Certolizumab pegol
DrugCertolizumab Pegol
- Pharmaceutical Form: Solution for injection in pre-filled syringe
- Route of Administration: Subcutaneous use
Other names: -Cimzia, -CDP870, -CZP
NCT Number: NCT04123795
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.
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Notify Me6 year–17 year
All sexes
Interventional
Phase 3
Ps0007 50183, Calgary, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Certolizumab Pegol
Other names: -Cimzia, -CDP870, -CZP
Placebo
Time frame: Week 16
Blood samples will be collected for measurement of plasma concentrations of CZP at Week 16.
Time frame: Week 16
Blood samples will be collected for measurement of anti-CZP antibody titers at Week 16.
Time frame: Week 52
Blood samples will be collected for measurement of plasma concentrations of CZP at Week 52.
Time frame: Week 52
Blood samples will be collected for measurement of anti-CZP antibody titers at Week 52.
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)
A serious treatment emergent adverse event (serious TEAE) is any untoward medical occurrence that at any dose:
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)
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.
UCB Biopharma SRL
Industry
Multicenter, Open Label or Double-Blind, Placebo-Controlled Study to Evaluate the Pharmacokinetics, Safety, and Effectiveness of Certolizumab Pegol in Pediatric Study Participants With Moderate to Severe Chronic Plaque Psoriasis
Acronym: CIMcare
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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NCT05637515
Moderate Chronic Plaque Psoriasis, Severe Chronic Plaque Psoriasis
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View Trial Details