Chronic Scalp Psoriasis
Conditions
Keywords
scalp psoriasis, plaque psoriasis, secukinumab, AIN457, biologic, monoclonal antibody, psoriasis, AIN457A
Brief summary
This study will assess the efficacy and safety of secukinumab compared to placebo in adult patients who have moderate to severe scalp psoriasis that is poorly controlled by current psoriasis treatments.
Interventions
BIOLOGICALSecukinumab 300 mg
Secukinumab 300 mg will be provided in 1 mL prefilled syringes of 150 mg. Each dose of 300 mg secukinumab will consist of two secukinumab 150 mg injections once weekly for 5 weeks (Baseline, Weeks 1, 2, 3 and 4), followed by dosing every four weeks starting at Week 8 through Week 20 inclusive. In order to maintain the blinding, patients will receive additional placebo injections at Weeks 13, 14 and 15. The patients (or caregivers) will self-inject each dose at the study site under the supervision of site personnel when injections occur of days of study visits. The injections not occurring during a study visit will be done by the patients (or caregivers) at home.
BIOLOGICALPlacebo
Placebo will be provided in 1 mL prefilled syringe. Each placebo dose will consist of two placebo injections once weekly for five weeks (Baseline, Weeks 1, 2, 3 and 4), then after four weeks at Week 8. At Week 12, PSSI responders will continue on placebo and receive their injections once weekly for five weeks (Weeks 12, 13, 14, 15 and 16), then followed by dosing after four weeks at Week 20. PSSI non-responders will be switched to receive 300 mg secukinumab at Weeks 12, 13, 14, 15 and 16, then after four weeks at Week 20. The patients (or caregivers) will self-inject each dose at the study site under the supervision of site personnel when injections occur on days of study visits. The injections not occurring during a study visit will be done by the patients (or caregivers) at home.
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
* Chronic scalp psoriasis for at least the previous six months * Moderate to severe scalp psoriasis as defined by a PSSI score of ≥12 and 30% or higher of scalp surface area affected * Must be candidates for systemic therapy, which means having scalp psoriasis inadequately controlled by topical treatments (corticosteroids), and/or phototherapy, and/or previous systemic therapy.
Exclusion criteria
* Forms of psoriasis other than chronic plaque * Drug-induced psoriasis (e.g., new onset or current exacerbation from β-blockers, calcium channel inhibitors) * Ongoing use of prohibited treatments (e.g., topical or systemic corticosteroids, UV therapy) * Prior exposure to secukinumab (AIN457) or any other biologic drug directly targeting IL17A or IL-17RA receptors * Use of other investigational drugs within 30 days prior to study entry, 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 * Active system infections (with the exception of the common cold) during the two weeks prior to starting study treatment * Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Psoriasis Scalp Severity Index 90 (PSSI 90) | 12 weeks | PSSI 90 response (yes) at Week 12; PSSI 90 response means at least a 90% improvement in scalp psoriasis Percentage of participants with Psoriasis Scalp Severity Index 90 (PSSI 90) response of yes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in PSSI Score | 12 weeks | Change from baseline in Psoriasis Scalp Severity Index (PSSI) score. PSSI score ranges from 0-72 with 72 being severe |
| Psoriasis Scalp Severity Index 75 (PSSI 75) Response | 12 weeks | PSSI 75 response (yes) at Week 12 (non-responder imputation); PSSI 75 response means at least a 75% improvement in scalp psoriasis |
| Psoriasis Scalp Severity Index 100 (PSSI 100) Response | 12 weeks | PSSI 100 response (yes) at Week 12 (non-responder imputation); PSSI 100 response means no sign of scalp psoriasis |
| Time to 50% Reduction in PSSI Score up to Week 12 | 12 weeks | Time to 50% reduction in PSSI score up to week 12 was estimated for drug arm The median time to reduction was not estimable for placebo because a 50% reduction in PSSI score was not achieved by enough participants receiving placebo |
| Psoriasis Area and Severity Index 75 (PASI 75) | 12 weeks | PASI 75 response (yes) at Week 12 (non-responder imputation); PASI 75 response means at least a 75% improvement in body psoriasis |
| Secondary: Investigator's Global Assessment Model 2011 (IGA Mod 2011) Score of 0 or 1 (Scalp Only) | 12 weeks | IGA mod 2011 score of 0 or 1 (scalp only) response at Week 12 (non-responder imputation); IGA mod 2011 score of 0 means no sign of scalp psoriasis, and IGA score of 1 means almost no scalp psoriasis |
