Psoriasis Clinical Trial
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
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.
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.
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.
Forms of psoriasis other than chronic plaque-type active at randomization
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
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There are 23 Locations for this study
Fountain Valley California, 92708, United States
Jacksonville Florida, 32256, United States
Lebanon New Hampshire, 03756, United States
San Antonio Texas, 78218, United States
Bruxelles , 1200, Belgium
Liege , 4000, Belgium
Hradec Kralove CZE, 500 0, Czechia
Prague Prague 1, 11000, Czechia
Tartu , 51014, Estonia
Dresden , 01307, Germany
Muenster , 48149, Germany
Lima , 1, Peru
Warszawa Mazowian, 02 49, Poland
Rzeszow , 35 05, Poland
Wroclaw , 50-56, Poland
Kazan , 42001, Russian Federation
Krasnodar , 35002, Russian Federation
Moscow , 11929, Russian Federation
Saint Petersburg , 19112, Russian Federation
Esplugues De Llobregat Barcelona, 08950, Spain
Sabadell Barcelona, 08208, Spain
Valencia Comunidad Valenciana, 46026, Spain
Madrid , 28041, Spain
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