Plaque Type Psorisis
Conditions
Brief summary
A study to evaluate the differences in the efficacy and safety of secukinumab between Cw6-negative and Cw6-positive patients with moderate to severe plaque-type psoriasis
Detailed description
Biological agents represent the most advanced type of treatment for psoriasis. Secukinumab is a human monoclonal anti IL-17A antibody that binds to human IL-17A and neutralizes its bioactivity by inhibiting IL17A produced by both Th17 cells and those of the innate immune system, thus providing complete anti IL17A blockage. Targeting IL-17A has the potential to reduce autoimmune inflammation while leaving other immune functions undisturbed. While targeting of Th1-promoting or Th17-promoting cytokines affects critical mediators such as IFN-γ, IL-22 and IL-21, selective targeting of IL-17A leaves these Th1/17 activities, as well as certain protective functions of innate cells intact. Furthermore, as a fully human monoclonal antibody, secukinumab should reduce immunogenic risks compared to current or emerging antibody therapies that are not fully human. Many recent studies have shown that highly selective biologic drugs are not effective in every patient and that variations in the genome can be associated with different clinical responses or side effects to a given drug. The PSORS1 locus on chromosome 6p is generally understood to confer the most risk for psoriasis. A specific allele for this locus, HLA C\*06, is present in about 60% of psoriatic patient cases. Data linking secukinumab efficacy to a particular genetic marker are lacking. Recent research has revealed a marked difference in the proportion of PASI 90 achievers at 12 weeks between Cw6-positive and Cw6-negative patients (85.7% vs 56.5%) treated with ustekinumab (Talamonti M et al. 2013) and a greater efficacy of anti-TNFα drugs in CW6 negative patients (Galli et al. 2013).Unlike anti-IL-12/23 agents, secukinumab inhibits IL-17 produced by both Th17 cells after presentation by antigen presenting cells (in this case Cw6) and cells of the innate immune system whose activation does not require antigen presentation. Providing a drug that is equally effective on both Cw6-negative and Cw6-positive patients would be an important clinical accomplishment and would eliminate the need for costly HLA-Cw6 tests. The choice of a cohort study would therefore seem appropriate for this clinical context. The purpose of this study was to explore the different efficacy and safety profile of secukinumab 300 mg in patients with moderate to severe chronic plaque-type psoriasis, stratified for the presence of HLA-C\*06, whose determination was blinded for patients and investigators. The study was conducted both on anti-TNFα-naïve and anti-TNFα failure patients and also stratified for TNFα - 308 polymorphism, BMI, smoking and metabolic syndrome, among others.
Interventions
BIOLOGICALSecukinumab
Secukinumab was supplied as 150 mg solution in pre-filled syringe for subcutaneous injection
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Arms represent stratification of Cw6 positive and Cw6 negative patients
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject must have been able to understand and communicate with the investigator and to comply with the requirements of the study and must have given a written, signed and dated informed consent before any study related activity was performed. 2. Men or women at least 18 years of age at time of screening. 3. Diagnosis of moderate to severe chronic plaque-type psoriasis for at least 6 months (including concomitant psoriatic arthritis as per the Classification Criteria for Psoriatic Arthritis criteria \[CASPAR\]). 4. Moderate to severe psoriasis as defined at enrollment by: * PASI score ≥ 10 or * PASI score \> 5 but \< 10 and DLQI ≥10 5. Patients that are candidates for systemic therapy, whether treatment naïve or after failed response to other systemic therapy (i.e. cyclosporine, methotrexate and PUVA) or to an anti-TNFα (or is intolerant and/or has a contraindication to these).
Exclusion criteria
1. Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis). 2. Cyclosporine or methotrexate therapy within 4 weeks prior to Day 1. 3. Anti-TNFα therapy within timelines depending on drug half-life. 4. Previous exposure to secukinumab or any other biologic drug directly targeting IL-17 or the IL-17 receptor. 5. Previous exposure to ustekinumab or any other biologic drug for the treatment of psoriasis that was not anti-TNFα therapy. 6. Intravenous or intramuscular steroids within 2 weeks prior to screening and during screening. 7. Ongoing use of corticosteroid topical treatments or UV therapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage (%) of Patients Who Reach Psoriasis Area Severity Index (PASI) 90 at 16 Weeks - LOCF Approach (ITT Set) | Baseline up to 16 weeks | PASI (Langley et al 2015) combines the assessment of the severity of lesions and the area affected into a single score with a range of 0 (no disease) to 72 (maximal disease). The PASI was assessed at all visits in CORE and extension phases. PASI 90 response: patients achieving ≥ 90% improvement (reduction) in PASI score compared to baseline are defined as PASI 90 responders. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Mean Changes From Baseline in IGA Mod 2011 Between Cohorts at Each Time Point (LOCF) (ITT) | Baseline up to approximately 72 weeks | IGA mod 2011 scale measures severity of the psoriasis on a five-point scale ranging from 0 (no disease, 'clear') to 4 ('very severe'). |
| Median Time to Reach PASI 90 and 75 (ITT) | Baseline up to approximately 72 weeks | Time in days to reach PASI scores of 90 and 75. |
| Change From Baseline in the Dermatology Life Quality Index (DLQI) (LOCF) (FAS) | Baseline up to approximatly 72 weeks | The DLQI total score was calculated by summing the score of each domain resulting in a maximum of 30 and a minimum of 0. The higher the score, the more Quality of Life was impaired. Meaning of DLQI Scores: 0-1 = no effect at all on patient's life, 2-5 = small effect on patient's life, 6-10 = moderate effect on patient's life, 11-20= very large effect on patient's life, 21-30 = extremely large effect on patient's life. It was pre-specified that results would be presented for all patients, not by cohort |
