Moderate to Severe Palmoplantar Psoriasis
Conditions
Keywords
Skin condition, itching, psoriasis vulgaris, relapsing remitting psoriasis, immune-med systemic disease, skin lesions, scaly patches, papules, plaques
Brief summary
Purpose of the study was to demonstrate the efficacy of secukinumab versus placebo on palmoplantar psoriasis and to assess the long term efficacy, safety and tolerability of secukinumab.
Interventions
BIOLOGICALsecukinumab 150 mg
Study treatment were provided in pre-filled syringes of secukinumab 150 mg in 1 mL. Each dosing consiseds of one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection and took place once weekly during five weeks (at Baseline, Weeks 1, 2, 3 and 4), then once every four weeks starting at Week 8 until Week 128 inclusive. In order to maintain the blinding, patients also received two placebo injections at Weeks 17, 18 and 19. Patients self-administered study treatment under the supervision of site personnel when injections occur during study visits, or at home otherwise.
BIOLOGICALsecukinumab 300 mg
Study treatment were provided in pre-filled syringes of secukinumab 150 mg in 1 mL. Each dosing consisted of two secukinumab 150 mg s.c. injections and took ke place once weekly during five weeks (at Baseline, Weeks 1, 2, 3 and 4), then once every four weeks starting at Week 8 until Week 128 inclusive. In order to maintain the blinding, patients also receives two placebo injections at Weeks 17, 18 and 19. Patients self-administered study treatment under the supervision of site personnel when injections occur during study visits, or at home otherwise.
BIOLOGICALPlacebo
Placebo were provided in 1 mL pre-filled syringes. Each dosing consisted of two s.c. injections and took place once weekly during five weeks (at Baseline, Weeks 1, 2, 3 and 4), then at Week 8 and at Week 12. At Week 16, ppIGA responders continued on placebo with dosing at Weeks 16, 17, 18, 19 and 20, then once every four weeks from Week 24 until Week 76 inclusive. At Week 80, ppIGA responders ended their participation in the study while ppIGA non-responders were re-randomized, to receive 150 mg or 300 mg secukinumab once every four weeks starting at Week 80 until Week 128 inclusive. Patients self-administered study treatment under the supervision of site personnel when injections occur during study visits, or at home otherwise.
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
* Subjects with chronic, moderate to severe plaque type psoriasis for at least 6 months prior to randomization and significant involvement of the palms and soles at baseline, defined as palmoplantar Investigator's Global Assessment (ppIGA) score of ≥ 3 on a 5-point scale, as well as at least one skin plaque at baseline which is not in the palmoplantar area * Candidates for systemic therapy, i.e. psoriasis inadequately controlled by topical treatment (including super potent topical corticosteroids) and/or phototherapy and/or previous systemic therapy
Exclusion criteria
* Forms of psoriasis other than chronic plaque type psoriasis (e.g., pustular psoriasis, palmoplantar pustulosis, acrodermatitis of Hallopeau, erythrodermic and guttate psoriasis) * Drug-induced psoriasis (e.g. new onset or current exacerbation from β-blockers, calcium channel inhibitors or lithium) * Ongoing use of prohibited treatments (e.g. topical or systemic corticosteroids (CS), UV therapy). Washout periods do apply. * Prior exposure to secukinumab (AIN457) or any other biological drug directly targeting IL-17 or the IL-17 receptor * Use of any investigational drugs within 4 weeks prior to study treatment initiation or within a period of 5 half-lives of the investigational treatment, whichever is longer * Active ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of secukinumab therapy * History of hypersensitivity to constituents of the study treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentages of Participants With Palmoplantar Investigator Global Assessmnet (ppIGA) 0 or 1 Response