Palmoplantar Pustular Psoriasis
Conditions
Keywords
palmoplantar, pustular, psoriasis
Brief summary
A one year study assessing the efficacy and safety of secukinumab compared with placebo in adult patients with moderate to severe palmoplantar pustular psoriasis - amended with an optional extension treatment period of up to a total of 148 weeks
Interventions
BIOLOGICALSecukinumab 300mg
Secukinumab was used as 150 mg pre-filled syringes (PFS) in a double-blinded fashion. Secukinumab 300 mg s.c. (two PFS injections of the 150 mg dose) self-administered
BIOLOGICALSecukinumab 150mg
secukinumab 150 mg s.c. (one PFS injection of the 150 mg dose + one PFS injection of placebo) self-administered
BIOLOGICALPlacebo
secukinumab placebo s.c. (two PFS injections of placebo) self-administered
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Palmoplantar pustular psoriasis for at least 6 months before Randomization * Moderate to severe palmoplantar pustular psoriasis as defined at Baseline by: * ppPASI score of ≥ 12 and * DLQI ≥ 10 * Candidate for systemic therapy, defined as having palmoplantar pustular psoriasis inadequately controlled by: * Topical treatment, and/or * Phototherapy, and/or * Previous systemic therapy
Exclusion criteria
* Forms of psoriasis other than chronic plaque psoriasis and pustular palmoplantar psoriasis (e.g., erythrodermic, guttate, or generalized pustular psoriasis) * Drug-induced psoriasis (e.g., new onset or current exacerbation from beta-blockers, calcium channel inhibitors, or lithium) or history of proven contact dermatitis * Patients not willing to limit UV light exposure (e.g. sunbathing and/or the use of tanning devices) during the course of the study * Ongoing use of prohibited psoriasis treatments (e.g., topical or systemic corticosteroids, UV therapy). Washout periods detailed in the protocol have to be adhered to * Previous exposure to any biologic drug directly targeting IL-17 or IL-17 Receptor (e.g., secukinumab, ixekizumab, or brodalumab) * Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment and for 16 weeks after stopping treatment * Active ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of secukinumab therapy * Use of any other investigational drugs within 4 weeks of study drug initiation or within a period of 5 half-lives of the investigational treatment, whichever is longer Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With ppPASI 75 Response at Week 16 (Period 1) | Baseline to Week 16 | The primary endpoint was assessed by the palmoplantar pustulosis Psoriasis Area and Severity Index 75 (ppPASI 75). The percentage of subjects who achieved a 75% reduction in ppPASI score from Baseline to Week 16 was measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region of the body is scored from 0 to 6. The total ppPASI score can range from a lower level of 0, corresponding to no signs of psoriasis, up to a maximum of 72. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With ppPASI 75 Response Over Time (Period 1) | Baseline to Week 16 | A secondary endpoint was assessed as response rate of patients to treatment measured by the palmoplantar pustulosis Psoriasis Area and Severity Index 75 (ppPASI 75). The percentage of subjects who achieve a 75% reduction in ppPASI score from Baseline to each post-baseline visit is measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region of the body is scored from 0 to 6. The total ppPASI score can range from a lower level of 0, corresponding to no signs of psoriasis, up to a maximum of 72. |
| Percentage of Participants With ppPASI 75 Response Over Time (Period 2) | Week 16 to Week 52 | A secondary endpoint was assessed as response rate of patients to treatment measured by the palmoplantar pustulosis Psoriasis Area and Severity Index 75 (ppPASI 75). The percentage of subjects who achieve a 75% reduction in ppPASI score from Baseline to each post-baseline visit is measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region of the body is scored from 0 to 6. The total ppPASI score can range from a lower level of 0, corresponding to no signs of psoriasis, up to a maximum of 72. |
| Percentage of Participants With ppPASI 75 Response Over Time (Extension Period) | Week 52 to Week 148 | A secondary endpoint was assessed as response rate of patients to treatment measured by the palmoplantar pustulosis Psoriasis Area and Severity Index 75 (ppPASI 75). The percentage of subjects who achieved a 75% reduction in ppPASI score from Baseline to each post-baseline visit was measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region of the body is scored from 0 to 6. The total ppPASI score can range from a lower level of 0, corresponding to no signs of psoriasis, up to a maximum of 72. |
| ppPASI: Absolute Change From Baseline to Week 16 | Baseline to Week 16 | A secondary endpoint was assessed by the palmoplantar pustulosis Psoriasis Area and Severity Index (ppPASI). The mean change of ppPASI score from Baseline to Week 16 was measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region is scored from 0 to 6. The total ppPASI score can range from a lower level of 0, corresponding to no signs of psoriasis, up to a maximum of 72. |
| Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) | Week 16 to Week 52 (Period 2) | Most frequent (at least 5% in any of the AIN457 groups) Adverse Events |
| Percentage of Participants With Most Frequent Adverse Events - Extension Period (Patient's Safety) | Week 52 to Week 148 (extension period) | Most frequent (at least 5% in any of the AIN457 groups) Adverse Events |
| Percentage of Participants With Most Frequent Adverse Events - Period 1 (Patient's Safety) | Baseline to Week 16 (Period 1) | Most frequent (at least 5% in any of the AIN457 groups) Adverse Events |
Countries
Austria, Belgium, France, Germany, Italy, Poland, Russia, Spain, Sweden, United Kingdom
Participant flow
Recruitment details
A total of 337 patients were screened, and 237 of these patients completed the screening phase and were randomized to treatment.
