Plaque Psoriasis
Conditions
Keywords
Plaque psoriasis, auto-injector, 2 mL injection, secukinumab
Brief summary
The primary purpose of this study is to assess efficacy, safety and tolerability of a 2 mL pre-filled auto-injector (AI) of 300 mg secukinumab in patients with moderate to severe plaque psoriasis
Detailed description
This is a 52-weeks multicenter, randomized, double-blind, placebo-controlled, parallel-group trial in approximately 120 subjects with moderate to severe plaque-type psoriasis
Interventions
DRUGPlacebo 2 mL auto-injector
All Placebo patients until week 8 (included): 2 mL auto-injector Placebo + 2x 1 mL prefilled syringe Placebo s.c. at randomization, weeks 1, 2, 3, 4 and 8. PASI 90 responders at week 12: 2 mL auto-injector placebo + 2x 1 mL prefilled syringe Placebo s.c. at weeks 12, 13, 14, 15, 16 and every 4 weeks thereafter until week 48. PASI 90 non-responders at week 12: 2 mL secukinumab 300 mg auto-injector + 2x 1 mL prefilled syringe Placebo s.c. at weeks 12, 13, 14, 15, 16 and 4-weekly thereafter until week 48
DRUGPlacebo 1 mL prefilled syringe
All Placebo patients until week 8 (included): 2 mL auto-injector Placebo + 2x 1 mL prefilled syringe Placebo s.c. at randomization, weeks 1, 2, 3, 4 and 8. PASI 90 responders at week 12: 2 mL auto-injector Placebo + 2x 1 mL prefilled syringe Placebo s.c. at weeks 12, 13, 14, 15, 16 and every 4 weeks thereafter until week 48. PASI 90 non-responders at week 12: 2x 1 mL secukinumab 150 mg prefilled syringe + 2 mL auto-injector Placebo s.c. at weeks 12, 13, 14, 15, 16 and 4-weekly thereafter until week 48
DRUGSecukinumab 2 mL auto-injector
2 mL secukinumab 300 mg auto-injector + 2x 1 mL prefilled syringe Placebo s.c. at randomization, weeks 1, 2, 3, 4, 8, 12, 13, 14, 15 , 16 and 4-weekly thereafter until week 48
DRUGSecukinumab 1 mL prefilled syringe
2 x 1 mL secukinumab 150 mg prefilled syringe + 2 mL auto-injector Placebo s.c. at randomization, weeks 1, 2, 3, 4, 8, 12, 13, 14, 15, 16 and 4-weekly thereafter until week 48
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
A Phase IIIb 52-week multicenter, randomized, double-blind, placebo-controlled, parallel-group trial in approximately 120 subjects with moderate to severe plaque-type psoriasis
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects eligible for inclusion in this study must have fulfilled all of the following criteria: 1. Men or Women of at least 18 years of age at time of Screening 2. Subjects able to understand and communicate with the investigator and comply with the requirements of the study and must have given a written, signed and dated informed consent before any study related activity was performed. Where relevant, a legal representative signed the informed study consent according to local laws and regulations. 3. Chronic plaque-type psoriasis present for at least 6 months and diagnosed before Randomization. 4. Moderate to severe psoriasis as defined at Randomization by: * PASI score of 12 or greater, and * IGA mod 2011 score of 3 or greater (based on a scale of 0 - 4), and * Body Surface Area (BSA) affected by plaque-type psoriasis of 10% or greater. 5. Candidate for systemic therapy. This is defined as a subject having moderate to severe chronic plaque-type psoriasis that is inadequately controlled by * Topical treatment and/or * Phototherapy and/or * Previous systemic therapy
Exclusion criteria
1. Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis) at Screening or Randomization. 2. Ongoing use of prohibited treatments. Washout periods detailed in the protocol had to be adhered to. Subjects not willing to limit UV light exposure (e.g., sunbathing and/or the use of tanning devices) during the course of the study were considered not eligible for this study since UV light exposure was prohibited. Note: administration of live vaccines 6 weeks prior to Randomization or during the study period was also prohibited. 3. Previous exposure to secukinumab (AIN457) or any other biologic drug directly targeting IL-17 or the IL-17 receptor. 4. Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days until the expected pharmacodynamic effect had returned to baseline, whichever is longer; or longer if required by local regulations. 5. Pregnant or nursing (lactating) women, where pregnancy was defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test. 6. History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system treated or untreated within the past 5 years, regardless of whether there was evidence of local recurrence or metastases (except for Bowen's disease, or basal cell carcinoma or actinic keratoses that had been treated with no evidence of recurrence in the past 12 weeks; carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed). 7. History of hypersensitivity to any of study drug constituent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PASI 75 Response After 12 Weeks of Treatment | 12 weeks | Percentage of participants who achieve ≥ 75% reduction in PASI compared to baseline. A PASI (Psoriasis Area and Severity Index) score is a tool used to measure the severity and extent of psoriasis. The score ranges from 0 (no signs of psoriasis) to a theoretic maximum of 72. The intensity of redness, thickness and scaling of the psoriasis is assessed as none (0), mild (1), moderate (2), severe (3) or very severe (4). |
| IGA Mod 2011 0 or 1 Response After 12 Weeks of Treatment | 12 weeks | Percentage of participants who achieve IGA mod 2011 0 or 1, and improved by at least 2 points on the IGA scale compared to baseline. This scale ranges from 0 (clear, no signs of psoriasis) to 4 (severe). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PASI 90 Response | 12 weeks | Percentage of participants who achieve ≥ 90% reduction in PASI compared to baseline |
| PASI 50, 75, 90 and 100 and IGA Mod 2011 0 or 1 Response | 52 weeks | Percentage of participants who achieve ≥ 50%, 75%, 90% and 100% reduction in PASI and achieve IGA mod 2011 0 or 1, and improved by at least 2 points on the IGA scale compared to baseline at each visit up to 52 weeks |
| Successful Self-injection | From randomization until Week 28 | Subject usability (ability to follow instructions for use and potential use-related hazards) and satisfaction with the new secukinumab 2 mL AI utilizing a self-administered Self-Injection Assessment Questionnaire (SIAQ) and investigator/site staff observation of secukinumab 300 mg 2 mL AI administration. The Satisfaction with Self-Injection (SA) domain score ranges from 0 (worst experience) to 10 (best experience). |
| Dermatology Life Quality Index, (DLQI) 0 or 1 Score (Total Score) | Change from Baseline up to 52 weeks | DLQI is a simple, compact, and practical questionnaire for use in a dermatology clinical setting to assess limitations related to the impact of skin disease. The instrument contains ten items dealing with the participant's skin. With the exception of Item Number 7, the participant responds on a four-point scale, ranging from Very Much (score 3) to Not at All or Not relevant (score 0). Item Number 7 is a multi-part item, the first part of which ascertains whether the participant's skin prevented them from working or studying (Yes or No, scores 3 or 0 respectively), and if No, then the participant is asked how much of a problem the skin has been at work or study over the past week, with response alternatives being A lot, A little, or Not at all (scores 2, 1, or 0 respectively). The DLQI total score is derived by summing all item scores, which has a possible range of 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best. |
Countries
Canada, Germany, Iceland, Poland, Spain, United States
Participant flow
Recruitment details
A total of 144 subjects were screened at 22 study centers in 6 countries, and 122 subjects were randomized.
Pre-assignment details
A total of 144 subjects were screened at 22 study centers in 6 countries, and 122 subjects were randomized.
