A Study to Evaluate Clear Skin Effect on Quality of Life in Patients With Plaque Psoriasis.

Study Overview
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Brief Summary
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Study of effects of secukinumab 300 mg s.c. on quality of life (QoL) in psoriasis in patients with or without prior exposure to systemic therapy.

Official Title
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An Open-label, Prospective, Non-randomized, Multicenter Study to Evaluate Clear Skin Effect on Health Related Quality of Life Outcomes at 16 and 52 Weeks in Patients With Moderate to Severe Plaque Psoriasis Treated With Secukinumab 300 mg s.c. With or Without Previous Exposure to Systemic Therapy.

Conditions
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Plaque Psoriasis

Intervention / Treatment
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* Drug: Secukinumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men or women aged at least 18 years at time of Screening. Moderate to severe plaque-type psoriasis diagnosed for at least 3 months prior to Screening and candidate for systemic therapy. Other protocol defined inclusion criteria may apply. Please refer to the protocol. Exclusion Criteria: Forms of psoriasis other than moderate to severe plaque-type psoriasis, e.g. drug-induced psoriasis at Screening. Patients with previous treatment with any agent targeting interleukin (IL)-17 directly or IL-17 receptor A (e.g. secukinumab, ixekizumab, or brodalumab). Pregnant or nursing (lactating) women Women of child-bearing potential unless they use effective contraception

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Secukinumab<br>All patients are received s.c. injections of secukinumab 300 mg at Week 0, 1, 2 and 3 during the first 4 weeks followed by monthly maintenance dosing of 300 mg secukinumab starting at Week 4 until Week 48. Consideration was given to discontinuing treatment in patients who showed no response up to 16 weeks of treatment (e.g. patients who did not achieve a PASI 50 response). If discontinued, patients completed the end of study visit assessments. Some patients with an initially partial response (e.g. patients who achieved a PASI 50 response but not a PASI 75 response) subsequently improved with continued treatment beyond 16 weeks. | Drug: Secukinumab<br>* Secukinumab was used as commercially available PFS of 150 mg. Patients received PFS at the site and were instructed to administer Secukinumab as needed (300 mg each application).<br>* Other names: AIN457;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With a Dermatology Life Quality Index 0/1 (DLQI 0/1) Response at Week 16 | The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). Not relevant is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With a Dermatology Life Quality Index 0/1 (DLQI 0/1) Response at Week 52 | The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). Not relevant is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. | 52 weeks | 
| Percentage of Participants in Each DLQI Score Category at Week 16 and Week 52 | The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). Not relevant is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. | 52 weeks | 
| Percentage of Participants With PASI 50, PASI 75, PASI 90, PASI 100 or IGA Mod 2011 0/1 Response at Week 16 and 52 | PASI is a combined assessment of lesion severity & affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself & scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), & severity is estimated by clinical signs, erythema, induration & desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 & 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline. 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. | Week 16, Week 52 | 
| Absolute Change From Baseline in EQ-5D-5L Crosswalk Index at Week 16 and Week 52 | The EQ-5D descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort & anxiety/depression. The 5 dimensions have 5 response levels scored from 1 (best) to 5 (worst). The first 3 dimensions have the response levels lasting from no problems, slight problems, moderate problems, severe problems to unable; the last 2 dimensions have the 5 response levels lasting from no, slight, moderate, severe to extreme. From these 5 dimensions the Crosswalk-index is calculated by concatenating the responses & choosing the corresponding country specific index value from the EQ-5D-5L_Crosswalk_Index_Value_Calculator.v2 excel file (https://euroqol.org/eq-5d-instruments/eq-5d-5labout/valuation-standard-value-sets/crosswalk-index-value-calculator/). This calculated participant-level index scores from -0.654 (worst health) to 1.0 (best health). | Week 16, Week 52 | 
| Absolute Change From Baseline in EQ-5D-5L Visual Analogue Scale (VAS) at Week 16 and Week 52 | A visual analogue scale (VAS) was used within the EQ-5D. This scale recorded the respondent's self-rated health on a vertical 20-cm VAS where the endpoints were labeled best imaginable health state and worst imaginable health state. This resulted in a numeric value set ranging from 0 (=worst imaginable health state) up to 100 (=best imaginable health state). | Week 16, Week 52 | 
| Absolute Change From Baseline in HAQ-DI at Week 16 and Week 52 | The HAQ-DI (Health Assessment Questionnaire - Disability Index) assesses a patient's level of functional ability & includes questions on fine movements of the upper extremity, locomotor activities of the lower extremity & activities that involve both upper & lower extremities. There are 20 items in 8 categories of functioning including dressing & grooming, arising, eating, walking, hygiene, reach, grip & usual activities. The stem of each item asks over the past week, Are you able to... perform a particular task. Each item is scored on a 4-point scale from 0 to 3, representing normal, no difficulty (0), some difficulty (1), much difficulty (2) & unable to do (3). The HAQ-DI also includes questions about the use of 'aids or devices' & aid from other people to supplement the answers given to the 20 items. Total scores were calculated by averaging all scores and ranging from 0 (best) to 3 (worst). Subtracting the baseline value from the week 16 or 52 values results in the change. | Week 16 and Week 52 | 
| Absolute Change From Baseline in Numeric Rating Scale (NRS) at Week 16 and Week 52 | Selfadministered 11-point numeric rating scales (NRS, 0-10) were used to evaluate the patients' assessment of their current pain, itching & scaling. Respondents answered the following questions for the assessment: Pain: Overall, how severe was your psoriasis-related pain over the past 24 hours?; Itching: Overall, how severe was your psoriasis-related itch over the past 24 hours?; & Scaling: Overall, how severe was your psoriasis related scaling over the past 24 hours? Patients had to rate their pain, itching, & scaling from 0 to 10 (11-point scale), with the understanding that the 0 represents the absence or null end of the pain, itching, or scale intensity (i.e. no pain, itching or scaling) & the 10 represents the other extreme of pain, itching, or scaling intensity (i.e. pain, itching or scaling as bad as it could be). The number that the patient selected represents his or her intensity score in the respective category. | 16 and 52 weeks | 
| Treatment Satisfaction Questionnaire for Medication (TSQM) Scale Scores at Week 16 and Week 52 | Treatment Satisfaction Questionnaire for Medication (TSQM) is general measure for treatment satisfaction. Each scale score was calculated by summing individual items and then transformed to a 0-100 scale. Higher summary scores indicate better satisfaction with study drug. | 16 and 52 weeks | 
| Patient Benefit Index (PBI) at Week 16 and Week 52 | The questionnaire includes 23 items on patient-relevant therapy needs & benefits. The first part of the instrument, the 'Patient Needs Questionnaire' (PNQ), is filled in by the patient before therapy. A 5-step Likert scale (0='not important at all' to 4='very important') records the individual relevance of the different items to the patients. The second part, the PBQ, is filled in by the patient during or after therapy. It comprises the same items as the PNQ, but in contrast, the patients evaluate the extent to which the treatment needs have been fulfilled by therapy (scaled from 0='treatment did not help at all' to 4='treatment helped a lot'). In addition, the Likert scale contains the option 'does not apply to me' in the PNQ & the option 'did not apply to me' in the PBQ. The needs prior to treatment (PNQ) & the benefits achieved by treatment (PBQ) are converted to a weighted index value, the PBI in the narrower sense. PBI can have a value from 0='no benefit' to 4='maximal benefit'. | Week 16 and Week 52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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scaly patches, secukinumab, AIN457, Moderate to severe plaque psoriasis, immune-mediated systemic disease, papules, plaques, itching