| Change From Baseline in Mean Scores of HAD-A and HAD-D (Anxiety and Depression) (LOCF) (FAS) | Baseline up approximately 72 weeks | The Hospital Anxiety and Depression Scale (HADS) is a fourteen-item scale.. Seven of the items relate to anxiety and seven relate to depression. This outcome measure was specifically developed to avoid reliance on aspects of these conditions that are also common somatic symptoms of illness, for example fatigue and insomnia or hypersomnia. Calculations of scores: each of the 14 items was rated on a 4-point scale. All items except 7 and 10 were scored as Yes, definitely = 3, Yes, sometimes = 2, No, not much = 1, to No, not at all = 0. Items 7 and 10 were scored as Yes, definitely = 0 to No, not at all = 3 in the reverse order. The HADS consisted of two sub-scores: the HAD-A (anxiety) and HAD-D (depression); each sub-score ranged from 0 to 21 points; scores ≥11 = presence of anxious or depressive disorders; scores between 8-10 points = borderline abnormal, and scores of ≤7 = disorder was not present. It was pre-specified that results would be presented for all patients, not by cohort |
| Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | Baseline up to approximately 72 weeks | IGA mod 2011 scale measures severity of the psoriasis on a five-point scale ranging from 0 (no disease, 'clear') to 4 ('very severe'). PASI 50,75,90,100 represent: patients achieving ≥ 50% improvement (reduction) in PASI score compared to baseline, ≥ 75% improvement (reduction), ≥ 90% improvement (reduction) and PASI 100 response/remission: complete clearing of psoriasis (PASI=0). |
| Changes From Baseline in Body Mass Index (Safety Set) | Baseline up to approximately 72 weeks | Change in Body mass index from baseline for patients with a value at baseline and the respective post-baseline visit |
| Changes From Baseline in Waist Circumference (Safety Set) | Baseline up to approximately 72 weeks | Change in waist circumference from baseline for patients with a value at baseline and the respective post-baseline visit |
| Changes From Baseline in Weight (Safety Set) | Baseline up to approximately 72 weeks | Change in weight from baseline for patients with a value at baseline and the respective post-baseline visit |
| Correlation Between the Hospital Anxiety and Depression Scale (HADS) and PASI (FAS) | Baseline up to approximately 72 weeks | PASI score, HADS questionnaire correlation using Spearman rank correlation coefficient. It was pre-specified that results would be presented for all patients, not by cohort |
Countries
Italy
Participant flow
Pre-assignment details
Five hundred thirty participants were screened and 434 entered the CORE Phase. However, there were 3 patients without Cw6 assessment which was necessary for stratification to the two arms, therefore 431 were considered enrolled.
Participants by arm
| Arm | Count |
|---|---|
| Cw6-positive AIN457 300 mg Stratified to Cw6 positive cohort. Investigators and patients were blinded to Cw6 results. All patients were treated according to an induction regimen of two injections of secukinumab 150 mg a week for five weeks starting at baseline (week 0), followed by a maintenance period of two injections per month. At week 16, patients achieving PASI 50 response were eligible to continue on secukinumab for an additional 8 weeks in CORE. Eligible patients with at least a PASI 75 response were included in the extension phase, up to 72 weeks | 185 |
| Cw6-negative AIN457 300 mg Stratified to Cw6 negative cohort. Investigators and patients were blinded to Cw6 results. All patients were treated according to an induction regimen of two injections of secukinumab 150 mg a week for five weeks starting at baseline (week 0), followed by a maintenance period of two injections per month. At week 16, patients achieving PASI 50 response were eligible to continue on secukinumab for an additional 8 weeks in CORE. Eligible patients with at least a PASI 75 response were included in the extension phase, up to 72 weeks | 246 |
| Total | 431 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| CORE Phase | Adverse Event | 7 | 9 |
| CORE Phase | Death | 0 | 1 |
| CORE Phase | Lack of Efficacy | 1 | 6 |
| CORE Phase | Lost to Follow-up | 1 | 0 |
| CORE Phase | Physician Decision | 1 | 1 |
| CORE Phase | Pregnancy | 1 | 0 |
| CORE Phase | Withdrawal by Subject | 2 | 2 |
| Extension Phase | Adverse Event | 6 | 1 |
| Extension Phase | Death | 0 | 1 |
| Extension Phase | Lack of Efficacy | 3 | 3 |
| Extension Phase | Lost to Follow-up | 1 | 0 |
| Extension Phase | Physician Decision | 0 | 2 |
| Extension Phase | Protocol Violation | 1 | 0 |
| Extension Phase | Withdrawal by Subject | 0 | 5 |
Baseline characteristics
| Characteristic | Cw6-positive AIN457 300 mg | Cw6-negative AIN457 300 mg | Total |
|---|---|---|---|
| Age, Continuous | 42.71 years STANDARD_DEVIATION 13.148 | 47.18 years STANDARD_DEVIATION 12.919 | 45.26 years STANDARD_DEVIATION 13.189 |
| Race/Ethnicity, Customized Asian | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Caucasian | 184 Participants | 241 Participants | 425 Participants |
| Race/Ethnicity, Customized Native American | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Unknown | 0 Participants | 2 Participants | 2 Participants |
| Sex: Female, Male Female | 60 Participants | 62 Participants | 122 Participants |
| Sex: Female, Male Male | 125 Participants | 184 Participants | 309 Participants |
| Time since first diagnosis of psoriasis | 19.63 years STANDARD_DEVIATION 12.489 | 17.46 years STANDARD_DEVIATION 11.343 | 18.39 years STANDARD_DEVIATION 11.883 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 246 | 0 / 185 |
| other Total, other adverse events | 14 / 246 | 20 / 185 |
| serious Total, serious adverse events | 21 / 246 | 10 / 185 |
Outcome results
Primary
Percentage (%) of Patients Who Reach Psoriasis Area Severity Index (PASI) 90 at 16 Weeks - LOCF Approach (ITT Set)
PASI (Langley et al 2015) combines the assessment of the severity of lesions and the area affected into a single score with a range of 0 (no disease) to 72 (maximal disease). The PASI was assessed at all visits in CORE and extension phases. PASI 90 response: patients achieving ≥ 90% improvement (reduction) in PASI score compared to baseline are defined as PASI 90 responders.
