Chronic Plaque Psoriasis
Conditions
Keywords
Psoriasis,, inflammatory skin disease,, scaly patches, Psoriasis, inflammatory skin disease
Brief summary
This study will assess the safety and efficacy of secukinumab compared to placebo and etanercept in patients that have moderate to severe, chronic, plaque-type psoriasis.
Interventions
DRUGPlacebo
Placebo to Match secukinumab (AIN457) 150mg or 300mg or Placebo to match etanercept
secukinumab (AIN457) 150mg or 300mg subcutaneous
DRUGetanercept
etanercept 50mg subcutaneous
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 with chronic, plaque-type psoriasis for at least 6 months * Must have moderate to severe psoriasis based on PASI greater than 12, IGA greater than 3, and greater than 10% body surface area * Must be inadequately controlled by prior treatments (topicals, phototherapy, and/or systemic therapies)
Exclusion criteria
* Forms of psoriasis other than chronic, plaque-type (such as pustular, erythrodermic and guttate psoriasis) * Drug induced psoriasis * Use of other psoriasis treatments during the study * Prior use of etanercept * Prior use of secukinumab or any other drug that target IL-17 (interleukin 17) or the IL-17 receptor * Pregnant or lactating women; women who do not agree to use contraception during the study and for 16 weeks after stopping treatment * Significant medical problems such as uncontrolled high blood pressure, congestive heart failure, etc. * History of an ongoing, chronic or recurrent infection or evidence of tuberculosis * Allergy to rubber or latex Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 75 (Psoriasis Area and Severity Index) . | 12 wks | A 75% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 75) is the current benchmark of primary endpoints for most clinical trials of psoriasis |
| Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure:IGA (Investigator's Global Assessment) Mod 2011 With a 0 or 1 Response at Week 12 | 12 wks | The IGA mod 2011 scale has been developed based on a previous version of the scale used in secukinumab phase II studies in collaboration with health authorities, in particular the FDA. The explanations/descriptions of the points on the scale have been improved to ensure appropriate differentiation between the points. The IGA mod 2011 used in this study is static, i.e. it refers exclusively to the subject's disease state at the time of the assessments, and does not attempt a comparison with any of the subject's previous disease states, whether at baseline or at a previous visit.IGA mod 2011 has a scale of 0-4 with the lower scores correlating to better performance. A score of 0= clear skin, 1= almost clear skin, 2=mild, 3=moderate,4=severe. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: :IGA (Investigator's Global Assessment) Mod 2011 With a 0 or 1 Response at Week 12 | 12 wks | The IGA mod 2011 scale has been developed based on a previous version of the scale used in secukinumab phase II studies in collaboration with health authorities, in particular the FDA. The explanations/descriptions of the points on the scale have been improved to ensure appropriate differentiation between the points. The IGA mod 2011 used in this study is static, i.e. it refers exclusively to the subject's disease state at the time of the assessments, and does not attempt a comparison with any of the subject's previous disease states, whether at baseline or at a previous visit.IGA mod 2011 has a scale of 0-4 with the lower scores correlating to better performance. A score of 0= clear skin, 1= almost clear skin, 2=mild, 3=moderate,4=severe. |
| Maintenance of PASI 75 Response at Week 52 for Patients Who Were PASI 75 Responders at Week 12 (Non-responder Imputation) | 52 wks | — |
| Maintenance of IGA Mod 2011 0 or 1 Response After 52 Weeks of Treatment for Subjects Who Were IGA Mod 2011 0 or 1 Responders After 12 Weeks of Treatment | 52 wks | — |
| Efficacy of Secukinumab Compared to Etanercept and Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 90 at Week 12 | 12 wks | A 90% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 90) is above current benchmark of primary endpoints for most clinical trials of psoriasis |