After 16 Weeks of Treatment | Week 16 | palmoplantar Investigator's Global Assessment (ppIGA) response after 16 weeks of treatment. To be considered a ppIGA responder at Week 16, a subject must have ppIGA of 0 or 1 at Week 16 and a reduction of at least 2 points on the ppIGA scale from baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentages of Subjects With ppIGA 0 or 1 Response (Observed Cases) - Treatment Period II | Week 16, Week 20, Week 28, Week 32, Week 64, Week 132 | ppIGA: Palmoplantar Ivestigator's Global Assessment. The IGA mod 2011 rating scale: The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. Based on this scale, a patient was considered as an IGA 0 or 1 responder if they achieved a score of 0 or 1 and improved by at least 2 points on the IGA scale at a given time point compared to their score at randomization (baseline). |
| Percentages of Subjects With ppIGA 0 or 1 Response (Observed Cases) - Entire Treatment Period | Week 16, Week 24, Week 28, Week 80 | ppIGA: Palmoplantar Ivestigator's Global Assessment. The IGA mod 2011 rating scale: The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. Based on this scale, a patient was considered as an IGA 0 or 1 responder if they achieved a score of 0 or 1 and improved by at least 2 points on the IGA scale at a given time point compared to their score at randomization (baseline). |
| Percentages of Participants With Palmoplantar Investigator Global Assessment (ppIGA) 0 or 1 Response - Treatment Period I | Week 1, week 2, week 4, week, 8, week 12, week 16 | ppIGA: Palmoplantar Ivestigator's Global Assessment. The IGA mod 2011 rating scale: The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. Based on this scale, a patient was considered as an IGA 0 or 1 responder if they achieved a score of 0 or 1 and improved by at least 2 points on the IGA scale at a given time point compared to their score at randomization (baseline). |
| Absolute Change From Baseline for Palmoplantar Psoriasis Area and Severity Index (ppPASI) Score (Observed Cases) - Entire Treatment Set | Week 16, Week 32, Week 80, Week 132 | Psoriasis Area and Severity Index (PASI) is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). |
| Number of Participants Developing Anti-secukinumab Antibodies | Over time up to week 132 | To investigate the development of immunogenicity against secukinumab |
| Absolute Change From Baseline for Palmoplantar Psoriasis Area and Severity Index (ppPASI) Score -Treatment Period I | Week 1, Week 2, Week 4, Week 8, Week 12, Week 16 | Psoriasis Area and Severity Index (PASI) is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). |
Countries
Australia, Belgium, Canada, Finland, Hungary, Israel, Netherlands, Norway, Portugal, Russia, Slovakia, Spain, Turkey (Türkiye), United Kingdom, United States
Participant flow
Recruitment details
Week 16 was considered the first dose of Treatment Period 2. Week 132 visit was the final visit of Treatment Period 2, and no study treatment was administered at this visit.
Pre-assignment details
Patients who completed Period 2 & patients who prematurely discontinued treatment or withdrew from study entered the treatment-free Follow-up (FU) Period (no study treatment was administered during Period) included only 1 visit at Week 140 (End of FU), which was 8 weeks after the end of Period 2 & 12 weeks after the last dose of study drug.
Participants by arm
| Arm | Count |
|---|---|
| AIN457 150mg AIN457 150mg sub-cutaneous (s.c.) injection plus a placebo AIN457 s.c. injection once weekly for 5 weeks followed by dosing every 4 weeks | 68 |
| AIN457 300 mg AIN457 300 mg (2 s.c. injections of the 150 mg dose) once weekly for 5 weeks followed by dosing every 4 weeks | 69 |
| Placebo placebo AIN457 (2 sc injections) once weekly for 5 weeks, followed by dosing every 4 weeks. | 68 |
| Total | 205 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Follow-up Period (Week 132 to Week 140) | Adverse Event | 0 | 0 | 0 | 0 | 0 | 2 |
