Psoriasis
Conditions
Keywords
psoriasis, secukinumab, pre-filled syringes
Brief summary
The aim of the study was to demonstrate efficacy, safety and tolerability of 2 mL pre-filled syringe of 300 mg secukinumab in treatment of moderate to severe plaque psoriasis.
Detailed description
This is a 52-weeks multicenter, randomized, double-blind, placebo-controlled, parallel-group trial in 24 subjects with moderate to severe plaque-type psoriasis.
Interventions
DRUGPlacebo
2 mL + 2 x 1 mL Placebo s.c. at randomization, weeks 1, 3, and 4, thereafter 4-weekly until week 48
DRUGSecukinumab 2 mL form
Secukinumab 300 mg/2mL + 2 x 1 mL placebo s.c. at randomization, week 1 , 3, 4, thereafter 4-weekly until Week 48
DRUGSecukinumab 1 mL form
Secukinumab 150 mg/1mL x 2 + 2 mL placebo s.c. at randomization, week 1 , 3, 4, thereafter 4-weekly until 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
Subjects eligible for inclusion in this study must fulfill all of the following criteria: 1. Subjects must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study related activity is performed. Where relevant, a legal representative will also sign the informed study consent according to local laws and regulations. 2. Men or women of at least 18 years of age at the time of Screening. 3. Chronic plaque-type psoriasis present for at least 6 months and diagnosed before Randomization. 4. Moderate to severe psoriasis as defined at Randomization by: * PASI score of 12 or greater, and * IGA mod 2011 score of 3 or greater (based on a 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 Randomization. 2. Ongoing use of prohibited treatments. Washout periods detailed in the protocol have to be adhered to. Subjects not willing to limit UV light exposure (e.g., sunbathing and/or the use of tanning devices) during the course of the study will be considered not eligible for this study since UV light exposure is prohibited. Note: administration of live vaccines 6 weeks prior to Randomization or during the study period is also prohibited. 3. Previous exposure to secukinumab (AIN457) or any other biologic drug directly targeting IL-17 or the IL-17 receptor. 4. 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. 5. 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. 6. History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system treated or untreated within the past 5 years, regardless of whether there is evidence of local recurrence or metastases (except for Bowen's disease, or basal cell carcinoma or actinic keratoses that have been treated with no evidence of recurrence in the past 12 weeks; carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed). 7. History of hypersensitivity to any of study drug constituent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants With Psoriasis Area and Severity Index (PASI) 75 Response After 12 Weeks of Treatment | 12 weeks | Number of participants who achieved ≥ 75% reduction in PASI compared to 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). |
| Participants With IGA Mod 2011 0 or 1 After 12 Weeks of Treatment | 12 weeks | 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. Number of participants who achieved IGA mod 2011 0 or 1 and improved by at least 2 points on the IGA scale compared to baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participants With PASI 90 After 12 Weeks of Treatment | 12 weeks | Number of participants who achieved ≥ 90% and 100% reduction in PASI compared to baseline |
| Number of Participants With PASI 100 Response After 12 Weeks of Treatment | 12 weeks | Participants who achieved 100% reduction in PASI compared to baseline |
| Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | up to week 52 | PASI response over time up to week 52: Number of participants who achieved ≥ 50%, 75%, 90% and 100% reduction in PASI and achieve IGA mod 2011 0 or 1 and improved by at least 2 points on the IGA scale compared to baseline |
Countries
Belgium, Canada, Germany, Iceland, Latvia, Poland, Russia, Spain, Turkey (Türkiye), United Kingdom, United States
Participant flow
Pre-assignment details
A total of 251 patients were screened and 214 patients were randomized
Participants by arm
| Arm | Count |
|---|---|
| Secukinumab 2 mL PFS Secukinumab 300 mg in one 2 mL pre-filled syringe | 72 |
| Secukinumab 2 x 1 mL PFS Secukinumab 300 mg provided in 2 pre-filled syringes of 1 mL/150 mg (current approved form) | 71 |
| Placebo Placebo, provided in a 2 mL pre-filled syringe Placebo, provided in a 1 mL pre-filled syringe | 71 |
| Total | 214 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Treatment Period 1 | Adverse Event | 0 | 1 | 0 | 0 | 0 |
| Treatment Period 1 | Lack of Efficacy | 0 | 0 | 1 | 0 | 0 |
| Treatment Period 1 | Withdrawal by Subject | 0 | 1 | 1 | 0 | 0 |
| Treatment Period 2 | Adverse Event | 3 | 2 | 0 | 2 | 0 |
| Treatment Period 2 | Lack of Efficacy | 0 | 1 | 0 | 0 | 0 |
| Treatment Period 2 | Lost to Follow-up | 2 | 0 | 0 | 0 | 0 |
| Treatment Period 2 | Pregnancy | 0 | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Secukinumab 2 mL PFS | Secukinumab 2 x 1 mL PFS | Placebo | Total |
|---|---|---|---|---|
| Age, Customized <65 years | 68 Participants | 64 Participants | 68 Participants | 200 Participants |
| Age, Customized >=65 years | 4 Participants | 7 Participants | 3 Participants | 14 Participants |
| Age, Customized >=75 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 4 Participants | 4 Participants | 4 Participants | 12 Participants |