Time frame: Baseline up to 16 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cw6-positive AIN457 300 mg | Percentage (%) of Patients Who Reach Psoriasis Area Severity Index (PASI) 90 at 16 Weeks - LOCF Approach (ITT Set) | 80.4 percentage of participants |
| Cw6-negative AIN457 300 mg | Percentage (%) of Patients Who Reach Psoriasis Area Severity Index (PASI) 90 at 16 Weeks - LOCF Approach (ITT Set) | 81.7 percentage of participants |
95% CI: [-8.8, 6.2]
Secondary
Change From Baseline in Mean Scores of HAD-A and HAD-D (Anxiety and Depression) (LOCF) (FAS)
The Hospital Anxiety and Depression Scale (HADS) is a fourteen-item scale.. Seven of the items relate to anxiety and seven relate to depression. This outcome measure was specifically developed to avoid reliance on aspects of these conditions that are also common somatic symptoms of illness, for example fatigue and insomnia or hypersomnia. Calculations of scores: each of the 14 items was rated on a 4-point scale. All items except 7 and 10 were scored as Yes, definitely = 3, Yes, sometimes = 2, No, not much = 1, to No, not at all = 0. Items 7 and 10 were scored as Yes, definitely = 0 to No, not at all = 3 in the reverse order. The HADS consisted of two sub-scores: the HAD-A (anxiety) and HAD-D (depression); each sub-score ranged from 0 to 21 points; scores ≥11 = presence of anxious or depressive disorders; scores between 8-10 points = borderline abnormal, and scores of ≤7 = disorder was not present. It was pre-specified that results would be presented for all patients, not by cohort
Time frame: Baseline up approximately 72 weeks
Population: Number of patients varies by visit. Both arms were combined because there is no clinical rationale to show a difference between the cohorts. Cw6 status does not have any impact on anxiety and depression.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cw6-positive AIN457 300 mg | Change From Baseline in Mean Scores of HAD-A and HAD-D (Anxiety and Depression) (LOCF) (FAS) | W16 Anxiety | -1.7 numbers on a scale | Standard Deviation 3.37 |
| Cw6-positive AIN457 300 mg | Change From Baseline in Mean Scores of HAD-A and HAD-D (Anxiety and Depression) (LOCF) (FAS) | W24 Anxiety | -2.0 numbers on a scale | Standard Deviation 3.38 |
| Cw6-positive AIN457 300 mg | Change From Baseline in Mean Scores of HAD-A and HAD-D (Anxiety and Depression) (LOCF) (FAS) | W48 Anxiety | -2.5 numbers on a scale | Standard Deviation 3.67 |
| Cw6-positive AIN457 300 mg | Change From Baseline in Mean Scores of HAD-A and HAD-D (Anxiety and Depression) (LOCF) (FAS) | W72 Anxiety | -2.3 numbers on a scale | Standard Deviation 3.44 |
| Cw6-positive AIN457 300 mg | Change From Baseline in Mean Scores of HAD-A and HAD-D (Anxiety and Depression) (LOCF) (FAS) | W16 Depression | -1.3 numbers on a scale | Standard Deviation 3.19 |
| Cw6-positive AIN457 300 mg | Change From Baseline in Mean Scores of HAD-A and HAD-D (Anxiety and Depression) (LOCF) (FAS) | W24 Depression | -1.4 numbers on a scale | Standard Deviation 3.22 |
| Cw6-positive AIN457 300 mg | Change From Baseline in Mean Scores of HAD-A and HAD-D (Anxiety and Depression) (LOCF) (FAS) | W48 Depression | -1.5 numbers on a scale | Standard Deviation 3.31 |
| Cw6-positive AIN457 300 mg | Change From Baseline in Mean Scores of HAD-A and HAD-D (Anxiety and Depression) (LOCF) (FAS) | W72 Depression | -1.7 numbers on a scale | Standard Deviation 3.19 |
p-value: <0.0001Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in the Dermatology Life Quality Index (DLQI) (LOCF) (FAS)
The DLQI total score was calculated by summing the score of each domain resulting in a maximum of 30 and a minimum of 0. The higher the score, the more Quality of Life was impaired. Meaning of DLQI Scores: 0-1 = no effect at all on patient's life, 2-5 = small effect on patient's life, 6-10 = moderate effect on patient's life, 11-20= very large effect on patient's life, 21-30 = extremely large effect on patient's life. It was pre-specified that results would be presented for all patients, not by cohort
Time frame: Baseline up to approximatly 72 weeks
Population: Number of patients varied across visits. Both arms were combined because there is no clinical rationale to show a difference between the cohorts. Cw6 status does not have any impact on Quality of Life.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cw6-positive AIN457 300 mg | Change From Baseline in the Dermatology Life Quality Index (DLQI) (LOCF) (FAS) | Week 24 | -8.8 numbers in a score | Standard Deviation 7.05 |
| Cw6-positive AIN457 300 mg | Change From Baseline in the Dermatology Life Quality Index (DLQI) (LOCF) (FAS) | Week 16 | -8.5 numbers in a score | Standard Deviation 6.79 |
| Cw6-positive AIN457 300 mg | Change From Baseline in the Dermatology Life Quality Index (DLQI) (LOCF) (FAS) | Week 48 | -8.9 numbers in a score | Standard Deviation 7.13 |
| Cw6-positive AIN457 300 mg | Change From Baseline in the Dermatology Life Quality Index (DLQI) (LOCF) (FAS) | Week 72 | -8.3 numbers in a score | Standard Deviation 6.7 |
p-value: <0.0001Wilcoxon (Mann-Whitney)
Secondary
Changes From Baseline in Body Mass Index (Safety Set)
Change in Body mass index from baseline for patients with a value at baseline and the respective post-baseline visit
Time frame: Baseline up to approximately 72 weeks
Population: Number of patients varied across visits
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cw6-positive AIN457 300 mg | Changes From Baseline in Body Mass Index (Safety Set) | Week 16 | -0.064 kg/m2 | Standard Deviation 0.7748 |
| Cw6-positive AIN457 300 mg | Changes From Baseline in Body Mass Index (Safety Set) | Week 24 | 0.086 kg/m2 | Standard Deviation 1.0213 |
| Cw6-positive AIN457 300 mg | Changes From Baseline in Body Mass Index (Safety Set) | Week 48 | 0.302 kg/m2 | Standard Deviation 1.3474 |