| Follow-up Period (Week 132 to Week 140) | Lack of Efficacy | 0 | 0 | 0 | 0 | 0 | 2 |
| Follow-up Period (Week 132 to Week 140) | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 2 |
| Follow-up Period (Week 132 to Week 140) | Physician Decision | 0 | 0 | 0 | 0 | 0 | 1 |
| Follow-up Period (Week 132 to Week 140) | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 5 |
| Period 1 (Baseline to Week 16) | Adverse Event | 1 | 1 | 0 | 0 | 2 | 0 |
| Period 1 (Baseline to Week 16) | Lack of Efficacy | 1 | 0 | 0 | 0 | 1 | 0 |
| Period 1 (Baseline to Week 16) | Physician Decision | 0 | 1 | 0 | 0 | 0 | 0 |
| Period 1 (Baseline to Week 16) | Protocol Violation | 0 | 1 | 0 | 0 | 0 | 0 |
| Period 1 (Baseline to Week 16) | Withdrawal by Subject | 3 | 2 | 0 | 0 | 2 | 0 |
| Treatment Period 2 (Week 16 to Week 132) | Adverse Event | 9 | 6 | 4 | 3 | 1 | 0 |
| Treatment Period 2 (Week 16 to Week 132) | Death | 1 | 0 | 0 | 0 | 0 | 0 |
| Treatment Period 2 (Week 16 to Week 132) | Lack of Efficacy | 12 | 5 | 3 | 1 | 0 | 0 |
| Treatment Period 2 (Week 16 to Week 132) | Lost to Follow-up | 2 | 0 | 0 | 0 | 0 | 0 |
| Treatment Period 2 (Week 16 to Week 132) | non-compliance with study treatment | 2 | 2 | 1 | 1 | 0 | 0 |
| Treatment Period 2 (Week 16 to Week 132) | Physician Decision | 1 | 1 | 0 | 0 | 0 | 0 |
| Treatment Period 2 (Week 16 to Week 132) | Protocol Violation | 2 | 0 | 0 | 0 | 0 | 0 |
| Treatment Period 2 (Week 16 to Week 132) | study terminated by sponsor | 0 | 1 | 0 | 1 | 0 | 0 |
| Treatment Period 2 (Week 16 to Week 132) | Withdrawal by Subject | 10 | 5 | 6 | 5 | 0 | 0 |
Baseline characteristics
| Characteristic | AIN457 150mg | AIN457 300 mg | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 52.4 years STANDARD_DEVIATION 12.56 | 48.8 years STANDARD_DEVIATION 14.21 | 50.9 years STANDARD_DEVIATION 12.95 | 50.7 years STANDARD_DEVIATION 13.28 |
| Sex: Female, Male Female | 28 Participants | 31 Participants | 34 Participants | 93 Participants |
| Sex: Female, Male Male | 40 Participants | 38 Participants | 34 Participants | 112 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 75 / 99 | 68 / 100 | 30 / 68 | 143 / 199 |
| serious Total, serious adverse events | 19 / 99 | 13 / 100 | 2 / 68 | 32 / 199 |
Outcome results
Primary
Percentages of Participants With Palmoplantar Investigator Global Assessmnet (ppIGA) 0 or 1 Response After 16 Weeks of Treatment
palmoplantar Investigator's Global Assessment (ppIGA) response after 16 weeks of treatment. To be considered a ppIGA responder at Week 16, a subject must have ppIGA of 0 or 1 at Week 16 and a reduction of at least 2 points on the ppIGA scale from baseline.
Time frame: Week 16
Population: Full Analysis Set (FAS): The FAS comprised of all patients from the randomized set to who study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AIN457 150mg | Percentages of Participants With Palmoplantar Investigator Global Assessmnet (ppIGA) 0 or 1 Response After 16 Weeks of Treatment | 22 Percentages of participants |
| AIN457 300 mg | Percentages of Participants With Palmoplantar Investigator Global Assessmnet (ppIGA) 0 or 1 Response After 16 Weeks of Treatment | 33.3 Percentages of participants |
| Placebo | Percentages of Participants With Palmoplantar Investigator Global Assessmnet (ppIGA) 0 or 1 Response After 16 Weeks of Treatment | 1.5 Percentages of participants |
Comparison: Data at Week 16 was analyzed using the stratified Cochran-Mantel-Haenszel-test. The test was stratified by body-weight category (\<90 kg or ≥90 kg).p-value: 0.000295% CI: [2.4, 154.6]Cochran-Mantel-Haenszel
Comparison: Data at Week 16 was analyzed using the stratified Cochran-Mantel-Haenszel-test. The test was stratified by body-weight category (\<90 kg or ≥90 kg).p-value: <0.000195% CI: [4.1, 211.9]Cochran-Mantel-Haenszel
Secondary
Absolute Change From Baseline for Palmoplantar Psoriasis Area and Severity Index (ppPASI) Score (Observed Cases) - Entire Treatment Set
Psoriasis Area and Severity Index (PASI) is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease).
