Plaque Psoriasis MedDRA version: 20.0 Level: LLT Classification code 10050576 Term: Psoriasis vulgaris System Organ Class: 100000004858
Conditions
Interventions
Trade Name: Cosentyx
Product Name: secukinumab
Product Code: AIN457
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Secukinumab
CAS Number: 1229022-83-6
Current
Sponsors
Novartis Farmacéutica, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed assent and parental permission (age as per local law) obtained at screening before any assessment is performed. 2. Must be 6 to less than 18 years of age at the time of randomization 3. 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. 4. History of plaque psoriasis for at least 3 months before randomization 5. Subject being regarded by the investigator to be a candidate for systemic therapy. Are the trial subjects under 18? yes Number of subjects for this age range: 80 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects fulfilling any of the following criteria: 1. Forms of psoriasis other than chronic plaque-type active at randomization 2. Drug-induced psoriasis 3. Ongoing use of prohibited treatments 4. 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 5. Pregnant or nursing (lactating) females 6. 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 7. Previous exposure to secukinumab or any other biologic drug directly targeting IL-17 or the IL-17 receptor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of secukinumab in pediatric subjects aged 6 years to less than 18 years old with moderate to severe chronic plaque psoriasis with respect to PASI 75 and IGA mod 2011 0/1 response (coprimary endpoints) at Week 12, compared to placebo (historical control).;Secondary Objective: To evaluate the efficacy of secukinumab in pediatric subjects aged 6 years to less than 18 years old with moderate to severe chronic plaque psoriasis with respect to PASI 90 at Week 12, compared to placebo (historical control). To investigate the clinical safety and tolerability of secukinumab as assessed by growth, weight gain, vital signs, clinical laboratory variables, ECGs, and adverse event monitoring To evaluate the pharmacokinetics of the two secukinumab doses in subjects.;Primary end point(s): PASI 75 and IGA mod 2011 0 or 1 response;Timepoint(s) of evaluation of this end point: week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. PASI 90 2. safety and tolerability 3. Pharmacokinetics;Timepoint(s) of evaluation of this end point: 1. week 12 2. up to week 224 3. up to week 224 | — |
Countries
Argentina, Belgium, Czech Republic, Estonia, Germany, Peru, Poland, Russian Federation, Spain, United States
Contacts
Public ContactTrial Monitoring Organization (TMo)
Novartis Farmacéutica, S.A.
Outcome results
None listed