| Cw6-positive AIN457 300 mg | Changes From Baseline in Body Mass Index (Safety Set) | Week 72 | 0.533 kg/m2 | Standard Deviation 1.8101 |
| Cw6-negative AIN457 300 mg | Changes From Baseline in Body Mass Index (Safety Set) | Week 72 | -0.015 kg/m2 | Standard Deviation 1.8982 |
| Cw6-negative AIN457 300 mg | Changes From Baseline in Body Mass Index (Safety Set) | Week 16 | -0.047 kg/m2 | Standard Deviation 0.9905 |
| Cw6-negative AIN457 300 mg | Changes From Baseline in Body Mass Index (Safety Set) | Week 48 | -0.052 kg/m2 | Standard Deviation 1.4991 |
| Cw6-negative AIN457 300 mg | Changes From Baseline in Body Mass Index (Safety Set) | Week 24 | -0.071 kg/m2 | Standard Deviation 1.226 |
Secondary
Changes From Baseline in Waist Circumference (Safety Set)
Change in waist circumference from baseline for patients with a value at baseline and the respective post-baseline visit
Time frame: Baseline up to approximately 72 weeks
Population: Number of patients varied across visits
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cw6-positive AIN457 300 mg | Changes From Baseline in Waist Circumference (Safety Set) | Week 16 | -0.86 cm | Standard Deviation 3.147 |
| Cw6-positive AIN457 300 mg | Changes From Baseline in Waist Circumference (Safety Set) | Week 24 | -0.81 cm | Standard Deviation 3.689 |
| Cw6-positive AIN457 300 mg | Changes From Baseline in Waist Circumference (Safety Set) | Week 48 | -0.76 cm | Standard Deviation 4.596 |
| Cw6-positive AIN457 300 mg | Changes From Baseline in Waist Circumference (Safety Set) | Week 72 | -1.81 cm | Standard Deviation 4.583 |
| Cw6-negative AIN457 300 mg | Changes From Baseline in Waist Circumference (Safety Set) | Week 72 | -0.47 cm | Standard Deviation 4.501 |
| Cw6-negative AIN457 300 mg | Changes From Baseline in Waist Circumference (Safety Set) | Week 16 | -0.40 cm | Standard Deviation 3.006 |
| Cw6-negative AIN457 300 mg | Changes From Baseline in Waist Circumference (Safety Set) | Week 48 | -0.72 cm | Standard Deviation 5.547 |
| Cw6-negative AIN457 300 mg | Changes From Baseline in Waist Circumference (Safety Set) | Week 24 | -0.73 cm | Standard Deviation 4.119 |
Secondary
Changes From Baseline in Weight (Safety Set)
Change in weight from baseline for patients with a value at baseline and the respective post-baseline visit
Time frame: Baseline up to approximately 72 weeks
Population: Number of patients varied across visits
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cw6-positive AIN457 300 mg | Changes From Baseline in Weight (Safety Set) | Week 16 | -0.20 kg | Standard Deviation 2.242 |
| Cw6-positive AIN457 300 mg | Changes From Baseline in Weight (Safety Set) | Week 24 | 0.24 kg | Standard Deviation 3.008 |
| Cw6-positive AIN457 300 mg | Changes From Baseline in Weight (Safety Set) | Week 48 | 0.87 kg | Standard Deviation 3.909 |
| Cw6-positive AIN457 300 mg | Changes From Baseline in Weight (Safety Set) | Week 72 | 1.40 kg | Standard Deviation 4.678 |
| Cw6-negative AIN457 300 mg | Changes From Baseline in Weight (Safety Set) | Week 72 | -0.05 kg | Standard Deviation 5.538 |
| Cw6-negative AIN457 300 mg | Changes From Baseline in Weight (Safety Set) | Week 16 | -0.13 kg | Standard Deviation 2.809 |
| Cw6-negative AIN457 300 mg | Changes From Baseline in Weight (Safety Set) | Week 48 | -0.15 kg | Standard Deviation 4.329 |
| Cw6-negative AIN457 300 mg | Changes From Baseline in Weight (Safety Set) | Week 24 | -0.21 kg | Standard Deviation 3.572 |
Secondary
Correlation Between the Hospital Anxiety and Depression Scale (HADS) and PASI (FAS)
PASI score, HADS questionnaire correlation using Spearman rank correlation coefficient. It was pre-specified that results would be presented for all patients, not by cohort
Time frame: Baseline up to approximately 72 weeks
Population: Both arms were combined because there is no clinical rationale to show a difference between the cohorts. Cw6 status does not have any impact on anxiety and depression.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cw6-positive AIN457 300 mg | Correlation Between the Hospital Anxiety and Depression Scale (HADS) and PASI (FAS) | Baseline | 0.02 numbers on scores |
| Cw6-positive AIN457 300 mg | Correlation Between the Hospital Anxiety and Depression Scale (HADS) and PASI (FAS) | Week 16 | 0.19 numbers on scores |
| Cw6-positive AIN457 300 mg | Correlation Between the Hospital Anxiety and Depression Scale (HADS) and PASI (FAS) | Week 24 | 0.18 numbers on scores |
| Cw6-positive AIN457 300 mg | Correlation Between the Hospital Anxiety and Depression Scale (HADS) and PASI (FAS) | Week 48 | 0.21 numbers on scores |
| Cw6-positive AIN457 300 mg | Correlation Between the Hospital Anxiety and Depression Scale (HADS) and PASI (FAS) | Week 72 | 0.32 numbers on scores |
Secondary
Median Time to Reach PASI 90 and 75 (ITT)
Time in days to reach PASI scores of 90 and 75.
Time frame: Baseline up to approximately 72 weeks
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cw6-positive AIN457 300 mg | Median Time to Reach PASI 90 and 75 (ITT) | PASI 90 | 57 days |
| Cw6-positive AIN457 300 mg | Median Time to Reach PASI 90 and 75 (ITT) | PASI 75 | 29 days |
| Cw6-negative AIN457 300 mg | Median Time to Reach PASI 90 and 75 (ITT) | PASI 90 | 58 days |
| Cw6-negative AIN457 300 mg | Median Time to Reach PASI 90 and 75 (ITT) | PASI 75 | 29 days |
p-value: 0.1295Log Rank
p-value: 0.447Log Rank
Secondary
Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set)
IGA mod 2011 scale measures severity of the psoriasis on a five-point scale ranging from 0 (no disease, 'clear') to 4 ('very severe'). PASI 50,75,90,100 represent: patients achieving ≥ 50% improvement (reduction) in PASI score compared to baseline, ≥ 75% improvement (reduction), ≥ 90% improvement (reduction) and PASI 100 response/remission: complete clearing of psoriasis (PASI=0).
