AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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.
Show all 9Show fewer
  • 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

Other trials in United States

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

Other trials in Germany

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

Other trials in Japan

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

Other trials in India

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

Other trials in Bulgaria

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

Other trials in Czechia

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

Other trials in Slovakia

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

Other trials in Canada

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

Other trials in France

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

Other trials in United Kingdom

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

Other trials in Austria

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

Other trials in Italy

Poland3 sites
  • Novartis Investigative Site

    Lodz, 90-265

  • Novartis Investigative Site

    Poznan, 60-539

  • Novartis Investigative Site

    Wroclaw, 50-368

Other trials in Poland

Switzerland3 sites
  • Novartis Investigative Site

    Bern, 3010

  • Novartis Investigative Site

    Lausanne, 1011

  • Novartis Investigative Site

    Zurich, 8091

Other trials in Switzerland

Vietnam3 sites
  • Novartis Investigative Site

    Hanoi, Vietnam, 1000

  • Novartis Investigative Site

    Hanoi, 1000

  • Novartis Investigative Site

    Ho Chi Minh City, 7000

Other trials in Vietnam

Singapore2 sites
  • Novartis Investigative Site

    Singapore, Singapore, 119074

  • Novartis Investigative Site

    Singapore, Singapore, 308205

Other trials in Singapore

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.

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 groups in NCT01406938
Study groupRoleWhat they receive
AIN457150 mg- Induction period Only(IPO)Experimentalsecukinumab 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 - IPOExperimentalsecukinumab- 2 x 150mg injections per dose
Receives: Drug: AIN457 300mg
AIN457 150 mg - Fixed Interval (FI)Experimental1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
Receives: Drug: AIN457 150mg
AIN457 300 mg FIExperimental2 s.c. secukinumab 150 mg injections
Receives: Drug: AIN457 300mg
AIN457 150 mg- Start of relapse (SoR)Experimental1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
Receives: Drug: AIN457 150mg
AIN457 300 mg- SoRExperimental2 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  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 (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

  5. 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

  6. 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.

  7. 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

  8. 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.

  9. % 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

  10. % 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

  11. 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.

  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 12

  13. 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

  14. 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

  15. 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

  16. 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.

  1. First posted1 Aug 2011 (estimated)
  2. Study startAug 2011
  3. Primary completionMay 2013
  4. Study completionMay 2013

Resources

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)
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
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 35305260
  • Dehlin 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

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.

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