Clinical trial NCT01412944: Efficacy and Safety of Intravenous and Subcutaneous Secukinumab in Moderate to Severe Chronic Plaque-type Psoriasis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Plaque-type Psoriasis
Keywords: Psoriasis
plaque
inflammatory skin disease
scaly patches
AIN457
secukinumab
Moderate to severe
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-08-09
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: 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
timeFrame: Week 8
measure: 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
timeFrame: Week 8
Secondary outcomes:
measure: Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
timeFrame: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40
measure: Mean Percent Change From Baseline in PASI Scores
timeFrame: Baseline, weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40
measure: Percentage of Participants in Each IGA Mod 2011 Score Category
timeFrame: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40
measure: Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) of 0 or 1
timeFrame: Baseline, Week 8, Week 16, Week 24, Week 32,up to Week 40
measure: Mean Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Scores
timeFrame: Baseline, weeks 8, 16, 24, 32 and 40
measure: Mean Percent Change From Baseline in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment (From 0 to 100)
timeFrame: Baseline, weeks 8, 16, 24, 32 and 40
measure: Number of Participants Who Developed Anti-secukinumab Antibodies
timeFrame: Baseline, weeks 12, 24 and 40
measure: Relationship Between Response to AIN457 and Failed Response to Previous Biologic Psoriasis Therapy
timeFrame: End of study
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Novartis Investigative Site
state: Florida
city: West Palm Beach
country: United States
facility: Novartis Investigative Site
state: Florida
city: Boston
country: United States
facility: Novartis Investigative Site
state: Massachusetts
city: St. Louis
country: United States
facility: Novartis Investigative Site
state: Missouri
city: Greensboro
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Greer
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Graz
country: Austria
facility: Novartis Investigative Site
city: Vienna
country: Austria
facility: Novartis Investigative Site
city: Wels
country: Austria
facility: Novartis Investigative Site
city: Barrie
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Waterloo
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Rouen
country: France
facility: Novartis Investigative Site
city: Toulouse Cedex
country: France
facility: Novartis Investigative Site
city: Essen
country: Germany
facility: Novartis Investigative Site
city: Frankfurt
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Luebeck
country: Germany
facility: Novartis Investigative Site
city: Mainz
country: Germany
facility: Novartis Investigative Site
city: Mangalore
country: India
facility: Novartis Investigative Site
state: Karnataka
city: Nagpur
country: India
facility: Novartis Investigative Site
state: Maharashtra
city: Nashik
country: India
facility: Novartis Investigative Site
state: Maharashtra
city: Kisarazu
country: Japan
facility: Novartis Investigative Site
state: Chiba
city: Hachioji-city
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Minato-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Kosice
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: