Moderate to Severe Plaque-type PsoriasisPhase 3SCULPTURENCT01406938
Efficacy and Safety of Subcutaneous Secukinumab (AIN457) for Moderate to Severe Chronic Plaque-type Psoriasis Assessing Different Doses and Dose Regimens
A Phase 3 study testing AIN457 150mg and AIN457 300mg in people with Moderate to Severe Plaque-type Psoriasis, run by Novartis Pharmaceuticals at 131 sites in 16 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Moderate to Severe Plaque-type Psoriasis
- What is being tested?
- AIN457 150mg and AIN457 300mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 967 participants
- Where
- 131 sitesin 16 countries
- Study dates
- Aug 2011to May 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
131 sites in 16 countries.
131 sites in 16 countries
United States33 sites
Novartis Investigative Site
Anderson, South Carolina, 29621
Novartis Investigative Site
Atlanta, Georgia, 30342
Novartis Investigative Site
Boston, Massachusetts, 02111
Novartis Investigative Site
Champaign, Illinois, 61820
Novartis Investigative Site
Dallas, Texas, 75230
Novartis Investigative Site
Dallas, Texas, 75231
Novartis Investigative Site
Fresno, California, 93710
Novartis Investigative Site
Fridley, Minnesota, 55432
Novartis Investigative Site
Goodlettsville, Tennessee, 37072-2301
Novartis Investigative Site
Greensboro, North Carolina, 27401
Novartis Investigative Site
Greer, South Carolina, 29651
Novartis Investigative Site
Henderson, Nevada, 89052
Novartis Investigative Site
High Point, North Carolina, 27262
Novartis Investigative Site
Indianapolis, Indiana, 46256
Novartis Investigative Site
Jacksonville, Florida, 32204
Novartis Investigative Site
Jacksonville, Florida, 32216
Novartis Investigative Site
Las Vegas, Nevada, 89119
Novartis Investigative Site
Miami, Florida, 33136
Novartis Investigative Site
Naples, Florida, 34119
Novartis Investigative Site
Overland Park, Kansas, 66215
Novartis Investigative Site
Owensboro, Kentucky, 42301
Novartis Investigative Site
Pasadena, California, 91105
Novartis Investigative Site
Sacramento, California, 95817
Novartis Investigative Site
Salt Lake City, Utah, 84124
Novartis Investigative Site
San Antonio, Texas, 78229
Novartis Investigative Site
San Francisco, California, 94118
Novartis Investigative Site
Skokie, Illinois, 60077
Novartis Investigative Site
South Miami, Florida, 33143
Novartis Investigative Site
Springfield, Illinois, 62703
Novartis Investigative Site
St Louis, Missouri, 63117
Novartis Investigative Site
Verona, New Jersey, 07044
Novartis Investigative Site
West Palm Beach, Florida, 33409
Novartis Investigative Site
Winston-Salem, North Carolina, 27103
Germany22 sites
Novartis Investigative Site
Bad Wildbad, 75323
Novartis Investigative Site
Bochum, 44803
Novartis Investigative Site
Buchholz I. D. Nordheide, 21244
Novartis Investigative Site
Cologne, 50937
Novartis Investigative Site
Dippoldiswalde-Schmiedeberg, 01744
Novartis Investigative Site
Duisburg, 47167
Novartis Investigative Site
Düsseldorf, 40225
Novartis Investigative Site
Essen, 45147
Novartis Investigative Site
Frankfurt, 60590
Novartis Investigative Site
Freiburg im Breisgau, 79104
Novartis Investigative Site
Hamburg, 20246
Novartis Investigative Site
Hamburg, 22143
Novartis Investigative Site
Hamburg, 22391
Novartis Investigative Site
Hanover, 30625
Novartis Investigative Site
Kiel, 24105
Novartis Investigative Site
Lübeck, 23538
Novartis Investigative Site
Mahlow, 15831
Novartis Investigative Site
Mainz, 55131
Novartis Investigative Site
Mannheim, 68167
Novartis Investigative Site