| Race/Ethnicity, Customized Black | 2 Participants | 1 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized Caucasian | 64 Participants | 64 Participants | 66 Participants | 194 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 1 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Female | 28 Participants | 28 Participants | 25 Participants | 81 Participants |
| Sex: Female, Male Male | 44 Participants | 43 Participants | 46 Participants | 133 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 | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 72 | 0 / 71 | 0 / 71 | 0 / 106 | 0 / 105 | 0 / 211 |
| other Total, other adverse events | 33 / 72 | 39 / 71 | 29 / 71 | 60 / 106 | 68 / 105 | 128 / 211 |
| serious Total, serious adverse events | 0 / 72 | 1 / 71 | 2 / 71 | 8 / 106 | 5 / 105 | 13 / 211 |
Outcome results
Primary
Participants With IGA Mod 2011 0 or 1 After 12 Weeks of Treatment
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. Number of participants who achieved IGA mod 2011 0 or 1 and improved by at least 2 points on the IGA scale compared to baseline
Time frame: 12 weeks
Population: The full analysis set (FAS) population was used for this analysis. The FAS included all participants to whom treatment was assigned. Only participants from the FAS, who had values at a given week, were included in the analysis for that week.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Secukinumab 2 mL PFS | Participants With IGA Mod 2011 0 or 1 After 12 Weeks of Treatment | 55 participants |
| Placebo | Participants With IGA Mod 2011 0 or 1 After 12 Weeks of Treatment | 1 participants |
p-value: <0.000195% CI: [47.48, 3379.99]Regression, Logistic
Primary
Participants With Psoriasis Area and Severity Index (PASI) 75 Response After 12 Weeks of Treatment
Number of participants who achieved ≥ 75% reduction in PASI compared to 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).
Time frame: 12 weeks
Population: The full analysis set (FAS) population was used for this analysis. The FAS included all participants to whom treatment was assigned. Only participants from the FAS, who had values at a given week, were included in the analysis for that week.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Secukinumab 2 mL PFS | Participants With Psoriasis Area and Severity Index (PASI) 75 Response After 12 Weeks of Treatment | 64 participants |
| Placebo | Participants With Psoriasis Area and Severity Index (PASI) 75 Response After 12 Weeks of Treatment | 1 participants |
p-value: <0.000195% CI: [68, 7569.56]Regression, Logistic
Secondary
Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
PASI response over time up to week 52: Number of participants who achieved ≥ 50%, 75%, 90% and 100% reduction in PASI and achieve IGA mod 2011 0 or 1 and improved by at least 2 points on the IGA scale compared to baseline
Time frame: up to week 52
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Secukinumab 2 mL PFS | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 2 PASI 100 | 0 participants |
| Secukinumab 2 mL PFS | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 16 PASI 90 | 56 participants |
| Secukinumab 2 mL PFS | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 4 PASI 100 | 3 participants |
| Secukinumab 2 mL PFS | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 1 PASI 50 | 5 participants |
| Secukinumab 2 mL PFS | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 1 PASI 90 | 0 participants |
| Secukinumab 2 mL PFS | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 3 IGA 0/1 | 6 participants |
| Secukinumab 2 mL PFS | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 16 PASI 50 | 69 participants |
| Secukinumab 2 mL PFS | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 4 PASI 90 | 10 participants |
| Secukinumab 2 mL PFS | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 1 IGA 0/1 | 1 participants |
| Secukinumab 2 mL PFS | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 2 PASI 50 | 18 participants |
| Secukinumab 2 mL PFS | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 3 PASI 50 | 39 participants |
| Secukinumab 2 mL PFS | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 28 PASI 100 | 44 participants |
| Secukinumab 2 mL PFS | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 40 PASI 100 | 40 participants |
| Secukinumab 2 mL PFS | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 4 PASI 75 | 29 participants |
| Secukinumab 2 mL PFS | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 52 PASI 50 | 67 participants |
| Secukinumab 2 mL PFS | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 3 PASI 75 | 14 participants |
| Secukinumab 2 mL PFS | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 16 PASI 100 | 37 participants |
| Secukinumab 2 mL PFS | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 4 PASI 50 | 53 participants |
| Secukinumab 2 mL PFS | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 4 IGA 0/1 | 19 participants |
| Secukinumab 2 mL PFS | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 52 IGA 0/1 | 55 participants |
| Secukinumab 2 mL PFS | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 3 PASI 90 | 4 participants |
| Secukinumab 2 mL PFS | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 16 IGA 0/1 | 57 participants |
