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

Plaque-type Psoriasis Clinical Trial

— STATURE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01412944
• Other study ID #: CAIN457A2307
• Secondary ID: 2011-002510-36
• Status: Completed
• Phase: Phase 3
• First received: August 5, 2011
• Last updated: March 17, 2015
• Start date: December 2011
• Est. completion date: April 2013

Study information

• Verified date: March 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationAustria: Agency for Health and Food SafetyBulgaria: Bulgarian Drug AgencyCanada: Health CanadaCzech Republic: State Institute for Drug ControlFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Paul-Ehrlich-InstitutIndia: Drugs Controller General of IndiaItaly: The Italian Medicines AgencyJapan: Ministry of Health, Labor and WelfarePeru: Ministry of HealthPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsSingapore: Health Sciences AuthoritySlovakia: State Institute for Drug ControlSwitzerland: SwissmedicTaiwan: Department of HealthUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyVietnam: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Plaque-type Psoriasis
• Psoriasis

Intervention

Drug:
• secukinumab 150mg
secukinumab 150mg (2 injections per dose)
• secukinumab 10mg/kg i.v. regimen
secukinumab 10mg/kg i.v. regimen

Locations

Country	Name	City	State
Austria	Novartis Investigative Site	Graz
Austria	Novartis Investigative Site	Vienna
Austria	Novartis Investigative Site	Wels
Canada	Novartis Investigative Site	Barrie	Ontario
Canada	Novartis Investigative Site	Montreal	Quebec
Canada	Novartis Investigative Site	Waterloo	Ontario
France	Novartis Investigative Site	Rouen
France	Novartis Investigative Site	Toulouse Cedex
Germany	Novartis Investigative Site	Essen
Germany	Novartis Investigative Site	Frankfurt
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Luebeck
Germany	Novartis Investigative Site	Mainz
India	Novartis Investigative Site	Mangalore	Karnataka
India	Novartis Investigative Site	Nagpur	Maharashtra
India	Novartis Investigative Site	Nashik	Maharashtra
Japan	Novartis Investigative Site	Hachioji-city	Tokyo
Japan	Novartis Investigative Site	Kisarazu	Chiba
Japan	Novartis Investigative Site	Minato-ku	Tokyo
Japan	Novartis Investigative Site	Shinjuku-ku	Tokyo
Slovakia	Novartis Investigative Site	Kosice	Slovak Republic
United States	Novartis Investigative Site	Boston	Massachusetts
United States	Novartis Investigative Site	Greensboro	North Carolina
United States	Novartis Investigative Site	Greer	South Carolina
United States	Novartis Investigative Site	Jacksonville	Florida
United States	Novartis Investigative Site	St. Louis	Missouri
United States	Novartis Investigative Site	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Austria,  Canada,  France,  Germany,  India,  Japan,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants (Who Achieved a Partial Response Defined as = 50% But < 75% Improvement in Psoriasis Area and Severity Index (PASI) After 12 Weeks of Treatment in Study AIN457A2304) With 75% Improvement From Baseline in PASI	PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).	Week 8	No
Primary	Percentage of Participants (Who Achieved a Partial Response Defined as = 50% But < 75% Improvement in PASI After 12 Weeks of Treatment in Study AIN457A2304) With Investigator's Global Assessment Model 2011 (IGA Mod 2011) 0 or 1 Response	The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. Treatment success was defined as achievement of IGA mod 2001 score of 0 or 1.	Week 8	No
Secondary	Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response	PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 and 100 were defined as participants achieving = 50%, 75%, 90% or 100% improvement from baseline. The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.	Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40	No
Secondary	Mean Percent Change From Baseline in PASI Scores	PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). A negative mean percentage change indicates improvement.	Baseline, weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40	No
Secondary	Percentage of Participants in Each IGA Mod 2011 Score Category	The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.	Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40	No
Secondary	Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) of 0 or 1	The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral warts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A DLQI of 0 or 1 indicates no impairment or little impairment, respectively. A negative mean percentage change from baseline indicates improvement.	Baseline, Week 8, Week 16, Week 24, Week 32,up to Week 40	No
Secondary	Mean Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Scores	The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative mean percentage change from baseline indicates improvement.	Baseline, weeks 8, 16, 24, 32 and 40	No
Secondary	Mean Percent Change From Baseline in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment (From 0 to 100)	The EQ-5D is an instrument used to assess a participant's health status. The instrument includes a descriptive profile and a visual analog scale (VAS). The descriptive profile includes 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension had 3 response levels: no problems, some problems and severe problems. The VAS is a vertical scale that assesses the health status from 0 (worst possible health state) to 100 (best possible health state). This outcome measures the percent change in VAS score. Positive mean percent changes indicate improvement.	Baseline, weeks 8, 16, 24, 32 and 40	No
Secondary	Number of Participants Who Developed Anti-secukinumab Antibodies	The development of anti-secunimubab anti-bodies would decrease a participant's ability to respond to secukinumab treatment.	Baseline, weeks 12, 24 and 40	No
Secondary	Relationship Between Response to AIN457 and Failed Response to Previous Biologic Psoriasis Therapy	This outcome measure was not analyzed due to the small sample size of the study (43 participants).	End of study	No