Participants by arm
| Arm | Count |
|---|---|
| Secukinumab 2 mL Auto-injector Secukinumab 300 mg provided in 2 mL auto-injector form | 41 |
| Secukinumab 1 mL Prefilled Syringe Secukinumab 300 mg provided as 2x 1 mL prefilled syringe of 150 mg/mL | 41 |
| Placebo Placebo to Secukinumab | 40 |
| Total | 122 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Treatment Period 1-Randomized Set | Adverse Event | 0 | 1 | 0 | 0 | 0 |
| Treatment Period 1-Randomized Set | Lack of Efficacy | 0 | 0 | 2 | 0 | 0 |
| Treatment Period 1-Randomized Set | Lost to Follow-up | 0 | 1 | 0 | 0 | 0 |
| Treatment Period 1-Randomized Set | Withdrawal by Subject | 0 | 0 | 1 | 0 | 0 |
| Treatment Period 2-Randomized Set | Adverse Event | 0 | 1 | 0 | 0 | 0 |
| Treatment Period 2-Randomized Set | Lost to Follow-up | 0 | 3 | 1 | 0 | 1 |
| Treatment Period 2-Randomized Set | Pregnancy | 1 | 0 | 0 | 0 | 0 |
| Treatment Period 2-Randomized Set | Withdrawal by Subject | 0 | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Secukinumab 2 mL Auto-injector | Secukinumab 1 mL Prefilled Syringe | Placebo | Total |
|---|---|---|---|---|
| Age, Customized < 65 | 39 Participants | 37 Participants | 36 Participants | 112 Participants |
| Age, Customized ≥ 65 | 2 Participants | 4 Participants | 4 Participants | 10 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 39 Participants | 39 Participants | 37 Participants | 115 Participants |
| Sex: Female, Male Female | 13 Participants | 12 Participants | 12 Participants | 37 Participants |
| Sex: Female, Male Male | 28 Participants | 29 Participants | 28 Participants | 85 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 / 41 | 0 / 41 | 0 / 57 | 0 / 58 | 0 / 40 | 0 / 115 |
| other Total, other adverse events | 19 / 41 | 16 / 41 | 24 / 57 | 21 / 58 | 5 / 40 | 45 / 115 |
| serious Total, serious adverse events | 1 / 41 | 3 / 41 | 1 / 57 | 4 / 58 | 0 / 40 | 5 / 115 |
Outcome results
Primary
IGA Mod 2011 0 or 1 Response After 12 Weeks of Treatment
Percentage of participants who achieve IGA mod 2011 0 or 1, and improved by at least 2 points on the IGA scale compared to baseline. This scale ranges from 0 (clear, no signs of psoriasis) to 4 (severe).
Time frame: 12 weeks
Population: Full Analysis Set: Set used for efficacy analysis (122 participants)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Secukinumab 2 mL Auto-injector | IGA Mod 2011 0 or 1 Response After 12 Weeks of Treatment | 31 Participants |
| Secukinumab 1 mL Prefilled Syringe | IGA Mod 2011 0 or 1 Response After 12 Weeks of Treatment | 28 Participants |
| Placebo | IGA Mod 2011 0 or 1 Response After 12 Weeks of Treatment | 3 Participants |
p-value: <0.000195% CI: [11.95, 221.64]Regression, Logistic
p-value: <0.000195% CI: [7.38, 119.57]Regression, Logistic
Primary
PASI 75 Response After 12 Weeks of Treatment
Percentage of participants who achieve ≥ 75% reduction in PASI compared to baseline. A PASI (Psoriasis Area and Severity Index) score is a tool used to measure the severity and extent of psoriasis. The score ranges from 0 (no signs of psoriasis) to a theoretic maximum of 72. The intensity of redness, thickness and scaling of the psoriasis is assessed as none (0), mild (1), moderate (2), severe (3) or very severe (4).