Münster, Germany, 48149
Novartis Investigative Site
Pommelsbrunn, 91224
Novartis Investigative Site
Wuppertal, 42103
Japan15 sites
Novartis Investigative Site
Asahikawa, Hokkaido, 078-8510
Novartis Investigative Site
Chiyoda-ku, Tokyo, 102-8798
Novartis Investigative Site
Fukuoka, Fukuoka, 815-8588
Novartis Investigative Site
Hachiōji, Tokyo, 193-0998
Novartis Investigative Site
Kisarazu, Chiba, 292-8535
Novartis Investigative Site
Kitakyushu, Fukuoka, 800-0296
Novartis Investigative Site
Maebashi, Gunma, 371-8511
Novartis Investigative Site
Minato-ku, Tokyo, 105-8471
Novartis Investigative Site
Nagoya, Aichi-ken, 467-8602
Novartis Investigative Site
Osaka, Osaka, 550-0012
Novartis Investigative Site
Sapporo, Hokkaido, 060-0033
Novartis Investigative Site
Shimotsuke, Tochigi, 329-0498
Novartis Investigative Site
Shinjuku-ku, Tokyo, 160-0023
Novartis Investigative Site
Shinjuku-ku, Tokyo, 160-8582
Novartis Investigative Site
tabashi City, Tokyo, 173-8610
India9 sites
Novartis Investigative Site
Bangalore, Karnataka, 560054
Novartis Investigative Site
Hyderabad, Andhra Pradesh, 500 058
Novartis Investigative Site
Mangalore, Karnataka, 575 004
Novartis Investigative Site
Mumbai, Maharashtra, 400 008
Novartis Investigative Site
Nagpur, Maharashtra, 440 010
Novartis Investigative Site
Nagpur, Maharashtra, 440013
Novartis Investigative Site
Nagpur, Maharashtra
Novartis Investigative Site
Nashik, Maharashtra
Novartis Investigative Site
Secunderabad, Andhra Pradesh, 500 094
Bulgaria6 sites
Novartis Investigative Site
Pleven, 5800
Novartis Investigative Site
Sofia, Bulgaria, 1606
Novartis Investigative Site
Sofia, 1231
Novartis Investigative Site
Sofia, 1404
Novartis Investigative Site
Sofia, 1431
Novartis Investigative Site
Varna, 9010
Czechia6 sites
Novartis Investigative Site
Brno-Bohunice, Czech Republic, 625 00
Novartis Investigative Site
České Budějovice, 370 01
Novartis Investigative Site
Hradec Králové, CZE, 500 05
Novartis Investigative Site
Nový Jičín, 741 01
Novartis Investigative Site
Prague, CZE, 180 81
Novartis Investigative Site
Prague, 100 34
Slovakia6 sites
Novartis Investigative Site
Bratislava, SK-81369
Novartis Investigative Site
Košice, Slovak Republic, 040 15
Novartis Investigative Site
Košice, Slovakia, 04011
Novartis Investigative Site
Poprad, Slovakia, 05845
Novartis Investigative Site
Svidník, Slovakia, 089 01
Novartis Investigative Site
Žilina, Slovakia, 01207
Canada5 sites
Novartis Investigative Site
Barrie, Ontario, L4M 6L2
Novartis Investigative Site
Montreal, Quebec, H2K 4L5
Novartis Investigative Site
Oakville, Ontario, L6J 7W5
Novartis Investigative Site
Waterloo, Ontario, N2J 1C4
Novartis Investigative Site
Windsor, Ontario, N8W 1E6
France5 sites
Novartis Investigative Site
Antony, 92160
Novartis Investigative Site
Nice, 06202
Novartis Investigative Site
Pierre-Benite Cédex, F-69495
Novartis Investigative Site
Rouen, 76031
Novartis Investigative Site
Toulouse, France, 31059
United Kingdom5 sites
Novartis Investigative Site
Birmingham, B15 2TH
Novartis Investigative Site
Blackpool, FY3 7EN
Novartis Investigative Site
Leicester, LE7 5WW
Novartis Investigative Site
London, England, E11 1NR
Novartis Investigative Site
Poole, BH15 2JB
Austria4 sites
Novartis Investigative Site
Graz, A-8036
Novartis Investigative Site
Linz, A-4010
Novartis Investigative Site
Vienna, A-1220
Novartis Investigative Site
Wels, Austria, 4600
Italy4 sites
Novartis Investigative Site
Roma, RM, 00133
Novartis Investigative Site
Roma, RM, 00144
Novartis Investigative Site
Siena, SI, 53100
Novartis Investigative Site
