A Study to Evaluate the Efficacy Safety and Drug Concentration of Certolizumab Pegol (CZP) in Children and Adolescent Study Participants With Moderate to Severe Chronic Plaque Psoriasis (PSO)

  • STATUS
    Recruiting
  • End date
    Dec 8, 2026
  • participants needed
    150
  • sponsor
    UCB Biopharma SRL
Updated on 12 September 2021
Investigator
UCB Cares
Primary Contact
Ps0007 50158 (2.0 mi away) Contact
+49 other location

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.

Details
Condition Moderate Chronic Plaque Psoriasis, Severe Chronic Plaque Psoriasis, Mixed Guttate/Plaque Psoriasis, Mixed Guttate/Plaque Psoriasis, Mixed Guttate/Plaque Psoriasis, Mixed Guttate/Plaque Psoriasis, Mixed Guttate/Plaque Psoriasis, Mixed Guttate/Plaque Psoriasis, Mixed Guttate/Plaque Psoriasis, Mixed Guttate/Plaque Psoriasis, Mixed Guttate/Plaque Psoriasis, Mixed Guttate/Plaque Psoriasis, Mixed Guttate/Plaque Psoriasis, Mixed Guttate/Plaque Psoriasis, Mixed Guttate/Plaque Psoriasis, Mixed Guttate/Plaque Psoriasis, Mixed Guttate/Plaque Psoriasis, Mixed Guttate/Plaque Psoriasis, Mixed Guttate/Plaque Psoriasis, Mixed Guttate/Plaque Psoriasis, Mixed Guttate/Plaque Psoriasis, Mixed Guttate/Plaque Psoriasis, Mixed Guttate/Plaque Psoriasis, Mixed Guttate/Plaque Psoriasis, Mixed Guttate/Plaque Psoriasis, Mixed Guttate/Plaque Psoriasis, Mixed Guttate/Plaque Psoriasis, Mixed Guttate/Plaque Psoriasis, Mixed Guttate/Plaque Psoriasis, Mixed Guttate/Plaque Psoriasis, Mixed Guttate/Plaque Psoriasis, Mixed Guttate/Plaque Psoriasis, Mixed Guttate/Plaque Psoriasis, Mixed Guttate/Plaque Psoriasis, Mixed Guttate/Plaque Psoriasis, Mixed Guttate/Plaque Psoriasis, Mixed Guttate/Plaque Psoriasis, Mixed Guttate/Plaque Psoriasis, Mixed Guttate/Plaque Psoriasis, Mixed Guttate/Plaque Psoriasis, Mixed Guttate/Plaque Psoriasis, Mixed Guttate/Plaque Psoriasis, Mixed Guttate/Plaque Psoriasis, Mixed Guttate/Plaque Psoriasis, Mixed Guttate/Plaque Psoriasis, Mixed Guttate/Plaque Psoriasis, Mixed Guttate/Plaque Psoriasis
Treatment Placebo, Certolizumab Pegol
Clinical Study IdentifierNCT04123795
SponsorUCB Biopharma SRL
Last Modified on12 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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 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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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