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Trial record 10 of 78 for:    psoriasis novartis

Safety and Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe, Chronic Plaque-Type Psoriasis (FIXTURE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01358578
Recruitment Status : Completed
First Posted : May 23, 2011
Results First Posted : September 23, 2015
Last Update Posted : April 9, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE May 20, 2011
First Posted Date  ICMJE May 23, 2011
Results First Submitted Date  ICMJE February 16, 2015
Results First Posted Date  ICMJE September 23, 2015
Last Update Posted Date April 9, 2019
Study Start Date  ICMJE June 2011
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 20, 2015)
  • Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 75 (Psoriasis Area and Severity Index) . [ Time Frame: 12 wks ]
    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
  • 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 [ Time Frame: 12 wks ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 20, 2011)
Efficacy of secukinumab compared to placebo in subjects with moderate to severe chronic plaque-type psoriasis Measure: PASI and IGA [ Time Frame: 12 wks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 20, 2015)
  • Efficacy of Secukinumab Compared to Etanercept and Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 90 at Week 12 [ Time Frame: 12 wks ]
    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
  • Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 75 at Week 12 [ Time Frame: 12 wks ]
    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
  • 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 [ Time Frame: 12 wks ]
    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.
  • Maintenance of PASI 75 Response at Week 52 for Patients Who Were PASI 75 Responders at Week 12 (Non-responder Imputation) [ Time Frame: 52 wks ]
  • 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 [ Time Frame: 52 wks ]
  • Change in Score From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Placebo [ Time Frame: baseline to week 12 ]
    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
  • Change From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Etanercept [ Time Frame: baseline to week 12 ]
    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
  • Number of Participants Developing Anti-secukinumab Antibodies [ Time Frame: 60 weeks ]
    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)
Original Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2011)
  • Efficacy of secukinumab compared to etanercept in subjects with moderate to severe chronic plaque-type psoriasis Measure: PASI and IGA [ Time Frame: 12 wks ]
  • Clinical safety and tolerability of secukinumab compared to etanercept and placebo Measure: vital signs, laboratory values, ECGs, adverse events [ Time Frame: 12 wks ]
  • Quality of life changes Measure: patient reported outcome questionnaires [ Time Frame: 12 & 52 wks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe, Chronic Plaque-Type Psoriasis
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Plaque Psoriasis
Intervention  ICMJE
  • Drug: Placebo
    Placebo to Match secukinumab (AIN457) 150mg or 300mg or Placebo to match etanercept
  • Drug: secukinumab (AIN457)
    secukinumab (AIN457) 150mg or 300mg subcutaneous
  • Drug: etanercept
    etanercept 50mg subcutaneous
Study Arms  ICMJE
  • Experimental: AIN457 150mg
    AIN457 150mg
    Interventions:
    • Drug: Placebo
    • Drug: secukinumab (AIN457)
  • Experimental: AIN457 300mg
    AIN457 300mg
    Interventions:
    • Drug: Placebo
    • Drug: secukinumab (AIN457)
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
  • Active Comparator: Etanercept
    Etanercept
    Interventions:
    • Drug: Placebo
    • Drug: etanercept
  • Experimental: AIN457 150mg from Placebo
    Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase
    Interventions:
    • Drug: Placebo
    • Drug: secukinumab (AIN457)
  • Experimental: AIN457 300mg from Placebo
    Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase
    Interventions:
    • Drug: Placebo
    • Drug: secukinumab (AIN457)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 20, 2015)
1306
Original Estimated Enrollment  ICMJE
 (submitted: May 20, 2011)
1264
Actual Study Completion Date  ICMJE July 2013
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Belgium,   Canada,   Colombia,   Egypt,   Finland,   France,   Germany,   Guatemala,   Hungary,   Iceland,   India,   Italy,   Korea, Republic of,   Philippines,   Poland,   Romania,   Singapore,   Spain,   Sweden,   United Kingdom,   United States
Removed Location Countries Russian Federation,   Turkey
 
Administrative Information
NCT Number  ICMJE NCT01358578
Other Study ID Numbers  ICMJE CAIN457A2303
2010-022228-66
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP