Current studies
PS0007
PS0007
, Open Label or , -Controlled Study to Evaluate the Pharmacokinetics, Safety, and Effectiveness of Certolizumab Pegol in Pediatric Study Participants With Moderate to Severe Chronic Plaque
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 (PSO) in order to support extrapolation of .
Medical Condition
Moderate chronic plaque
Min. Age
6
Years
Max. Age
17
Years
Who Can Join?
All
Status
Recruiting
Inclusion criteria
Study participant must have a diagnosis of moderate to severe plaque (PSO) for ≥3 months and: 1. Body Surface Area (BSA) affected by ≥10 % 2. Physician’s Global Assessment (PGA) score ≥3 (on a scale from 0 to 4) 3. 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 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 (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
Study Medication Description
Study Medication:
Cimzia®
Other Descriptive Name:
certolizumab pegol
Yes
Comparator:
No
Refer to a friend
Study Dates
January 2020
Actual Start Date of Enrollment
August 2034
Planned Study Completion Date
General Information
Study ID:
PS0007
EudraCT Number:
2021-003371-33
CT.gov Number:
NCT04123795
Phase:
Phase 3