STUDY TO ASSESS THE EFFICACY, SAFETY, TOLERABILITY AND PK OF SECUKINUMAB IN SUBJECTS 6 TO LESS THAN 18 YEARS OF AGE WITH MODERATE TO SEVERE CHRONIC PLAQUE PSORIASIS
- Conditions
- -L40L40
- Registration Number
- PER-031-18
- Lead Sponsor
- OVARTIS BIOSCIENSES PERU S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
1. Must be 6 to less than 18 years of age at the time of randomization.
2. 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
3. History of plaque psoriasis for at least 3 months before randomization
1. Forms of psoriasis other than chronic plaque-type (eg, pustular, erythrodermic and guttate psoriasis), active at randomization.
2. Drug-induced psoriasis (ie new onset or current exacerbation from beta-blockers, calcium channel blockers or lithium)
3. Previous exposure to secukinumab or any other biologic drug directly targeting IL-17 or the IL-17 receptor,
4. Subjects with an estimated Glomerular Filtration Rate (eGFR), estimated by the Schwartz equation, of < 60 mL/min/1.73 m2 at screening. Assessment may be repeated once, two or more days later, and if eGFR value 60, subject may be included at the discretion of the investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Bayesian analysis<br>Measure:Proportion of subjects who achieved PASI 75 and IGA mod 2011 0 or 1 r<br>Timepoints:at Week 12 in each secukinumab treatment group (low dose and high dose).<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:Bayesian analysis<br>Measure:Proportion of subjects who achieved PASI 90.<br>Timepoints:at Week 12 in each secukinumab treatment group (low dose and high dose).<br>