Last updated on January 2019

Pediatric Study in Children and Adolescents With Severe Plaque Psoriasis


Brief description of study

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

Detailed Study 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 posttreatment 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

Clinical Study Identifier: NCT02471144

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Novartis Pharmaceuticals

Novartis Investigative Site
Amiens cedex 1, France
0.01miles
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Novartis Pharmaceuticals

Novartis Investigative Site
Amiens Cedex 1, France
2.92miles
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Recruitment Status: Open


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