Verona, VR, 37126
Poland3 sites
Novartis Investigative Site
Lodz, 90-265
Novartis Investigative Site
Poznan, 60-539
Novartis Investigative Site
Wroclaw, 50-368
Switzerland3 sites
Novartis Investigative Site
Bern, 3010
Novartis Investigative Site
Lausanne, 1011
Novartis Investigative Site
Zurich, 8091
Vietnam3 sites
Novartis Investigative Site
Hanoi, Vietnam, 1000
Novartis Investigative Site
Hanoi, 1000
Novartis Investigative Site
Ho Chi Minh City, 7000
Singapore2 sites
Novartis Investigative Site
Singapore, Singapore, 119074
Novartis Investigative Site
Singapore, Singapore, 308205
About this study
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
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.
- Conditions
- Moderate to Severe Plaque-type Psoriasis
- Being tested
- AIN457 150mg, AIN457 300mg
- Keywords
- Psoriasis, plaque, inflammatory skin disease, scaly patches, AIN457, secukinumab, Moderate to Severe Plaque-type Psoriasis
- Medical subject headings
- Psoriasis, Plaque, Amyloid, Dermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AIN457 150mgDrug
Also called secukinumab 150 mg
(1 injection per dose) and placebo to secukinumab 150 mg
AIN457 300mgDrug
Also called secukinumab
secukinumab 150 mg (2 injections per dose)
| Study group | Role | What they receive |
|---|---|---|
| AIN457150 mg- Induction period Only(IPO) | Experimental | secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO) Receives: Drug: AIN457 150mg |
| AIN457 300 mg - IPO | Experimental | secukinumab- 2 x 150mg injections per dose Receives: Drug: AIN457 300mg |
| AIN457 150 mg - Fixed Interval (FI) | Experimental | 1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection Receives: Drug: AIN457 150mg |
| AIN457 300 mg FI | Experimental | 2 s.c. secukinumab 150 mg injections Receives: Drug: AIN457 300mg |
| AIN457 150 mg- Start of relapse (SoR) | Experimental | 1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection Receives: Drug: AIN457 150mg |
| AIN457 300 mg- SoR | Experimental | 2 s.c. secukinumab 150 mg injections Receives: Drug: AIN457 300mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
For the Fixed Interval Group and the Start of Relapse (SoR) 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
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)
Measured: Week 40 , week 52
Secondary outcomes (16)
Absolute Change From Baseline for PASI 50 / 75 / 90 / 100 and IGA 2011 Score of 0 or 1 at Week 2, 4, 6, 8, 12
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)
Measured: Baseline, week 2, 3 , 4, 8, 12
Absolute Change From Baseline for PASI 50 / 75 / 90 / 100 and IGA 2011 Score of 0 or 1 at Week at Week 16, 20, 24,28,32,36,40,44,48,and Week 52
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)
Measured: Baseline, week 12,16,20,24,28,32,36,40,44,48 and week 52
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 (Induction)
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
Measured: Baseline, week 2, 4, 6, 8, 12
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 (Maintenance Period))
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
Measured: Baseline, week 16,20,24,28,32,36,40,44,48, and Week 52
Change From Baseline in EQ-5D at Each Visit, up to Week 52, (Induction)
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)
Measured: Baseline to week 2, 4, 8, 12
Change From Baseline in EQ-5D at Each Visit, up to Week 52, (Maintenance)
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)
Measured: Baseline to week 16, 20, 24, 28, 32, 36, 40, 44, 48, and Week 52.
