timepoint [3]
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12 wks
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Secondary outcome [4]
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Maintenance of PASI 75 Response at Week 52 for Patients Who Were PASI 75 Responders at Week 12 (Non-responder Imputation)
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Assessment method [4]
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Timepoint [4]
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52 wks
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Secondary outcome [5]
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Maintenance of IGA Mod 2011 0 or 1 Response After 52 Weeks of Treatment for Subjects Who Were IGA Mod 2011 0 or 1 Responders After 12 Weeks of Treatment
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Assessment method [5]
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0
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Timepoint [5]
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52 wks
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Secondary outcome [6]
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Change in Score From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Placebo
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Assessment method [6]
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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. The range for each question is 0 to 10 with the higher score depicting a more progressed disease state. A reduction in score from baseline shows efficacy
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Timepoint [6]
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baseline to week 12
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Secondary outcome [7]
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Change From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Etanercept
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Assessment method [7]
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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. The range for each question is 0 to 10 with the higher score depicting a more progressed disease state. A reduction in score from baseline shows efficacy
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Timepoint [7]
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baseline to week 12
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Secondary outcome [8]
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Number of Participants Developing Anti-secukinumab Antibodies
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Assessment method [8]
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Describes the number of participants tested positive for anti-secukinumab antibodies. It refers to the number of patients who had no positive values at baseline but developed them only after start of active study treatment (AIN457 or etanercept)
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Timepoint [8]
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60 weeks
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Eligibility
Key inclusion criteria
- Subjects with chronic, plaque-type psoriasis for at least 6 months
- Must have moderate to severe psoriasis based on PASI greater than 12, IGA greater than
3, and greater than 10% body surface area
- Must be inadequately controlled by prior treatments (topicals, phototherapy, and/or
systemic therapies)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Forms of psoriasis other than chronic, plaque-type (such as pustular, erythrodermic
and guttate psoriasis)
- Drug induced psoriasis
- Use of other psoriasis treatments during the study
- Prior use of etanercept
- Prior use of secukinumab or any other drug that target IL-17 (interleukin 17) or the
IL-17 receptor
- Pregnant or lactating women; women who do not agree to use contraception during the
study and for 16 weeks after stopping treatment
- Significant medical problems such as uncontrolled high blood pressure, congestive
heart failure, etc.
- History of an ongoing, chronic or recurrent infection or evidence of tuberculosis
- Allergy to rubber or latex
Other protocol-defined inclusion/exclusion criteria may apply
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/06/2011
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/07/2013
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Sample size
Target
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Accrual to date
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Final
1306
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Novartis Investigative Site - Kogarah
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Recruitment hospital [2]
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Novartis Investigative Site - Woolloongabba
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Recruitment hospital [3]
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Novartis Investigative Site - Carlton
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Recruitment hospital [4]
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Novartis Investigative Site - East Melbourne
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Recruitment postcode(s) [1]
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2217 - Kogarah
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Recruitment postcode(s) [2]
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4102 - Woolloongabba
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Recruitment postcode(s) [3]
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3053 - Carlton
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Recruitment postcode(s) [4]
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3002 - East Melbourne
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Recruitment outside Australia
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United States of America
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Alabama
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Spain
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State/province [102]
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Barcelona
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Country [103]
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0
Spain
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State/province [103]
0
0
Cataluña
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Country [104]
0
0
Spain
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State/province [104]
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0
Comunidad Valenciana
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Country [105]
0
0
Spain
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State/province [105]
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0
Madrid
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Country [106]
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0
Sweden
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State/province [106]
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0
Göteborg
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Country [107]
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0
Sweden
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State/province [107]
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0
Luleå
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Country [108]
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0
Sweden
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State/province [108]
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0
Malmo
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Country [109]
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Sweden
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State/province [109]
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Uppsala
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Country [110]
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0
United Kingdom
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State/province [110]
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0
Devon
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Country [111]
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0
United Kingdom
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State/province [111]
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0
Manchester
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Country [112]
0
0
United Kingdom
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State/province [112]
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0
Somerset
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Country [113]
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0
United Kingdom
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State/province [113]
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0
Dudley
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Country [114]
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0
United Kingdom
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State/province [114]
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0
Harrogate
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Country [115]
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0
United Kingdom
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State/province [115]
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0
London
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Country [116]
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0
United Kingdom
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State/province [116]
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0
Nuneaton
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novartis Pharmaceuticals
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study will assess the safety and efficacy of secukinumab compared to placebo and
etanercept in patients that have moderate to severe, chronic, plaque-type psoriasis.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01358578
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Novartis Pharmaceuticals
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Address
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Novartis Pharmaceuticals
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Country
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0
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Phone
0
0
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Fax
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Email
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Contact person for public queries
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0
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01358578
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