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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01365455
First received: June 1, 2011
Last updated: October 22, 2014
Last verified: October 2014

June 1, 2011
October 22, 2014
June 2011
April 2013   (final data collection date for primary outcome measure)
  • Number of patients who achieve >75 or higher (Psoriasis Area and Severity Index) PASI score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Measure: PASI score
  • Number of patients who achieve (Investigator's Global Assessment) IGA scor of 0 or 1 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Number of patients who achieve (Investigator's Global Assessment) IGA scor of 0 or 1 as an indicator of efficacy of efficacy of secukinumab in subjects with moderate to severe chronic plaque-type psoriasis
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
Complete list of historical versions of study NCT01365455 on ClinicalTrials.gov Archive Site
  • Number of patients who achieve >75 or higher. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Number of patients who achieve >75 or higher (Psoriasis Area and Severity Index) PASI score to measure efficacy of secukinumab in subjects with moderate to severe chronic plaque-type psoriasis
  • 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
  • Number of patients with a IGA score of 0 or 1 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Number of patients who achieve (Investigator's Global Assessment) IGA scor of 0 or 1 as an indicator of efficacy of efficacy of secukinumab in subjects with moderate to severe chronic plaque-type psoriasis
  • 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
Not Provided
Not Provided
 
Efficacy and Safety of Subcutaneous Secukinumab for Moderate to Severe Chronic Plaque-type Psoriasis for up to 1 Year
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

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Moderate to Severe Plaque-type Psoriasis
  • Drug: secukinumab 150 mg
    secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose); secukinumab 150 mg (2 injection per does)
  • Drug: placebo to secukinumab 150 mg
    placebo to secukinumab 150 mg (2 injections per dose)
  • Experimental: secukinumab 150 mg
    secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose)
    Intervention: Drug: secukinumab 150 mg
  • Experimental: secukinumab 300 mg
    secukinumab 150 mg (2 injections per dose)
    Intervention: Drug: secukinumab 150 mg
  • Placebo Comparator: placebo
    placebo to secukinumab 150 mg (2 injections per dose)
    Intervention: Drug: placebo to secukinumab 150 mg
Langley RG, Elewski BE, Lebwohl M, Reich K, Griffiths CE, Papp K, Puig L, Nakagawa H, Spelman L, Sigurgeirsson B, Rivas E, Tsai TF, Wasel N, Tyring S, Salko T, Hampele I, Notter M, Karpov A, Helou S, Papavassilis C; ERASURE Study Group; FIXTURE Study Group. Secukinumab in plaque psoriasis--results of two phase 3 trials. N Engl J Med. 2014 Jul 24;371(4):326-38. doi: 10.1056/NEJMoa1314258. Epub 2014 Jul 9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
739
April 2013
April 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Taiwan,   Argentina,   Canada,   Colombia,   Estonia,   Iceland,   Israel,   Japan,   Latvia,   Lithuania,   Mexico
 
NCT01365455
CAIN457A2302, 2010-023512-13
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Study Director: Novartis Pharmceuticals Novartis Pharmaceuticals
Novartis
October 2014

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