Time frame: Week 16, Week 32, Week 80, Week 132
Population: FAS
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AIN457 150mg | Absolute Change From Baseline for Palmoplantar Psoriasis Area and Severity Index (ppPASI) Score (Observed Cases) - Entire Treatment Set | Week 80 | -18.05 Units on a scale | Standard Deviation 15.232 |
| AIN457 150mg | Absolute Change From Baseline for Palmoplantar Psoriasis Area and Severity Index (ppPASI) Score (Observed Cases) - Entire Treatment Set | Week 132 | -16.74 Units on a scale | Standard Deviation 14.658 |
| AIN457 150mg | Absolute Change From Baseline for Palmoplantar Psoriasis Area and Severity Index (ppPASI) Score (Observed Cases) - Entire Treatment Set | Week 16 | -8.97 Units on a scale | Standard Deviation 15.624 |
| AIN457 150mg | Absolute Change From Baseline for Palmoplantar Psoriasis Area and Severity Index (ppPASI) Score (Observed Cases) - Entire Treatment Set | Week 32 | -16.29 Units on a scale | Standard Deviation 14.307 |
| AIN457 300 mg | Absolute Change From Baseline for Palmoplantar Psoriasis Area and Severity Index (ppPASI) Score (Observed Cases) - Entire Treatment Set | Week 132 | -19.16 Units on a scale | Standard Deviation 11.688 |
| AIN457 300 mg | Absolute Change From Baseline for Palmoplantar Psoriasis Area and Severity Index (ppPASI) Score (Observed Cases) - Entire Treatment Set | Week 16 | -12.67 Units on a scale | Standard Deviation 12.074 |
| AIN457 300 mg | Absolute Change From Baseline for Palmoplantar Psoriasis Area and Severity Index (ppPASI) Score (Observed Cases) - Entire Treatment Set | Week 32 | -17.43 Units on a scale | Standard Deviation 13.104 |
| AIN457 300 mg | Absolute Change From Baseline for Palmoplantar Psoriasis Area and Severity Index (ppPASI) Score (Observed Cases) - Entire Treatment Set | Week 80 | -19.27 Units on a scale | Standard Deviation 14.258 |
| Placebo | Absolute Change From Baseline for Palmoplantar Psoriasis Area and Severity Index (ppPASI) Score (Observed Cases) - Entire Treatment Set | Week 80 | -13.71 Units on a scale | Standard Deviation 14.56 |
| Placebo | Absolute Change From Baseline for Palmoplantar Psoriasis Area and Severity Index (ppPASI) Score (Observed Cases) - Entire Treatment Set | Week 16 | -1.57 Units on a scale | Standard Deviation 8.88 |
| Placebo | Absolute Change From Baseline for Palmoplantar Psoriasis Area and Severity Index (ppPASI) Score (Observed Cases) - Entire Treatment Set | Week 32 | -15.49 Units on a scale | Standard Deviation 11.57 |
| Placebo | Absolute Change From Baseline for Palmoplantar Psoriasis Area and Severity Index (ppPASI) Score (Observed Cases) - Entire Treatment Set | Week 132 | -17.07 Units on a scale | Standard Deviation 11.728 |
| Placebo - AIN457 300 mg | Absolute Change From Baseline for Palmoplantar Psoriasis Area and Severity Index (ppPASI) Score (Observed Cases) - Entire Treatment Set | Week 32 | -15.09 Units on a scale | Standard Deviation 12.625 |
| Placebo - AIN457 300 mg | Absolute Change From Baseline for Palmoplantar Psoriasis Area and Severity Index (ppPASI) Score (Observed Cases) - Entire Treatment Set | Week 16 | -3.11 Units on a scale | Standard Deviation 7.983 |
| Placebo - AIN457 300 mg | Absolute Change From Baseline for Palmoplantar Psoriasis Area and Severity Index (ppPASI) Score (Observed Cases) - Entire Treatment Set | Week 80 | -16.70 Units on a scale | Standard Deviation 10.441 |
| Placebo - AIN457 300 mg | Absolute Change From Baseline for Palmoplantar Psoriasis Area and Severity Index (ppPASI) Score (Observed Cases) - Entire Treatment Set | Week 132 | -13.82 Units on a scale | Standard Deviation 5.844 |
| Placebo | Absolute Change From Baseline for Palmoplantar Psoriasis Area and Severity Index (ppPASI) Score (Observed Cases) - Entire Treatment Set | Week 16 | -7.15 Units on a scale | Standard Deviation 4.479 |
| Placebo | Absolute Change From Baseline for Palmoplantar Psoriasis Area and Severity Index (ppPASI) Score (Observed Cases) - Entire Treatment Set | Week 32 | -11.40 Units on a scale | — |
Secondary
Absolute Change From Baseline for Palmoplantar Psoriasis Area and Severity Index (ppPASI) Score -Treatment Period I
Psoriasis Area and Severity Index (PASI) is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease).