Pre-assignment details
At baseline patients were randomized at 61 study centers to one of the three treatment groups in a 1:1:1 ratio.
Participants by arm
| Arm | Count |
|---|---|
| AIN457 150mg Secukinumab 150mg at each dosing in period 1. | 80 |
| AIN457 300mg Secukinumab 300mg at each dosing in period 1. | 79 |
| Placebo Placebo at each dosing in period 1. | 78 |
| Total | 237 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Extension Period | Adverse Event | 1 | 3 | 0 | 0 | 2 |
| Extension Period | Lost to Follow-up | 1 | 0 | 0 | 0 | 0 |
| Extension Period | Withdrawal by Subject | 3 | 2 | 0 | 4 | 2 |
| Period 1 | Adverse Event | 6 | 8 | 6 | 0 | 0 |
| Period 1 | Physician Decision | 1 | 0 | 1 | 0 | 0 |
| Period 1 | Pregnancy | 1 | 0 | 0 | 0 | 0 |
| Period 1 | Withdrawal by Subject | 7 | 7 | 5 | 0 | 0 |
| Period 2 | Adverse Event | 12 | 7 | 0 | 5 | 5 |
| Period 2 | Lost to Follow-up | 0 | 0 | 1 | 0 | 0 |
| Period 2 | Physician Decision | 4 | 0 | 0 | 2 | 1 |
| Period 2 | Withdrawal by Subject | 11 | 8 | 0 | 7 | 2 |
Baseline characteristics
| Characteristic | AIN457 150mg | AIN457 300mg | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 50.7 Years STANDARD_DEVIATION 13.68 | 50.6 Years STANDARD_DEVIATION 14.77 | 52.9 Years STANDARD_DEVIATION 11.33 | 51.4 Years STANDARD_DEVIATION 13.33 |
| Race/Ethnicity, Customized Black | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Caucasian | 78 Participants | 78 Participants | 76 Participants | 232 Participants |
| Race/Ethnicity, Customized Missing | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Female | 63 Participants | 64 Participants | 59 Participants | 186 Participants |
| Sex: Female, Male Male | 17 Participants | 15 Participants | 19 Participants | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 80 | 0 / 79 | 0 / 78 | 0 / 107 | 0 / 107 | 0 / 214 |
| other Total, other adverse events | 73 / 80 | 73 / 79 | 53 / 78 | 92 / 107 | 94 / 107 | 186 / 214 |
| serious Total, serious adverse events | 9 / 80 | 13 / 79 | 5 / 78 | 11 / 107 | 17 / 107 | 28 / 214 |
Outcome results
Primary
Percentage of Participants With ppPASI 75 Response at Week 16 (Period 1)
The primary endpoint was assessed by the palmoplantar pustulosis Psoriasis Area and Severity Index 75 (ppPASI 75). The percentage of subjects who achieved a 75% reduction in ppPASI score from Baseline to Week 16 was measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region of the body is scored from 0 to 6. The total ppPASI score can range from a lower level of 0, corresponding to no signs of psoriasis, up to a maximum of 72.
Time frame: Baseline to Week 16
Population: Full Analysis Set (FAS = Started). A patient with a missing ppPASI assessment at Week 16 was considered as a responder if he/she has met the response criterion already at the time of drop-out. Otherwise he/she was considered as a non-responder.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AIN457 150mg | Percentage of Participants With ppPASI 75 Response at Week 16 (Period 1) | 17.5 percentage of participants |
| AIN457 300mg | Percentage of Participants With ppPASI 75 Response at Week 16 (Period 1) | 26.6 percentage of participants |
| Placebo | Percentage of Participants With ppPASI 75 Response at Week 16 (Period 1) | 14.1 percentage of participants |
p-value: 0.572295% CI: [0.5, 3.53]Regression, Logistic
p-value: 0.041195% CI: [1.04, 6.6]Regression, Logistic
Secondary
Percentage of Participants With Most Frequent Adverse Events - Extension Period (Patient's Safety)
Most frequent (at least 5% in any of the AIN457 groups) Adverse Events
Time frame: Week 52 to Week 148 (extension period)
Population: Safety Set - including only patients entering the extension period
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AIN457 150mg | Percentage of Participants With Most Frequent Adverse Events - Extension Period (Patient's Safety) | Urinary tract infection | 9.8 percentage of participants |
| AIN457 150mg | Percentage of Participants With Most Frequent Adverse Events - Extension Period (Patient's Safety) | Headache | 7.3 percentage of participants |
| AIN457 150mg | Percentage of Participants With Most Frequent Adverse Events - Extension Period (Patient's Safety) | Upper respiratory tract infection | 2.4 percentage of participants |
| AIN457 150mg | Percentage of Participants With Most Frequent Adverse Events - Extension Period (Patient's Safety) | Diarrhoea | 4.9 percentage of participants |
| AIN457 150mg | Percentage of Participants With Most Frequent Adverse Events - Extension Period (Patient's Safety) | Tonsillitis | 2.4 percentage of participants |
| AIN457 150mg | Percentage of Participants With Most Frequent Adverse Events - Extension Period (Patient's Safety) | Ear infection | 7.3 percentage of participants |
| AIN457 150mg | Percentage of Participants With Most Frequent Adverse Events - Extension Period (Patient's Safety) | Oropharyngeal pain | 0.0 percentage of participants |
| AIN457 150mg | Percentage of Participants With Most Frequent Adverse Events - Extension Period (Patient's Safety) | Viral upper respiratory tract infection | 12.2 percentage of participants |
| AIN457 300mg | Percentage of Participants With Most Frequent Adverse Events - Extension Period (Patient's Safety) | Upper respiratory tract infection | 9.4 percentage of participants |
| AIN457 300mg | Percentage of Participants With Most Frequent Adverse Events - Extension Period (Patient's Safety) | Viral upper respiratory tract infection | 18.9 percentage of participants |
| AIN457 300mg | Percentage of Participants With Most Frequent Adverse Events - Extension Period (Patient's Safety) | Tonsillitis | 5.7 percentage of participants |
| AIN457 300mg | Percentage of Participants With Most Frequent Adverse Events - Extension Period (Patient's Safety) | Headache | 5.7 percentage of participants |
| AIN457 300mg | Percentage of Participants With Most Frequent Adverse Events - Extension Period (Patient's Safety) | Oropharyngeal pain | 5.7 percentage of participants |
| AIN457 300mg | Percentage of Participants With Most Frequent Adverse Events - Extension Period (Patient's Safety) | Urinary tract infection | 3.8 percentage of participants |
| AIN457 300mg | Percentage of Participants With Most Frequent Adverse Events - Extension Period (Patient's Safety) | Ear infection | 0.0 percentage of participants |
| AIN457 300mg | Percentage of Participants With Most Frequent Adverse Events - Extension Period (Patient's Safety) | Diarrhoea | 5.7 percentage of participants |
Secondary
Percentage of Participants With Most Frequent Adverse Events - Period 1 (Patient's Safety)
Most frequent (at least 5% in any of the AIN457 groups) Adverse Events
Time frame: Baseline to Week 16 (Period 1)
Population: Safety Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AIN457 150mg | Percentage of Participants With Most Frequent Adverse Events - Period 1 (Patient's Safety) | Folliculitis | 3.8 percentage of participants |
| AIN457 150mg | Percentage of Participants With Most Frequent Adverse Events - Period 1 (Patient's Safety) | Psoriasis | 6.3 percentage of participants |
| AIN457 150mg | Percentage of Participants With Most Frequent Adverse Events - Period 1 (Patient's Safety) | Oral herpes | 5.0 percentage of participants |
| AIN457 150mg | Percentage of Participants With Most Frequent Adverse Events - Period 1 (Patient's Safety) | Cough | 6.3 percentage of participants |
| AIN457 150mg | Percentage of Participants With Most Frequent Adverse Events - Period 1 (Patient's Safety) | Urinary tract infection | 2.5 percentage of participants |
| AIN457 150mg | Percentage of Participants With Most Frequent Adverse Events - Period 1 (Patient's Safety) | Nasopharyngitis | 10.0 percentage of participants |
| AIN457 150mg | Percentage of Participants With Most Frequent Adverse Events - Period 1 (Patient's Safety) | Headache | 5.0 percentage of participants |
| AIN457 150mg | Percentage of Participants With Most Frequent Adverse Events - Period 1 (Patient's Safety) | Pustular psoriasis | 12.5 percentage of participants |
| AIN457 150mg | Percentage of Participants With Most Frequent Adverse Events - Period 1 (Patient's Safety) | Nausea | 3.8 percentage of participants |
| AIN457 150mg | Percentage of Participants With Most Frequent Adverse Events - Period 1 (Patient's Safety) | Pruritus | 6.3 percentage of participants |
| AIN457 150mg | Percentage of Participants With Most Frequent Adverse Events - Period 1 (Patient's Safety) | Rash pustular | 5.0 percentage of participants |
| AIN457 300mg | Percentage of Participants With Most Frequent Adverse Events - Period 1 (Patient's Safety) | Urinary tract infection | 5.1 percentage of participants |
| AIN457 300mg | Percentage of Participants With Most Frequent Adverse Events - Period 1 (Patient's Safety) | Nasopharyngitis | 20.3 percentage of participants |
| AIN457 300mg | Percentage of Participants With Most Frequent Adverse Events - Period 1 (Patient's Safety) | Pustular psoriasis | 16.5 percentage of participants |
| AIN457 300mg | Percentage of Participants With Most Frequent Adverse Events - Period 1 (Patient's Safety) | Headache | 12.7 percentage of participants |
| AIN457 300mg | Percentage of Participants With Most Frequent Adverse Events - Period 1 (Patient's Safety) | Pruritus | 8.9 percentage of participants |
| AIN457 300mg | Percentage of Participants With Most Frequent Adverse Events - Period 1 (Patient's Safety) | Psoriasis | 5.1 percentage of participants |
| AIN457 300mg | Percentage of Participants With Most Frequent Adverse Events - Period 1 (Patient's Safety) | Cough | 3.8 percentage of participants |
| AIN457 300mg | Percentage of Participants With Most Frequent Adverse Events - Period 1 (Patient's Safety) | Folliculitis | 5.1 percentage of participants |
| AIN457 300mg | Percentage of Participants With Most Frequent Adverse Events - Period 1 (Patient's Safety) | Nausea | 5.1 percentage of participants |
| AIN457 300mg | Percentage of Participants With Most Frequent Adverse Events - Period 1 (Patient's Safety) | Oral herpes | 1.3 percentage of participants |
| AIN457 300mg | Percentage of Participants With Most Frequent Adverse Events - Period 1 (Patient's Safety) | Rash pustular | 1.3 percentage of participants |
| Placebo | Percentage of Participants With Most Frequent Adverse Events - Period 1 (Patient's Safety) | Oral herpes | 0 percentage of participants |
| Placebo | Percentage of Participants With Most Frequent Adverse Events - Period 1 (Patient's Safety) | Folliculitis | 1.3 percentage of participants |
| Placebo | Percentage of Participants With Most Frequent Adverse Events - Period 1 (Patient's Safety) | Headache | 14.1 percentage of participants |
| Placebo | Percentage of Participants With Most Frequent Adverse Events - Period 1 (Patient's Safety) | Nasopharyngitis | 14.1 percentage of participants |
