A Study to Evaluate the Pharmacokinetics, Safety, and Effectiveness of Certolizumab Pegol in Children With Moderate to Severe Chronic Plaque Psoriasis

Description

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.

Conditions

Moderate Chronic Plaque Psoriasis, Severe Chronic Plaque Psoriasis, Mixed Guttate/Plaque Psoriasis

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Study Overview

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Study Details

Study overview

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.

Multicenter, Open Label or Double-Blind, Placebo-Controlled Study to Evaluate the Pharmacokinetics, Safety, and Effectiveness of Certolizumab Pegol in Pediatric Study Participants With Moderate to Severe Chronic Plaque Psoriasis

A Study to Evaluate the Pharmacokinetics, Safety, and Effectiveness of Certolizumab Pegol in Children With Moderate to Severe Chronic Plaque Psoriasis

Condition
Moderate Chronic Plaque Psoriasis
Intervention / Treatment

-

Contacts and Locations

Auburn

Ps0007 50214, Auburn, Alabama, United States, 36832

Phoenix

Ps0007 50175, Phoenix, Arizona, United States, 85006

Anaheim

Ps0007 50213, Anaheim, California, United States, 92804

Fountain Valley

Ps0007 50162, Fountain Valley, California, United States, 92708

Los Angeles

Ps0007 50161, Los Angeles, California, United States, 90045

Thousand Oaks

Ps0007 50196, Thousand Oaks, California, United States, 91320

Aurora

Ps0007 50312, Aurora, Colorado, United States, 80012

Boca Raton

Ps0007 50217, Boca Raton, Florida, United States, 33428

Hialeah

Ps0007 50248, Hialeah, Florida, United States, 33016

Jacksonville

Ps0007 50169, Jacksonville, Florida, United States, 32256

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

6 Years to 17 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

UCB Biopharma SRL,

UCB Cares, STUDY_DIRECTOR, 001 844 599 2273 (UCB)

Study Record Dates

2034-08-15