Time frame: 12 weeks
Population: Full Analysis Set: Set used for efficacy analysis (122 participants)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Secukinumab 2 mL Auto-injector | PASI 75 Response After 12 Weeks of Treatment | 39 Participants |
| Secukinumab 1 mL Prefilled Syringe | PASI 75 Response After 12 Weeks of Treatment | 34 Participants |
| Placebo | PASI 75 Response After 12 Weeks of Treatment | 4 Participants |
Comparison: PASI 75p-value: <0.000195% CI: [68.83, 14940.62]Regression, Logistic
Comparison: PASI 75p-value: <0.000195% CI: [17.22, 537.78]Regression, Logistic
Secondary
Dermatology Life Quality Index, (DLQI) 0 or 1 Score (Total Score)
DLQI is a simple, compact, and practical questionnaire for use in a dermatology clinical setting to assess limitations related to the impact of skin disease. The instrument contains ten items dealing with the participant's skin. With the exception of Item Number 7, the participant responds on a four-point scale, ranging from Very Much (score 3) to Not at All or Not relevant (score 0). Item Number 7 is a multi-part item, the first part of which ascertains whether the participant's skin prevented them from working or studying (Yes or No, scores 3 or 0 respectively), and if No, then the participant is asked how much of a problem the skin has been at work or study over the past week, with response alternatives being A lot, A little, or Not at all (scores 2, 1, or 0 respectively). The DLQI total score is derived by summing all item scores, which has a possible range of 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best.
Time frame: Change from Baseline up to 52 weeks
Population: Full Analysis Set-For each post-baseline visit only subjects with a value at both baseline and the respective post-baseline visit are included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Secukinumab 2 mL Auto-injector | Dermatology Life Quality Index, (DLQI) 0 or 1 Score (Total Score) | Week 28 | -13.59 Scores on a Scale | Standard Deviation 7.639 |
| Secukinumab 2 mL Auto-injector | Dermatology Life Quality Index, (DLQI) 0 or 1 Score (Total Score) | Week 12 | -13.21 Scores on a Scale | Standard Deviation 7.701 |
| Secukinumab 2 mL Auto-injector | Dermatology Life Quality Index, (DLQI) 0 or 1 Score (Total Score) | Week 52 | -12.44 Scores on a Scale | Standard Deviation 8.219 |
| Secukinumab 1 mL Prefilled Syringe | Dermatology Life Quality Index, (DLQI) 0 or 1 Score (Total Score) | Week 28 | -12.23 Scores on a Scale | Standard Deviation 8.438 |
| Secukinumab 1 mL Prefilled Syringe | Dermatology Life Quality Index, (DLQI) 0 or 1 Score (Total Score) | Week 12 | -11.95 Scores on a Scale | Standard Deviation 7.861 |
| Secukinumab 1 mL Prefilled Syringe | Dermatology Life Quality Index, (DLQI) 0 or 1 Score (Total Score) | Week 52 | -12.23 Scores on a Scale | Standard Deviation 8.408 |
| Placebo | Dermatology Life Quality Index, (DLQI) 0 or 1 Score (Total Score) | Week 12 | -1.97 Scores on a Scale | Standard Deviation 6.966 |
| Placebo | Dermatology Life Quality Index, (DLQI) 0 or 1 Score (Total Score) | Week 52 | -14.33 Scores on a Scale | Standard Deviation 11.24 |
| Placebo | Dermatology Life Quality Index, (DLQI) 0 or 1 Score (Total Score) | Week 28 | -13.00 Scores on a Scale | Standard Deviation 12.49 |
Secondary
PASI 50, 75, 90 and 100 and IGA Mod 2011 0 or 1 Response
Percentage of participants who achieve ≥ 50%, 75%, 90% and 100% reduction in PASI and achieve IGA mod 2011 0 or 1, and improved by at least 2 points on the IGA scale compared to baseline at each visit up to 52 weeks
Time frame: 52 weeks
Population: Full Analysis Set: Set used for efficacy analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Secukinumab 2 mL Auto-injector | PASI 50, 75, 90 and 100 and IGA Mod 2011 0 or 1 Response | PASI 90 | 30 Participants |
| Secukinumab 2 mL Auto-injector | PASI 50, 75, 90 and 100 and IGA Mod 2011 0 or 1 Response | PASI 75 | 38 Participants |