| Placebo | Percentage of Participants With Most Frequent Adverse Events - Period 1 (Patient's Safety) | Nausea | 0 percentage of participants |
| Placebo | Percentage of Participants With Most Frequent Adverse Events - Period 1 (Patient's Safety) | Pustular psoriasis | 5.1 percentage of participants |
| Placebo | Percentage of Participants With Most Frequent Adverse Events - Period 1 (Patient's Safety) | Urinary tract infection | 3.8 percentage of participants |
| Placebo | Percentage of Participants With Most Frequent Adverse Events - Period 1 (Patient's Safety) | Psoriasis | 3.8 percentage of participants |
| Placebo | Percentage of Participants With Most Frequent Adverse Events - Period 1 (Patient's Safety) | Rash pustular | 0 percentage of participants |
| Placebo | Percentage of Participants With Most Frequent Adverse Events - Period 1 (Patient's Safety) | Cough | 0 percentage of participants |
| Placebo | Percentage of Participants With Most Frequent Adverse Events - Period 1 (Patient's Safety) | Pruritus | 5.1 percentage of participants |
Secondary
Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety)
Most frequent (at least 5% in any of the AIN457 groups) Adverse Events
Time frame: Week 16 to Week 52 (Period 2)
Population: Safety Set - Including only patients entering period 2
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AIN457 150mg | Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) | Cough | 0.0 percentage of participants |
| AIN457 150mg | Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) | Pain in extremity | 0.0 percentage of participants |
| AIN457 150mg | Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) | Folliculitis | 3.1 percentage of participants |
| AIN457 150mg | Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) | Nasopharyngitis | 12.5 percentage of participants |
| AIN457 150mg | Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) | Pruritus generalised | 1.6 percentage of participants |
| AIN457 150mg | Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) | Bronchitis | 4.7 percentage of participants |
| AIN457 150mg | Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) | Urinary tract infection | 0.0 percentage of participants |
| AIN457 150mg | Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) | Headache | 4.7 percentage of participants |
| AIN457 150mg | Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) | Rash | 0.0 percentage of participants |
| AIN457 150mg | Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) | Skin infection | 1.6 percentage of participants |
| AIN457 150mg | Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) | Eczema | 1.6 percentage of participants |
| AIN457 150mg | Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) | Pustular psoriasis | 18.8 percentage of participants |
| AIN457 150mg | Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) | Sinusitis | 0.0 percentage of participants |
| AIN457 150mg | Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) | Psoriasis | 3.1 percentage of participants |
| AIN457 150mg | Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) | Pruritus | 3.1 percentage of participants |
| AIN457 300mg | Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) | Psoriasis | 4.7 percentage of participants |
| AIN457 300mg | Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) | Pruritus | 4.7 percentage of participants |
| AIN457 300mg | Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) | Nasopharyngitis | 21.9 percentage of participants |
| AIN457 300mg | Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) | Pain in extremity | 7.8 percentage of participants |
| AIN457 300mg | Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) | Headache | 6.3 percentage of participants |
| AIN457 300mg | Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) | Sinusitis | 1.6 percentage of participants |
| AIN457 300mg | Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) | Folliculitis | 6.3 percentage of participants |
| AIN457 300mg | Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) | Skin infection | 3.1 percentage of participants |
| AIN457 300mg | Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) | Pruritus generalised | 1.6 percentage of participants |
| AIN457 300mg | Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) | Pustular psoriasis | 10.9 percentage of participants |
| AIN457 300mg | Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) | Cough | 6.3 percentage of participants |
| AIN457 300mg | Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) | Bronchitis | 9.4 percentage of participants |
| AIN457 300mg | Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) | Rash | 6.3 percentage of participants |
| AIN457 300mg | Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) | Urinary tract infection | 4.7 percentage of participants |
| AIN457 300mg | Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) | Eczema | 9.4 percentage of participants |
| Placebo | Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) | Folliculitis | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) | Nasopharyngitis | 10.0 percentage of participants |
| Placebo | Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) | Pustular psoriasis | 10.0 percentage of participants |
