PS0007
PS0007
Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled (12-17 Years) Including a Single Open-Label Arm (6-11 Years) Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Certolizumab Pegol (CZP) in Pediatric Study Participants With Moderate to Severe Chronic Plaque Psoriasis (PSO)
Brief summary
The purpose of the study is to demonstrate the efficacy and safety of certolizumab pegol in the treatment of moderate to severe chronic plaque psoriasis in study participants aged 6 to 11 and 12 to 17 years.Medical Condition
Moderate chronic plaque psoriasis
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 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
Study Medication Description
Study Medication:
CIMZIA
Other Descriptive Name:
certolizumab pegol
Placebo
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