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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01358578
First received: May 20, 2011
Last updated: November 18, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Chronic Plaque Psoriasis
Drug: Placebo etanercept and placebo secukinumab
Drug: 50 mg etanercept and placebo secukinumab
Drug: 150 mg secukinumab and placebo etanercept
Drug: 300 mg secukinumab and placebo etanercept
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Efficacy of secukinumab compared to placebo in subjects with moderate to severe chronic plaque-type psoriasis, Measure: PASI (psoriasis area and severity index) and IGA (investigator's global assessment) [ Time Frame: 12 wks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy of secukinumab compared to etanercept in subjects with moderate to severe chronic plaque-type psoriasis, Measure: Psoriasis area and severity index (PASI) and investigator's global assessment(IGA) [ Time Frame: 12 wks ] [ Designated as safety issue: No ]
  • Clinical safety and tolerability of secukinumab compared to etanercept and placebo, Measure: vital signs, laboratory values, electrocardiograms (ECG), adverse events [ Time Frame: 12 wks ] [ Designated as safety issue: Yes ]
  • Quality of life (QoL) changes Measure: patient reported outcome questionnaires [ Time Frame: 12 & 52 wks ] [ Designated as safety issue: No ]

Estimated Enrollment: 1264
Study Start Date: June 2011
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo etanercept and placebo secukinumab
Placebo
Active Comparator: 50 mg etanercept Drug: 50 mg etanercept and placebo secukinumab
50 mg etanercept and placebo secukinumab
Experimental: 150 mg secukinumab Drug: 150 mg secukinumab and placebo etanercept
150 mg secukinumab
Experimental: 300 mg secukinumab Drug: 300 mg secukinumab and placebo etanercept
300 mg secukinumab and placebo etanercept

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01358578

  Show 141 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01358578     History of Changes
Other Study ID Numbers: CAIN457A2303, 2010-022228-66
Study First Received: May 20, 2011
Last Updated: November 18, 2013
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Brazil: National Committee of Ethics in Research
Canada: Health Canada
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Egypt: Egyptian Ministry of Health (MOH), Egyptian Drug Authority (EDA)
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Guatemala: Ministry of Public Health and Social Assistance
Hungary: National Institute of Pharmacy
Iceland: Icelandic Medicines Control Agency
India: Drugs Controller General of India
Italy: The Italian Medicines Agency
Korea: Food and Drug Administration
Peru: Ministry of Health
Philippines : Food and Drug Administration
Poland: Ministry of Health
Romania: National Medicines Agency
Russia: Ministry of Health of the Russian Federation
Singapore: Health Sciences Authority
Spain: Ministry of Health
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration
Venezuela: Ministry of Health and Social Development

Keywords provided by Novartis:
Psoriasis
inflammatory skin disease
scaly patches

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
TNFR-Fc fusion protein
Antibodies, Monoclonal
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 28, 2014