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Pediatric Study in Children and Adolescents With Severe Plaque Psoriasis

  Purpose

This is a multicenter, randomized, double-blind, placebo- and active-controlled (etanercept in single blinded arm) study in pediatric subjects aged 6 years to less than 18 years with severe chronic plaque psoriasis. Approximately 160 subjects aged 6 years to <18 years will be enrolled, of which at least 30 will be 6 years to <12 years old. It is expected that subjects will be enrolled at approximately 70 study sites worldwide.

Condition Intervention Phase
Chronic Severe Plaque-type Psoriasis Biological: Experimental : Secukinumab low dose Biological: Experimental: Secukinumab high dose Biological: Placebo Comparator: Secukinumab Placebo Biological: Active Comparator: Etanercept Phase 3

Study Type: Interventional
Study Design:Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title:A Randomized, Double-blind, Placebo- and Active Controlled Multicenter Trial to Demonstrate Efficacy of Subcutaneous Secukinumab Compared to Placebo and Etanercept (in a Single-blinded Arm) After Twelve Weeks of Treatment, and to Assess the Safety, Tolerability, and Long-term Efficacy in Subjects From 6 to Less Than 18 Years of Age With Severe Chronic Plaque Psoriasis

Resource links provided by NLM:

Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:

  • The percentage of Participants achieving a 75% Improvement from Baseline in PASI Score at week 12. The percentage of Participants who showed Investgator’s Global Assessment (IGA) mod 2011 response of 0 or 1 at week 12 [ Time Frame: 12 weeks ]
    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, arms, trunk, legs; 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, induration and 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) . IGA: The IGA mod 2011 scale has following different scores: 0 : Clear, No signs of psoriasis. 1: Almost clear 2: Mild 3: Moderate 4 : Severe

Secondary Outcome Measures:

  • Percentage of Participants achieving a 90% Improvement from baseline in PASI score at week 12 [ Time Frame: 12 weeks ]
    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, arms, trunk, legs; 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, induration and 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)

  • Percentage of Participants achieving a 50%, 100% Improvement from baseline in PASI score at week 12 [ Time Frame: 12 weeks ]
    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, arms, trunk, legs; 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, induration and 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)

  • Percentage of Participants achieving a 50%, 75%, 90% or 100% Improvement from baseline in (PASI ) Score and an IGA mod 2011 score of 0 or 1 at week 1, 2, 3, 4, 6, 8,12,13,14,15 ,16, 20, 24,28,32,36,40,44,48,and Week 52 [ Time Frame: Weeks 1, 2, 3, 4, 6, 8,12,13,14,15 ,16, 20, 24,28,32,36,40,44,48 and 52 ]
    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, arms, trunk, legs; 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, induration and 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) . IGA: The IGA mod 2011 scale has following different scores: 0 : Clear, No signs of psoriasis. 1: Almost clear 2: Mild 3: Moderate 4 : Severe

  • Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) score and IGA mod 2011 0 or 1 score over time at week 12 and 52 [ Time Frame: Baseline, week 1, 2, 3 ,4, 6, 8, 12, 13, 14, 15, 16,20,24,28,32,36,40,44,48, and Week 52 ]
    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, arms, trunk, legs; 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, induration and 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) . IGA: The IGA mod 2011 scale has following different scores: 0 : Clear, No signs of psoriasis. 1: Almost clear 2: Mild 3: Moderate 4 : Severe

  • Change from Baseline in Children’s Dermatology Life Quality Index (cDLQI) score up to week 52 [ Time Frame: Weeks 4, 8, 12, 24, 36, 52 ]
    The CDLQI measures functional disability of subjects with dermatological disorders who are less than 18 years of age and it has been utilized as a relevant clinical measure in atopic dermatitis, as well as other dermatitis clinical trials. The CDLQI is a simple, validated, self-administered 10-item questionnaire. The instrument contains six functional scales (i.e., symptoms and feeling, leisure, school or holidays, personal relationships, sleep and treatment). The questions are based on the preceding week to permit accurate recall. For the CDLQI, each question will be answered on a 4-point Likert scale scored from 0 to 3. Seven scores will be derived from the CDLQI: the total score of each of the six dimensions as well as the total score over all items. The higher the score, the more quality of life is impaired.

  • Percentage of participants achieving a Childrens’ DLQI score of 0 or 1 at each visit up to week 52 [ Time Frame: Weeks 4, 8, 12, 24, 36, 52 ]
    The CDLQI measures functional disability of subjects with dermatological disorders who are less than 18 years of age and it has been utilized as a relevant clinical measure in atopic dermatitis, as well as other dermatitis clinical trials. The CDLQI is a simple, validated, self-administered 10-item questionnaire. The instrument contains six functional scales (i.e., symptoms and feeling, leisure, school or holidays, personal relationships, sleep and treatment). The questions are based on the preceding week to permit accurate recall. For the CDLQI, each question will be answered on a 4-point Likert scale scored from 0 to 3. Seven scores will be derived from the CDLQI: the total score of each of the six dimensions as well as the total score over all items. The higher the score, the more quality of life is impaired.