| Secukinumab 2 mL Auto-injector | PASI 50, 75, 90 and 100 and IGA Mod 2011 0 or 1 Response | PASI 50 | 41 Participants |
| Secukinumab 2 mL Auto-injector | PASI 50, 75, 90 and 100 and IGA Mod 2011 0 or 1 Response | PASI 100 | 23 Participants |
| Secukinumab 2 mL Auto-injector | PASI 50, 75, 90 and 100 and IGA Mod 2011 0 or 1 Response | IGA 0/1 | 30 Participants |
| Secukinumab 1 mL Prefilled Syringe | PASI 50, 75, 90 and 100 and IGA Mod 2011 0 or 1 Response | PASI 90 | 28 Participants |
| Secukinumab 1 mL Prefilled Syringe | PASI 50, 75, 90 and 100 and IGA Mod 2011 0 or 1 Response | PASI 50 | 40 Participants |
| Secukinumab 1 mL Prefilled Syringe | PASI 50, 75, 90 and 100 and IGA Mod 2011 0 or 1 Response | PASI 75 | 37 Participants |
| Secukinumab 1 mL Prefilled Syringe | PASI 50, 75, 90 and 100 and IGA Mod 2011 0 or 1 Response | PASI 100 | 18 Participants |
| Secukinumab 1 mL Prefilled Syringe | PASI 50, 75, 90 and 100 and IGA Mod 2011 0 or 1 Response | IGA 0/1 | 33 Participants |
| Placebo | PASI 50, 75, 90 and 100 and IGA Mod 2011 0 or 1 Response | IGA 0/1 | 0 Participants |
| Placebo | PASI 50, 75, 90 and 100 and IGA Mod 2011 0 or 1 Response | PASI 50 | 4 Participants |
| Placebo | PASI 50, 75, 90 and 100 and IGA Mod 2011 0 or 1 Response | PASI 90 | 0 Participants |
| Placebo | PASI 50, 75, 90 and 100 and IGA Mod 2011 0 or 1 Response | PASI 100 | 0 Participants |
| Placebo | PASI 50, 75, 90 and 100 and IGA Mod 2011 0 or 1 Response | PASI 75 | 1 Participants |
| Placebo-Secukinumab 300 mg (2 mL Auto-injector) | PASI 50, 75, 90 and 100 and IGA Mod 2011 0 or 1 Response | PASI 75 | 13 Participants |
| Placebo-Secukinumab 300 mg (2 mL Auto-injector) | PASI 50, 75, 90 and 100 and IGA Mod 2011 0 or 1 Response | PASI 50 | 15 Participants |
| Placebo-Secukinumab 300 mg (2 mL Auto-injector) | PASI 50, 75, 90 and 100 and IGA Mod 2011 0 or 1 Response | PASI 90 | 12 Participants |
| Placebo-Secukinumab 300 mg (2 mL Auto-injector) | PASI 50, 75, 90 and 100 and IGA Mod 2011 0 or 1 Response | IGA 0/1 | 12 Participants |
| Placebo-Secukinumab 300 mg (2 mL Auto-injector) | PASI 50, 75, 90 and 100 and IGA Mod 2011 0 or 1 Response | PASI 100 | 11 Participants |
| Placebo-Secukinumab 300 mg (2x 1 mL Prefilled Syringe) | PASI 50, 75, 90 and 100 and IGA Mod 2011 0 or 1 Response | PASI 100 | 11 Participants |
| Placebo-Secukinumab 300 mg (2x 1 mL Prefilled Syringe) | PASI 50, 75, 90 and 100 and IGA Mod 2011 0 or 1 Response | IGA 0/1 | 13 Participants |
| Placebo-Secukinumab 300 mg (2x 1 mL Prefilled Syringe) | PASI 50, 75, 90 and 100 and IGA Mod 2011 0 or 1 Response | PASI 90 | 14 Participants |
| Placebo-Secukinumab 300 mg (2x 1 mL Prefilled Syringe) | PASI 50, 75, 90 and 100 and IGA Mod 2011 0 or 1 Response | PASI 50 | 15 Participants |
| Placebo-Secukinumab 300 mg (2x 1 mL Prefilled Syringe) | PASI 50, 75, 90 and 100 and IGA Mod 2011 0 or 1 Response | PASI 75 | 14 Participants |
Secondary
PASI 90 Response
Percentage of participants who achieve ≥ 90% reduction in PASI compared to baseline
Time frame: 12 weeks
Population: Full Analysis Set: Set used for efficacy analysis (122 participants)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Secukinumab 2 mL Auto-injector | PASI 90 Response | 31 Participants |
| Secukinumab 1 mL Prefilled Syringe | PASI 90 Response | 26 Participants |
| Placebo | PASI 90 Response | 2 Participants |
p-value: <0.000195% CI: [16.15, 484.52]Regression, Logistic
p-value: <0.000195% CI: [7.6, 189.01]Regression, Logistic
Secondary
Successful Self-injection
Subject usability (ability to follow instructions for use and potential use-related hazards) and satisfaction with the new secukinumab 2 mL AI utilizing a self-administered Self-Injection Assessment Questionnaire (SIAQ) and investigator/site staff observation of secukinumab 300 mg 2 mL AI administration. The Satisfaction with Self-Injection (SA) domain score ranges from 0 (worst experience) to 10 (best experience).
Time frame: From randomization until Week 28
Population: Safety Set was used for this analyses. For each visit only subjects with a value at both PRE-module at baseline and the respective POST-baseline visit are included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Secukinumab 2 mL Auto-injector | Successful Self-injection | Week 12 | 5.70 Scores on a scale | Standard Deviation 2.523 |
| Secukinumab 2 mL Auto-injector | Successful Self-injection | Week 4 | 5.70 Scores on a scale | Standard Deviation 2.495 |
| Secukinumab 2 mL Auto-injector | Successful Self-injection | Baseline | 5.75 Scores on a scale | Standard Deviation 2.442 |
| Secukinumab 2 mL Auto-injector | Successful Self-injection | Week 8 | 5.68 Scores on a scale | Standard Deviation 2.49 |
| Secukinumab 2 mL Auto-injector | Successful Self-injection | Week 28 | 5.62 Scores on a scale | Standard Deviation 2.485 |
| Secukinumab 2 mL Auto-injector | Successful Self-injection | Week 1 | 5.72 Scores on a scale | Standard Deviation 2.463 |
| Secukinumab 2 mL Auto-injector | Successful Self-injection | Baseline (1) =POST-module at baseline visit | 5.75 Scores on a scale | Standard Deviation 2.452 |
| Secukinumab 1 mL Prefilled Syringe | Successful Self-injection | Week 28 | 8.69 Scores on a scale | Standard Deviation 1.681 |
| Secukinumab 1 mL Prefilled Syringe | Successful Self-injection | Baseline (1) =POST-module at baseline visit | 7.52 Scores on a scale | Standard Deviation 2.046 |
| Secukinumab 1 mL Prefilled Syringe | Successful Self-injection | Week 1 | 8.11 Scores on a scale | Standard Deviation 1.759 |
| Secukinumab 1 mL Prefilled Syringe | Successful Self-injection | Week 4 | 8.27 Scores on a scale | Standard Deviation 1.731 |
| Secukinumab 1 mL Prefilled Syringe | Successful Self-injection | Week 8 | 8.62 Scores on a scale | Standard Deviation 1.545 |
| Secukinumab 1 mL Prefilled Syringe | Successful Self-injection | Week 12 | 8.56 Scores on a scale | Standard Deviation 1.623 |
| Placebo | Successful Self-injection | Week 8 | 2.94 Scores on a scale | Standard Deviation 2.869 |
| Placebo | Successful Self-injection | Week 1 | 2.39 Scores on a scale | Standard Deviation 3.169 |
| Placebo | Successful Self-injection | Week 28 | 3.07 Scores on a scale | Standard Deviation 3.238 |
| Placebo | Successful Self-injection | Week 12 | 2.86 Scores on a scale | Standard Deviation 2.985 |
| Placebo | Successful Self-injection | Week 4 | 2.57 Scores on a scale | Standard Deviation 3.08 |
| Placebo | Successful Self-injection | Baseline (1) =POST-module at baseline visit | 1.77 Scores on a scale | Standard Deviation 2.789 |