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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01406938
First received: July 12, 2011
Last updated: January 5, 2015
Last verified: January 2015
  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
Drug: AIN457 150mg
Drug: AIN457 300mg
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:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • For the fixed interval group, the percentage of Participants (who responded to treatment at week 12) maintaining a 75% Improvement from Baseline in Psoriasis Area and Severity Index (PASI) Score at week 52 [ Time Frame: Week 40 , week 52 ] [ Designated as safety issue: No ]
    PASI: 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)

  • For the start of relapse (SoR) group, % of Participants maintaining a 75% Improvement from baseline in Psoriasis Area and Severity Index (PASI) Score at week 52 and week 40 when treatment was restarted [ Time Frame: Week 40 , week 52 ] [ Designated as safety issue: No ]
    PASI: 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)


Secondary Outcome Measures:
  • Percentage of Participants achieving a 50%, 75%, 90% or 100% Improvement from baseline in (PASI ) Score and an Investigator's Global Assessment modified 2011 (IGA) 2011 score of 0 or 1 at week 2, 4, 6, 8, 12,16, 20, 24,28,32,36,40,44,48,and Week 52 [ Time Frame: Baseline, week 2, , 4, 6, 8, 12 ,16,20,24,28,32,36,40,44,48,and Week 52 ] [ Designated as safety issue: No ]
    PASI: 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:01, arms:0.2 body:0.3 legs:0.4)

  • Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) score and IGA mod 2011 0 or 1 score over time at week 12 and 52 [ Time Frame: Baseline, week 2, 4, 6, 8, 12 ,16,20,24,28,32,36,40,44,48, and Week 52 ] [ Designated as safety issue: No ]
    The IGA mod 2011 is a static scale, i.e., it refers exclusively to the participant's disease state at the time of the assessments and does not attempt a comparison to any of the participant's previous disease states at prior visits. The score ranges from 0 (clear) to 4 (severe. The score 0 is clear, 1 is almost clear, 2 is mild, 3 is moderate, and 4 is severe

  • Change from baseline in EQ-5D at each visit, up to week 52. [ Time Frame: Baseline to week 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and Week 52. ] [ Designated as safety issue: No ]
    ED-5Q: Participant rated questionnaire to assess health related quality of life in terms of a single utility score. Five domains are assessed mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each with three possible score: 1 indicates no problems, better state of health; 3 indicates worst state of health (example "confined to bed") A visual analog scale (VAS) assesses the health status from 0 (worst possible health state) to 100 (best possible health state)

  • Change from Baseline in Dermatology Life Quality Index (DLQI) score. up to week 52 [ Time Frame: Baseline to week 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and Week 52. ] [ Designated as safety issue: No ]
    The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions

  • % of participants achieving a DLQI score of 0 or 1 at each visit up to week 52. [ Time Frame: Baseline to week 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and Week 52 ] [ Designated as safety issue: No ]
    The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions

  • Median Time to relapse (weeks) from Week 12. [ Time Frame: Week 12 to week 16, 20, 24, 28, 32, 36, 40, 44, 48, and Week 52. ] [ Designated as safety issue: No ]
    Median time to relapse (weeks) from week 12. Relapse is defined as greater than 50% loss of the maximal PASI improvement from baseline

  • Percent of Responders with PASI equal to or greater than 50, PASI 75, PASI 90, PASI 100 and Percent of responders with IGA score of 0 or 1 who failed to respond to a previous biologic psoriasis therapy [ Time Frame: Week 12, week 52 ] [ Designated as safety issue: No ]
    Response variables PASI 50, PASI 75, PASI 90, PASI 100 and IGA mod 2011 0 or 1 response by visit were tabulated versus previous psoriasis systemic therapy and response to previous biologic systemic therapy, by treatment group. (This is covered by subgroup analyses)

  • Number of visits with PASI 50, 75, 90, 100 score and IGA mod 2011 0 or 1 [ Time Frame: Week 16, 20, 24,28,32,36,40,44,48,and Week 52 ] [ Designated as safety issue: No ]
    Number of visits with participants achieving a PASI 50, PASI 75, PASI 90, PASI 100 and IGA mod 2011 0 or 1 response