| Psoriasis Area and Severity Index 100 (PASI 100) | 12 weeks | PASI 100 response (yes) at Week 12 (non-responder imputation); PASI 100 response means no sign of body psoriasis |
| Investigator's Global Assessment Model 2011 (GA Mod 2011) Score of 0 or 1 (Entire Body Including Scalp) | 12 weeks | IGA mod 2011 score of 0 or 1 (entire body including scalp); IGA mod 2011 score of 0 means no sign of psoriasis, and IGA mod 2011 score of 1 means almost no psoriasis |
| Change From Baseline in Subject Assessment of Pain | 12 weeks | Change from baseline in the Subject Assessment of Pain Scale of 0-10 with 10 being the most painful |
| Change From Baseline in Subject Assessment of Itching | 12 weeks | Change from baseline in the Subject Assessment of Itching Scale of 0-10 with 10 being the most itchy |
| Change From Baseline in Subject Assessment of Scaling (Scalp Only) | 12 weeks | Change from baseline in the Subject Assessment of Scaling (scalp only) Scale of 0-10 with 10 being the most scaling |
| Psoriasis Area and Severity Index 90 (PASI 90) | 12 weeks | PASI 90 response (yes) at Week 12 (non-responder imputation); PASI 90 response means at least a 90% improvement in body psoriasis |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Secukinumab Eligible patients received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by monthly dosing starting at Week 8 through Week 20 inclusive | 51 |
| Placebo Eligible participants received placebo doses once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by a dose after four weeks at Week 8. Prior to taking the Week 12 dose, participants were assessed for response to treatment using the Psoriasis Scalp Severity Index (PSSI). If the participant was a responder, the participant continued on placebo through Week 20. Participants who were not responders were switched to treatment with secukinumab 300 mg. | 51 |
| Total | 102 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1 (Randomized Set) | Lost to Follow-up | 0 | 1 |
| Period 1 (Randomized Set) | Withdrawal by Subject | 1 | 3 |
| Period 2 (Randomized Set) | Adverse Event | 2 | 0 |
| Period 2 (Randomized Set) | Lost to Follow-up | 1 | 1 |
| Period 2 (Randomized Set) | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Secukinumab | Placebo | Total |
|---|---|---|---|
| Age, Customized Mean | 42.7 Age (years) STANDARD_DEVIATION 13.39 | 41.1 Age (years) STANDARD_DEVIATION 14.17 | 41.9 Age (years) STANDARD_DEVIATION 13.74 |
| Sex: Female, Male Female | 24 Participants | 30 Participants | 54 Participants |
| Sex: Female, Male Male | 27 Participants | 21 Participants | 48 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 | 8 / 51 | 5 / 51 | 5 / 46 | 5 / 96 |
| serious Total, serious adverse events | 0 / 51 | 1 / 51 | 1 / 46 | 1 / 96 |
Outcome results
Primary
Psoriasis Scalp Severity Index 90 (PSSI 90)
PSSI 90 response (yes) at Week 12; PSSI 90 response means at least a 90% improvement in scalp psoriasis Percentage of participants with Psoriasis Scalp Severity Index 90 (PSSI 90) response of yes
Time frame: 12 weeks
Population: Full Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Secukinumab | Psoriasis Scalp Severity Index 90 (PSSI 90) | 52.9 Percent of Participants |
| Placebo | Psoriasis Scalp Severity Index 90 (PSSI 90) | 2.0 Percent of Participants |
p-value: <0.00195% CI: [37, 65]Cochran-Mantel-Haenszel
Secondary
Change From Baseline in PSSI Score
Change from baseline in Psoriasis Scalp Severity Index (PSSI) score. PSSI score ranges from 0-72 with 72 being severe
Time frame: 12 weeks
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Secukinumab | Change From Baseline in PSSI Score | -25.47 Scores on a scale | Standard Deviation 17.052 |
| Placebo | Change From Baseline in PSSI Score | -5.98 Scores on a scale | Standard Deviation 12.868 |
Secondary
Change From Baseline in Subject Assessment of Itching
Change from baseline in the Subject Assessment of Itching Scale of 0-10 with 10 being the most itchy
Time frame: 12 weeks
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Secukinumab | Change From Baseline in Subject Assessment of Itching | -4.10 Scores on a scale | Standard Deviation 3.008 |
| Placebo | Change From Baseline in Subject Assessment of Itching | -0.24 Scores on a scale | Standard Deviation 2.84 |
Secondary
Change From Baseline in Subject Assessment of Pain
Change from baseline in the Subject Assessment of Pain Scale of 0-10 with 10 being the most painful
Time frame: 12 weeks
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Secukinumab | Change From Baseline in Subject Assessment of Pain | -1.43 Scores on a scale | Standard Deviation 3.233 |
| Placebo | Change From Baseline in Subject Assessment of Pain | 1.04 Scores on a scale | Standard Deviation 2.615 |