| Secukinumab 2 mL PFS | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 1 PASI 75 | 0 participants |
| Secukinumab 2 mL PFS | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 52 PASI 100 | 40 participants |
| Secukinumab 2 mL PFS | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 12 PASI 50 | 67 participants |
| Secukinumab 2 mL PFS | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 3 PASI 100 | 0 participants |
| Secukinumab 2 mL PFS | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 12 PASI 90 | 48 participants |
| Secukinumab 2 mL PFS | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 12 IGA 0/1 | 55 participants |
| Secukinumab 2 mL PFS | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 28 IGA 0/1 | 64 participants |
| Secukinumab 2 mL PFS | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 12 PASI 100 | 28 participants |
| Secukinumab 2 mL PFS | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 28 PASI 50 | 71 participants |
| Secukinumab 2 mL PFS | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 40 PASI 50 | 69 participants |
| Secukinumab 2 mL PFS | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 40 PASI 75 | 66 participants |
| Secukinumab 2 mL PFS | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 8 PASI 100 | 8 participants |
| Secukinumab 2 mL PFS | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 28 PASI 90 | 62 participants |
| Secukinumab 2 mL PFS | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 28 PASI 75 | 69 participants |
| Secukinumab 2 mL PFS | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 1 PASI 100 | 0 participants |
| Secukinumab 2 mL PFS | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 8 PASI 90 | 35 participants |
| Secukinumab 2 mL PFS | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 8 PASI 75 | 53 participants |
| Secukinumab 2 mL PFS | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 40 PASI 90 | 58 participants |
| Secukinumab 2 mL PFS | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 2 PASI 75 | 4 participants |
| Secukinumab 2 mL PFS | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 16 PASI 75 | 65 participants |
| Secukinumab 2 mL PFS | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 8 PASI 50 | 66 participants |
| Secukinumab 2 mL PFS | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 2 IGA 0/1 | 2 participants |
| Secukinumab 2 mL PFS | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 12 PASI 75 | 64 participants |
| Secukinumab 2 mL PFS | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 2 PASI 90 | 0 participants |
| Secukinumab 2 mL PFS | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 52 PASI 90 | 54 participants |
| Secukinumab 2 mL PFS | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 8 IGA 0/1 | 43 participants |
| Secukinumab 2 mL PFS | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 40 IGA 0/1 | 60 participants |
| Secukinumab 2 mL PFS | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 52 PASI 75 | 63 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 28 PASI 75 | 60 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 2 IGA 0/1 | 1 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 40 IGA 0/1 | 55 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 16 IGA 0/1 | 52 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 16 PASI 50 | 61 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 1 IGA 0/1 | 0 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 16 PASI 75 | 60 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 28 PASI 100 | 34 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 16 PASI 90 | 55 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 16 PASI 100 | 31 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 2 PASI 50 | 28 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 28 PASI 90 | 56 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 28 PASI 50 | 66 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 2 PASI 75 | 5 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 28 IGA 0/1 | 54 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 52 PASI 75 | 62 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 2 PASI 90 | 1 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 52 PASI 100 | 37 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 2 PASI 100 | 1 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 3 IGA 0/1 | 11 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 1 PASI 50 | 5 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 52 PASI 50 | 67 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 3 PASI 50 | 40 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 3 PASI 75 | 17 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 3 PASI 90 | 4 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 52 IGA 0/1 | 55 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 3 PASI 100 | 1 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 4 IGA 0/1 | 23 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 1 PASI 75 | 2 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 4 PASI 50 | 52 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 40 PASI 100 | 37 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 4 PASI 75 | 32 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 4 PASI 90 | 13 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 8 IGA 0/1 | 41 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 4 PASI 100 | 3 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 