Pediatric Study in Children and Adolescents With Severe Plaque Psoriasis
Condition: Chronic Severe Plaque-type Psoriasis
MeSH terms: Psoriasis
Intervention: Experimental : Secukinumab low dose; Experimental: Secukinumab high dose; Placebo Comparator: Secukinumab Placebo; Active Comparator: Etanercept
Intervention description: 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.; 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 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.; 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.
Intervention MeSH terms: Etanercept; Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 162.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: pediatric; chronic severe plaque psoriasis; secukinumab; etanercept

Summary:

      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.
    

Eligibility criteria:

        Inclusion criteria:

          -  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:

               1. inadequate control of symptoms with topical treatment, or

               2. failure to respond to or tolerate previous systemic treatment and/or UV therapy

        Exclusion criteria

          -  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.