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

Primary Purpose

Moderate to Severe Plaque-type Psoriasis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
AIN457 150mg
AIN457 300mg
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Moderate to Severe Plaque-type Psoriasis focused on measuring Psoriasis, plaque, inflammatory skin disease, scaly patches, AIN457, secukinumab, Moderate to Severe Plaque-type Psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Novartis Investigative Site
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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

AIN457150 mg- Induction period Only(IPO)

AIN457 300 mg - IPO

AIN457 150 mg - Fixed Interval (FI)

AIN457 300 mg FI

AIN457 150 mg- Start of relapse (SoR)

AIN457 300 mg- SoR

Arm Description

secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)

secukinumab- 2 x 150mg injections per dose

1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection

2 s.c. secukinumab 150 mg injections

1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection

2 s.c. secukinumab 150 mg injections

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)
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)
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
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
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)
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)
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
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
% 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
% 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
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
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.
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.
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.
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
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

Full Information

First Posted
July 12, 2011
Last Updated
April 30, 2015
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01406938
Brief Title
Efficacy and Safety of Subcutaneous Secukinumab (AIN457) for Moderate to Severe Chronic Plaque-type Psoriasis Assessing Different Doses and Dose Regimens
Acronym
SCULPTURE
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate to Severe Plaque-type Psoriasis
Keywords
Psoriasis, plaque, inflammatory skin disease, scaly patches, AIN457, secukinumab, Moderate to Severe Plaque-type Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
967 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AIN457150 mg- Induction period Only(IPO)
Arm Type
Experimental
Arm Description
secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
Arm Title
AIN457 300 mg - IPO
Arm Type
Experimental
Arm Description
secukinumab- 2 x 150mg injections per dose
Arm Title
AIN457 150 mg - Fixed Interval (FI)
Arm Type
Experimental
Arm Description
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
Arm Title
AIN457 300 mg FI
Arm Type
Experimental
Arm Description
2 s.c. secukinumab 150 mg injections
Arm Title
AIN457 150 mg- Start of relapse (SoR)
Arm Type
Experimental
Arm Description
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
Arm Title
AIN457 300 mg- SoR
Arm Type
Experimental
Arm Description
2 s.c. secukinumab 150 mg injections
Intervention Type
Drug
Intervention Name(s)
AIN457 150mg
Other Intervention Name(s)
secukinumab 150 mg
Intervention Description
(1 injection per dose) and placebo to secukinumab 150 mg
Intervention Type
Drug
Intervention Name(s)
AIN457 300mg
Other Intervention Name(s)
secukinumab
Intervention Description
secukinumab 150 mg (2 injections per dose)
Primary Outcome Measure Information:
Title
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
Description
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)
Time Frame
Week 40 , week 52
Secondary Outcome Measure Information:
Title
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
Description
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)
Time Frame
Baseline, week 2, 3 , 4, 8, 12
Title
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
Description
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)
Time Frame
Baseline, week 12,16,20,24,28,32,36,40,44,48 and week 52
Title
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)
Description
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
Time Frame
Baseline, week 2, 4, 6, 8, 12
Title
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))
Description
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
Time Frame
Baseline, week 16,20,24,28,32,36,40,44,48, and Week 52
Title
Change From Baseline in EQ-5D at Each Visit, up to Week 52, (Induction)
Description
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)
Time Frame
Baseline to week 2, 4, 8, 12
Title
Change From Baseline in EQ-5D at Each Visit, up to Week 52, (Maintenance)
Description
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)
Time Frame
Baseline to week 16, 20, 24, 28, 32, 36, 40, 44, 48, and Week 52.
Title
Change From Baseline in Dermatology Life Quality Index (DLQI) Score. up to Week 52, (Induction)
Description
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
Time Frame
Baseline to week 2, 4, 8, 12
Title
Change From Baseline in Dermatology Life Quality Index (DLQI) Score. up to Week 52, (Maintenance)
Description
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
Time Frame
Baseline to week 16, 20, 24, 28, 32, 36, 40, 44, 48, and Week 52.
Title
% of Participants Achieving a DLQI Score of 0 or 1 at Each Visit up to Week 52, (Induction)
Description
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
Time Frame
Baseline to week 2, 4, 6, 8, 12
Title
% of Participants Achieving a DLQI Score of 0 or 1 at Each Visit up to Week 52, (Maintenance).
Description
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
Time Frame
Baseline to week 16, 20, 24, 28, 32, 36, 40, 44, 48, and Week 52
Title
Median Time to Relapse (Weeks) From Week 12.
Description
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
Time Frame
Week 12 to week 16, 20, 24, 28, 32, 36, 40, 44, 48, and Week 52.
Title
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
Description
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.
Time Frame
Week 12
Title
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
Description
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.
Time Frame
Week 52
Title
Number of Visits With PASI 50, 75, 90, 100 Score and IGA Mod 2011 0 or 1
Description
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.
Time Frame
Week 16, 20, 24,28,32,36,40,44,48,and Week 52
Title
Number of Secukinumab Injections Needed to Regain PASI 75 Response From Start of Relapse After Week 12
Description
The number of secukinumab injections needed for participants to regain PASI 75 response from the start of relapse after week 12
Time Frame
week 16, 20, 24,28,32,36,40,44,48,and Week 52
Title
Number of Participants Developing Anti-secukinumab Antibodies
Description
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
Time Frame
Baseline, weeks 12, 24, 52 and 60

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
35305260
Citation
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.
Results Reference
derived
PubMed Identifier
33748660
Citation
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.
Results Reference
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Efficacy and Safety of Subcutaneous Secukinumab (AIN457) for Moderate to Severe Chronic Plaque-type Psoriasis Assessing Different Doses and Dose Regimens

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