1 PASI 90 | 0 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 40 PASI 90 | 57 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 8 PASI 50 | 60 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 8 PASI 75 | 51 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 8 PASI 90 | 31 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 40 PASI 75 | 63 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 8 PASI 100 | 11 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 1 PASI 100 | 0 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 12 IGA 0/1 | 49 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 12 PASI 50 | 61 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 40 PASI 50 | 67 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 12 PASI 75 | 58 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 52 PASI 90 | 58 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 12 PASI 90 | 50 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 12 PASI 100 | 26 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 2 PASI 100 | 0 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 16 IGA 0/1 | 0 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 4 PASI 100 | 0 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 12 PASI 50 | 5 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 40 PASI 90 | 0 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 2 PASI 90 | 0 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 1 PASI 90 | 0 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 16 PASI 90 | 0 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 2 PASI 75 | 0 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 12 PASI 90 | 1 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 8 PASI 50 | 5 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 52 PASI 100 | 0 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 52 PASI 75 | 0 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 1 IGA 0/1 | 0 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 16 PASI 75 | 0 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 8 PASI 75 | 0 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 52 PASI 90 | 0 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 40 PASI 75 | 0 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 28 PASI 75 | 0 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 2 IGA 0/1 | 1 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 8 PASI 90 | 0 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 12 PASI 100 | 0 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 12 PASI 75 | 1 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 2 PASI 50 | 1 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 40 IGA 0/1 | 0 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 8 PASI 100 | 0 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 28 PASI 100 | 0 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 3 PASI 100 | 0 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 3 PASI 90 | 0 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 52 IGA 0/1 | 0 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 28 IGA 0/1 | 0 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 28 PASI 50 | 0 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 4 IGA 0/1 | 0 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 28 PASI 90 | 0 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 40 PASI 100 | 0 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 3 PASI 75 | 0 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 16 PASI 50 | 0 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 4 PASI 50 | 6 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 1 PASI 75 | 0 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 12 IGA 0/1 | 1 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 1 PASI 50 | 1 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 1 PASI 100 | 0 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 4 PASI 75 | 1 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 8 IGA 0/1 | 0 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 3 PASI 50 | 5 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 3 IGA 0/1 | 1 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 40 PASI 50 | 0 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 4 PASI 90 | 0 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 52 PASI 50 | 0 participants |
| Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 16 PASI 100 | 0 participants |
| Secukinumab 2 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 40 PASI 90 | 27 participants |
| Secukinumab 2 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 28 IGA 0/1 | 30 participants |
| Secukinumab 2 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 1 IGA 0/1 | 0 participants |
| Secukinumab 2 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 1 PASI 50 | 0 participants |
| Secukinumab 2 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 1 PASI 75 | 0 participants |
| Secukinumab 2 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 1 PASI 90 | 0 participants |
| Secukinumab 2 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 1 PASI 100 | 0 participants |
| Secukinumab 2 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 2 IGA 0/1 | 0 participants |
| Secukinumab 2 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 2 PASI 50 | 1 participants |
| Secukinumab 2 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 2 PASI 75 | 0 participants |
