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
  Purpose

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.


Condition Intervention Phase
Moderate to Severe Plaque-type Psoriasis
Drug: secukinumab 150 mg
Drug: secukinumab 150 mg active or placebo depending on response
Drug: secukinumab 300 mg
Drug: secukinumab 300 mg active or placebo depending on response
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, 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 967
Study Start Date: August 2011
Study Completion Date: May 2013
Primary Completion Date: May 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
(1 injection per dose) and placebo to secukinumab 150 mg
Experimental: secukinumab 150 mg if disease relapses
(personalized therapy: active treatment given only if disease relapses)
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.
Experimental: secukinumab 300 mg
secukinumab- 2 x 150mg injections per dose
Drug: secukinumab 300 mg
secukinumab 150 mg (2 injections per dose)
Experimental: secukinumab 300 mg if disease relapses
(personalized therapy: active treatment given only if disease relapses)
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.

  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 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01406938

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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: NCT01406938     History of Changes
Other Study ID Numbers: CAIN457A2304, 2011-000767-27
Study First Received: July 12, 2011
Last Updated: June 26, 2014
Health Authority: United States: Food and Drug Administration
Austria: Federal Ministry for Health and Women
Bulgaria: Bulgarian Drug Agency
Canada: Health Canada
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Paul-Ehrlich-Institut
India: Drugs Controller General of India
Italy: The Italian Medicines Agency
Japan: Ministry of Health, Labor and Welfare
Peru: Instituto Nacional de Salud
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Singapore: Health Sciences Authority
Slovakia: State Institute for Drug Control
Switzerland: Swissmedic
Taiwan: Department of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Vietnam: Ministry of Health

Keywords provided by Novartis:
Psoriasis
plaque
inflammatory skin disease
scaly patches
AIN457
secukinumab
Moderate to Severe Plaque-type Psoriasis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 09, 2014