| Change From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Etanercept | baseline to week 12 | The Psoriasis Symptom Diary©, a 16-item patient reported outcome (PRO) measure developed and validated in accordance with the FDA PRO Guidance (FDA Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims, 2009), demonstrated favorable psychometric properties and usefulness for treatment efficacy evaluation alongside other measures of disease severity in clinical trials for chronic plaque psoriasis.Weekly averages will be derived for each of the 16 questions of the Psoriasis Diary up to Week 12. A weekly average is the sum of the scored item over the course of the study week divided by the number of days on which the item was completed and will be set to missing if four or more daily assessments were missing of the corresponding question. The range for each question is 0 to 10 with the higher score depicting a more progressed disease state. A reduction in score from baseline shows efficacy |
| Number of Participants Developing Anti-secukinumab Antibodies | 60 weeks | Describes the number of participants tested positive for anti-secukinumab antibodies. It refers to the number of patients who had no positive values at baseline but developed them only after start of active study treatment (AIN457 or etanercept) |
| Change in Score From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Placebo | baseline to week 12 | The Psoriasis Symptom Diary©, a 16-item patient reported outcome (PRO) measure developed and validated in accordance with the FDA PRO Guidance (FDA Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims, 2009), demonstrated favorable psychometric properties and usefulness for treatment efficacy evaluation alongside other measures of disease severity in clinical trials for chronic plaque psoriasis.Weekly averages will be derived for each of the 16 questions of the Psoriasis Diary up to Week 12. A weekly average is the sum of the scored item over the course of the study week divided by the number of days on which the item was completed and will be set to missing if four or more daily assessments were missing of the corresponding question. The range for each question is 0 to 10 with the higher score depicting a more progressed disease state. A reduction in score from baseline shows efficacy |
| Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 75 at Week 12 | 12 wks | A 75% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 75) is the current benchmark of primary endpoints for most clinical trials of psoriasis |
Countries
Argentina, Australia, Belgium, Canada, Colombia, Egypt, Finland, France, Germany, Guatemala, Hungary, Iceland, India, Italy, Philippines, Poland, Romania, Singapore, South Korea, Spain, Sweden, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AIN457 150mg AIN457 150mg | 327 |
| AIN457 300mg AIN457 300mg | 327 |
| Placebo Placebo | 326 |
| Etanercept Etanercept | 326 |
| Total | 1,306 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Follow-up Period | Adverse Event | 1 | 1 | 0 | 0 | 0 | 0 |
| Follow-up Period | Lack of Efficacy | 3 | 0 | 4 | 1 | 0 | 0 |
| Follow-up Period | Lost to Follow-up | 0 | 1 | 0 | 4 | 0 | 0 |
| Follow-up Period | non- compliance with study treatment | 1 | 0 | 0 | 0 | 0 | 0 |
| Follow-up Period | Physician Decision | 1 | 1 | 0 | 2 | 0 | 0 |
| Follow-up Period | Pregnancy | 1 | 0 | 0 | 0 | 0 | 0 |
| Follow-up Period | Withdrawal by Subject | 3 | 3 | 1 | 12 | 0 | 0 |
| Induction Period | Adverse Event | 2 | 4 | 2 | 6 | 0 | 0 |
| Induction Period | Lack of Efficacy | 0 | 0 | 9 | 1 | 0 | 0 |
| Induction Period | Lost to Follow-up | 0 | 0 | 1 | 4 | 0 | 0 |
| Induction Period | Physician Decision | 2 | 1 | 2 | 0 | 0 | 0 |
| Induction Period | Protocol Deviation | 3 | 5 | 0 | 3 | 0 | 0 |
| Induction Period | technical problems | 0 | 0 | 1 | 1 | 0 | 0 |
| Induction Period | Withdrawal by Subject | 5 | 5 | 10 | 6 | 0 | 0 |