Time frame: Week 1, Week 2, Week 4, Week 8, Week 12, Week 16
Population: FAS
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AIN457 150mg | Absolute Change From Baseline for Palmoplantar Psoriasis Area and Severity Index (ppPASI) Score -Treatment Period I | Week 1 | -1.13 Units on a scale | Standard Deviation 4.797 |
| AIN457 150mg | Absolute Change From Baseline for Palmoplantar Psoriasis Area and Severity Index (ppPASI) Score -Treatment Period I | Week 2 | -3.11 Units on a scale | Standard Deviation 7.669 |
| AIN457 150mg | Absolute Change From Baseline for Palmoplantar Psoriasis Area and Severity Index (ppPASI) Score -Treatment Period I | Week 4 | -6.69 Units on a scale | Standard Deviation 9.89 |
| AIN457 150mg | Absolute Change From Baseline for Palmoplantar Psoriasis Area and Severity Index (ppPASI) Score -Treatment Period I | Week 8 | -9.74 Units on a scale | Standard Deviation 12.779 |
| AIN457 150mg | Absolute Change From Baseline for Palmoplantar Psoriasis Area and Severity Index (ppPASI) Score -Treatment Period I | Week 12 | -10.15 Units on a scale | Standard Deviation 14.409 |
| AIN457 150mg | Absolute Change From Baseline for Palmoplantar Psoriasis Area and Severity Index (ppPASI) Score -Treatment Period I | Week 16 | -9.41 Units on a scale | Standard Deviation 15.984 |
| AIN457 300 mg | Absolute Change From Baseline for Palmoplantar Psoriasis Area and Severity Index (ppPASI) Score -Treatment Period I | Week 16 | -13.35 Units on a scale | Standard Deviation 12.941 |
| AIN457 300 mg | Absolute Change From Baseline for Palmoplantar Psoriasis Area and Severity Index (ppPASI) Score -Treatment Period I | Week 1 | -2.22 Units on a scale | Standard Deviation 4.334 |
| AIN457 300 mg | Absolute Change From Baseline for Palmoplantar Psoriasis Area and Severity Index (ppPASI) Score -Treatment Period I | Week 8 | -11.30 Units on a scale | Standard Deviation 11.954 |
| AIN457 300 mg | Absolute Change From Baseline for Palmoplantar Psoriasis Area and Severity Index (ppPASI) Score -Treatment Period I | Week 12 | -12.83 Units on a scale | Standard Deviation 12.286 |
| AIN457 300 mg | Absolute Change From Baseline for Palmoplantar Psoriasis Area and Severity Index (ppPASI) Score -Treatment Period I | Week 2 | -5.32 Units on a scale | Standard Deviation 6.12 |
| AIN457 300 mg | Absolute Change From Baseline for Palmoplantar Psoriasis Area and Severity Index (ppPASI) Score -Treatment Period I | Week 4 | -9.18 Units on a scale | Standard Deviation 9.734 |
| Placebo | Absolute Change From Baseline for Palmoplantar Psoriasis Area and Severity Index (ppPASI) Score -Treatment Period I | Week 2 | -1.90 Units on a scale | Standard Deviation 5.434 |
| Placebo | Absolute Change From Baseline for Palmoplantar Psoriasis Area and Severity Index (ppPASI) Score -Treatment Period I | Week 4 | -3.95 Units on a scale | Standard Deviation 7.424 |
| Placebo | Absolute Change From Baseline for Palmoplantar Psoriasis Area and Severity Index (ppPASI) Score -Treatment Period I | Week 16 | -2.43 Units on a scale | Standard Deviation 8.527 |
| Placebo | Absolute Change From Baseline for Palmoplantar Psoriasis Area and Severity Index (ppPASI) Score -Treatment Period I | Week 8 | -3.22 Units on a scale | Standard Deviation 8.316 |
| Placebo | Absolute Change From Baseline for Palmoplantar Psoriasis Area and Severity Index (ppPASI) Score -Treatment Period I | Week 1 | -0.85 Units on a scale | Standard Deviation 3.355 |
| Placebo | Absolute Change From Baseline for Palmoplantar Psoriasis Area and Severity Index (ppPASI) Score -Treatment Period I | Week 12 | -3.07 Units on a scale | Standard Deviation 8.479 |
Secondary
Number of Participants Developing Anti-secukinumab Antibodies
To investigate the development of immunogenicity against secukinumab
Time frame: Over time up to week 132
Population: FAS
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AIN457 150mg | Number of Participants Developing Anti-secukinumab Antibodies | 2 Participants |
| AIN457 300 mg | Number of Participants Developing Anti-secukinumab Antibodies | 2 Participants |
| Placebo | Number of Participants Developing Anti-secukinumab Antibodies | 2 Participants |
| Placebo - AIN457 300 mg | Number of Participants Developing Anti-secukinumab Antibodies | 3 Participants |
Secondary
Percentages of Participants With Palmoplantar Investigator Global Assessment (ppIGA) 0 or 1 Response - Treatment Period I
ppIGA: Palmoplantar Ivestigator's Global Assessment. The IGA mod 2011 rating scale: The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. Based on this scale, a patient was considered as an IGA 0 or 1 responder if they achieved a score of 0 or 1 and improved by at least 2 points on the IGA scale at a given time point compared to their score at randomization (baseline).
