We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : January 5, 2021
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Chronic Plaque Psoriasis Drug: Placebo Drug: secukinumab (AIN457) Drug: etanercept Phase 3

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1306 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : June 2011
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: AIN457 150mg
AIN457 150mg
 Drug: Placebo
Placebo to Match secukinumab (AIN457) 150mg or 300mg or Placebo to match etanercept

Drug: secukinumab (AIN457)
secukinumab (AIN457) 150mg or 300mg subcutaneous
Experimental: AIN457 300mg
AIN457 300mg
 Drug: Placebo
Placebo to Match secukinumab (AIN457) 150mg or 300mg or Placebo to match etanercept

Drug: secukinumab (AIN457)
secukinumab (AIN457) 150mg or 300mg subcutaneous
Placebo Comparator: Placebo
Placebo
 Drug: Placebo
Placebo to Match secukinumab (AIN457) 150mg or 300mg or Placebo to match etanercept
Active Comparator: Etanercept
Etanercept
 Drug: Placebo
Placebo to Match secukinumab (AIN457) 150mg or 300mg or Placebo to match etanercept

Drug: etanercept
etanercept 50mg subcutaneous
Experimental: AIN457 150mg from Placebo
Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase
 Drug: Placebo
Placebo to Match secukinumab (AIN457) 150mg or 300mg or Placebo to match etanercept

Drug: secukinumab (AIN457)
secukinumab (AIN457) 150mg or 300mg subcutaneous
Experimental: AIN457 300mg from Placebo
Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase
 Drug: Placebo
Placebo to Match secukinumab (AIN457) 150mg or 300mg or Placebo to match etanercept

Drug: secukinumab (AIN457)
secukinumab (AIN457) 150mg or 300mg subcutaneous


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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

  2. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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.

  4. 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 ]
  5. 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 ]
  6. 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

  7. 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

  8. 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)


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01358578


Locations
Show Show 152 study locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Layout table for investigator information
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01358578    
Other Study ID Numbers: CAIN457A2303
2010-022228-66
First Posted: May 23, 2011    Key Record Dates
Results First Posted: September 23, 2015
Last Update Posted: January 5, 2021
Last Verified: March 2019
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Psoriasis,
inflammatory skin disease,
scaly patches
Psoriasis
inflammatory skin disease
Additional relevant MeSH terms:
Layout table for MeSH terms
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Etanercept
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors