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Active Not Recruiting
NCT04123795
A Study to Evaluate the Pharmacokinetics, Safety, and Effectiveness of Certolizumab Pegol in Children With Moderate to Severe Chronic Plaque Psoriasis
Conditions: Moderate Chronic Plaque Psoriasis, Severe Chronic Plaque Psoriasis, Mixed Guttate/Plaque Psoriasis
Sex: All
Ages: 6 Years – 17 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 49
Sponsor: UCB Biopharma SRL
Location: Ps0007 50175 Phoenix Arizona
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.
Eligibility Criteria
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 \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 \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
Source: ClinicalTrials.gov (NCT04123795). StuddyBuddy aggregates publicly available trial information.