| Placebo | Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) | Bronchitis | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) | Headache | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) | Eczema | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) | Psoriasis | 20.0 percentage of participants |
| Placebo | Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) | Pruritus | 10.0 percentage of participants |
| Placebo | Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) | Pain in extremity | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) | Cough | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) | Sinusitis | 10.0 percentage of participants |
| Placebo | Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) | Skin infection | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) | Urinary tract infection | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) | Pruritus generalised | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) | Rash | 0.0 percentage of participants |
| Placebo - AIN457 150 mg | Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) | Sinusitis | 7.4 percentage of participants |
| Placebo - AIN457 150 mg | Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) | Bronchitis | 3.7 percentage of participants |
| Placebo - AIN457 150 mg | Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) | Cough | 0.0 percentage of participants |
| Placebo - AIN457 150 mg | Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) | Urinary tract infection | 7.4 percentage of participants |
| Placebo - AIN457 150 mg | Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) | Eczema | 7.4 percentage of participants |
| Placebo - AIN457 150 mg | Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) | Headache | 3.7 percentage of participants |
| Placebo - AIN457 150 mg | Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) | Pustular psoriasis | 14.8 percentage of participants |
| Placebo - AIN457 150 mg | Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) | Rash | 0.0 percentage of participants |
| Placebo - AIN457 150 mg | Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) | Folliculitis | 0.0 percentage of participants |
| Placebo - AIN457 150 mg | Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) | Nasopharyngitis | 11.1 percentage of participants |
| Placebo - AIN457 150 mg | Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) | Skin infection | 7.4 percentage of participants |
| Placebo - AIN457 150 mg | Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) | Pruritus | 0.0 percentage of participants |
| Placebo - AIN457 150 mg | Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) | Pruritus generalised | 7.4 percentage of participants |
| Placebo - AIN457 150 mg | Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) | Pain in extremity | 7.4 percentage of participants |
| Placebo - AIN457 150 mg | Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) | Psoriasis | 7.4 percentage of participants |
| Placebo - AIN457 300 mg | Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) | Pain in extremity | 0.0 percentage of participants |
| Placebo - AIN457 300 mg | Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) | Pruritus generalised | 0.0 percentage of participants |
| Placebo - AIN457 300 mg | Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) | Cough | 3.6 percentage of participants |
| Placebo - AIN457 300 mg | Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) | Eczema | 0.0 percentage of participants |
| Placebo - AIN457 300 mg | Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) | Nasopharyngitis | 21.4 percentage of participants |
| Placebo - AIN457 300 mg | Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) | Sinusitis | 3.6 percentage of participants |
| Placebo - AIN457 300 mg | Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) | Headache | 7.1 percentage of participants |
| Placebo - AIN457 300 mg | Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) | Skin infection | 0.0 percentage of participants |
| Placebo - AIN457 300 mg | Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) | Bronchitis | 10.7 percentage of participants |
| Placebo - AIN457 300 mg | Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) | Rash | 0.0 percentage of participants |
| Placebo - AIN457 300 mg | Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) | Urinary tract infection | 0.0 percentage of participants |
| Placebo - AIN457 300 mg | Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) | Pustular psoriasis | 21.4 percentage of participants |
| Placebo - AIN457 300 mg | Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) | Folliculitis | 3.6 percentage of participants |
| Placebo - AIN457 300 mg | Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) | Pruritus | 7.1 percentage of participants |
| Placebo - AIN457 300 mg | Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) | Psoriasis | 0.0 percentage of participants |
Secondary
Percentage of Participants With ppPASI 75 Response Over Time (Extension Period)
A secondary endpoint was assessed as response rate of patients to treatment measured by the palmoplantar pustulosis Psoriasis Area and Severity Index 75 (ppPASI 75). The percentage of subjects who achieved a 75% reduction in ppPASI score from Baseline to each post-baseline visit was measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region of the body is scored from 0 to 6. The total ppPASI score can range from a lower level of 0, corresponding to no signs of psoriasis, up to a maximum of 72.
