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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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) .
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
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
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
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
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
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
Timepoint [7] 0 0
baseline to week 12
Secondary outcome [8] 0 0
Number of Participants Developing Anti-secukinumab Antibodies
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
Sex
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
1/06/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2013
Sample size
Target
Accrual to date
Final
1306
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
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United States of America
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Alabama
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Arizona
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California
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North Carolina
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Ohio
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Oregon
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Rhode Island
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South Carolina
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Tennessee
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Texas
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Virginia
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Buenos Aires
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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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Liège
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British Columbia
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Nova Scotia
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Ontario
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Quebec
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Barranquilla
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Bogotá
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Devon
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Dudley
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Harrogate
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London
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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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01358578