Time frame: Baseline up to approximately 72 weeks
Population: Number of patients varied across visits
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cw6-positive AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | W8 PASI 75 | 84.8 percentage of participants |
| Cw6-positive AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | W2 PASI 50 | 44.0 percentage of participants |
| Cw6-positive AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK24 PASI 90 | 84.2 percentage of participants |
| Cw6-positive AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | W8 PASI 90 | 61.4 percentage of participants |
| Cw6-positive AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | W2 PASI 75 | 15.8 percentage of participants |
| Cw6-positive AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK24 PASI 75 | 94.6 percentage of participants |
| Cw6-positive AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | W8 PASI 100 | 34.8 percentage of participants |
| Cw6-positive AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK48 PASI 75 | 93.9 percentage of participants |
| Cw6-positive AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK24 PASI 50 | 97.3 percentage of participants |
| Cw6-positive AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK12 IGA 0/1 | 81.0 percentage of participants |
| Cw6-positive AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK60 PASI 90 | 82.5 percentage of participants |
| Cw6-positive AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK24 IGA 0/1 | 89.7 percentage of participants |
| Cw6-positive AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK12 PASI 50 | 97.3 percentage of participants |
| Cw6-positive AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | W2 PASI 90 | 3.3 percentage of participants |
| Cw6-positive AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK20 PASI 100 | 59.8 percentage of participants |
| Cw6-positive AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK60 PASI 75 | 90.0 percentage of participants |
| Cw6-positive AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK20 PASI 90 | 81.0 percentage of participants |
| Cw6-positive AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | W2 PASI 100 | 0.5 percentage of participants |
| Cw6-positive AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK20 PASI 75 | 94.6 percentage of participants |
| Cw6-positive AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK12 PASI 100 | 49.5 percentage of participants |
| Cw6-positive AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | W1 IGA 0/1 | 2.2 percentage of participants |
| Cw6-positive AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK20 PASI 50 | 97.8 percentage of participants |
| Cw6-positive AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK16 IGA 0/1 | 85.3 percentage of participants |
| Cw6-positive AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK60 PASI 50 | 96.3 percentage of participants |
| Cw6-positive AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK20 IGA0/1 | 87.0 percentage of participants |
| Cw6-positive AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK16 PASI 50 | 97.8 percentage of participants |
| Cw6-positive AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | W3 IGA 0/1 | 24.5 percentage of participants |
| Cw6-positive AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK16 PASI 100 | 59.2 percentage of participants |
| Cw6-positive AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK16 PASI 75 | 94.0 percentage of participants |
| Cw6-positive AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK72 PASI 100 | 58.5 percentage of participants |
| Cw6-positive AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK16 PASI 90 | 80.4 percentage of participants |
| Cw6-positive AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK60 IGA 0/1 | 87.5 percentage of participants |
| Cw6-positive AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | W3 PASI 50 | 76.1 percentage of participants |
| Cw6-positive AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK72 PASI 75 | 85.4 percentage of participants |
| Cw6-positive AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK48 PASI 100 | 68.7 percentage of participants |
| Cw6-positive AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | W3 PASI 75 | 38.6 percentage of participants |
| Cw6-positive AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | W1 PASI 50 | 13.4 percentage of participants |
| Cw6-positive AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK48 PASI 90 | 84.3 percentage of participants |
| Cw6-positive AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | W3 PASI 90 | 13.0 percentage of participants |
| Cw6-positive AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK72 PASI 90 | 75.6 percentage of participants |
| Cw6-positive AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK48 PASI 50 | 98.3 percentage of participants |
| Cw6-positive AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | W3 PASI 100 | 2.7 percentage of participants |
| Cw6-positive AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK72 PASI 50 | 92.7 percentage of participants |
| Cw6-positive AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK48 IGA 0/1 | 87.8 percentage of participants |
| Cw6-positive AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | W4 IGA 0/1 | 42.4 percentage of participants |
| Cw6-positive AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | W4 PASI 50 | 87.5 percentage of participants |
| Cw6-positive AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | W1 PASI 75 | 2.2 percentage of participants |
| Cw6-positive AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK36 PASI 100 | 65.8 percentage of participants |
| Cw6-positive AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | W4 PASI 75 | 61.4 percentage of participants |
| Cw6-positive AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK12 PASI 75 | 92.9 percentage of participants |
| Cw6-positive AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK36 PASI 90 | 88.8 percentage of participants |
| Cw6-positive AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | W4 PASI 90 | 27.7 percentage of participants |
| Cw6-positive AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK72 IGA 0/1 | 85.4 percentage of participants |
| Cw6-positive AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK36 PASI 75 | 94.4 percentage of participants |
| Cw6-positive AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | W4 PASI 100 | 10.3 percentage of participants |
| Cw6-positive AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | W2 IGA 0/1 | 8.7 percentage of participants |
| Cw6-positive AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK36 PASI 50 | 98.8 percentage of participants |
| Cw6-positive AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | W8 IGA 0/1 | 72.3 percentage of participants |
| Cw6-positive AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK12 PASI 90 | 72.8 percentage of participants |
| Cw6-positive AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK36 IGA 0/1 | 91.9 percentage of participants |
| Cw6-positive AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | W8 PASI 50 | 95.7 percentage of participants |
| Cw6-positive AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK60 PASI 100 | 65.0 percentage of participants |
| Cw6-positive AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK24 PASI 100 | 62.0 percentage of participants |
| Cw6-negative AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | W2 PASI 50 | 44.5 percentage of participants |
| Cw6-negative AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | W2 PASI 90 | 2.4 percentage of participants |
| Cw6-negative AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | W4 IGA 0/1 | 39.8 percentage of participants |
| Cw6-negative AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | W1 IGA 0/1 | 2.1 percentage of participants |