| Maintenance Period | Adverse Event | 2 | 7 | 0 | 6 | 4 | 3 |
| Maintenance Period | Lack of Efficacy | 10 | 2 | 0 | 11 | 3 | 0 |
| Maintenance Period | Lost to Follow-up | 4 | 0 | 0 | 5 | 1 | 1 |
| Maintenance Period | Non-compliance with study treatment | 3 | 1 | 0 | 2 | 1 | 2 |
| Maintenance Period | Physician Decision | 0 | 1 | 0 | 1 | 0 | 0 |
| Maintenance Period | Pregnancy | 1 | 0 | 0 | 0 | 0 | 0 |
| Maintenance Period | Protocol deviation | 7 | 4 | 0 | 2 | 2 | 2 |
| Maintenance Period | Withdrawal by Subject | 12 | 7 | 2 | 15 | 6 | 3 |
Baseline characteristics
| Characteristic | AIN457 150mg | AIN457 300mg | Placebo | Etanercept | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 23 Participants | 22 Participants | 15 Participants | 18 Participants | 78 Participants |
| Age, Categorical Between 18 and 65 years | 304 Participants | 305 Participants | 311 Participants | 308 Participants | 1228 Participants |
| Age, Continuous | 45.4 years STANDARD_DEVIATION 12.92 | 44.5 years STANDARD_DEVIATION 13.19 | 44.1 years STANDARD_DEVIATION 12.64 | 43.8 years STANDARD_DEVIATION 12.95 | 44.4 years STANDARD_DEVIATION 12.93 |
| Race (NIH/OMB) American Indian or Alaska Native | 28 Participants | 22 Participants | 25 Participants | 27 Participants | 102 Participants |
| Race (NIH/OMB) Asian | 72 Participants | 73 Participants | 72 Participants | 74 Participants | 291 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 2 Participants | 3 Participants | 0 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 5 Participants | 5 Participants | 4 Participants | 19 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) White | 219 Participants | 224 Participants | 218 Participants | 219 Participants | 880 Participants |
| Sex: Female, Male Female | 91 Participants | 103 Participants | 89 Participants | 94 Participants | 377 Participants |
| Sex: Female, Male Male | 236 Participants | 224 Participants | 237 Participants | 232 Participants | 929 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 | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 157 / 327 | 145 / 326 | 121 / 327 | 130 / 323 | 225 / 327 | 230 / 326 | 297 / 469 | 316 / 467 | 122 / 327 | 213 / 323 | 25 / 148 | 11 / 125 | 7 / 27 | 59 / 278 |
| serious Total, serious adverse events | 7 / 327 | 4 / 326 | 6 / 327 | 3 / 323 | 18 / 327 | 21 / 326 | 24 / 469 | 27 / 467 | 7 / 327 | 20 / 323 | 2 / 148 | 2 / 125 | 0 / 27 | 2 / 278 |
Outcome results
Primary
Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure:IGA (Investigator's Global Assessment) Mod 2011 With a 0 or 1 Response at Week 12
The IGA mod 2011 scale has been developed based on a previous version of the scale used in secukinumab phase II studies in collaboration with health authorities, in particular the FDA. The explanations/descriptions of the points on the scale have been improved to ensure appropriate differentiation between the points. The IGA mod 2011 used in this study is static, i.e. it refers exclusively to the subject's disease state at the time of the assessments, and does not attempt a comparison with any of the subject's previous disease states, whether at baseline or at a previous visit.IGA mod 2011 has a scale of 0-4 with the lower scores correlating to better performance. A score of 0= clear skin, 1= almost clear skin, 2=mild, 3=moderate,4=severe.
Time frame: 12 wks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AIN457 150mg | Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure:IGA (Investigator's Global Assessment) Mod 2011 With a 0 or 1 Response at Week 12 | 167 participants acheiving goal |
| AIN457 300mg | Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure:IGA (Investigator's Global Assessment) Mod 2011 With a 0 or 1 Response at Week 12 | 202 participants acheiving goal |
| Placebo | Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure:IGA (Investigator's Global Assessment) Mod 2011 With a 0 or 1 Response at Week 12 | 9 participants acheiving goal |
Primary
Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 75 (Psoriasis Area and Severity Index) .
