Efficacy and Safety of Subcutaneous Secukinumab (AIN457) for Moderate to Severe Chronic Plaque-type Psoriasis Assessing Different Doses and Dose Regimens (SCULPTURE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01406938
First received: July 12, 2011
Last updated: June 26, 2014
Last verified: June 2014

July 12, 2011
June 26, 2014
August 2011
May 2013   (final data collection date for primary outcome measure)
Proportion of subjects who maintain Psoriasis Area and Severity Index 75 (PASI 75) response relative to baseline after having achieved PASI 75 response after 12 weeks of treatment with secukinumab [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01406938 on ClinicalTrials.gov Archive Site
Proportion of subjects who achieve PASI 50/75/90/100 response or Investigator's Global Assessment (IGA) 0 or 1 response relative to baseline after 12 weeks and after 52 weeks of treatment with secukinumab [ Time Frame: 12 and 52 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of Subcutaneous Secukinumab (AIN457) for Moderate to Severe Chronic Plaque-type Psoriasis Assessing Different Doses and Dose Regimens
A Randomized, Double-blind, Multicenter Study of Subcutaneous Secukinumab, Assessing Psoriasis Area and Severity Index (PASI) Response and Maintenance of Response in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis on Either a Fixed Dose Regimen or on a Retreatment at Start of Relapse Regimen

This study will assess the safety and efficacy of two different doses and two different dose regimens of subcutaneous secukinumab 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
    (1 injection per dose) and placebo to secukinumab 150 mg
  • Drug: secukinumab 150 mg active or placebo depending on response
    (personalized therapy: active treatment given only if disease relapses)
    Other Name: If disease relapses patient is treated with secukinumab 150 mg. If disease does not relapse patient is treated with placebo.
  • Drug: secukinumab 300 mg
    secukinumab 150 mg (2 injections per dose)
  • Drug: secukinumab 300 mg active or placebo depending on response
    If disease relapses patient is treated with secukinumab 300 mg
    Other Name: If disease relapses patient is treated with secukinumab 300 mg. If disease does not relapse patient is treated with placebo.
  • 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 150 mg if disease relapses
    (personalized therapy: active treatment given only if disease relapses)
    Intervention: Drug: secukinumab 150 mg active or placebo depending on response
  • Experimental: secukinumab 300 mg
    secukinumab- 2 x 150mg injections per dose
    Intervention: Drug: secukinumab 300 mg
  • Experimental: secukinumab 300 mg if disease relapses
    (personalized therapy: active treatment given only if disease relapses)
    Intervention: Drug: secukinumab 300 mg active or placebo depending on response
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
967
May 2013
May 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 disease meeting all of the following three criteria:

  • 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.
  • 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,   Austria,   Bulgaria,   Canada,   Czech Republic,   France,   Germany,   India,   Italy,   Japan,   Poland,   Singapore,   Slovakia,   Switzerland,   United Kingdom,   Vietnam
 
NCT01406938
CAIN457A2304, 2011-000767-27
Yes
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
June 2014

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