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Efficacy and Safety of Subcutaneous Secukinumab for Moderate to Severe Chronic Plaque-type Psoriasis for up to 1 Year (ERASURE)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01365455
First received: June 1, 2011
Last updated: January 15, 2013
Last verified: January 2013
History of Changes
  Purpose

This study will assess the safety and efficacy of secukinumab compared to placebo in patients that have moderate to severe, chronic, plaque-type psoriasis.


Condition Intervention Phase
Moderate to Severe Plaque-type Psoriasis
 Drug: secukinumab 150 mg
Drug: placebo to secukinumab 150 mg
 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, Placebo Controlled, Multicenter Study of Subcutaneous Secukinumab to Demonstrate Efficacy After Twelve Weeks of Treatment, 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:

MedlinePlus related topics: Psoriasis
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Efficacy of secukinumab in subjects with moderate to severe chronic plaque-type psoriasis [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Measure: PASI and IGA


Secondary Outcome Measures:
  • Efficacy of secukinumab in subjects with moderate to severe chronic plaque-type psoriasis [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Measure: PASI and IGA

  • Clinical safety and tolerability of secukinumab [ Time Frame: 12 and 52 weeks ] [ Designated as safety issue: Yes ]
    Measure: vital signs, clinical laboratory variables, ECGs, adverse events

  • Quality of life assessments [ Time Frame: 12 and 52 weeks ] [ Designated as safety issue: No ]
    Measure: Patient reported outcome questionnaires


Estimated Enrollment: 720
Study Start Date: June 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: secukinumab 150 mg
secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose)
 Drug: secukinumab 150 mg
secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose)
Experimental: secukinumab 300 mg
secukinumab 150 mg (2 injections per dose)
 Drug: secukinumab 150 mg
secukinumab 150 mg (2 injections per dose)
Placebo Comparator: placebo
placebo to secukinumab 150 mg (2 injections per dose)
 Drug: placebo to secukinumab 150 mg
placebo to secukinumab 150 mg (2 injections per dose)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Moderate and severe plaque-type psoriasis diagnosed for at least 6 months.
  • Severity of psoriasis disease meeting all of the following three criteria:
  • Psoriasis Area and Severity Index (PASI) score of 12 or greater,
  • Investigator's Global Assessment (IGA) score of 3 or greater,
  • Total body surface area (BSA) affected of 10% or greater.
  • Inadequate control by prior use of topical treatment, phototherapy and/or systemic therapy.

Exclusion criteria:

  • Current forms of psoriasis other than chronic plaque-type psoriasis (for example, pustular, erythrodermic, guttate).
  • Current drug-induced psoriasis.
  • Previous use of secukinumab or any drug that targets IL-17 or IL-17 receptor.
  • Significant medical problems such as uncontrolled hypertension, congestive heart failure or a condition that significantly immunocompromises the subject.
  • Hematological abnormalities.
  • History of an ongoing, chronic or recurrent infectious disease, or evidence of untreated tuberculosis.
  • History of lymphoproliferative disease or history of malignancy of any organ system within the past 5 years.
  • Pregnant or nursing (lactating) women.
  • Subjects not willing to limit UV light exposure during the study Other protocol-defined inclusion/exclusion criteria may apply.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01365455

  Show 99 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: NCT01365455     History of Changes
Other Study ID Numbers: CAIN457A2302, 2010-023512-13
Study First Received: June 1, 2011
Last Updated: January 15, 2013
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Canada: Health Canada
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Estonia: The State Agency of Medicine
Iceland: Icelandic Medicines Control Agency
Israel: Ministry of Health
Japan: Ministry of Health, Labor and Welfare
Latvia: State Agency of Medicines
Lithuania: State Medicine Control Agency - Ministry of Health
Mexico: Federal Commission for Sanitary Risks Protection
Panama: Ministry of Health
Peru: Ministry of Health
Russia: Ministry of Health of the Russian Federation
Taiwan: Department of Health

Keywords provided by Novartis:
Psoriasis
plaque
plaque-type psoriasis
IL-17 blocker
subcutaneous
 psoriatic arthritis
injection
AIN457
AIN457A
secukinumab

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on May 16, 2013