  • Composite clinical safety and tolerability as assessed by growth, weight gain, tolerability of s.c. injections, vital signs, clinical laboratory variables, ECGs, and adverse events monitoring [ Time Frame: from screening to Week 252 ]
    Composite measure

  • Percentage of participants with clinically important reduction in disability as evaluated by CHAQ questionnaire over time at Week 12 and Week 52 [ Time Frame: Week 4, 8, 12, 24, 36, 52 ]
    The CHAQ questionnaire is only done for children who in addition to psoriasis are also suffering from psoriatic arthirtis. The questionnaire is completed by parent or legal quardian. It consists of multiple choice items concerning difficulty in performing eight common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and other “activities”. The person completing the questionnaire chooses from four response categories, ranging from ‘without any difficulty’ to ‘unable to do’. Additionnaly two visual analog scales (overal well being and pain of patient) must be performed.

Estimated Enrollment:160
Study Start Date:September 2015
Estimated Study Completion Date:December 2022
Estimated Primary Completion Date:December 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Secukinumab low dose

Secukinumab
Biological: Experimental : Secukinumab low dose

Depending on weight group subject will receive per dose a) 75 mg if weighing less than 50 kg b) 150 mg if weighing 50 kg or more. Secukinumab injections (one or two per dose, depending on the weight group) will be administered subcutaneously at Randomization, Weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48, and Placebo secukinumab at Weeks 13, 14 and 15 during the blinded phase of the study; thereafter at Week 52 and every 4 weeks during the extension treatment period until Week 232.
Other Name: Secukinumab low dose
Experimental: Secukinumab high dose

Secukinumab
Biological: Experimental: Secukinumab high dose

Depending on weight group subject will receive per dose a) 75 mg if weighing less than 25 kg b) 150 mg if weighing between 25 and less than 50 kg c) 300 mg if weighing more than 50 kg. Secukinumab injections (one or two per dose, depending on the weight group) will be administered subcutaneously at Randomization, Weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48, and Placebo secukinumab at Weeks 13, 14 and 15 during the blinded phase of the study; thereafter at Week 52 and every 4 weeks during the extension treatment period until Week 232.
Placebo Comparator: Placebo

Placebo
Biological: Placebo Comparator: Secukinumab Placebo

Placebo secukinumab (one or two subcutaneous injections per dose, depending on weight group) at Randomization and Weeks 1, 2, 3 4 and 8. At Week 12, subjects in the placebo group based on their PASI 75 response status at Week 12 will proceed as follows: • PASI 75 responders will discontinue study treatment at Week 12 and enter the treatment-free follow-up period • PASI 75 non-responders will receive high dose or low dose secukinumab, according to the pre-assignment at the Randomization visit. They will receive their treatment based on the weight category(<25 kg, 25- <50kg, ≥50 kg), on Weeks 12, 13, 14, 15, and then every four weeks starting at Week 16 until Week 48 during the maintenance period; thereafter at week 52 and every 4 weeks during the extension treatment period until Week 232.
Other Name: Secukinumab placebo
Active Comparator: Etanercept Comparator

Etanercept
Biological: Active Comparator: Etanercept

Etanercept 0.8 mg/kg of subject weight and up to a maximum of 50 mg per dose. Subcutaneous etanercept 0.8 mg/kg (one or two injections per dose) once per week, for 51 weeks administered at home (self-injected or by caregiver) or at the study site. At Wk 52 subjects in the etanercept group will move into the treatment-free follow up period and terminate the study.
Other Name: Etanercept

Detailed Description:

This is a multicenter, randomized, double-blind, placebo- and active-controlled (etanercept in single blinded arm) study in pediatric subjects aged 6 years to less than 18 years with severe chronic plaque psoriasis. Approximately 160 subjects aged 6 years to <18 years will be enrolled, of which at least 30 will be 6 years to <12 years old. It is expected that subjects will be enrolled at approximately 70 study sites worldwide.

The purpose of this study is to demonstrate superior efficacy of secukinumab versus placebo at Week 12, based on both PASI 75 and IGA mod 2011 0 or 1 response rates in children and adolescents aged 6 to less than 18 years with severe chronic plaque psoriasis who had inadequate control of symptoms with topical treatment, or failed to respond to or tolerate previous systemic treatment and/or UV therapy.

The study will assess the long term safety and tolerability of secukinumab in this pediatric age group and will describe the efficacy and safety of secukinumab compared to etanercept. This study will provide efficacy and safety data to support the extension of label of secukinumab to include children and adolescents (6 years to <18 years) with severe chronic plaque psoriasis

Two age subgroups will be studied in a staggered approach within this clinical study: 12 to less than 18 years of age, and 6 to less than 12 years of age . Enrolment of children aged 6 to less than 12 years will begin after a favorable recommendation by an independent external Data Monitoring Committee (DMC) who will review data of approximately 80 adolescents. Adolescents will continue to be recruited while the data from the first 80 subjects are being collected and analyzed.

Subjects will be randomized using a 1:1:1:1 ratio into one of the treatment arms: secukinumab low dose, secukinumab high dose, etanercept or placebo. Subjects randomized to secukinumab treatment arms (high dose and low dose) will receive dose based on the weight category (<25 kg, 25 to <50kg, ≥50 kg).

The study consists of 5 periods: screening (up to 4 weeks), induction (of 12 weeks), maintenance (of 40 weeks), extension treatment epoch (open-label of 184 weeks) and post- treatment follow-up epoch (of 16 weeks).

The primary objectiove of the study is to demonstrate the superiority of secukinumab (low and high dose) in pediatric subjects with severe chronic plaque psoriasis with respect to both PASI 75 and IGA mod 2011 0 or 1 response (co-primary endpoints) at Week 12, compared to placebo

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