Time frame: Week 1, week 2, week 4, week, 8, week 12, week 16
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AIN457 150mg | Percentages of Participants With Palmoplantar Investigator Global Assessment (ppIGA) 0 or 1 Response - Treatment Period I | Week 1 | 1.5 Percentages of participants |
| AIN457 150mg | Percentages of Participants With Palmoplantar Investigator Global Assessment (ppIGA) 0 or 1 Response - Treatment Period I | Week 2 | 1.5 Percentages of participants |
| AIN457 150mg | Percentages of Participants With Palmoplantar Investigator Global Assessment (ppIGA) 0 or 1 Response - Treatment Period I | Week 8 | 17.6 Percentages of participants |
| AIN457 150mg | Percentages of Participants With Palmoplantar Investigator Global Assessment (ppIGA) 0 or 1 Response - Treatment Period I | Week 4 | 4.4 Percentages of participants |
| AIN457 150mg | Percentages of Participants With Palmoplantar Investigator Global Assessment (ppIGA) 0 or 1 Response - Treatment Period I | Week 16 | 22.1 Percentages of participants |
| AIN457 150mg | Percentages of Participants With Palmoplantar Investigator Global Assessment (ppIGA) 0 or 1 Response - Treatment Period I | Week 12 | 20.6 Percentages of participants |
| AIN457 300 mg | Percentages of Participants With Palmoplantar Investigator Global Assessment (ppIGA) 0 or 1 Response - Treatment Period I | Week 1 | 1.4 Percentages of participants |
| AIN457 300 mg | Percentages of Participants With Palmoplantar Investigator Global Assessment (ppIGA) 0 or 1 Response - Treatment Period I | Week 8 | 26.1 Percentages of participants |
| AIN457 300 mg | Percentages of Participants With Palmoplantar Investigator Global Assessment (ppIGA) 0 or 1 Response - Treatment Period I | Week 2 | 7.2 Percentages of participants |
| AIN457 300 mg | Percentages of Participants With Palmoplantar Investigator Global Assessment (ppIGA) 0 or 1 Response - Treatment Period I | Week 4 | 8.7 Percentages of participants |
| AIN457 300 mg | Percentages of Participants With Palmoplantar Investigator Global Assessment (ppIGA) 0 or 1 Response - Treatment Period I | Week 12 | 33.3 Percentages of participants |
| AIN457 300 mg | Percentages of Participants With Palmoplantar Investigator Global Assessment (ppIGA) 0 or 1 Response - Treatment Period I | Week 16 | 33.3 Percentages of participants |
| Placebo | Percentages of Participants With Palmoplantar Investigator Global Assessment (ppIGA) 0 or 1 Response - Treatment Period I | Week 4 | 0 Percentages of participants |
| Placebo | Percentages of Participants With Palmoplantar Investigator Global Assessment (ppIGA) 0 or 1 Response - Treatment Period I | Week 16 | 1.5 Percentages of participants |
| Placebo | Percentages of Participants With Palmoplantar Investigator Global Assessment (ppIGA) 0 or 1 Response - Treatment Period I | Week 1 | 0 Percentages of participants |
| Placebo | Percentages of Participants With Palmoplantar Investigator Global Assessment (ppIGA) 0 or 1 Response - Treatment Period I | Week 12 | 1.5 Percentages of participants |
| Placebo | Percentages of Participants With Palmoplantar Investigator Global Assessment (ppIGA) 0 or 1 Response - Treatment Period I | Week 2 | 0 Percentages of participants |
| Placebo | Percentages of Participants With Palmoplantar Investigator Global Assessment (ppIGA) 0 or 1 Response - Treatment Period I | Week 8 | 0 Percentages of participants |
Secondary
Percentages of Subjects With ppIGA 0 or 1 Response (Observed Cases) - Entire Treatment Period
ppIGA: Palmoplantar Ivestigator's Global Assessment. The IGA mod 2011 rating scale: The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. Based on this scale, a patient was considered as an IGA 0 or 1 responder if they achieved a score of 0 or 1 and improved by at least 2 points on the IGA scale at a given time point compared to their score at randomization (baseline).
