Efficacy and Safety of Intravenous and Subcutaneous Secukinumab in Moderate to Severe Chronic Plaque-type Psoriasis - Full Text View

Purpose

The study will assess the safety and efficacy of intravenous (10mg/kg) and subcutaneous (300mg) secukinumab in moderate to severe chronic plaque-type psoriasis who are partial responders to secukinumab.

Condition	Intervention	Phase
Plaque-type Psoriasis	Drug: secukinumab 150mg Drug: secukinumab 10mg/kg i.v. regimen	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, Double Dummy, Multicenter Study to Assess the Safety, Tolerability and Long-term Efficacy of Intravenous (10mg/kg) and Subcutaneous (300mg) Secukinumab in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Who Are Partial Responders to Secukinumab

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:

Efficacy of intravenous administration of secukinumab compared with subcutaneous administration secukinumab with respect to both PASI 75 and IGA 0 or 1 response. [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Efficacy of a higher dose of secukinumab than administered in CAIN457A2304 in achieving PASI 75 or IGA 0 or 1 response over time. [ Time Frame: Week 40 ] [ Designated as safety issue: No ]
Efficacy of secukinumab treatment regimens in subjects with respect to PASI 50/75/90/100 response and IGA 0 or 1 response overtime. [ Time Frame: Week 40 ] [ Designated as safety issue: No ]
Efficacy treatment regimens with secukinumab with respect to PASI score and IGA mod 2011 score over time. [ Time Frame: Week 40 ] [ Designated as safety issue: No ]
Safety and tolerability of secukinumab treatment regimens as assessed by vital signs, clinical laboratory variables, ECGs and adverse events monitoring. [ Time Frame: (Vital signs, Clinical lab variables and AE monitoring) randomization, Wk 2,Wk4,Wk8,Wk12, Wk16, Wk 20, Wk 24,Wk 28,Wk 28,Wk 32,Wk 36,Wk 40,Wk 44,Wk 48 and unscheduled visits. For ECGs, randomization, Wk 8, Wk 24, Wk 40, Wk 48 and unscheduled visits. ] [ Designated as safety issue: Yes ]
Effects of treatment regimens with secukinubab with respect to the dermatology life quality index (DLQI) 0 or 1 achievement. [ Time Frame: Randomization, Week 8, Week 16, Week 24, Week 32,up to Week 40 ] [ Designated as safety issue: No ]

Estimated Enrollment:	140
Study Start Date:	November 2011
Estimated Primary Completion Date:	July 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: secukinumab secukinumab 150 mg (2 injections per dose)	Drug: secukinumab 150mg secukinumab 150mg(2 injections per dose)
Experimental: secukinumab 10mg/kg i.v. regimen secukinumab 10mg/kg i.v. regimen	Drug: secukinumab 10mg/kg i.v. regimen secukinumab 10mg/kg i.v. regimen

Eligibility

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

Criteria

Inclusion criteria:

Written Informed Consent must be obtained before any assessment is performed,
Subject must be able to understand and communicate with the investigator and comply with the requirements of the study.
Subjects must have participated in the study CAIN457A2304 and have achieved a partial response after twelve weeks of treatment with no major protocol deviations.

A partial response is defined as having achieved ≥ PASI 50 but < 75 response.

Exclusion criteria

Pregnant women or lactating women
Forms of psoriasis other than chronic plaque -type
Ongoing use of prohibited psoriasis treatments
Ongoing use of other non-psoriasis prohibited treatments
Previous exposure to any biologic drug directly targeting IL-17 or the IL-17 receptor, except secukinumab in study CAIN457A2304
Active ongoing inflammation diseases other than psoriasis that might confound the evaluation of the benefits of secukinumab therapy
UV therapy or excessive exposure to sunlight

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01412944

Show 87 Study Locations

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceticals

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT01412944 History of Changes
Other Study ID Numbers:	CAIN457A2307, 2011-002510-36
Study First Received:	August 5, 2011
Last Updated:	January 15, 2013
Health Authority:	Austria: Agency for Health and Food Safety 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 Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Slovakia: State Institute for Drug Control Switzerland: Swissmedic Taiwan: Department of Health United Kingdom: Medicines and Healthcare Products Regulatory Agency United States: Food and Drug Administration

Keywords provided by Novartis:

Psoriasis
plaque
inflammatory skin disease
scaly patches

AIN457
secukinumab
Moderate to severe

Additional relevant MeSH terms:

Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on May 23, 2013

Efficacy and Safety of Intravenous and Subcutaneous Secukinumab in Moderate to Severe Chronic Plaque-type Psoriasis (STATURE)