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Completed

NCT Number: NCT04123795

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

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.

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Key information

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ps0007 50183, Calgary, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Certolizumab pegol

Drug

Certolizumab Pegol

  • Pharmaceutical Form: Solution for injection in pre-filled syringe
  • Route of Administration: Subcutaneous use

Other names: -Cimzia, -CDP870, -CZP

Placebo

Drug

Placebo

  • Pharmaceutical Form: Solution for injection in pre-filled syringe
  • Route of Administration: Subcutaneous use

Primary outcomes

  1. Plasma concentrations of Certolizumab pegol (CZP) at Week 16

    Time frame: Week 16

    Blood samples will be collected for measurement of plasma concentrations of CZP at Week 16.

  2. Plasma anti-CZP antibody titers at Week 16

    Time frame: Week 16

    Blood samples will be collected for measurement of anti-CZP antibody titers at Week 16.

  3. Plasma concentrations of CZP at Week 52

    Time frame: Week 52

    Blood samples will be collected for measurement of plasma concentrations of CZP at Week 52.

  4. Plasma anti-CZP antibody titers at Week 52

    Time frame: Week 52

    Blood samples will be collected for measurement of anti-CZP antibody titers at Week 52.

Secondary outcomes

  1. Incidence of serious treatment emergent adverse events

    Time frame: From Baseline until participant reaches 18 years of age or Cimzia becomes commercially available for pediatric PSO in participant's region (up to 12 years)

    A serious treatment emergent adverse event (serious TEAE) is any untoward medical occurrence that at any dose:

    • Results in death
    • Is life-threatening
    • Requires in patient hospitalization or prolongation of existing hospitalization
    • Is a congenital anomaly or birth defect
    • Is an infection that requires treatment parenteral antibiotics
    • Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above
  2. Incidence of treatment emergent adverse events leading to withdrawal

    Time frame: From Baseline until participant reaches 18 years of age or Cimzia becomes commercially available for pediatric PSO in participant's region (up to 12 years)

    An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation participants administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. Treatment emergent adverse events (TEAEs) are events that emerge during treatment, having been absent pre-treatment, or worsens relative to the pre-treatment state.

Sponsors and collaborators

Lead sponsor

UCB Biopharma SRL

Industry

Registry information

Official study title

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

Acronym: CIMcare

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Oct 11, 2019
Registry last updated
Jul 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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