Secondary
Change From Baseline in Subject Assessment of Scaling (Scalp Only)
Change from baseline in the Subject Assessment of Scaling (scalp only) Scale of 0-10 with 10 being the most scaling
Time frame: 12 weeks
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Secukinumab | Change From Baseline in Subject Assessment of Scaling (Scalp Only) | -5.24 Scores on a scale | Standard Deviation 2.861 |
| Placebo | Change From Baseline in Subject Assessment of Scaling (Scalp Only) | -0.65 Scores on a scale | Standard Deviation 2.763 |
Secondary
Investigator's Global Assessment Model 2011 (GA Mod 2011) Score of 0 or 1 (Entire Body Including Scalp)
IGA mod 2011 score of 0 or 1 (entire body including scalp); IGA mod 2011 score of 0 means no sign of psoriasis, and IGA mod 2011 score of 1 means almost no psoriasis
Time frame: 12 weeks
Population: Full Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Secukinumab | Investigator's Global Assessment Model 2011 (GA Mod 2011) Score of 0 or 1 (Entire Body Including Scalp) | 52.9 Percent of Participants |
| Placebo | Investigator's Global Assessment Model 2011 (GA Mod 2011) Score of 0 or 1 (Entire Body Including Scalp) | 3.9 Percent of Participants |
Secondary
Psoriasis Area and Severity Index 100 (PASI 100)
PASI 100 response (yes) at Week 12 (non-responder imputation); PASI 100 response means no sign of body psoriasis
Time frame: 12 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Secukinumab | Psoriasis Area and Severity Index 100 (PASI 100) | 23.5 Percent of Participants |
| Placebo | Psoriasis Area and Severity Index 100 (PASI 100) | 0.0 Percent of Participants |
Secondary
Psoriasis Area and Severity Index 75 (PASI 75)
PASI 75 response (yes) at Week 12 (non-responder imputation); PASI 75 response means at least a 75% improvement in body psoriasis
Time frame: 12 weeks
Population: Full Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Secukinumab | Psoriasis Area and Severity Index 75 (PASI 75) | 64.7 Percent of participants |
| Placebo | Psoriasis Area and Severity Index 75 (PASI 75) | 2.0 Percent of participants |
Secondary
Psoriasis Area and Severity Index 90 (PASI 90)
PASI 90 response (yes) at Week 12 (non-responder imputation); PASI 90 response means at least a 90% improvement in body psoriasis
Time frame: 12 weeks
Population: Full Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Secukinumab | Psoriasis Area and Severity Index 90 (PASI 90) | 47.1 Percent of Participants |
| Placebo | Psoriasis Area and Severity Index 90 (PASI 90) | 0.0 Percent of Participants |
Secondary
Psoriasis Scalp Severity Index 100 (PSSI 100) Response
PSSI 100 response (yes) at Week 12 (non-responder imputation); PSSI 100 response means no sign of scalp psoriasis
Time frame: 12 weeks
Population: Full Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Secukinumab | Psoriasis Scalp Severity Index 100 (PSSI 100) Response | 35.3 Percent of Participants |
| Placebo | Psoriasis Scalp Severity Index 100 (PSSI 100) Response | 0.0 Percent of Participants |
Secondary
Psoriasis Scalp Severity Index 75 (PSSI 75) Response
PSSI 75 response (yes) at Week 12 (non-responder imputation); PSSI 75 response means at least a 75% improvement in scalp psoriasis
Time frame: 12 weeks
Population: Full Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Secukinumab | Psoriasis Scalp Severity Index 75 (PSSI 75) Response | 62.7 Percent of Participants |
| Placebo | Psoriasis Scalp Severity Index 75 (PSSI 75) Response | 5.9 Percent of Participants |
Secondary
Secondary: Investigator's Global Assessment Model 2011 (IGA Mod 2011) Score of 0 or 1 (Scalp Only)
IGA mod 2011 score of 0 or 1 (scalp only) response at Week 12 (non-responder imputation); IGA mod 2011 score of 0 means no sign of scalp psoriasis, and IGA score of 1 means almost no scalp psoriasis
Time frame: 12 weeks
Population: Full Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Secukinumab | Secondary: Investigator's Global Assessment Model 2011 (IGA Mod 2011) Score of 0 or 1 (Scalp Only) | 56.9 Percent of Participants |
| Placebo | Secondary: Investigator's Global Assessment Model 2011 (IGA Mod 2011) Score of 0 or 1 (Scalp Only) | 5.9 Percent of Participants |
Secondary
Time to 50% Reduction in PSSI Score up to Week 12
Time to 50% reduction in PSSI score up to week 12 was estimated for drug arm The median time to reduction was not estimable for placebo because a 50% reduction in PSSI score was not achieved by enough participants receiving placebo
Time frame: 12 weeks
Population: Full Analysis Set
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Secukinumab | Time to 50% Reduction in PSSI Score up to Week 12 | 3.29 weeks |