| Cw6-negative AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | W1 PASI 50 | 12.1 percentage of participants |
| Cw6-negative AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | W1 PASI 75 | 0.4 percentage of participants |
| Cw6-negative AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | W2 IGA 0/1 | 6.9 percentage of participants |
| Cw6-negative AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | W2 PASI 75 | 10.2 percentage of participants |
| Cw6-negative AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | W2 PASI 100 | 0.4 percentage of participants |
| Cw6-negative AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | W3 IGA 0/1 | 21.1 percentage of participants |
| Cw6-negative AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | W3 PASI 50 | 71.8 percentage of participants |
| Cw6-negative AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | W3 PASI 75 | 34.3 percentage of participants |
| Cw6-negative AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | W3 PASI 90 | 11.4 percentage of participants |
| Cw6-negative AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | W3 PASI 100 | 2.4 percentage of participants |
| Cw6-negative AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | W4 PASI 50 | 87.4 percentage of participants |
| Cw6-negative AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | W4 PASI 75 | 57.3 percentage of participants |
| Cw6-negative AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | W4 PASI 90 | 22.0 percentage of participants |
| Cw6-negative AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | W4 PASI 100 | 9.8 percentage of participants |
| Cw6-negative AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | W8 IGA 0/1 | 73.2 percentage of participants |
| Cw6-negative AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | W8 PASI 50 | 95.1 percentage of participants |
| Cw6-negative AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | W8 PASI 75 | 85.0 percentage of participants |
| Cw6-negative AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | W8 PASI 90 | 60.6 percentage of participants |
| Cw6-negative AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | W8 PASI 100 | 34.6 percentage of participants |
| Cw6-negative AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK12 IGA 0/1 | 81.7 percentage of participants |
| Cw6-negative AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK12 PASI 50 | 97.2 percentage of participants |
| Cw6-negative AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK12 PASI 75 | 90.7 percentage of participants |
| Cw6-negative AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK12 PASI 90 | 73.6 percentage of participants |
| Cw6-negative AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK12 PASI 100 | 43.9 percentage of participants |
| Cw6-negative AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK16 IGA 0/1 | 86.2 percentage of participants |
| Cw6-negative AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK16 PASI 50 | 98.8 percentage of participants |
| Cw6-negative AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK16 PASI 75 | 93.1 percentage of participants |
| Cw6-negative AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK16 PASI 90 | 81.7 percentage of participants |
| Cw6-negative AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK16 PASI 100 | 53.3 percentage of participants |
| Cw6-negative AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK20 IGA0/1 | 87.4 percentage of participants |
| Cw6-negative AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK20 PASI 50 | 97.6 percentage of participants |
| Cw6-negative AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK20 PASI 75 | 92.7 percentage of participants |
| Cw6-negative AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK20 PASI 90 | 81.7 percentage of participants |
| Cw6-negative AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK20 PASI 100 | 57.3 percentage of participants |
| Cw6-negative AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK24 IGA 0/1 | 85.4 percentage of participants |
| Cw6-negative AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK24 PASI 50 | 97.2 percentage of participants |
| Cw6-negative AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK24 PASI 75 | 93.1 percentage of participants |
| Cw6-negative AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK24 PASI 90 | 83.3 percentage of participants |
| Cw6-negative AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK24 PASI 100 | 61.4 percentage of participants |
| Cw6-negative AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK36 IGA 0/1 | 90.9 percentage of participants |
| Cw6-negative AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK36 PASI 50 | 99.1 percentage of participants |
| Cw6-negative AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK36 PASI 75 | 95.0 percentage of participants |
| Cw6-negative AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK36 PASI 90 | 84.0 percentage of participants |
| Cw6-negative AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK36 PASI 100 | 64.4 percentage of participants |
| Cw6-negative AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK48 IGA 0/1 | 86.8 percentage of participants |
| Cw6-negative AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK48 PASI 50 | 98.1 percentage of participants |
| Cw6-negative AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK48 PASI 75 | 91.2 percentage of participants |
| Cw6-negative AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK48 PASI 90 | 80.5 percentage of participants |
| Cw6-negative AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK48 PASI 100 | 61.6 percentage of participants |
| Cw6-negative AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK60 IGA 0/1 | 83.9 percentage of participants |
| Cw6-negative AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK60 PASI 50 | 95.0 percentage of participants |
| Cw6-negative AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK60 PASI 75 | 89.9 percentage of participants |
| Cw6-negative AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK60 PASI 90 | 74.8 percentage of participants |
| Cw6-negative AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK60 PASI 100 | 56.3 percentage of participants |
| Cw6-negative AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK72 IGA 0/1 | 80.0 percentage of participants |
| Cw6-negative AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK72 PASI 50 | 93.4 percentage of participants |
| Cw6-negative AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK72 PASI 75 | 88.5 percentage of participants |
| Cw6-negative AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK72 PASI 90 | 73.8 percentage of participants |
| Cw6-negative AIN457 300 mg | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK72 PASI 100 | 50.8 percentage of participants |
| Difference in % (Cw6-pos vs Cw6-neg) | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK24 PASI 90 | 0.91 percentage of participants |
| Difference in % (Cw6-pos vs Cw6-neg) | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | W8 PASI 50 | 0.53 percentage of participants |
| Difference in % (Cw6-pos vs Cw6-neg) | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | W2 PASI 75 | 5.56 percentage of participants |
| Difference in % (Cw6-pos vs Cw6-neg) | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK24 PASI 100 | 0.57 percentage of participants |
| Difference in % (Cw6-pos vs Cw6-neg) | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | W8 IGA 0/1 | -0.89 percentage of participants |
| Difference in % (Cw6-pos vs Cw6-neg) | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK72 PASI 75 | -3.16 percentage of participants |
| Difference in % (Cw6-pos vs Cw6-neg) | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK36 IGA 0/1 | 1.06 percentage of participants |
| Difference in % (Cw6-pos vs Cw6-neg) | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | W4 PASI 100 | 0.57 percentage of participants |
