Plaque Psoriasis
Conditions
Keywords
Plaque psoriasis, Secukinumab, Skin condition, skin disease, itching, psoriasis vulgaris, immune-mediated systemic disease, skin lesions, scaly patches, papules, psoriasis
Brief summary
The purpose of this study was to determine if secukinumab is effective and safe in the treatment of plaque type psoriasis
Interventions
DRUGSecukinumab 150 mg s.c.
150 mg s.c. at randomization, Weeks 1, 2, 3, 4 and every 4 weeks till Week 48
DRUGSecukinumab 300 mg s.c.
300 mg s.c. at randomization, Weeks 1, 2, 3, 4 and every 4 weeks till Week 48
DRUGPlacebo
Placebo 150 or 300 mg s.c at randomization, Weeks 1, 2, 3, 4, and 8. PASI responders at week 12 continued to receive placebo till Week 48. PASI non-responders at Week 12 received Secukinumab 300mg at Weeks 12, 13, 14, 15, 16 and every 4 weeks till Week 48
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects must give a written, signed and dated informed consent. 2. Men or women at least 18 years of age at time of screening. 3. Chronic plaque-type psoriasis present for at least 6 months and diagnosed before Baseline. 4. Moderate to severe psoriasis as defined at Baseline by: * PASI score of 12 or greater, and * IGA mod 2011 score of 3 or greater (based on a static scale of 0 - 4), and * Body Surface Area (BSA) affected by plaque-type psoriasis of 10% or greater. 5. Candidate for systemic therapy. This is defined as a subject having moderate to severe chronic plaque-type psoriasis that is inadequately controlled by * topical treatment and/or, * phototherapy and/or, * previous systemic therapy.
Exclusion criteria
1. Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis) at Screening or Baseline. 2. Drug-induced psoriasis. 3. Ongoing use of prohibited treatments. 4. Previous exposure to secukinumab (AIN457) or any other biologic drug directly targeting IL-17 or the IL-17 receptor. 5. Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days until the expected pharmacodynamic effect has returned to baseline, whichever is longer; or longer if required by local regulations. 6. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Psoriasis Area and Severity Index (PASI) 75 (Multiple Imputation) | Week 12 | Psoriasis Area and Severity Index (PASI) was assessed/calculated as per usual standard. result given in terms of count of participants with response in 100 imputations. 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). |
| Investigator's Global Assessment (IGA) Mod 2011 0/1 (Multiple Imputation) | Week 12 | Investigator assessed disease using a validated scale (IGA mod 2011) and rate the disease from a score of 0 (clear skin) to 4 (severe disease). result given in terms of count of participants with response in 100 imputations. The Investigator's Global Assessment (IGA) mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. Treatment success was defined as achievement of IGA mod 2001 score of 0 or 1. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of Secukinumab in Maintaining IGA Mod 2011 0 or 1 Response at Week 52 in Subjects Who Were IGA Mod 2011 0 or 1 Responders at Week 12 (Multiple Imputation) | Week 52 | Investigator assessed disease using a validated scale (IGA mod 2011) and rate the disease from a score of 0 (clear skin) to 4 (severe disease). result given in terms of count of participants with response in 100 imputations. The Investigator's Global Assessment (IGA) mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. Treatment success was defined as achievement of IGA mod 2001 score of 0 or 1. |
| PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | week 1, week 12, week 24, week 52 | Number (%) of subjects with PASI 50, PASI 75, PASI 90, PASI 100 and IGA mod 2011 0 or 1 response |
| Psoriasis Area and Severity Index (PASI) 90 (Multiple Imputation) | Week 12 | Psoriasis Area and Severity Index (PASI) was assessed/calculated as per usual standard. result given in terms of count of participants with response in 100 imputations. 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). |
| Time to PASI 75 Response up to Week 12 | week 12 | Psoriasis Area and Severity Index (PASI) was assessed/calculated as per usual standard. result given in terms of count of participants with response in 100 imputations. 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). |
| American Collage of Rheumatology (ACR) Response 20/50/70 | week 12, week 24, week 52 | Percentage of patients who achieved ACR 20/50/70 at Week 12 and up to Week 52. The subset of patients who had active PsA at baseline included 7 patients in the secukinumab 150 mg group, 17 patients in the secukinumab 300 mg group and 4 patients in the placebo group. ACR 20, 50 or 70 responses correspond, respectively, to at least 20%, 50% or 70% improvement in comparison with baseline in the number of tender and swollen joint counts, in addition to similar improvements in at least three of five other measure of disability or disease activity |
| Efficacy of Secukinumab in Maintaining PASI 75 Response at Week 52 in Subjects Who Were PASI 75 Responders at Week 12 (Multiple Imputation) | Week 52 | Psoriasis Area and Severity Index (PASI) was assessed/calculated as per usual standard. result given in terms of count of participants with response in 100 imputations. 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). |
Countries
China, Hungary, Malaysia, Philippines, Thailand, Turkey (Türkiye)
Participant flow
Recruitment details
A total of 664 patients were screened and 543 patients were randomized to one of three treatment groups in the induction period: secukinumab 300 mg (n=272), secukinumab 150 mg (n=136), and placebo (n=135)
Participants by arm
| Arm | Count |
|---|---|
| Secukinumab 150mg Secukinumab 150mg s.c. | 136 |
| Secukinumab 300mg Secukinumab 300mg s.c. | 272 |
| Placebo Placebo | 135 |
| Total | 543 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| INDUCTION | Adverse Event | 2 | 2 | 0 | 0 |
| INDUCTION | Lack of Efficacy | 0 | 0 | 1 | 0 |
| INDUCTION | Pregnancy | 0 | 0 | 1 | 0 |
| MAINTENANCE | Adverse Event | 0 | 0 | 0 | 1 |
| MAINTENANCE | Lack of Efficacy | 2 | 1 | 0 | 1 |
| MAINTENANCE | Lost to Follow-up | 0 | 1 | 1 | 0 |
| MAINTENANCE | Pregnancy | 1 | 0 | 0 | 0 |
| MAINTENANCE | Withdrawal by Subject | 4 | 2 | 1 | 1 |
| OVERALL STUDY | Adverse Event | 2 | 2 | 0 | 1 |
| OVERALL STUDY | discontinued follow up | 0 | 2 | 0 | 0 |
| OVERALL STUDY | Lack of Efficacy | 2 | 1 | 1 | 1 |
| OVERALL STUDY | Lost to Follow-up | 1 | 1 | 1 | 1 |
| OVERALL STUDY | Pregnancy | 1 | 0 | 1 | 0 |
| OVERALL STUDY | Withdrawal by Subject | 4 | 2 | 1 | 2 |
Baseline characteristics
| Characteristic | Secukinumab 300mg | Total | Placebo | Secukinumab 150mg |
|---|---|---|---|---|
| Age, Continuous | 39.9 years STANDARD_DEVIATION 12.35 | 40.2 years STANDARD_DEVIATION 11.78 | 40.1 years STANDARD_DEVIATION 11.01 | 41 years STANDARD_DEVIATION 11.39 |
| Race/Ethnicity, Customized Asian | 252 Participants | 506 Participants | 125 Participants | 129 Participants |
| Race/Ethnicity, Customized Caucasian | 20 Participants | 37 Participants | 10 Participants | 7 Participants |
| Race/Ethnicity, Customized East Asian | 220 Participants | 438 Participants | 109 Participants | 109 Participants |
| Race/Ethnicity, Customized not reported | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized other | 17 Participants | 33 Participants | 10 Participants | 6 Participants |
| Race/Ethnicity, Customized South Asian | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Southeast Asian | 32 Participants | 67 Participants | 16 Participants | 19 Participants |
| Race/Ethnicity, Customized West Asian | 3 Participants | 3 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 67 Participants | 131 Participants | 27 Participants | 37 Participants |
| Sex: Female, Male Male | 205 Participants | 412 Participants | 108 Participants | 99 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 136 | 0 / 272 | 0 / 401 | 0 / 537 | 0 / 135 |
| other Total, other adverse events | 115 / 136 | 221 / 272 | 312 / 401 | 427 / 537 | 71 / 135 |
| serious Total, serious adverse events | 5 / 136 | 9 / 272 | 14 / 401 | 19 / 537 | 2 / 135 |
Outcome results
Primary
Investigator's Global Assessment (IGA) Mod 2011 0/1 (Multiple Imputation)
Investigator assessed disease using a validated scale (IGA mod 2011) and rate the disease from a score of 0 (clear skin) to 4 (severe disease). result given in terms of count of participants with response in 100 imputations. The Investigator's Global Assessment (IGA) mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. Treatment success was defined as achievement of IGA mod 2001 score of 0 or 1.
Time frame: Week 12
Population: full analysis set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Secukinumab 150mg | Investigator's Global Assessment (IGA) Mod 2011 0/1 (Multiple Imputation) | 92 Participants |
| Secukinumab 300mg | Investigator's Global Assessment (IGA) Mod 2011 0/1 (Multiple Imputation) | 214 Participants |
| Placebo | Investigator's Global Assessment (IGA) Mod 2011 0/1 (Multiple Imputation) | 4 Participants |
Comparison: IGAp-value: <0.000195% CI: [25.81, 222.72]Regression, Logistic
Comparison: IGAp-value: <0.000195% CI: [51.83, 432.42]Regression, Logistic
Primary
Psoriasis Area and Severity Index (PASI) 75 (Multiple Imputation)
Psoriasis Area and Severity Index (PASI) was assessed/calculated as per usual standard. result given in terms of count of participants with response in 100 imputations. 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).
Time frame: Week 12
Population: full analysis set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Secukinumab 150mg | Psoriasis Area and Severity Index (PASI) 75 (Multiple Imputation) | 112 Participants |
| Secukinumab 300mg | Psoriasis Area and Severity Index (PASI) 75 (Multiple Imputation) | 254 Participants |
| Placebo | Psoriasis Area and Severity Index (PASI) 75 (Multiple Imputation) | 6 Participants |
Comparison: PASI 75p-value: <0.000195% CI: [54.02, 438.67]Regression, Logistic
Comparison: PASI 75p-value: <0.000195% CI: [187.2, 1663.4]Regression, Logistic
Secondary
American Collage of Rheumatology (ACR) Response 20/50/70
Percentage of patients who achieved ACR 20/50/70 at Week 12 and up to Week 52. The subset of patients who had active PsA at baseline included 7 patients in the secukinumab 150 mg group, 17 patients in the secukinumab 300 mg group and 4 patients in the placebo group. ACR 20, 50 or 70 responses correspond, respectively, to at least 20%, 50% or 70% improvement in comparison with baseline in the number of tender and swollen joint counts, in addition to similar improvements in at least three of five other measure of disability or disease activity
Time frame: week 12, week 24, week 52
Population: full analysis set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Secukinumab 150mg | American Collage of Rheumatology (ACR) Response 20/50/70 | Week 12 ACR 70 | 2 Participants |
| Secukinumab 150mg | American Collage of Rheumatology (ACR) Response 20/50/70 | Week 52 ACR 70 | 2 Participants |
| Secukinumab 150mg | American Collage of Rheumatology (ACR) Response 20/50/70 | Week 24 ACR 50 | 4 Participants |
| Secukinumab 150mg | American Collage of Rheumatology (ACR) Response 20/50/70 | Week 24 ACR 20 | 5 Participants |
| Secukinumab 150mg | American Collage of Rheumatology (ACR) Response 20/50/70 | Week 52 ACR 50 | 3 Participants |
| Secukinumab 150mg | American Collage of Rheumatology (ACR) Response 20/50/70 | Week 12 ACR 50 | 3 Participants |
| Secukinumab 150mg | American Collage of Rheumatology (ACR) Response 20/50/70 | Week 12 ACR 20 | 4 Participants |
| Secukinumab 150mg | American Collage of Rheumatology (ACR) Response 20/50/70 | Week 52 ACR 20 | 4 Participants |
| Secukinumab 150mg | American Collage of Rheumatology (ACR) Response 20/50/70 | Week 24 ACR 70 | 2 Participants |
| Secukinumab 300mg | American Collage of Rheumatology (ACR) Response 20/50/70 | Week 52 ACR 20 | 13 Participants |
| Secukinumab 300mg | American Collage of Rheumatology (ACR) Response 20/50/70 | Week 12 ACR 20 | 13 Participants |
| Secukinumab 300mg | American Collage of Rheumatology (ACR) Response 20/50/70 | Week 12 ACR 50 | 12 Participants |
| Secukinumab 300mg | American Collage of Rheumatology (ACR) Response 20/50/70 | Week 12 ACR 70 | 6 Participants |
| Secukinumab 300mg | American Collage of Rheumatology (ACR) Response 20/50/70 | Week 24 ACR 20 | 14 Participants |
| Secukinumab 300mg | American Collage of Rheumatology (ACR) Response 20/50/70 | Week 24 ACR 50 | 10 Participants |
| Secukinumab 300mg | American Collage of Rheumatology (ACR) Response 20/50/70 | Week 24 ACR 70 | 6 Participants |
| Secukinumab 300mg | American Collage of Rheumatology (ACR) Response 20/50/70 | Week 52 ACR 50 | 11 Participants |
| Secukinumab 300mg | American Collage of Rheumatology (ACR) Response 20/50/70 | Week 52 ACR 70 | 8 Participants |
| Placebo | American Collage of Rheumatology (ACR) Response 20/50/70 | Week 12 ACR 20 | 0 Participants |
| Placebo | American Collage of Rheumatology (ACR) Response 20/50/70 | Week 24 ACR 50 | 0 Participants |
| Placebo | American Collage of Rheumatology (ACR) Response 20/50/70 | Week 24 ACR 70 | 0 Participants |
| Placebo | American Collage of Rheumatology (ACR) Response 20/50/70 | Week 12 ACR 50 | 0 Participants |
| Placebo | American Collage of Rheumatology (ACR) Response 20/50/70 | Week 52 ACR 20 | 0 Participants |
| Placebo | American Collage of Rheumatology (ACR) Response 20/50/70 | Week 52 ACR 70 | 0 Participants |
| Placebo | American Collage of Rheumatology (ACR) Response 20/50/70 | Week 52 ACR 50 | 0 Participants |
| Placebo | American Collage of Rheumatology (ACR) Response 20/50/70 | Week 24 ACR 20 | 0 Participants |
| Placebo | American Collage of Rheumatology (ACR) Response 20/50/70 | Week 12 ACR 70 | 0 Participants |
| Placebo - AIN457 300 mg | American Collage of Rheumatology (ACR) Response 20/50/70 | Week 52 ACR 20 | 3 Participants |
| Placebo - AIN457 300 mg | American Collage of Rheumatology (ACR) Response 20/50/70 | Week 12 ACR 20 | 0 Participants |
| Placebo - AIN457 300 mg | American Collage of Rheumatology (ACR) Response 20/50/70 | Week 24 ACR 50 | 1 Participants |
| Placebo - AIN457 300 mg | American Collage of Rheumatology (ACR) Response 20/50/70 | Week 12 ACR 50 | 0 Participants |
| Placebo - AIN457 300 mg | American Collage of Rheumatology (ACR) Response 20/50/70 | Week 52 ACR 70 | 0 Participants |
| Placebo - AIN457 300 mg | American Collage of Rheumatology (ACR) Response 20/50/70 | Week 52 ACR 50 | 2 Participants |
| Placebo - AIN457 300 mg | American Collage of Rheumatology (ACR) Response 20/50/70 | Week 24 ACR 70 | 1 Participants |
| Placebo - AIN457 300 mg | American Collage of Rheumatology (ACR) Response 20/50/70 | Week 24 ACR 20 | 2 Participants |
| Placebo - AIN457 300 mg | American Collage of Rheumatology (ACR) Response 20/50/70 | Week 12 ACR 70 | 0 Participants |
Secondary
Efficacy of Secukinumab in Maintaining IGA Mod 2011 0 or 1 Response at Week 52 in Subjects Who Were IGA Mod 2011 0 or 1 Responders at Week 12 (Multiple Imputation)
Investigator assessed disease using a validated scale (IGA mod 2011) and rate the disease from a score of 0 (clear skin) to 4 (severe disease). result given in terms of count of participants with response in 100 imputations. The Investigator's Global Assessment (IGA) mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. Treatment success was defined as achievement of IGA mod 2001 score of 0 or 1.
Time frame: Week 52
Population: full analysis set with measure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Secukinumab 150mg | Efficacy of Secukinumab in Maintaining IGA Mod 2011 0 or 1 Response at Week 52 in Subjects Who Were IGA Mod 2011 0 or 1 Responders at Week 12 (Multiple Imputation) | 65 Participants |
| Secukinumab 300mg | Efficacy of Secukinumab in Maintaining IGA Mod 2011 0 or 1 Response at Week 52 in Subjects Who Were IGA Mod 2011 0 or 1 Responders at Week 12 (Multiple Imputation) | 162 Participants |
Secondary
Efficacy of Secukinumab in Maintaining PASI 75 Response at Week 52 in Subjects Who Were PASI 75 Responders at Week 12 (Multiple Imputation)
Psoriasis Area and Severity Index (PASI) was assessed/calculated as per usual standard. result given in terms of count of participants with response in 100 imputations. 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).
Time frame: Week 52
Population: full analysis set with measure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Secukinumab 150mg | Efficacy of Secukinumab in Maintaining PASI 75 Response at Week 52 in Subjects Who Were PASI 75 Responders at Week 12 (Multiple Imputation) | 94 Participants |
| Secukinumab 300mg | Efficacy of Secukinumab in Maintaining PASI 75 Response at Week 52 in Subjects Who Were PASI 75 Responders at Week 12 (Multiple Imputation) | 235 Participants |
Secondary
PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation)
Number (%) of subjects with PASI 50, PASI 75, PASI 90, PASI 100 and IGA mod 2011 0 or 1 response
Time frame: week 1, week 12, week 24, week 52
Population: full analysis set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Secukinumab 150mg | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 12 IGA 0/1 | 92 Participants |
| Secukinumab 150mg | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 52 PASI 100 | 42 Participants |
| Secukinumab 150mg | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 1 IGA 0/1 | 0 Participants |
| Secukinumab 150mg | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 1 PASI 50 | 5 Participants |
| Secukinumab 150mg | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 1 PASI 75 | 0 Participants |
| Secukinumab 150mg | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 1 PASI 90 | 0 Participants |
| Secukinumab 150mg | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 1 PASI 100 | 0 Participants |
| Secukinumab 150mg | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 12 PASI 50 | 130 Participants |
| Secukinumab 150mg | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 12 PASI 75 | 112 Participants |
| Secukinumab 150mg | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 12 PASI 90 | 85 Participants |
| Secukinumab 150mg | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 12 PASI 100 | 28 Participants |
| Secukinumab 150mg | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 16 IGA 0/1 | 100 Participants |
| Secukinumab 150mg | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 16 PASI 50 | 134 Participants |
| Secukinumab 150mg | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 16 PASI 75 | 124 Participants |
| Secukinumab 150mg | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 16 PASI 90 | 98 Participants |
| Secukinumab 150mg | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 16 PASI 100 | 39 Participants |
| Secukinumab 150mg | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 24 IGA 0/1 | 91 Participants |
| Secukinumab 150mg | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 24 PASI 50 | 135 Participants |
| Secukinumab 150mg | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 24 PASI 75 | 123 Participants |
| Secukinumab 150mg | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 24 PASI 90 | 93 Participants |
| Secukinumab 150mg | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 24 PASI 100 | 47 Participants |
| Secukinumab 150mg | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 52 IGA 0/1 | 79 Participants |
| Secukinumab 150mg | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 52 PASI 50 | 128 Participants |
| Secukinumab 150mg | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 52 PASI 75 | 111 Participants |
| Secukinumab 150mg | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 52 PASI 90 | 86 Participants |
| Secukinumab 300mg | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 12 IGA 0/1 | 214 Participants |
| Secukinumab 300mg | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 16 PASI 75 | 261 Participants |
| Secukinumab 300mg | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 12 PASI 90 | 210 Participants |
| Secukinumab 300mg | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 1 IGA 0/1 | 1 Participants |
| Secukinumab 300mg | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 24 PASI 90 | 230 Participants |
| Secukinumab 300mg | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 16 PASI 90 | 233 Participants |
| Secukinumab 300mg | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 52 IGA 0/1 | 194 Participants |
| Secukinumab 300mg | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 24 PASI 75 | 257 Participants |
| Secukinumab 300mg | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 1 PASI 90 | 0 Participants |
| Secukinumab 300mg | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 16 PASI 100 | 99 Participants |
| Secukinumab 300mg | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 1 PASI 75 | 0 Participants |
| Secukinumab 300mg | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 24 PASI 50 | 271 Participants |
| Secukinumab 300mg | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 52 PASI 75 | 259 Participants |
| Secukinumab 300mg | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 24 IGA 0/1 | 217 Participants |
| Secukinumab 300mg | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 12 PASI 100 | 81 Participants |
| Secukinumab 300mg | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 12 PASI 75 | 254 Participants |
| Secukinumab 300mg | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 24 PASI 100 | 107 Participants |
| Secukinumab 300mg | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 52 PASI 100 | 110 Participants |
| Secukinumab 300mg | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 16 IGA 0/1 | 219 Participants |
| Secukinumab 300mg | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 12 PASI 50 | 267 Participants |
| Secukinumab 300mg | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 1 PASI 50 | 25 Participants |
| Secukinumab 300mg | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 52 PASI 50 | 269 Participants |
| Secukinumab 300mg | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 16 PASI 50 | 270 Participants |
| Secukinumab 300mg | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 1 PASI 100 | 0 Participants |
| Secukinumab 300mg | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 52 PASI 90 | 218 Participants |
| Placebo | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 1 IGA 0/1 | 0 Participants |
| Placebo | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 52 PASI 90 | 1 Participants |
| Placebo | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 12 PASI 50 | 16 Participants |
| Placebo | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 12 PASI 75 | 6 Participants |
| Placebo | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 52 IGA 0/1 | 0 Participants |
| Placebo | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 12 PASI 90 | 2 Participants |
| Placebo | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 12 PASI 100 | 1 Participants |
| Placebo | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 16 IGA 0/1 | 2 Participants |
| Placebo | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 16 PASI 50 | 4 Participants |
| Placebo | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 52 PASI 50 | 4 Participants |
| Placebo | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 16 PASI 75 | 3 Participants |
| Placebo | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 16 PASI 90 | 2 Participants |
| Placebo | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 52 PASI 100 | 1 Participants |
| Placebo | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 16 PASI 100 | 0 Participants |
| Placebo | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 24 IGA 0/1 | 1 Participants |
| Placebo | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 52 PASI 75 | 4 Participants |
| Placebo | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 24 PASI 50 | 4 Participants |
| Placebo | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 24 PASI 75 | 2 Participants |
| Placebo | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 12 IGA 0/1 | 4 Participants |
| Placebo | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 24 PASI 90 | 2 Participants |
| Placebo | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 1 PASI 50 | 1 Participants |
| Placebo | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 1 PASI 75 | 0 Participants |