A 75% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 75) is the current benchmark of primary endpoints for most clinical trials of psoriasis
Time frame: 12 wks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AIN457 150mg | Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 75 (Psoriasis Area and Severity Index) . | 219 participants achieving goal |
| AIN457 300mg | Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 75 (Psoriasis Area and Severity Index) . | 249 participants achieving goal |
| Placebo | Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 75 (Psoriasis Area and Severity Index) . | 16 participants achieving goal |
Secondary
Change From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Etanercept
The Psoriasis Symptom Diary©, a 16-item patient reported outcome (PRO) measure developed and validated in accordance with the FDA PRO Guidance (FDA Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims, 2009), demonstrated favorable psychometric properties and usefulness for treatment efficacy evaluation alongside other measures of disease severity in clinical trials for chronic plaque psoriasis.Weekly averages will be derived for each of the 16 questions of the Psoriasis Diary up to Week 12. A weekly average is the sum of the scored item over the course of the study week divided by the number of days on which the item was completed and will be set to missing if four or more daily assessments were missing of the corresponding question. The range for each question is 0 to 10 with the higher score depicting a more progressed disease state. A reduction in score from baseline shows efficacy
Time frame: baseline to week 12
Population: Full analysis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AIN457 150mg | Change From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Etanercept | Pain | -4.10 Units on a scale | Standard Error 0.268 |
| AIN457 150mg | Change From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Etanercept | Itching | -4.92 Units on a scale | Standard Error 0.277 |
| AIN457 150mg | Change From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Etanercept | Scaling | -4.89 Units on a scale | Standard Error 0.241 |
| AIN457 300mg | Change From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Etanercept | Pain | -4.48 Units on a scale | Standard Error 0.269 |
| AIN457 300mg | Change From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Etanercept | Itching | -4.93 Units on a scale | Standard Error 0.278 |
| AIN457 300mg | Change From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Etanercept | Scaling | -4.93 Units on a scale | Standard Error 0.258 |
| Placebo | Change From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Etanercept | Itching | -3.80 Units on a scale | Standard Error 0.257 |
| Placebo | Change From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Etanercept | Scaling | -3.74 Units on a scale | Standard Error 0.26 |
| Placebo | Change From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Etanercept | Pain | -3.48 Units on a scale | Standard Error 0.251 |
Secondary
Change in Score From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Placebo
The Psoriasis Symptom Diary©, a 16-item patient reported outcome (PRO) measure developed and validated in accordance with the FDA PRO Guidance (FDA Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims, 2009), demonstrated favorable psychometric properties and usefulness for treatment efficacy evaluation alongside other measures of disease severity in clinical trials for chronic plaque psoriasis.Weekly averages will be derived for each of the 16 questions of the Psoriasis Diary up to Week 12. A weekly average is the sum of the scored item over the course of the study week divided by the number of days on which the item was completed and will be set to missing if four or more daily assessments were missing of the corresponding question. The range for each question is 0 to 10 with the higher score depicting a more progressed disease state. A reduction in score from baseline shows efficacy
Time frame: baseline to week 12
Population: Full analysis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AIN457 150mg | Change in Score From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Placebo | Pain | -4.10 units on scale | Standard Error 0.277 |
| AIN457 150mg | Change in Score From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Placebo | Itching | -4.92 units on scale | Standard Error 0.249 |
| AIN457 150mg | Change in Score From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Placebo | Scaling | -4.89 units on scale | Standard Error 0.241 |
| AIN457 300mg | Change in Score From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Placebo | Pain | -4.48 units on scale | Standard Error 0.278 |
| AIN457 300mg | Change in Score From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Placebo | Itching | -4.93 units on scale | Standard Error 0.247 |
| AIN457 300mg | Change in Score From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Placebo | Scaling | -4.93 units on scale | Standard Error 0.258 |
| Placebo | Change in Score From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Placebo | Itching | -0.54 units on scale | Standard Error 0.201 |
| Placebo | Change in Score From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Placebo | Scaling | -0.42 units on scale | Standard Error 0.217 |
| Placebo | Change in Score From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Placebo | Pain | -0.33 units on scale | Standard Error 0.216 |
Secondary
Efficacy of Secukinumab Compared to Etanercept and Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 90 at Week 12
A 90% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 90) is above current benchmark of primary endpoints for most clinical trials of psoriasis
Time frame: 12 wks
Population: FAS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AIN457 150mg | Efficacy of Secukinumab Compared to Etanercept and Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 90 at Week 12 | 137 participant who acheived goal |
| AIN457 300mg | Efficacy of Secukinumab Compared to Etanercept and Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 90 at Week 12 | 175 participant who acheived goal |
| Placebo | Efficacy of Secukinumab Compared to Etanercept and Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 90 at Week 12 | 67 participant who acheived goal |
| Placebo | Efficacy of Secukinumab Compared to Etanercept and Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 90 at Week 12 | 5 participant who acheived goal |
Secondary
Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: :IGA (Investigator's Global Assessment) Mod 2011 With a 0 or 1 Response at Week 12
The IGA mod 2011 scale has been developed based on a previous version of the scale used in secukinumab phase II studies in collaboration with health authorities, in particular the FDA. The explanations/descriptions of the points on the scale have been improved to ensure appropriate differentiation between the points. The IGA mod 2011 used in this study is static, i.e. it refers exclusively to the subject's disease state at the time of the assessments, and does not attempt a comparison with any of the subject's previous disease states, whether at baseline or at a previous visit.IGA mod 2011 has a scale of 0-4 with the lower scores correlating to better performance. A score of 0= clear skin, 1= almost clear skin, 2=mild, 3=moderate,4=severe.