Change From Baseline in Dermatology Life Quality Index (DLQI) Score. up to Week 52, (Induction)
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
Measured: Baseline to week 2, 4, 8, 12
Change From Baseline in Dermatology Life Quality Index (DLQI) Score. up to Week 52, (Maintenance)
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
Measured: Baseline to week 16, 20, 24, 28, 32, 36, 40, 44, 48, and Week 52.
% of Participants Achieving a DLQI Score of 0 or 1 at Each Visit up to Week 52, (Induction)
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
Measured: Baseline to week 2, 4, 6, 8, 12
% of Participants Achieving a DLQI Score of 0 or 1 at Each Visit up to Week 52, (Maintenance).
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
Measured: Baseline to week 16, 20, 24, 28, 32, 36, 40, 44, 48, and Week 52
Median Time to Relapse (Weeks) From Week 12.
Median time to relapse (weeks) from week 12. Relapse is defined as greater than 50% loss of the maximal PASI improvement from baseline. 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
Measured: Week 12 to week 16, 20, 24, 28, 32, 36, 40, 44, 48, and Week 52.
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
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.
Measured: Week 12
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
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.
Measured: Week 52
Number of Visits With PASI 50, 75, 90, 100 Score and IGA Mod 2011 0 or 1
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.
Measured: Week 16, 20, 24,28,32,36,40,44,48,and Week 52
Number of Secukinumab Injections Needed to Regain PASI 75 Response From Start of Relapse After Week 12
The number of secukinumab injections needed for participants to regain PASI 75 response from the start of relapse after week 12
Measured: week 16, 20, 24,28,32,36,40,44,48,and Week 52
Number of Participants Developing Anti-secukinumab Antibodies
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
Measured: Baseline, weeks 12, 24, 52 and 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Moderate to Severe Plaque-type PsoriasisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 967 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01406938
- Sponsor's protocol ID
- CAIN457A2304
- Other IDs
- 2011-000767-27
- Acronym
- SCULPTURE
- Status last verified
- Apr 2015
- First submitted
- 12 Jul 2011
- Last updated
- 19 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Merola JF, McInnes IB, Deodhar AA, Dey AK, Adamstein NH, Quebe-Fehling E, Aassi M, Peine M, Mehta NN. Effect of Secukinumab on Traditional Cardiovascular Risk Factors and Inflammatory Biomarkers: Post Hoc Analyses of Pooled Data Across Three Indications. Rheumatol Ther. 2022 Jun;9(3):935-955. doi: 10.1007/s40744-022-00434-z. Epub 2022 Mar 19.
PubMed 35305260Dehlin M, Fasth AER, Reinhardt M, Jacobsson LTH. Impact of psoriasis disease activity and other risk factors on serum urate levels in patients with psoriasis and psoriatic arthritis-a post-hoc analysis of pooled data from three phase 3 trials with secukinumab. Rheumatol Adv Pract. 2021 Feb 18;5(1):rkab009. doi: 10.1093/rap/rkab009. eCollection 2021.
PubMed 33748660
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01406938
- Acronym / sponsor ID
- SCULPTURE / CAIN457A2304
- Conditions
- Moderate to Severe Plaque-type Psoriasis
- Keywords
- Psoriasis, plaque, inflammatory skin disease, scaly patches, AIN457, secukinumab, Moderate to Severe Plaque-type Psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 967 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 1 Aug 2011 (estimated)
- Results
- Posted 19 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| AIN457150 mg- Induction period Only(IPO) | Experimental | Drug: AIN457 150mgsecukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO) |
| AIN457 300 mg - IPO | Experimental | Drug: AIN457 300mgsecukinumab- 2 x 150mg injections per dose |
| AIN457 150 mg - Fixed Interval (FI) | Experimental | Drug: AIN457 150mg1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection |
| AIN457 300 mg FI | Experimental | Drug: AIN457 300mg2 s.c. secukinumab 150 mg injections |
| AIN457 150 mg- Start of relapse (SoR) | Experimental | Drug: AIN457 150mg1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection |
| AIN457 300 mg- SoR | Experimental | Drug: AIN457 300mg2 s.c. secukinumab 150 mg injections |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Moderate and severe plaque-type psoriasis diagnosed for at least 6 months.