Time frame: Week 52 to Week 148
Population: FAS - Including only patients entering extension period (Placebo Week 16 responders not eligible)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AIN457 150mg | Percentage of Participants With ppPASI 75 Response Over Time (Extension Period) | Week 124 | 93.3 percentage of participants |
| AIN457 150mg | Percentage of Participants With ppPASI 75 Response Over Time (Extension Period) | Week 112 | 100.0 percentage of participants |
| AIN457 150mg | Percentage of Participants With ppPASI 75 Response Over Time (Extension Period) | Week 148 | 100.0 percentage of participants |
| AIN457 150mg | Percentage of Participants With ppPASI 75 Response Over Time (Extension Period) | Week 88 | 88.2 percentage of participants |
| AIN457 150mg | Percentage of Participants With ppPASI 75 Response Over Time (Extension Period) | Week 76 | 68.2 percentage of participants |
| AIN457 150mg | Percentage of Participants With ppPASI 75 Response Over Time (Extension Period) | Week 64 | 56.7 percentage of participants |
| AIN457 150mg | Percentage of Participants With ppPASI 75 Response Over Time (Extension Period) | Week 136 | 93.3 percentage of participants |
| AIN457 150mg | Percentage of Participants With ppPASI 75 Response Over Time (Extension Period) | Week 100 | 100.0 percentage of participants |
| AIN457 150mg | Percentage of Participants With ppPASI 75 Response Over Time (Extension Period) | Week 52 | 64.5 percentage of participants |
| AIN457 300mg | Percentage of Participants With ppPASI 75 Response Over Time (Extension Period) | Week 100 | 75.0 percentage of participants |
| AIN457 300mg | Percentage of Participants With ppPASI 75 Response Over Time (Extension Period) | Week 124 | 78.3 percentage of participants |
| AIN457 300mg | Percentage of Participants With ppPASI 75 Response Over Time (Extension Period) | Week 112 | 75.0 percentage of participants |
| AIN457 300mg | Percentage of Participants With ppPASI 75 Response Over Time (Extension Period) | Week 64 | 66.7 percentage of participants |
| AIN457 300mg | Percentage of Participants With ppPASI 75 Response Over Time (Extension Period) | Week 52 | 63.9 percentage of participants |
| AIN457 300mg | Percentage of Participants With ppPASI 75 Response Over Time (Extension Period) | Week 76 | 67.7 percentage of participants |
| AIN457 300mg | Percentage of Participants With ppPASI 75 Response Over Time (Extension Period) | Week 148 | 78.3 percentage of participants |
| AIN457 300mg | Percentage of Participants With ppPASI 75 Response Over Time (Extension Period) | Week 136 | 77.3 percentage of participants |
| AIN457 300mg | Percentage of Participants With ppPASI 75 Response Over Time (Extension Period) | Week 88 | 80.0 percentage of participants |
| Placebo | Percentage of Participants With ppPASI 75 Response Over Time (Extension Period) | Week 100 | 33.3 percentage of participants |
| Placebo | Percentage of Participants With ppPASI 75 Response Over Time (Extension Period) | Week 52 | 50.0 percentage of participants |
| Placebo | Percentage of Participants With ppPASI 75 Response Over Time (Extension Period) | Week 64 | 40.0 percentage of participants |
| Placebo | Percentage of Participants With ppPASI 75 Response Over Time (Extension Period) | Week 76 | 62.5 percentage of participants |
| Placebo | Percentage of Participants With ppPASI 75 Response Over Time (Extension Period) | Week 88 | 42.9 percentage of participants |
| Placebo | Percentage of Participants With ppPASI 75 Response Over Time (Extension Period) | Week 112 | 60.0 percentage of participants |
| Placebo | Percentage of Participants With ppPASI 75 Response Over Time (Extension Period) | Week 124 | 40.0 percentage of participants |
| Placebo | Percentage of Participants With ppPASI 75 Response Over Time (Extension Period) | Week 136 | 40.0 percentage of participants |
| Placebo | Percentage of Participants With ppPASI 75 Response Over Time (Extension Period) | Week 148 | 75.0 percentage of participants |
| Placebo - AIN457 150 mg | Percentage of Participants With ppPASI 75 Response Over Time (Extension Period) | Week 124 | 70.0 percentage of participants |
| Placebo - AIN457 150 mg | Percentage of Participants With ppPASI 75 Response Over Time (Extension Period) | Week 88 | 75.0 percentage of participants |
| Placebo - AIN457 150 mg | Percentage of Participants With ppPASI 75 Response Over Time (Extension Period) | Week 76 | 60.0 percentage of participants |
| Placebo - AIN457 150 mg | Percentage of Participants With ppPASI 75 Response Over Time (Extension Period) | Week 148 | 77.8 percentage of participants |
| Placebo - AIN457 150 mg | Percentage of Participants With ppPASI 75 Response Over Time (Extension Period) | Week 136 | 66.7 percentage of participants |
| Placebo - AIN457 150 mg | Percentage of Participants With ppPASI 75 Response Over Time (Extension Period) | Week 64 | 82.4 percentage of participants |
| Placebo - AIN457 150 mg | Percentage of Participants With ppPASI 75 Response Over Time (Extension Period) | Week 112 | 66.7 percentage of participants |
| Placebo - AIN457 150 mg | Percentage of Participants With ppPASI 75 Response Over Time (Extension Period) | Week 100 | 54.5 percentage of participants |
| Placebo - AIN457 150 mg | Percentage of Participants With ppPASI 75 Response Over Time (Extension Period) | Week 52 | 64.7 percentage of participants |
Secondary
Percentage of Participants With ppPASI 75 Response Over Time (Period 1)
A secondary endpoint was assessed as response rate of patients to treatment measured by the palmoplantar pustulosis Psoriasis Area and Severity Index 75 (ppPASI 75). The percentage of subjects who achieve a 75% reduction in ppPASI score from Baseline to each post-baseline visit is measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region of the body is scored from 0 to 6. The total ppPASI score can range from a lower level of 0, corresponding to no signs of psoriasis, up to a maximum of 72.
