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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01358578
First received: May 20, 2011
Last updated: March 6, 2013
Last verified: March 2013
History of Changes
  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:

Drug Information available for: Etanercept
U.S. FDA Resources

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
Estimated Primary Completion Date: April 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
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

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: March 6, 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
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 June 17, 2013