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AIN457 150mgAlso: secukinumab 150 mg(1 injection per dose) and placebo to secukinumab 150 mg | Drug | AIN457 150 mg - Fixed Interval (FI), AIN457 150 mg- Start of relapse (SoR), AIN457150 mg- Induction period Only(IPO) |
| AIN457 300mgAlso: secukinumabsecukinumab 150 mg (2 injections per dose) | Drug | AIN457 300 mg - IPO, AIN457 300 mg FI, AIN457 300 mg- SoR |
Primary outcome
For the Fixed Interval Group and the Start of Relapse (SoR) 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
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)
16 secondary outcomes
Absolute Change From Baseline for PASI 50 / 75 / 90 / 100 and IGA 2011 Score of 0 or 1 at Week 2, 4, 6, 8, 12
Time frame: Baseline, week 2, 3 , 4, 8, 12
Absolute Change From Baseline for PASI 50 / 75 / 90 / 100 and IGA 2011 Score of 0 or 1 at Week at Week 16, 20, 24,28,32,36,40,44,48,and Week 52
Time frame: Baseline, week 12,16,20,24,28,32,36,40,44,48 and week 52
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 (Induction)
Time frame: Baseline, week 2, 4, 6, 8, 12
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 (Maintenance Period))
Time frame: Baseline, week 16,20,24,28,32,36,40,44,48, and Week 52
Change From Baseline in EQ-5D at Each Visit, up to Week 52, (Induction)
Time frame: Baseline to week 2, 4, 8, 12
Change From Baseline in EQ-5D at Each Visit, up to Week 52, (Maintenance)
Time frame: Baseline to week 16, 20, 24, 28, 32, 36, 40, 44, 48, and Week 52.
Change From Baseline in Dermatology Life Quality Index (DLQI) Score. up to Week 52, (Induction)
Time frame: Baseline to week 2, 4, 8, 12
Change From Baseline in Dermatology Life Quality Index (DLQI) Score. up to Week 52, (Maintenance)
Time frame: Baseline to week 16, 20, 24, 28, 32, 36, 40, 44, 48, and Week 52.
% of Participants Achieving a DLQI Score of 0 or 1 at Each Visit up to Week 52, (Induction)
Time frame: Baseline to week 2, 4, 6, 8, 12
% of Participants Achieving a DLQI Score of 0 or 1 at Each Visit up to Week 52, (Maintenance).
Time frame: Baseline to week 16, 20, 24, 28, 32, 36, 40, 44, 48, and Week 52
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.
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
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 52
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
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
Number of Participants Developing Anti-secukinumab Antibodies
Time frame: Baseline, weeks 12, 24, 52 and 60
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35305260Merola JF, McInnes IB, Deodhar AA, Dey AK, Adamstein NH, Quebe-Fehling E, Aassi M, Peine M, Mehta NN. Effect of Secukinumab on Traditional Cardiovascular Risk Factors and Inflammatory Biomarkers: Post Hoc Analyses of Pooled Data Across Three Indications. Rheumatol Ther. 2022 Jun;9(3):935-955. doi: 10.1007/s40744-022-00434-z. Epub 2022 Mar 19.
- Derived from this study: PubMed 33748660Dehlin M, Fasth AER, Reinhardt M, Jacobsson LTH. Impact of psoriasis disease activity and other risk factors on serum urate levels in patients with psoriasis and psoriatic arthritis-a post-hoc analysis of pooled data from three phase 3 trials with secukinumab. Rheumatol Adv Pract. 2021 Feb 18;5(1):rkab009. doi: 10.1093/rap/rkab009. eCollection 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
131 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AIN457 150mg and AIN457 300mg in people with Moderate to Severe Plaque-type Psoriasis, run by Novartis Pharmaceuticals at 131 sites in 16 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 131 sites in United States, Germany, Japan, India, Bulgaria and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
For the Fixed Interval Group and the Start of Relapse (SoR) 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01406938, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2015.