Time frame: 12 wks
Population: FAS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AIN457 150mg | Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: :IGA (Investigator's Global Assessment) Mod 2011 With a 0 or 1 Response at Week 12 | 167 participant acheiving goal |
| AIN457 300mg | Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: :IGA (Investigator's Global Assessment) Mod 2011 With a 0 or 1 Response at Week 12 | 202 participant acheiving goal |
| Placebo | Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: :IGA (Investigator's Global Assessment) Mod 2011 With a 0 or 1 Response at Week 12 | 88 participant acheiving goal |
Secondary
Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 75 at Week 12
A 75% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 75) is the current benchmark of primary endpoints for most clinical trials of psoriasis
Time frame: 12 wks
Population: FAS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AIN457 150mg | Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 75 at Week 12 | 219 participant who acheived goal |
| AIN457 300mg | Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 75 at Week 12 | 249 participant who acheived goal |
| Placebo | Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 75 at Week 12 | 142 participant who acheived goal |
Secondary
Maintenance of IGA Mod 2011 0 or 1 Response After 52 Weeks of Treatment for Subjects Who Were IGA Mod 2011 0 or 1 Responders After 12 Weeks of Treatment
Time frame: 52 wks
Population: Full analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AIN457 150mg | Maintenance of IGA Mod 2011 0 or 1 Response After 52 Weeks of Treatment for Subjects Who Were IGA Mod 2011 0 or 1 Responders After 12 Weeks of Treatment | 113 participants who reached goal |
| AIN457 300mg | Maintenance of IGA Mod 2011 0 or 1 Response After 52 Weeks of Treatment for Subjects Who Were IGA Mod 2011 0 or 1 Responders After 12 Weeks of Treatment | 161 participants who reached goal |
| Placebo | Maintenance of IGA Mod 2011 0 or 1 Response After 52 Weeks of Treatment for Subjects Who Were IGA Mod 2011 0 or 1 Responders After 12 Weeks of Treatment | 50 participants who reached goal |
Secondary
Maintenance of PASI 75 Response at Week 52 for Patients Who Were PASI 75 Responders at Week 12 (Non-responder Imputation)
Time frame: 52 wks
Population: Full analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AIN457 150mg | Maintenance of PASI 75 Response at Week 52 for Patients Who Were PASI 75 Responders at Week 12 (Non-responder Imputation) | 180 participants who reached goal |
| AIN457 300mg | Maintenance of PASI 75 Response at Week 52 for Patients Who Were PASI 75 Responders at Week 12 (Non-responder Imputation) | 210 participants who reached goal |
| Placebo | Maintenance of PASI 75 Response at Week 52 for Patients Who Were PASI 75 Responders at Week 12 (Non-responder Imputation) | 103 participants who reached goal |
Secondary
Number of Participants Developing Anti-secukinumab Antibodies
Describes the number of participants tested positive for anti-secukinumab antibodies. It refers to the number of patients who had no positive values at baseline but developed them only after start of active study treatment (AIN457 or etanercept)
Time frame: 60 weeks
Population: Full Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AIN457 150mg | Number of Participants Developing Anti-secukinumab Antibodies | 2 # participants tested positive |
| AIN457 300mg | Number of Participants Developing Anti-secukinumab Antibodies | 3 # participants tested positive |
| Placebo | Number of Participants Developing Anti-secukinumab Antibodies | 0 # participants tested positive |
| Placebo | Number of Participants Developing Anti-secukinumab Antibodies | 0 # participants tested positive |
| Placebo | Number of Participants Developing Anti-secukinumab Antibodies | 0 # participants tested positive |
| Etanercept | Number of Participants Developing Anti-secukinumab Antibodies | 6 # participants tested positive |