The purpose of the study is to evaluate the pharmacokinetic (PK) of certolizumab pegol (CZP) in study participants aged 6 to 17 years with moderate to severe chronic plaque psoriasis (PSO) in order to support extrapolation of efficacy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
49
Certolizumab Pegol * Pharmaceutical Form: Solution for injection in pre-filled syringe * Route of Administration: Subcutaneous use
Placebo * Pharmaceutical Form: Solution for injection in pre-filled syringe * Route of Administration: Subcutaneous use
Ps0007 50175
Phoenix, Arizona, United States
Ps0007 50162
Fountain Valley, California, United States
Plasma concentrations of Certolizumab pegol (CZP) at Week 16
Blood samples will be collected for measurement of plasma concentrations of CZP at Week 16.
Time frame: Week 16
Plasma anti-CZP antibody titers at Week 16
Blood samples will be collected for measurement of anti-CZP antibody titers at Week 16.
Time frame: Week 16
Plasma concentrations of CZP at Week 52
Blood samples will be collected for measurement of plasma concentrations of CZP at Week 52.
Time frame: Week 52
Plasma anti-CZP antibody titers at Week 52
Blood samples will be collected for measurement of anti-CZP antibody titers at Week 52.
Time frame: Week 52
Incidence of serious treatment emergent adverse events
A serious treatment emergent adverse event (serious TEAE) is any untoward medical occurrence that at any dose: * Results in death * Is life-threatening * Requires in patient hospitalization or prolongation of existing hospitalization * Is a congenital anomaly or birth defect * Is an infection that requires treatment parenteral antibiotics * Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above
Time frame: From Baseline until participant reaches 18 years of age or Cimzia becomes commercially available for pediatric PSO in participant's region (up to 12 years)
Incidence of treatment emergent adverse events leading to withdrawal
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation participants administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. Treatment emergent adverse events (TEAEs) are events that emerge during treatment, having been absent pre-treatment, or worsens relative to the pre-treatment state.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Ps0007 50161
Los Angeles, California, United States
Ps0007 50196
Thousand Oaks, California, United States
Ps0007 50217
Boca Raton, Florida, United States
Ps0007 50248
Hialeah, Florida, United States
Ps0007 50169
Jacksonville, Florida, United States
Ps0007 50268
Miami, Florida, United States
Ps0007 50246
Pembroke Pines, Florida, United States
Ps0007 50269
Wellington, Florida, United States
...and 13 more locations
Time frame: From Baseline until participant reaches 18 years of age or Cimzia becomes commercially available for pediatric PSO in participant's region (up to 12 years)