  • Number of secukinumab injections needed to regain PASI 75 response from start of relapse after week 12 [ Time Frame: week 16, 20, 24,28,32,36,40,44,48,and Week 52 ] [ Designated as safety issue: No ]
    The number of secukinumab injections needed for participants to regain PASI 75 response from the start of relapse after week 12

  • Number of participants developing anti-secukinumab antibodies [ Time Frame: Baseline, weeks 12, 24, 52 and 60 ] [ Designated as safety issue: No ]
    The development of anti-secunimubab anti-bodies will decrease a participant's ability to respond to secukinumab treatment. The number of participants developing anti-secukinumab anti-bodies was measured from Baseline to week 12, 24, 52 and 8 weeks after treatment at week 60


Enrollment: 967
Study Start Date: August 2011
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AIN457150 mg- Induction period Only(IPO)
secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
Drug: AIN457 150mg
(1 injection per dose) and placebo to secukinumab 150 mg
Other Name: secukinumab 150 mg
Experimental: AIN457 300 mg - IPO
secukinumab- 2 x 150mg injections per dose
Drug: AIN457 300mg
secukinumab 150 mg (2 injections per dose)
Other Name: secukinumab
Experimental: AIN457 150 mg - Fixed Interval (FI)
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
Drug: AIN457 150mg
(1 injection per dose) and placebo to secukinumab 150 mg
Other Name: secukinumab 150 mg
Experimental: AIN457 300 mg FI
2 s.c. secukinumab 150 mg injections
Drug: AIN457 300mg
secukinumab 150 mg (2 injections per dose)
Other Name: secukinumab
Experimental: AIN457 150 mg- Start of relapse (SoR)
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
Drug: AIN457 150mg
(1 injection per dose) and placebo to secukinumab 150 mg
Other Name: secukinumab 150 mg
Experimental: AIN457 300 mg- SoR
2 s.c. secukinumab 150 mg injections
Drug: AIN457 300mg
secukinumab 150 mg (2 injections per dose)
Other Name: secukinumab

