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

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	Biological: secukinumab 150 mg Drug: If disease relapses patient is treated with secukinumab 150 mg. If disease does not relapse patient is treated with placebo Biological: secukinumab 300 mg Biological: If disease relapses patient is treated with secukinumab 300 mg. If disease does not relapse patient is treated with placebo.	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:

MedlinePlus related topics: Psoriasis Skin Conditions

U.S. FDA Resources

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 ]

Estimated Enrollment:	967
Study Start Date:	August 2011
Estimated Primary Completion Date:	May 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: secukinumab 150 mg (fixed interval treatment) secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose)	Biological: secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg
Experimental: secukinumab 150 mg (personalized therapy: active treatment given only if disease relapses)	Drug: If disease relapses patient is treated with secukinumab 150 mg. If disease does not relapse patient is treated with placebo (personalized therapy: active treatment given only if disease relapses)
Experimental: secukinumab 300 mg	Biological: 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)	Biological: If disease relapses patient is treated with secukinumab 300 mg. If disease does not relapse patient is treated with placebo. If disease relapses patient is treated with secukinumab 300 mg

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.

Contacts and Locations

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

Show 69 Study Locations

Sponsors and Collaborators

Novartis

More Information

No publications provided

Responsible Party:	Novartis
ClinicalTrials.gov Identifier:	NCT01406938 History of Changes
Other Study ID Numbers:	CAIN457A2304, 2011-000767-27
Study First Received:	July 12, 2011
Last Updated:	August 29, 2012
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

ClinicalTrials.gov processed this record on May 19, 2013

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