| Difference in % (Cw6-pos vs Cw6-neg) | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK60 PASI 90 | 7.71 percentage of participants |
| Difference in % (Cw6-pos vs Cw6-neg) | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK36 PASI 50 | -0.33 percentage of participants |
| Difference in % (Cw6-pos vs Cw6-neg) | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | W4 PASI 90 | 5.77 percentage of participants |
| Difference in % (Cw6-pos vs Cw6-neg) | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | W2 IGA 0/1 | 1.79 percentage of participants |
| Difference in % (Cw6-pos vs Cw6-neg) | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK36 PASI 75 | -0.57 percentage of participants |
| Difference in % (Cw6-pos vs Cw6-neg) | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | W4 PASI 75 | 4.10 percentage of participants |
| Difference in % (Cw6-pos vs Cw6-neg) | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | W4 IGA 0/1 | 2.55 percentage of participants |
| Difference in % (Cw6-pos vs Cw6-neg) | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK36 PASI 90 | 4.80 percentage of participants |
| Difference in % (Cw6-pos vs Cw6-neg) | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | W4 PASI 50 | 0.10 percentage of participants |
| Difference in % (Cw6-pos vs Cw6-neg) | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK60 PASI 100 | 8.70 percentage of participants |
| Difference in % (Cw6-pos vs Cw6-neg) | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK36 PASI 100 | 1.45 percentage of participants |
| Difference in % (Cw6-pos vs Cw6-neg) | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | W3 PASI 100 | 0.27 percentage of participants |
| Difference in % (Cw6-pos vs Cw6-neg) | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | W1 PASI 75 | 1.82 percentage of participants |
| Difference in % (Cw6-pos vs Cw6-neg) | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK48 IGA 0/1 | 1.03 percentage of participants |
| Difference in % (Cw6-pos vs Cw6-neg) | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | W3 PASI 90 | 1.61 percentage of participants |
| Difference in % (Cw6-pos vs Cw6-neg) | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK72 PASI 100 | 7.72 percentage of participants |
| Difference in % (Cw6-pos vs Cw6-neg) | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK48 PASI 50 | 0.15 percentage of participants |
| Difference in % (Cw6-pos vs Cw6-neg) | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK72 IGA 0/1 | 5.37 percentage of participants |
| Difference in % (Cw6-pos vs Cw6-neg) | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK48 PASI 75 | 2.72 percentage of participants |
| Difference in % (Cw6-pos vs Cw6-neg) | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | W3 PASI 75 | 4.30 percentage of participants |
| Difference in % (Cw6-pos vs Cw6-neg) | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | W1 PASI 50 | 1.32 percentage of participants |
| Difference in % (Cw6-pos vs Cw6-neg) | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK48 PASI 90 | 3.84 percentage of participants |
| Difference in % (Cw6-pos vs Cw6-neg) | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | W3 PASI 50 | 4.25 percentage of participants |
| Difference in % (Cw6-pos vs Cw6-neg) | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK16 PASI 75 | 0.93 percentage of participants |
| Difference in % (Cw6-pos vs Cw6-neg) | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK72 PASI 90 | 1.84 percentage of participants |
| Difference in % (Cw6-pos vs Cw6-neg) | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK16 PASI 90 | -1.27 percentage of participants |
| Difference in % (Cw6-pos vs Cw6-neg) | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK16 PASI 50 | -0.95 percentage of participants |
| Difference in % (Cw6-pos vs Cw6-neg) | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK48 PASI 100 | 7.06 percentage of participants |
| Difference in % (Cw6-pos vs Cw6-neg) | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK16 PASI 100 | 5.99 percentage of participants |
| Difference in % (Cw6-pos vs Cw6-neg) | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK16 IGA 0/1 | -0.85 percentage of participants |
| Difference in % (Cw6-pos vs Cw6-neg) | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | W3 IGA 0/1 | 3.32 percentage of participants |
| Difference in % (Cw6-pos vs Cw6-neg) | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK20 IGA0/1 | -0.44 percentage of participants |
| Difference in % (Cw6-pos vs Cw6-neg) | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK12 PASI 100 | 5.55 percentage of participants |
| Difference in % (Cw6-pos vs Cw6-neg) | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK72 PASI 50 | -0.76 percentage of participants |
| Difference in % (Cw6-pos vs Cw6-neg) | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK20 PASI 50 | 0.27 percentage of participants |
| Difference in % (Cw6-pos vs Cw6-neg) | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK12 PASI 90 | -0.75 percentage of participants |
| Difference in % (Cw6-pos vs Cw6-neg) | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK60 IGA 0/1 | 3.60 percentage of participants |
| Difference in % (Cw6-pos vs Cw6-neg) | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK20 PASI 75 | 1.88 percentage of participants |
| Difference in % (Cw6-pos vs Cw6-neg) | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK12 PASI 75 | 2.28 percentage of participants |
| Difference in % (Cw6-pos vs Cw6-neg) | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | W2 PASI 100 | 0.14 percentage of participants |
| Difference in % (Cw6-pos vs Cw6-neg) | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK20 PASI 90 | -0.73 percentage of participants |
| Difference in % (Cw6-pos vs Cw6-neg) | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK12 PASI 50 | 0.13 percentage of participants |
| Difference in % (Cw6-pos vs Cw6-neg) | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | W1 IGA 0/1 | 0.16 percentage of participants |
| Difference in % (Cw6-pos vs Cw6-neg) | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK20 PASI 100 | 2.47 percentage of participants |
| Difference in % (Cw6-pos vs Cw6-neg) | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK12 IGA 0/1 | -0.73 percentage of participants |
| Difference in % (Cw6-pos vs Cw6-neg) | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK60 PASI 50 | 1.29 percentage of participants |
| Difference in % (Cw6-pos vs Cw6-neg) | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK24 IGA 0/1 | 4.31 percentage of participants |
| Difference in % (Cw6-pos vs Cw6-neg) | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | W8 PASI 100 | 0.23 percentage of participants |
| Difference in % (Cw6-pos vs Cw6-neg) | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | W2 PASI 90 | 0.81 percentage of participants |
| Difference in % (Cw6-pos vs Cw6-neg) | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK24 PASI 50 | 0.13 percentage of participants |
| Difference in % (Cw6-pos vs Cw6-neg) | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | W8 PASI 90 | 0.84 percentage of participants |
| Difference in % (Cw6-pos vs Cw6-neg) | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | W2 PASI 50 | -0.47 percentage of participants |
| Difference in % (Cw6-pos vs Cw6-neg) | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK24 PASI 75 | 1.48 percentage of participants |
| Difference in % (Cw6-pos vs Cw6-neg) | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | W8 PASI 75 | -0.18 percentage of participants |
| Difference in % (Cw6-pos vs Cw6-neg) | Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) | WK60 PASI 75 | 0.08 percentage of participants |
Secondary
Percent Mean Changes From Baseline in IGA Mod 2011 Between Cohorts at Each Time Point (LOCF) (ITT)
IGA mod 2011 scale measures severity of the psoriasis on a five-point scale ranging from 0 (no disease, 'clear') to 4 ('very severe').
