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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01412944
First received: August 5, 2011
Last updated: March 17, 2015
Last verified: March 2015

August 5, 2011
March 17, 2015
December 2011
April 2013   (final data collection date for primary outcome 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 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    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).
  • 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 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    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.
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 ]
Complete list of historical versions of study NCT01412944 on ClinicalTrials.gov Archive Site
  • Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response [ Time Frame: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40 ] [ Designated as safety issue: No ]
    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.
  • Mean Percent Change From Baseline in PASI Scores [ Time Frame: Baseline, weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40 ] [ Designated as safety issue: No ]
    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.
  • Percentage of Participants in Each IGA Mod 2011 Score Category [ Time Frame: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40 ] [ Designated as safety issue: No ]
    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.
  • Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) of 0 or 1 [ Time Frame: Baseline, Week 8, Week 16, Week 24, Week 32,up to Week 40 ] [ Designated as safety issue: No ]
    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.
  • Mean Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Scores [ Time Frame: Baseline, weeks 8, 16, 24, 32 and 40 ] [ Designated as safety issue: No ]
    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.
  • Mean Percent Change From Baseline in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment (From 0 to 100) [ Time Frame: Baseline, weeks 8, 16, 24, 32 and 40 ] [ Designated as safety issue: No ]
    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.
  • Number of Participants Who Developed Anti-secukinumab Antibodies [ Time Frame: Baseline, weeks 12, 24 and 40 ] [ Designated as safety issue: No ]
    The development of anti-secunimubab anti-bodies would decrease a participant's ability to respond to secukinumab treatment.
  • Relationship Between Response to AIN457 and Failed Response to Previous Biologic Psoriasis Therapy [ Time Frame: End of study ] [ Designated as safety issue: No ]
    This outcome measure was not analyzed due to the small sample size of the study (43 participants).
  • 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 ]
Not Provided
Not Provided
 
Efficacy and Safety of Intravenous and Subcutaneous Secukinumab in Moderate to Severe Chronic Plaque-type Psoriasis
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Plaque-type Psoriasis
  • Drug: secukinumab 150mg
    secukinumab 150mg (2 injections per dose)
  • Drug: secukinumab 10mg/kg i.v. regimen
    secukinumab 10mg/kg i.v. regimen
  • Experimental: AIN457 subcutaneous (s.c.)
    During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
    Intervention: Drug: secukinumab 150mg
  • Experimental: AIN457 I.V.
    During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
    Intervention: Drug: secukinumab 10mg/kg i.v. regimen
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
43
April 2013
April 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Austria,   Canada,   France,   Germany,   India,   Japan,   Slovakia
Bulgaria,   Czech Republic,   Italy,   Poland,   Switzerland,   Taiwan,   Vietnam
 
NCT01412944
CAIN457A2307, 2011-002510-36
Not Provided
Not Provided
Not Provided
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP