Mixed Guttate/Plaque Psoriasis, Moderate Chronic Plaque Psoriasis, Severe Chronic Plaque Psoriasis
Conditions
Keywords
Chronic plaque psoriasis, Certolizumab pegol, Cimzia, Pediatric study, Phase 3
Brief summary
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.
Interventions
DRUGCertolizumab pegol
Certolizumab Pegol * Pharmaceutical Form: Solution for injection in pre-filled syringe * Route of Administration: Subcutaneous use
DRUGPlacebo
Placebo * Pharmaceutical Form: Solution for injection in pre-filled syringe * Route of Administration: Subcutaneous use
Sponsors
UCB Biopharma SRL
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Study participant must have a diagnosis of moderate to severe plaque psoriasis (PSO) for ≥3 months and: 1. Body Surface Area (BSA) affected by psoriasis ≥10 % 2. Physician's Global Assessment (PGA) score ≥3 (on a scale from 0 to 4) 3. Psoriasis Area and Severity Index (PASI) score is ≥12 or 4. PASI score is ≥10 and \<12 with at least one of the following: * \>Clinically relevant facial or scalp involvement * \>Clinically relevant genital involvement * \>Clinically relevant palm and sole involvement * \>Clinically relevant axillary involvement Study participants aged ≥12 years may alternatively have a diagnosis of moderate to severe mixed guttate/plaque PSO with \>50 % to \<80 % guttate lesions for ≥3 months, and must meet the same criteria listed above * Study participant must be a candidate for systemic psoriasis therapy and/or phototherapy and/or photochemotherapy
Exclusion criteria
* Study participant previously participated in this study or has previously been treated with certolizumab pegol (CZP) * Study participant has generalized pustular or erythrodermic psoriasis (PSO) * Study participant has guttate PSO without plaque PSO * Study participant has had a primary failure to an anti-tumor necrosis factor agent * Study participant has had prior exposure to \>2 biologic therapies * Study participant has a history of severe major depression or suicide attempt (including an actual attempt, interrupted attempt, or aborted attempt), or has had suicidal ideation in the past 6 months as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the "Screening/Baseline" version of the Columbia Suicide Severity Rating Scale (CSSRS) at Screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma concentrations of Certolizumab pegol (CZP) at Week 16 | Week 16 | Blood samples will be collected for measurement of plasma concentrations of CZP at Week 16. |
| Plasma anti-CZP antibody titers at Week 16 | Week 16 | Blood samples will be collected for measurement of anti-CZP antibody titers at Week 16. |
| Plasma concentrations of CZP at Week 52 | Week 52 | Blood samples will be collected for measurement of plasma concentrations of CZP at Week 52. |
| Plasma anti-CZP antibody titers at Week 52 | Week 52 | Blood samples will be collected for measurement of anti-CZP antibody titers at Week 52. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of serious treatment emergent adverse events | 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: * 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 |
| Incidence of treatment emergent adverse events leading to withdrawal | 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. |
Countries
Canada, Puerto Rico, United States
Contacts
STUDY_DIRECTORUCB Cares
001 844 599 2273 (UCB)
Outcome results
None listed