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
Locations
United States, California
Novartis Investigative Site
Fresno, California, United States, 93710
Novartis Investigative Site
Pasadena, California, United States, 91105
Novartis Investigative Site
Sacramento, California, United States, 95817
Novartis Investigative Site
San Francisco, California, United States, 94118
United States, Florida
Novartis Investigative Site
Jacksonville, Florida, United States, 32204
Novartis Investigative Site
Jacksonville, Florida, United States, 32216
Novartis Investigative Site
Miami, Florida, United States, 33136
Novartis Investigative Site
Naples, Florida, United States, 34119
Novartis Investigative Site
South Miami, Florida, United States, 33143
Novartis Investigative Site
West Palm Beach, Florida, United States, 33409
United States, Georgia
Novartis Investigative Site
Atlanta, Georgia, United States, 30342
United States, Illinois
Novartis Investigative Site
Champaign, Illinois, United States, 61820
Novartis Investigative Site
Skokie, Illinois, United States, 60077
Novartis Investigative Site
Springfield, Illinois, United States, 62703
United States, Indiana
Novartis Investigative Site
Indianapolis, Indiana, United States, 46256
United States, Kansas
Novartis Investigative Site
Overland Park, Kansas, United States, 66215
United States, Kentucky
Novartis Investigative Site
Owensboro, Kentucky, United States, 42301
United States, Massachusetts
Novartis Investigative Site
Boston, Massachusetts, United States, 02111
United States, Minnesota
Novartis Investigative Site
Fridley, Minnesota, United States, 55432
United States, Missouri
Novartis Investigative Site
St. Louis, Missouri, United States, 63117
United States, Nevada
Novartis Investigative Site
Henderson, Nevada, United States, 89052
Novartis Investigative Site
Las Vegas, Nevada, United States, 89119
United States, New Jersey
Novartis Investigative Site
Verona, New Jersey, United States, 07044
United States, North Carolina
Novartis Investigative Site
Greensboro, North Carolina, United States, 27401
Novartis Investigative Site
High Point, North Carolina, United States, 27262
Novartis Investigative Site
Winston-Salem, North Carolina, United States, 27103
United States, South Carolina
Novartis Investigative Site
Anderson, South Carolina, United States, 29621
Novartis Investigative Site
Greer, South Carolina, United States, 29651
United States, Tennessee
Novartis Investigative Site
Goodlettsville, Tennessee, United States, 37072-2301
United States, Texas
Novartis Investigative Site
Dallas, Texas, United States, 75231
Novartis Investigative Site
Dallas, Texas, United States, 75230
Novartis Investigative Site
San Antonio, Texas, United States, 78229
United States, Utah
Novartis Investigative Site
Salt Lake City, Utah, United States, 84124
Austria
Novartis Investigative Site
Graz, Austria, A-8036
Novartis Investigative Site
Linz, Austria, A-4010
Novartis Investigative Site
Vienna, Austria, A-1220
Novartis Investigative Site
Wels, Austria, 4600
Bulgaria
Novartis Investigative Site
Pleven, Bulgaria, 5800
Novartis Investigative Site
Sofia, Bulgaria, 1606
Novartis Investigative Site
Sofia, Bulgaria, 1431
Novartis Investigative Site
Sofia, Bulgaria, 1404
Novartis Investigative Site
Sofia, Bulgaria, 1231
Novartis Investigative Site
Varna, Bulgaria, 9010
Canada, Ontario
Novartis Investigative Site
Barrie, Ontario, Canada, L4M 6L2
Novartis Investigative Site
Oakville, Ontario, Canada, L6J 7W5
Novartis Investigative Site
Waterloo, Ontario, Canada, N2J 1C4
Novartis Investigative Site
Windsor, Ontario, Canada, N8W 1E6
Canada, Quebec
Novartis Investigative Site
Montreal, Quebec, Canada, H2K 4L5
Czech Republic
Novartis Investigative Site
Hradec Kralove, CZE, Czech Republic, 500 05
Novartis Investigative Site
Prague 8, CZE, Czech Republic, 180 81
Novartis Investigative Site
Brno - Bohunice, Czech Republic, 625 00
Novartis Investigative Site
Ceske Budejovice, Czech Republic, 370 01
Novartis Investigative Site
Novy Jicin, Czech Republic, 741 01
Novartis Investigative Site
Prague 10, Czech Republic, 100 34
France
Novartis Investigative Site
Antony, France, 92160
Novartis Investigative Site
Nice Cedex 3, France, 06202
Novartis Investigative Site
Pierre-Benite Cédex, France, F-69495
Novartis Investigative Site
Rouen, France, 76031
Novartis Investigative Site
Toulouse Cedex, France, 31059
Germany
Novartis Investigative Site
Bad Wildbad, Germany, 75323
Novartis Investigative Site
Bochum, Germany, 44803
Novartis Investigative Site
Buchholz i. d. Nordheide, Germany, 21244
Novartis Investigative Site
Dippoldiswalde-Schmiedeberg, Germany, 01744
Novartis Investigative Site
Duisburg, Germany, 47167
Novartis Investigative Site
Düsseldorf, Germany, 40225
Novartis Investigative Site
Essen, Germany, 45147
Novartis Investigative Site
Frankfurt, Germany, 60590
Novartis Investigative Site
Freiburg, Germany, 79104
Novartis Investigative Site
Hamburg, Germany, 22391
Novartis Investigative Site
Hamburg, Germany, 22143
Novartis Investigative Site
Hamburg, Germany, 20246
Novartis Investigative Site
Hannover, Germany, 30625
Novartis Investigative Site
Kiel, Germany, 24105
Novartis Investigative Site
Köln, Germany, 50937
Novartis Investigative Site
Luebeck, Germany, 23538
Novartis Investigative Site
Mahlow, Germany, 15831
Novartis Investigative Site
Mainz, Germany, 55131
Novartis Investigative Site
Mannheim, Germany, 68167
Novartis Investigative Site
Muenster, Germany, 48149
Novartis Investigative Site
Pommelsbrunn, Germany, 91224
Novartis Investigative Site
Wuppertal, Germany, 42103
India
Novartis Investigative Site
Hyderabad, Andhra Pradesh, India, 500 058
Novartis Investigative Site
Secunderabad, Andhra Pradesh, India, 500 094
Novartis Investigative Site
Bangalore, Karnataka, India, 560054
Novartis Investigative Site
Mangalore, Karnataka, India, 575 004
Novartis Investigative Site
Mumbai, Maharashtra, India, 400 008
Novartis Investigative Site
Nagpur, Maharashtra, India
Novartis Investigative Site
Nagpur, Maharashtra, India, 440 010
Novartis Investigative Site
Nagpur, Maharashtra, India, 440013
Novartis Investigative Site
Nashik, Maharashtra, India
Italy
Novartis Investigative Site
Roma, RM, Italy, 00144
Novartis Investigative Site
Roma, RM, Italy, 00133
Novartis Investigative Site
Siena, SI, Italy, 53100
Novartis Investigative Site
Verona, VR, Italy, 37126
Japan
Novartis Investigative Site
Nagoya-city, Aichi, Japan, 467-8602
Novartis Investigative Site
Kisarazu, Chiba, Japan, 292-8535
Novartis Investigative Site
Fukuoka-city, Fukuoka, Japan, 815-8588
Novartis Investigative Site
Kitakyushu-city, Fukuoka, Japan, 800-0296
Novartis Investigative Site
Maebashi-city, Gunma, Japan, 371-8511
Novartis Investigative Site
Asahikawa-city, Hokkaido, Japan, 078-8510
Novartis Investigative Site
Sapporo-city, Hokkaido, Japan, 060-0033
Novartis Investigative Site
Osaka-city, Osaka, Japan, 550-0012
Novartis Investigative Site
Shimotsuke-city, Tochigi, Japan, 329-0498
Novartis Investigative Site
Chiyoda-ku, Tokyo, Japan, 102-8798
Novartis Investigative Site
Hachioji-city, Tokyo, Japan, 193-0998
Novartis Investigative Site
Itabashi-ku, Tokyo, Japan, 173-8610
Novartis Investigative Site
Minato-ku, Tokyo, Japan, 105-8471
Novartis Investigative Site
Shinjuku-ku, Tokyo, Japan, 160-0023
Novartis Investigative Site
Shinjuku-ku, Tokyo, Japan, 160-8582
Poland
Novartis Investigative Site
Lodz, Poland, 90-265
Novartis Investigative Site
Poznan, Poland, 60-539
Novartis Investigative Site
Wroclaw, Poland, 50-368
Singapore
Novartis Investigative Site
Singapore, Singapore, 119074
Novartis Investigative Site
Singapore, Singapore, 308205
Slovakia
Novartis Investigative Site
Kosice, Slovak Republic, Slovakia, 040 15
Novartis Investigative Site
Bratislava, Slovakia, SK-81369
Novartis Investigative Site
Kosice, Slovakia, 04011
Novartis Investigative Site
Poprad, Slovakia, 05845
Novartis Investigative Site
Svidnik, Slovakia, 089 01
Novartis Investigative Site
Zilina, Slovakia, 01207
Switzerland
Novartis Investigative Site
Bern, Switzerland, 3010
Novartis Investigative Site
Lausanne, Switzerland, 1011
Novartis Investigative Site
Zuerich, Switzerland, 8091
United Kingdom
Novartis Investigative Site
London, England, United Kingdom, E11 1NR
Novartis Investigative Site
Birmingham, United Kingdom, B15 2TH
Novartis Investigative Site
Blackpool, United Kingdom, FY3 7EN
Novartis Investigative Site
Leicester, United Kingdom, LE7 5WW
Novartis Investigative Site
Poole, United Kingdom, BH15 2JB
Vietnam
Novartis Investigative Site
Hanoi, Vietnam, 1000
Novartis Investigative Site
Ho Chi Minh, Vietnam, 7000
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01406938     History of Changes
Other Study ID Numbers: CAIN457A2304, 2011-000767-27
Study First Received: July 12, 2011
Last Updated: January 5, 2015
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
Skin Diseases, Papulosquamous
Antibodies, Monoclonal
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on March 31, 2015