| Secukinumab 2 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 2 PASI 90 | 0 participants |
| Secukinumab 2 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 2 PASI 100 | 0 participants |
| Secukinumab 2 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 3 IGA 0/1 | 0 participants |
| Secukinumab 2 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 3 PASI 50 | 3 participants |
| Secukinumab 2 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 3 PASI 75 | 0 participants |
| Secukinumab 2 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 3 PASI 90 | 0 participants |
| Secukinumab 2 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 3 PASI 100 | 0 participants |
| Secukinumab 2 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 4 IGA 0/1 | 0 participants |
| Secukinumab 2 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 4 PASI 50 | 5 participants |
| Secukinumab 2 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 4 PASI 75 | 1 participants |
| Secukinumab 2 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 4 PASI 90 | 0 participants |
| Secukinumab 2 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 4 PASI 100 | 0 participants |
| Secukinumab 2 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 8 IGA 0/1 | 0 participants |
| Secukinumab 2 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 8 PASI 50 | 3 participants |
| Secukinumab 2 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 8 PASI 75 | 0 participants |
| Secukinumab 2 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 8 PASI 90 | 0 participants |
| Secukinumab 2 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 8 PASI 100 | 0 participants |
| Secukinumab 2 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 12 IGA 0/1 | 0 participants |
| Secukinumab 2 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 12 PASI 50 | 2 participants |
| Secukinumab 2 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 12 PASI 75 | 0 participants |
| Secukinumab 2 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 12 PASI 90 | 0 participants |
| Secukinumab 2 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 12 PASI 100 | 0 participants |
| Secukinumab 2 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 16 IGA 0/1 | 14 participants |
| Secukinumab 2 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 16 PASI 50 | 27 participants |
| Secukinumab 2 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 16 PASI 75 | 17 participants |
| Secukinumab 2 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 16 PASI 90 | 8 participants |
| Secukinumab 2 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 16 PASI 100 | 5 participants |
| Secukinumab 2 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 28 PASI 50 | 33 participants |
| Secukinumab 2 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 28 PASI 75 | 32 participants |
| Secukinumab 2 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 28 PASI 90 | 26 participants |
| Secukinumab 2 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 28 PASI 100 | 16 participants |
| Secukinumab 2 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 40 IGA 0/1 | 28 participants |
| Secukinumab 2 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 40 PASI 50 | 33 participants |
| Secukinumab 2 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 40 PASI 75 | 31 participants |
| Secukinumab 2 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 40 PASI 100 | 20 participants |
| Secukinumab 2 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 52 IGA 0/1 | 28 participants |
| Secukinumab 2 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 52 PASI 50 | 31 participants |
| Secukinumab 2 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 52 PASI 75 | 30 participants |
| Secukinumab 2 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 52 PASI 90 | 25 participants |
| Secukinumab 2 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 52 PASI 100 | 20 participants |
| Secukinumab 2 x 1 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 16 IGA 0/1 | 5 participants |
| Secukinumab 2 x 1 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 12 PASI 100 | 0 participants |
| Secukinumab 2 x 1 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 12 PASI 90 | 0 participants |
| Secukinumab 2 x 1 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 1 PASI 100 | 0 participants |
| Secukinumab 2 x 1 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 40 IGA 0/1 | 25 participants |
| Secukinumab 2 x 1 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 12 PASI 75 | 0 participants |
| Secukinumab 2 x 1 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 12 PASI 50 | 2 participants |
| Secukinumab 2 x 1 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 12 IGA 0/1 | 0 participants |
| Secukinumab 2 x 1 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 1 PASI 90 | 0 participants |
| Secukinumab 2 x 1 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 40 PASI 50 | 33 participants |
| Secukinumab 2 x 1 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 8 PASI 100 | 0 participants |
| Secukinumab 2 x 1 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 8 PASI 90 | 0 participants |
| Secukinumab 2 x 1 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 8 PASI 75 | 0 participants |
| Secukinumab 2 x 1 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 52 PASI 100 | 16 participants |