Time frame: Baseline to Week 16
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AIN457 150mg | Percentage of Participants With ppPASI 75 Response Over Time (Period 1) | Week 2 | 1.3 percentage of participants |
| AIN457 150mg | Percentage of Participants With ppPASI 75 Response Over Time (Period 1) | Week 8 | 13.0 percentage of participants |
| AIN457 150mg | Percentage of Participants With ppPASI 75 Response Over Time (Period 1) | Week 4 | 6.5 percentage of participants |
| AIN457 150mg | Percentage of Participants With ppPASI 75 Response Over Time (Period 1) | Week 1 | 0 percentage of participants |
| AIN457 150mg | Percentage of Participants With ppPASI 75 Response Over Time (Period 1) | Week 16 | 17.5 percentage of participants |
| AIN457 150mg | Percentage of Participants With ppPASI 75 Response Over Time (Period 1) | Week 12 | 14.7 percentage of participants |
| AIN457 150mg | Percentage of Participants With ppPASI 75 Response Over Time (Period 1) | Week 3 | 2.6 percentage of participants |
| AIN457 300mg | Percentage of Participants With ppPASI 75 Response Over Time (Period 1) | Week 4 | 9.1 percentage of participants |
| AIN457 300mg | Percentage of Participants With ppPASI 75 Response Over Time (Period 1) | Week 1 | 1.3 percentage of participants |
| AIN457 300mg | Percentage of Participants With ppPASI 75 Response Over Time (Period 1) | Week 2 | 1.3 percentage of participants |
| AIN457 300mg | Percentage of Participants With ppPASI 75 Response Over Time (Period 1) | Week 3 | 5.4 percentage of participants |
| AIN457 300mg | Percentage of Participants With ppPASI 75 Response Over Time (Period 1) | Week 8 | 13.3 percentage of participants |
| AIN457 300mg | Percentage of Participants With ppPASI 75 Response Over Time (Period 1) | Week 12 | 23.9 percentage of participants |
| AIN457 300mg | Percentage of Participants With ppPASI 75 Response Over Time (Period 1) | Week 16 | 26.6 percentage of participants |
| Placebo | Percentage of Participants With ppPASI 75 Response Over Time (Period 1) | Week 8 | 9.6 percentage of participants |
| Placebo | Percentage of Participants With ppPASI 75 Response Over Time (Period 1) | Week 2 | 0 percentage of participants |
| Placebo | Percentage of Participants With ppPASI 75 Response Over Time (Period 1) | Week 16 | 14.1 percentage of participants |
| Placebo | Percentage of Participants With ppPASI 75 Response Over Time (Period 1) | Week 12 | 10.1 percentage of participants |
| Placebo | Percentage of Participants With ppPASI 75 Response Over Time (Period 1) | Week 4 | 1.4 percentage of participants |
| Placebo | Percentage of Participants With ppPASI 75 Response Over Time (Period 1) | Week 3 | 0 percentage of participants |
| Placebo | Percentage of Participants With ppPASI 75 Response Over Time (Period 1) | Week 1 | 1.3 percentage of participants |
Secondary
Percentage of Participants With ppPASI 75 Response Over Time (Period 2)
A secondary endpoint was assessed as response rate of patients to treatment measured by the palmoplantar pustulosis Psoriasis Area and Severity Index 75 (ppPASI 75). The percentage of subjects who achieve a 75% reduction in ppPASI score from Baseline to each post-baseline visit is measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region of the body is scored from 0 to 6. The total ppPASI score can range from a lower level of 0, corresponding to no signs of psoriasis, up to a maximum of 72.
Time frame: Week 16 to Week 52
Population: FAS - Including only patients entering period 2
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AIN457 150mg | Percentage of Participants With ppPASI 75 Response Over Time (Period 2) | Week 16 | 18.8 percentage of participants |
| AIN457 150mg | Percentage of Participants With ppPASI 75 Response Over Time (Period 2) | Week 52 | 57.9 percentage of participants |
| AIN457 150mg | Percentage of Participants With ppPASI 75 Response Over Time (Period 2) | Week 48 | 52.4 percentage of participants |
| AIN457 150mg | Percentage of Participants With ppPASI 75 Response Over Time (Period 2) | Week 24 | 30.2 percentage of participants |
| AIN457 150mg | Percentage of Participants With ppPASI 75 Response Over Time (Period 2) | Week 20 | 20.3 percentage of participants |
| AIN457 150mg | Percentage of Participants With ppPASI 75 Response Over Time (Period 2) | Week 32 | 36.4 percentage of participants |
| AIN457 150mg | Percentage of Participants With ppPASI 75 Response Over Time (Period 2) | Week 40 | 44.4 percentage of participants |
| AIN457 300mg | Percentage of Participants With ppPASI 75 Response Over Time (Period 2) | Week 40 | 56.4 percentage of participants |
| AIN457 300mg | Percentage of Participants With ppPASI 75 Response Over Time (Period 2) | Week 32 | 48.3 percentage of participants |
| AIN457 300mg | Percentage of Participants With ppPASI 75 Response Over Time (Period 2) | Week 20 | 31.3 percentage of participants |