Time frame: Baseline up to approximately 72 weeks
Population: The number of patients across visits varied
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cw6-positive AIN457 300 mg | Percent Mean Changes From Baseline in IGA Mod 2011 Between Cohorts at Each Time Point (LOCF) (ITT) | W12 | -78.7 percent change | Standard Deviation 27.31 |
| Cw6-positive AIN457 300 mg | Percent Mean Changes From Baseline in IGA Mod 2011 Between Cohorts at Each Time Point (LOCF) (ITT) | W72 | -79.1 percent change | Standard Deviation 32.92 |
| Cw6-positive AIN457 300 mg | Percent Mean Changes From Baseline in IGA Mod 2011 Between Cohorts at Each Time Point (LOCF) (ITT) | W20 | -85.3 percent change | Standard Deviation 24.26 |
| Cw6-positive AIN457 300 mg | Percent Mean Changes From Baseline in IGA Mod 2011 Between Cohorts at Each Time Point (LOCF) (ITT) | W1 | -8.5 percent change | Standard Deviation 16.08 |
| Cw6-positive AIN457 300 mg | Percent Mean Changes From Baseline in IGA Mod 2011 Between Cohorts at Each Time Point (LOCF) (ITT) | W36 | -88.6 percent change | Standard Deviation 22.34 |
| Cw6-positive AIN457 300 mg | Percent Mean Changes From Baseline in IGA Mod 2011 Between Cohorts at Each Time Point (LOCF) (ITT) | W2 | -22.4 percent change | Standard Deviation 22.73 |
| Cw6-positive AIN457 300 mg | Percent Mean Changes From Baseline in IGA Mod 2011 Between Cohorts at Each Time Point (LOCF) (ITT) | W24 | -86.2 percent change | Standard Deviation 25.17 |
| Cw6-positive AIN457 300 mg | Percent Mean Changes From Baseline in IGA Mod 2011 Between Cohorts at Each Time Point (LOCF) (ITT) | W3 | -38.0 percent change | Standard Deviation 25.45 |
| Cw6-positive AIN457 300 mg | Percent Mean Changes From Baseline in IGA Mod 2011 Between Cohorts at Each Time Point (LOCF) (ITT) | W48 | -86.2 percent change | Standard Deviation 25.75 |
| Cw6-positive AIN457 300 mg | Percent Mean Changes From Baseline in IGA Mod 2011 Between Cohorts at Each Time Point (LOCF) (ITT) | W4 | -49.6 percent change | Standard Deviation 29.36 |
| Cw6-positive AIN457 300 mg | Percent Mean Changes From Baseline in IGA Mod 2011 Between Cohorts at Each Time Point (LOCF) (ITT) | W16 | -84.1 percent change | Standard Deviation 24.52 |
| Cw6-positive AIN457 300 mg | Percent Mean Changes From Baseline in IGA Mod 2011 Between Cohorts at Each Time Point (LOCF) (ITT) | W8 | -71.2 percent change | Standard Deviation 28.6 |
| Cw6-positive AIN457 300 mg | Percent Mean Changes From Baseline in IGA Mod 2011 Between Cohorts at Each Time Point (LOCF) (ITT) | W60 | -83.3 percent change | Standard Deviation 28.44 |
| Cw6-negative AIN457 300 mg | Percent Mean Changes From Baseline in IGA Mod 2011 Between Cohorts at Each Time Point (LOCF) (ITT) | W8 | -71.2 percent change | Standard Deviation 28.91 |
| Cw6-negative AIN457 300 mg | Percent Mean Changes From Baseline in IGA Mod 2011 Between Cohorts at Each Time Point (LOCF) (ITT) | W36 | -87.6 percent change | Standard Deviation 23.82 |
| Cw6-negative AIN457 300 mg | Percent Mean Changes From Baseline in IGA Mod 2011 Between Cohorts at Each Time Point (LOCF) (ITT) | W12 | -79.0 percent change | Standard Deviation 25.37 |
| Cw6-negative AIN457 300 mg | Percent Mean Changes From Baseline in IGA Mod 2011 Between Cohorts at Each Time Point (LOCF) (ITT) | W16 | -83.3 percent change | Standard Deviation 22.97 |
| Cw6-negative AIN457 300 mg | Percent Mean Changes From Baseline in IGA Mod 2011 Between Cohorts at Each Time Point (LOCF) (ITT) | W20 | -84.5 percent change | Standard Deviation 23.8 |
| Cw6-negative AIN457 300 mg | Percent Mean Changes From Baseline in IGA Mod 2011 Between Cohorts at Each Time Point (LOCF) (ITT) | W48 | -84.9 percent change | Standard Deviation 26.06 |
| Cw6-negative AIN457 300 mg | Percent Mean Changes From Baseline in IGA Mod 2011 Between Cohorts at Each Time Point (LOCF) (ITT) | W60 | -81.0 percent change | Standard Deviation 26.97 |
| Cw6-negative AIN457 300 mg | Percent Mean Changes From Baseline in IGA Mod 2011 Between Cohorts at Each Time Point (LOCF) (ITT) | W72 | -75.8 percent change | Standard Deviation 29.58 |
| Cw6-negative AIN457 300 mg | Percent Mean Changes From Baseline in IGA Mod 2011 Between Cohorts at Each Time Point (LOCF) (ITT) | W1 | -7.3 percent change | Standard Deviation 17.04 |
| Cw6-negative AIN457 300 mg | Percent Mean Changes From Baseline in IGA Mod 2011 Between Cohorts at Each Time Point (LOCF) (ITT) | W2 | -21.6 percent change | Standard Deviation 22.72 |
| Cw6-negative AIN457 300 mg | Percent Mean Changes From Baseline in IGA Mod 2011 Between Cohorts at Each Time Point (LOCF) (ITT) | W3 | -36.5 percent change | Standard Deviation 27.2 |
| Cw6-negative AIN457 300 mg | Percent Mean Changes From Baseline in IGA Mod 2011 Between Cohorts at Each Time Point (LOCF) (ITT) | W4 | -49.5 percent change | Standard Deviation 29.24 |
| Cw6-negative AIN457 300 mg | Percent Mean Changes From Baseline in IGA Mod 2011 Between Cohorts at Each Time Point (LOCF) (ITT) | W24 | -84.1 percent change | Standard Deviation 26.34 |