| Secukinumab 2 x 1 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 40 PASI 75 | 31 participants |
| Secukinumab 2 x 1 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 8 PASI 50 | 2 participants |
| Secukinumab 2 x 1 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 8 IGA 0/1 | 0 participants |
| Secukinumab 2 x 1 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 4 PASI 100 | 0 participants |
| Secukinumab 2 x 1 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 4 PASI 90 | 0 participants |
| Secukinumab 2 x 1 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 40 PASI 90 | 24 participants |
| Secukinumab 2 x 1 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 4 PASI 75 | 0 participants |
| Secukinumab 2 x 1 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 4 PASI 50 | 1 participants |
| Secukinumab 2 x 1 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 4 IGA 0/1 | 0 participants |
| Secukinumab 2 x 1 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 52 PASI 90 | 26 participants |
| Secukinumab 2 x 1 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 40 PASI 100 | 17 participants |
| Secukinumab 2 x 1 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 3 PASI 100 | 0 participants |
| Secukinumab 2 x 1 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 3 PASI 90 | 0 participants |
| Secukinumab 2 x 1 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 3 PASI 75 | 0 participants |
| Secukinumab 2 x 1 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 1 PASI 50 | 1 participants |
| Secukinumab 2 x 1 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 52 IGA 0/1 | 26 participants |
| Secukinumab 2 x 1 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 3 PASI 50 | 1 participants |
| Secukinumab 2 x 1 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 3 IGA 0/1 | 1 participants |
| Secukinumab 2 x 1 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 2 PASI 100 | 0 participants |
| Secukinumab 2 x 1 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 1 IGA 0/1 | 0 participants |
| Secukinumab 2 x 1 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 52 PASI 50 | 32 participants |
| Secukinumab 2 x 1 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 2 PASI 90 | 0 participants |
| Secukinumab 2 x 1 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 2 PASI 75 | 0 participants |
| Secukinumab 2 x 1 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 2 PASI 50 | 0 participants |
| Secukinumab 2 x 1 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 1 PASI 75 | 0 participants |
| Secukinumab 2 x 1 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 28 PASI 75 | 28 participants |
| Secukinumab 2 x 1 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 28 PASI 50 | 30 participants |
| Secukinumab 2 x 1 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 28 IGA 0/1 | 25 participants |
| Secukinumab 2 x 1 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 16 PASI 100 | 1 participants |
| Secukinumab 2 x 1 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 52 PASI 75 | 31 participants |
| Secukinumab 2 x 1 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 28 PASI 90 | 21 participants |
| Secukinumab 2 x 1 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 16 PASI 90 | 4 participants |
| Secukinumab 2 x 1 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 16 PASI 75 | 13 participants |
| Secukinumab 2 x 1 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 16 PASI 50 | 20 participants |
| Secukinumab 2 x 1 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 2 IGA 0/1 | 1 participants |
| Secukinumab 2 x 1 mL PFS Following Placebo | Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | Week 28 PASI 100 | 12 participants |
Secondary
Number of Participants With PASI 100 Response After 12 Weeks of Treatment
Participants who achieved 100% reduction in PASI compared to baseline
Time frame: 12 weeks
Population: The full analysis set (FAS) population was used for this analysis. The FAS included all participants to whom treatment was assigned. Only participants from the FAS, who had values at a given week, were included in the analysis for that week.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Secukinumab 2 mL PFS | Number of Participants With PASI 100 Response After 12 Weeks of Treatment | 28 participants |
| Placebo | Number of Participants With PASI 100 Response After 12 Weeks of Treatment | 26 participants |
| Placebo | Number of Participants With PASI 100 Response After 12 Weeks of Treatment | 0 participants |
p-value: <0.000195% CI: [27.41, 50.09]t-test, 2 sided
p-value: <0.000195% CI: [25.19, 47.76]t-test, 2 sided
Secondary
Participants With PASI 90 After 12 Weeks of Treatment
Number of participants who achieved ≥ 90% and 100% reduction in PASI compared to baseline
Time frame: 12 weeks
Population: The full analysis set (FAS) population was used for this analysis. The FAS included all participants to whom treatment was assigned. Only participants from the FAS, who had values at a given week, were included in the analysis for that week.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Secukinumab 2 mL PFS | Participants With PASI 90 After 12 Weeks of Treatment | 48 participants |
| Placebo | Participants With PASI 90 After 12 Weeks of Treatment | 1 participants |
p-value: <0.000195% CI: [21.2, 1337.22]Regression, Logistic