| Placebo | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 24 PASI 100 | 0 Participants |
| Placebo | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 1 PASI 90 | 0 Participants |
| Placebo | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 1 PASI 100 | 0 Participants |
| Placebo - AIN457 300 mg | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 52 PASI 50 | 126 Participants |
| Placebo - AIN457 300 mg | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 1 PASI 100 | 0 Participants |
| Placebo - AIN457 300 mg | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 52 PASI 90 | 101 Participants |
| Placebo - AIN457 300 mg | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 1 PASI 90 | 0 Participants |
| Placebo - AIN457 300 mg | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 24 PASI 90 | 94 Participants |
| Placebo - AIN457 300 mg | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 16 PASI 75 | 72 Participants |
| Placebo - AIN457 300 mg | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 12 IGA 0/1 | 0 Participants |
| Placebo - AIN457 300 mg | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 1 IGA 0/1 | 0 Participants |
| Placebo - AIN457 300 mg | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 16 PASI 50 | 108 Participants |
| Placebo - AIN457 300 mg | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 16 IGA 0/1 | 32 Participants |
| Placebo - AIN457 300 mg | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 24 PASI 100 | 31 Participants |
| Placebo - AIN457 300 mg | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 1 PASI 50 | 0 Participants |
| Placebo - AIN457 300 mg | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 12 PASI 100 | 0 Participants |
| Placebo - AIN457 300 mg | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 52 IGA 0/1 | 96 Participants |
| Placebo - AIN457 300 mg | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 12 PASI 75 | 0 Participants |
| Placebo - AIN457 300 mg | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 24 IGA 0/1 | 88 Participants |
| Placebo - AIN457 300 mg | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 1 PASI 75 | 0 Participants |
| Placebo - AIN457 300 mg | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 16 PASI 100 | 3 Participants |
| Placebo - AIN457 300 mg | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 12 PASI 50 | 0 Participants |
| Placebo - AIN457 300 mg | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 24 PASI 50 | 123 Participants |
| Placebo - AIN457 300 mg | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 52 PASI 75 | 119 Participants |
| Placebo - AIN457 300 mg | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 16 PASI 90 | 22 Participants |
| Placebo - AIN457 300 mg | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 12 PASI 90 | 0 Participants |
| Placebo - AIN457 300 mg | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 24 PASI 75 | 113 Participants |
| Placebo - AIN457 300 mg | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | Week 52 PASI 100 | 55 Participants |
Secondary
Psoriasis Area and Severity Index (PASI) 90 (Multiple Imputation)
Psoriasis Area and Severity Index (PASI) was assessed/calculated as per usual standard. result given in terms of count of participants with response in 100 imputations. 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).
Time frame: Week 12
Population: full analysis set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Secukinumab 150mg | Psoriasis Area and Severity Index (PASI) 90 (Multiple Imputation) | 85 Participants |
| Secukinumab 300mg | Psoriasis Area and Severity Index (PASI) 90 (Multiple Imputation) | 210 Participants |
| Placebo | Psoriasis Area and Severity Index (PASI) 90 (Multiple Imputation) | 2 Participants |
Comparison: PASI 90p-value: <0.000195% CI: [26.94, 489.59]Regression, Logistic
Comparison: PASI 90p-value: <0.000195% CI: [58.41, 1037.1]Regression, Logistic
Secondary
Time to PASI 75 Response up to Week 12
Psoriasis Area and Severity Index (PASI) was assessed/calculated as per usual standard. result given in terms of count of participants with response in 100 imputations. 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).
Time frame: week 12
Population: full analysis set
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Secukinumab 150mg | Time to PASI 75 Response up to Week 12 | 57 days |
| Secukinumab 300mg | Time to PASI 75 Response up to Week 12 | 55 days |