Time frame: Week 16, Week 24, Week 28, Week 80
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AIN457 150mg | Percentages of Subjects With ppIGA 0 or 1 Response (Observed Cases) - Entire Treatment Period | Week 16 | 23.4 Percentages of participants |
| AIN457 150mg | Percentages of Subjects With ppIGA 0 or 1 Response (Observed Cases) - Entire Treatment Period | Week 28 | 34.5 Percentages of participants |
| AIN457 150mg | Percentages of Subjects With ppIGA 0 or 1 Response (Observed Cases) - Entire Treatment Period | Week 24 | 40.7 Percentages of participants |
| AIN457 150mg | Percentages of Subjects With ppIGA 0 or 1 Response (Observed Cases) - Entire Treatment Period | Week 80 | 41.7 Percentages of participants |
| AIN457 300 mg | Percentages of Subjects With ppIGA 0 or 1 Response (Observed Cases) - Entire Treatment Period | Week 28 | 50.8 Percentages of participants |
| AIN457 300 mg | Percentages of Subjects With ppIGA 0 or 1 Response (Observed Cases) - Entire Treatment Period | Week 80 | 65.3 Percentages of participants |
| AIN457 300 mg | Percentages of Subjects With ppIGA 0 or 1 Response (Observed Cases) - Entire Treatment Period | Week 24 | 44.1 Percentages of participants |
| AIN457 300 mg | Percentages of Subjects With ppIGA 0 or 1 Response (Observed Cases) - Entire Treatment Period | Week 16 | 37.7 Percentages of participants |
| Placebo | Percentages of Subjects With ppIGA 0 or 1 Response (Observed Cases) - Entire Treatment Period | Week 24 | 20.0 Percentages of participants |
| Placebo | Percentages of Subjects With ppIGA 0 or 1 Response (Observed Cases) - Entire Treatment Period | Week 28 | 20.0 Percentages of participants |
| Placebo | Percentages of Subjects With ppIGA 0 or 1 Response (Observed Cases) - Entire Treatment Period | Week 16 | 0.0 Percentages of participants |
| Placebo | Percentages of Subjects With ppIGA 0 or 1 Response (Observed Cases) - Entire Treatment Period | Week 80 | 45.0 Percentages of participants |
| Placebo - AIN457 300 mg | Percentages of Subjects With ppIGA 0 or 1 Response (Observed Cases) - Entire Treatment Period | Week 80 | 68.2 Percentages of participants |
| Placebo - AIN457 300 mg | Percentages of Subjects With ppIGA 0 or 1 Response (Observed Cases) - Entire Treatment Period | Week 16 | 0.0 Percentages of participants |
| Placebo - AIN457 300 mg | Percentages of Subjects With ppIGA 0 or 1 Response (Observed Cases) - Entire Treatment Period | Week 24 | 36.7 Percentages of participants |
| Placebo - AIN457 300 mg | Percentages of Subjects With ppIGA 0 or 1 Response (Observed Cases) - Entire Treatment Period | Week 28 | 48.3 Percentages of participants |
| Placebo | Percentages of Subjects With ppIGA 0 or 1 Response (Observed Cases) - Entire Treatment Period | Week 28 | 0.0 Percentages of participants |
| Placebo | Percentages of Subjects With ppIGA 0 or 1 Response (Observed Cases) - Entire Treatment Period | Week 24 | 100.0 Percentages of participants |
| Placebo | Percentages of Subjects With ppIGA 0 or 1 Response (Observed Cases) - Entire Treatment Period | Week 16 | 25.0 Percentages of participants |
Secondary
Percentages of Subjects With ppIGA 0 or 1 Response (Observed Cases) - Treatment Period II
ppIGA: Palmoplantar Ivestigator's Global Assessment. The IGA mod 2011 rating scale: The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. Based on this scale, a patient was considered as an IGA 0 or 1 responder if they achieved a score of 0 or 1 and improved by at least 2 points on the IGA scale at a given time point compared to their score at randomization (baseline).