| AIN457 300mg | Percentage of Participants With ppPASI 75 Response Over Time (Period 2) | Week 16 | 31.3 percentage of participants |
| AIN457 300mg | Percentage of Participants With ppPASI 75 Response Over Time (Period 2) | Week 48 | 58.0 percentage of participants |
| AIN457 300mg | Percentage of Participants With ppPASI 75 Response Over Time (Period 2) | Week 24 | 37.5 percentage of participants |
| AIN457 300mg | Percentage of Participants With ppPASI 75 Response Over Time (Period 2) | Week 52 | 58.8 percentage of participants |
| Placebo | Percentage of Participants With ppPASI 75 Response Over Time (Period 2) | Week 32 | 80.0 percentage of participants |
| Placebo | Percentage of Participants With ppPASI 75 Response Over Time (Period 2) | Week 16 | 90.0 percentage of participants |
| Placebo | Percentage of Participants With ppPASI 75 Response Over Time (Period 2) | Week 20 | 80.0 percentage of participants |
| Placebo | Percentage of Participants With ppPASI 75 Response Over Time (Period 2) | Week 24 | 80.0 percentage of participants |
| Placebo | Percentage of Participants With ppPASI 75 Response Over Time (Period 2) | Week 40 | 70.0 percentage of participants |
| Placebo | Percentage of Participants With ppPASI 75 Response Over Time (Period 2) | Week 48 | 60.0 percentage of participants |
| Placebo | Percentage of Participants With ppPASI 75 Response Over Time (Period 2) | Week 52 | 66.7 percentage of participants |
| Placebo - AIN457 150 mg | Percentage of Participants With ppPASI 75 Response Over Time (Period 2) | Week 24 | 19.2 percentage of participants |
| Placebo - AIN457 150 mg | Percentage of Participants With ppPASI 75 Response Over Time (Period 2) | Week 40 | 37.5 percentage of participants |
| Placebo - AIN457 150 mg | Percentage of Participants With ppPASI 75 Response Over Time (Period 2) | Week 20 | 7.7 percentage of participants |
| Placebo - AIN457 150 mg | Percentage of Participants With ppPASI 75 Response Over Time (Period 2) | Week 52 | 50.0 percentage of participants |
| Placebo - AIN457 150 mg | Percentage of Participants With ppPASI 75 Response Over Time (Period 2) | Week 48 | 40.0 percentage of participants |
| Placebo - AIN457 150 mg | Percentage of Participants With ppPASI 75 Response Over Time (Period 2) | Week 16 | 0 percentage of participants |
| Placebo - AIN457 150 mg | Percentage of Participants With ppPASI 75 Response Over Time (Period 2) | Week 32 | 25.0 percentage of participants |
| Placebo - AIN457 300 mg | Percentage of Participants With ppPASI 75 Response Over Time (Period 2) | Week 24 | 38.5 percentage of participants |
| Placebo - AIN457 300 mg | Percentage of Participants With ppPASI 75 Response Over Time (Period 2) | Week 52 | 60.0 percentage of participants |
| Placebo - AIN457 300 mg | Percentage of Participants With ppPASI 75 Response Over Time (Period 2) | Week 48 | 47.4 percentage of participants |
| Placebo - AIN457 300 mg | Percentage of Participants With ppPASI 75 Response Over Time (Period 2) | Week 40 | 50.0 percentage of participants |
| Placebo - AIN457 300 mg | Percentage of Participants With ppPASI 75 Response Over Time (Period 2) | Week 20 | 17.9 percentage of participants |
| Placebo - AIN457 300 mg | Percentage of Participants With ppPASI 75 Response Over Time (Period 2) | Week 16 | 0 percentage of participants |
| Placebo - AIN457 300 mg | Percentage of Participants With ppPASI 75 Response Over Time (Period 2) | Week 32 | 44.0 percentage of participants |
Secondary
ppPASI: Absolute Change From Baseline to Week 16
A secondary endpoint was assessed by the palmoplantar pustulosis Psoriasis Area and Severity Index (ppPASI). The mean change of ppPASI score from Baseline to Week 16 was measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region is scored from 0 to 6. The total ppPASI score can range from a lower level of 0, corresponding to no signs of psoriasis, up to a maximum of 72.
Time frame: Baseline to Week 16
Population: FAS - Including only Patients with ppPASI Scores at Baseline and Week 16
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AIN457 150mg | ppPASI: Absolute Change From Baseline to Week 16 | Baseline | 21.79 units on a scale | Standard Deviation 8.211 |
| AIN457 150mg | ppPASI: Absolute Change From Baseline to Week 16 | Change from Baseline to Week 16 | -6.99 units on a scale | Standard Deviation 10.904 |
| AIN457 300mg | ppPASI: Absolute Change From Baseline to Week 16 | Baseline | 23.01 units on a scale | Standard Deviation 10.787 |
| AIN457 300mg | ppPASI: Absolute Change From Baseline to Week 16 | Change from Baseline to Week 16 | -9.74 units on a scale | Standard Deviation 12.13 |
| Placebo | ppPASI: Absolute Change From Baseline to Week 16 | Baseline | 23.10 units on a scale | Standard Deviation 10.198 |
| Placebo | ppPASI: Absolute Change From Baseline to Week 16 | Change from Baseline to Week 16 | -6.73 units on a scale | Standard Deviation 9.868 |
p-value: 0.943195% CI: [-4.59, 3.47]Regression, Linear
p-value: 0.157695% CI: [-7.14, 0.88]Regression, Linear