Study to Assess the Long-term Safety, Tolerability, Efficacy of Secukinumab in Pediatric Patients of Age 6 to <18 Years, With Moderate to Severe Plaque Psoriasis

Study Overview
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Brief Summary
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This was an open-label, parallel-group, two-arm, multicenter study in pediatric subjects aged 6 years to less than 18 years, at randomization, with moderate to severe chronic plaque psoriasis. 84 subjects (most with moderate severity) were enrolled. Subjects were stratified by weight and disease severity.

Detailed Description
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This was an open-label, parallel group, two-arm, multi-center, trial in pediatric subjects aged 6 years to less than 18 years, at randomization, with moderate to severe chronic, plaque psoriasis. The study consists of 3 periods: screening (up to 4 weeks), treatment (of 208 weeks) and post-treatment follow-up (of 16 weeks). Approximately 80 subjects (at least 60 subjects with moderate psoriasis) were planned to be enrolled in about 40 centers worldwide and targeted to have at least 5 subjects in the < 25kg body weight, and at least 10 subjects in each of the other two weight groups (25-< 50 kg and ≥ 50 kg). Adolescents (12-< 18 years) and children (6-< 12 years) were included from the beginning of this study, since the DMC had approved already the enrollment of children (6-< 12 years) in the study CAIN457A2310. Subjects received the appropriate dose based on their body weight category. If the subject moved into a higher or lower weight group at two consecutive visits with weight measurements during the maintenance (from Week 12 onwards as assessed at 4 weekly visits or during extension treatment period (as assessed at scheduled site visits), then the subject was dosed according to the new (higher or lower) weight group respectively.

Official Title
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A Randomized, Open-label, Multicenter Trial to Assess the Efficacy of Subcutaneous Secukinumab after12 Weeks of Treatment, and to Assess the Long-term Safety, Tolerability, Efficacy in Subjects From 6 to <18 Years of Age With Moderate to Severe Chronic Plaque Psoriasis

Conditions
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Moderate to Severe Chronic Plaque-type Psoriasis

Intervention / Treatment
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* Drug: secukinumab low dose
* Drug: secukinumab high dose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed assent and parental permission (age as per local law) obtained at screening before any assessment is performed. Must be 6 to less than 18 years of age at the time of randomization Moderate to Severe plaque psoriasis, defined as a PASI score ≥ 12, and IGA mod 2011 score of ≥ 3, and BSA involvement of ≥10%, at randomization. Subject being regarded by the investigator to be a candidate for systemic therapy. Exclusion Criteria: Forms of psoriasis other than chronic plaque-type active at randomization Drug-induced psoriasis Ongoing use of prohibited treatments Female subjects of childbearing potential defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing and for 16 weeks after stopping study treatment Pregnant or nursing (lactating) females Subjects with total WBC count <2,500/μL, or platelets <100,000/μL or neutrophils <1,500/μL or hemoglobin <8.5 g/dL at screening Previous exposure to secukinumab or any other biologic drug directly targeting IL-17 or the IL-17 receptor

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: secukinumab low dose<br>secukinumab low dose | Drug: secukinumab low dose<br>* dose depends on the weight group<br>* Other names: AIN457;|
| Experimental: secukinumab high dose<br>secukinumab high dose | Drug: secukinumab high dose<br>* dose depends on the weight group<br>* Other names: AIN457;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and Percentage of Participants With PASI 75 Response | Psoriasis Area and Severity Index (PASI):Combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, trunk, upper limbs and lower limbs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, Erythema,Thickening (plaque elevation, induration) & Scaling(desquamation). Scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section(head: 0.1, upper limbs: 0.2 body: 0.3 lower limbs: 0.4). Psoriasis Area and Severity Index (PASI) will be assessed/calculated as per standard procedure. PASI 75 represents the percentage (or number)of patients who have achieved a 75% or more reduction in their PASI score from baseline. PASI 100 indicates patients who have achieved a complete resolution of all disease. | Week 12 | 
| Number and Percentage of Participants With IGA Mod 2011 0 or 1 Response | Investigator will assess the disease using the validated Investigator Global Assessment (IGA) mod 2011 and rate the disease from a score of 0 (clear skin) to 4 (severe disease) | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and Percentage of Participants With PASI 90 Response | Psoriasis Area and Severity Index (PASI) will be assessed/calculated as per the standard procedure PASI 90 represents the percentage (or number) of patients who have achieved a 90% or more reduction in their PASI score from baseline. PASI 100 indicates patients who have achieved a complete resolution of all disease. | Week 12 | 
| Secukinumab Concentration in Serum | Standard pharmacokinetic parameters will be evaluated | up to week 224 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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secukinumab, plaque psoriasis, AIN457A, pediatric