Time frame: Week 16, Week 20, Week 28, Week 32, Week 64, Week 132
Population: FAS
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| AIN457 150mg | Percentages of Subjects With ppIGA 0 or 1 Response (Observed Cases) - Treatment Period II | Week 28 | 29.4 Percentages of participants | 15.232 |
| AIN457 150mg | Percentages of Subjects With ppIGA 0 or 1 Response (Observed Cases) - Treatment Period II | Week 20 | 32.4 Percentages of participants | 14.307 |
| AIN457 150mg | Percentages of Subjects With ppIGA 0 or 1 Response (Observed Cases) - Treatment Period II | Week 132 | 22.1 Percentages of participants | — |
| AIN457 150mg | Percentages of Subjects With ppIGA 0 or 1 Response (Observed Cases) - Treatment Period II | Week 64 | 26.5 Percentages of participants | — |
| AIN457 150mg | Percentages of Subjects With ppIGA 0 or 1 Response (Observed Cases) - Treatment Period II | Week 16 | 22.1 Percentages of participants | 15.624 |
| AIN457 150mg | Percentages of Subjects With ppIGA 0 or 1 Response (Observed Cases) - Treatment Period II | Week 32 | 29.4 Percentages of participants | 14.658 |
| AIN457 300 mg | Percentages of Subjects With ppIGA 0 or 1 Response (Observed Cases) - Treatment Period II | Week 32 | 42.0 Percentages of participants | 11.688 |
| AIN457 300 mg | Percentages of Subjects With ppIGA 0 or 1 Response (Observed Cases) - Treatment Period II | Week 16 | 33.3 Percentages of participants | 12.074 |
| AIN457 300 mg | Percentages of Subjects With ppIGA 0 or 1 Response (Observed Cases) - Treatment Period II | Week 20 | 33.3 Percentages of participants | 13.104 |
| AIN457 300 mg | Percentages of Subjects With ppIGA 0 or 1 Response (Observed Cases) - Treatment Period II | Week 132 | 27.5 Percentages of participants | — |
| AIN457 300 mg | Percentages of Subjects With ppIGA 0 or 1 Response (Observed Cases) - Treatment Period II | Week 28 | 44.9 Percentages of participants | 14.258 |
| AIN457 300 mg | Percentages of Subjects With ppIGA 0 or 1 Response (Observed Cases) - Treatment Period II | Week 64 | 46.4 Percentages of participants | — |
| Placebo | Percentages of Subjects With ppIGA 0 or 1 Response (Observed Cases) - Treatment Period II | Week 132 | 12.9 Percentages of participants | — |
| Placebo | Percentages of Subjects With ppIGA 0 or 1 Response (Observed Cases) - Treatment Period II | Week 32 | 35.5 Percentages of participants | 11.728 |
| Placebo | Percentages of Subjects With ppIGA 0 or 1 Response (Observed Cases) - Treatment Period II | Week 28 | 32.3 Percentages of participants | 14.56 |
| Placebo | Percentages of Subjects With ppIGA 0 or 1 Response (Observed Cases) - Treatment Period II | Week 20 | 12.9 Percentages of participants | 11.57 |
| Placebo | Percentages of Subjects With ppIGA 0 or 1 Response (Observed Cases) - Treatment Period II | Week 64 | 29.0 Percentages of participants | — |
| Placebo | Percentages of Subjects With ppIGA 0 or 1 Response (Observed Cases) - Treatment Period II | Week 16 | 0.0 Percentages of participants | 8.88 |
| Placebo - AIN457 300 mg | Percentages of Subjects With ppIGA 0 or 1 Response (Observed Cases) - Treatment Period II | Week 28 | 51.6 Percentages of participants | 10.441 |
| Placebo - AIN457 300 mg | Percentages of Subjects With ppIGA 0 or 1 Response (Observed Cases) - Treatment Period II | Week 16 | 0.0 Percentages of participants | 7.983 |
| Placebo - AIN457 300 mg | Percentages of Subjects With ppIGA 0 or 1 Response (Observed Cases) - Treatment Period II | Week 20 | 9.7 Percentages of participants | 12.625 |
| Placebo - AIN457 300 mg | Percentages of Subjects With ppIGA 0 or 1 Response (Observed Cases) - Treatment Period II | Week 32 | 41.9 Percentages of participants | 5.844 |
| Placebo - AIN457 300 mg | Percentages of Subjects With ppIGA 0 or 1 Response (Observed Cases) - Treatment Period II | Week 64 | 48.4 Percentages of participants | — |
| Placebo - AIN457 300 mg | Percentages of Subjects With ppIGA 0 or 1 Response (Observed Cases) - Treatment Period II | Week 132 | 35.5 Percentages of participants | — |
| Placebo | Percentages of Subjects With ppIGA 0 or 1 Response (Observed Cases) - Treatment Period II | Week 132 | 0.0 Percentages of participants | — |
| Placebo | Percentages of Subjects With ppIGA 0 or 1 Response (Observed Cases) - Treatment Period II | Week 64 | 0.0 Percentages of participants | — |
| Placebo | Percentages of Subjects With ppIGA 0 or 1 Response (Observed Cases) - Treatment Period II | Week 20 | 0.0 Percentages of participants | — |
| Placebo | Percentages of Subjects With ppIGA 0 or 1 Response (Observed Cases) - Treatment Period II | Week 16 | 100.0 Percentages of participants | 4.479 |
| Placebo | Percentages of Subjects With ppIGA 0 or 1 Response (Observed Cases) - Treatment Period II | Week 32 | 0.0 Percentages of participants | — |
| Placebo | Percentages of Subjects With ppIGA 0 or 1 Response (Observed Cases) - Treatment Period II | Week 28 | 100.0 Percentages of participants | — |