Psoriasis Clinical Trial
Pediatric Study in Children and Adolescents With Severe Plaque Psoriasis
This was 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 were enrolled, of which at least 30 were 6 years to <12 years old. Subjects were enrolled at approximately 70 study sites worldwide.
The purpose of this study was 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 assessed the long term safety and tolerability of secukinumab in this pediatric age group and described the efficacy and safety of secukinumab compared to etanercept. This study provided 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 were 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 began after a favorable recommendation by an independent external Data Monitoring Committee (DMC) who reviewed data of approximately 80 adolescents. Adolescents continued to be recruited while the data from the first 80 subjects was being collected and analyzed
Subjects were 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) received dose based on the weight category (<25 kg, 25 to <50kg, â‰¥50 kg).
The study consisted 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 was 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.
Must be 6 to less than 18 years of age at the time of randomization
Plaque-type psoriasis history for at least 3 months.
Severe plaque-type psoriasis meeting all of the following three criteria:
PASI score of 20 or greater,
Investigator's Global Assessment (IGA) score of 4
Total body surface area (BSA) affected of 10% or greater.
Patient being regarded by the investigator to be a candidate for systemic therapy because of:
inadequate control of symptoms with topical treatment, or
failure to respond to or tolerate previous systemic treatment and/or UV therapy
Current forms of psoriasis other than chronic plaque-type psoriasis (for example, pustular, erythrodermic, guttate) at randomization.
Current drug-induced psoriasis.
Previous use of secukinumab or any drug that targets IL-17 or IL-17 receptor.
Underlying condition (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal) which in the opinion of the investigator significantly immunocompromises the subject and/or places the subject at unacceptable risk for receiving an immunomodulatory therapy
History of an ongoing, chronic or recurrent infectious disease, or evidence of untreated tuberculosis.
History of lymphoproliferative disease or history of malignancy of any organ system within the past 5 years.
Pregnant or nursing (lactating) women.
Other protocol-defined inclusion/exclusion criteria may apply.
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There are 45 Locations for this study
San Antonio Texas, 78218, United States
Bruxelles , 1200, Belgium
Gent , 9000, Belgium
Liege , 4000, Belgium
Medellin Antioquia, 05001, Colombia
Bogota , 11022, Colombia
Alexandria , 21131, Egypt
Cairo , 11341, Egypt
Tartu , 51014, Estonia
Amiens Cedex 1 , 80054, France
Nice Cedex , 06202, France
Paris , 75015, France
Bad Bentheim , 48455, Germany
Bochum , 44791, Germany
Dresden , 01307, Germany
Erlangen , 91054, Germany
Mainz , 55131, Germany
Muenchen , 80377, Germany
Muenster , 48149, Germany
Guatemala city , 01010, Guatemala
Guatemala City , 1015, Guatemala
Budapest , 1125, Hungary
Budapest , H-108, Hungary
Debrecen , 4032, Hungary
Afula , 18341, Israel
Be'er Sheva , 84571, Israel
Ramat Gan , 52621, Israel
Parma PR, 43100, Italy
Roma RM, 00133, Italy
Nagoya-city Aichi, 467-8, Japan
Riga , LV-10, Latvia
Riga , LV-10, Latvia
Lodz , 90-26, Poland
Lublin , 20-07, Poland
Warszawa , 03-92, Poland
Cluj Napoca Cluj, 40000, Romania
Kazan , 42001, Russian Federation
Krasnodar , 35002, Russian Federation
Moscow , 11929, Russian Federation
Saint Petersburg , 19112, Russian Federation
Yekaterinburg , 62007, Russian Federation
Esplugues de Llobregat Barcelona, 08950, Spain
Barcelona , 08041, Spain
Madrid , 28046, Spain
Zuerich , CH - , Switzerland
Scunthorpe , DN15 , United Kingdom
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