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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01358578




Registration number
NCT01358578
Ethics application status
Date submitted
20/05/2011
Date registered
23/05/2011
Date last updated
9/04/2019

Titles & IDs
Public title
Safety and Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe, Chronic Plaque-Type Psoriasis
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
Secondary ID [1] 0 0
2010-022228-66
Secondary ID [2] 0 0
CAIN457A2303
Universal Trial Number (UTN)
Trial acronym
FIXTURE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Plaque Psoriasis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 75 (Psoriasis Area and Severity Index) . - 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
Timepoint [1] 0 0
12 wks
Primary outcome [2] 0 0
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 - 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.
Timepoint [2] 0 0
12 wks
Secondary outcome [1] 0 0
Efficacy of Secukinumab Compared to Etanercept and Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 90 at Week 12 - 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
Timepoint [1] 0 0
12 wks
Secondary outcome [2] 0 0
Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 75 at Week 12 - 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
Timepoint [2] 0 0
12 wks
Secondary outcome [3] 0 0
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 - 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.
Timepoint [3] 0 0
12 wks
Secondary outcome [4] 0 0
Maintenance of PASI 75 Response at Week 52 for Patients Who Were PASI 75 Responders at Week 12 (Non-responder Imputation)
Timepoint [4] 0 0
52 wks
Secondary outcome [5] 0 0
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
Timepoint [5] 0 0
52 wks
Secondary outcome [6] 0 0
Change in Score 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. 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
Timepoint [6] 0 0
baseline to week 12
Secondary outcome [7] 0 0
Change From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Etanercept - 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
Timepoint [7] 0 0
baseline to week 12
Secondary outcome [8] 0 0
Number of Participants Developing Anti-secukinumab Antibodies - 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)
Timepoint [8] 0 0
60 weeks

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)
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Kogarah
Recruitment hospital [2] 0 0
Novartis Investigative Site - Woolloongabba
Recruitment hospital [3] 0 0
Novartis Investigative Site - Carlton
Recruitment hospital [4] 0 0
Novartis Investigative Site - East Melbourne
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 0 0
3053 - Carlton
Recruitment postcode(s) [4] 0 0
3002 - East Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
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Arizona
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United States of America
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California
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Indiana
Country [5] 0 0
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State/province [5] 0 0
North Carolina
Country [6] 0 0
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Ohio
Country [7] 0 0
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Oregon
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Rhode Island
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South Carolina
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United States of America
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Tennessee
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Texas
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Virginia
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Argentina
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Buenos Aires
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Argentina
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Capital Federal
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Argentina
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Mendoza
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Belgium
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Brussel
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Belgium
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Bruxelles
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Belgium
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Gent
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Belgium
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Liège
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Alberta
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British Columbia
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Canada
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Nova Scotia
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Canada
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Ontario
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Canada
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Quebec
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Colombia
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Barranquilla
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Bogotá
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Marseille Cedex 9
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Martigues
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France
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CT
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MO
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Daejeon
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Gwangju
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Manila
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Lodz
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Poznan
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Wroclaw
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Romania
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Bucuresti
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Singapore
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Singapore
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Barcelona
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Cataluña
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Comunidad Valenciana
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Luleå
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Malmo
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Uppsala
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Devon
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Manchester
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Somerset
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Dudley
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Harrogate
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London
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United Kingdom
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Nuneaton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT01358578
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications