Status:
RECRUITING
A Study to Evaluate the Pharmacokinetics, Safety, and Effectiveness of Certolizumab Pegol in Children With Moderate to Severe Chronic Plaque Psoriasis
Lead Sponsor:
UCB Biopharma SRL
Conditions:
Moderate Chronic Plaque Psoriasis
Severe Chronic Plaque Psoriasis
Eligibility:
All Genders
6-17 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- Study participant must have a diagnosis of moderate to severe plaque psoriasis (PSO) for ≥3 months and:
- Body Surface Area (BSA) affected by psoriasis ≥10 %
- Physician's Global Assessment (PGA) score ≥3 (on a scale from 0 to 4)
- Psoriasis Area and Severity Index (PASI) score is ≥12 or
- 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
- 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
Key Trial Info
Start Date :
January 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 15 2034
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT04123795
Start Date
January 21 2020
End Date
August 15 2034
Last Update
December 17 2025
Active Locations (51)
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1
Ps0007 50214
Auburn, Alabama, United States, 36832
2
Ps0007 50175
Phoenix, Arizona, United States, 85006
3
Ps0007 50213
Anaheim, California, United States, 92804
4
Ps0007 50162
Fountain Valley, California, United States, 92708