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Evaluating Certolizumab Pegol for Children with Moderate to Severe Chronic Plaque Psoriasis

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

Phase 3 Interventional UCB Pharma · NCT04123795

This study is testing if a new medication called certolizumab pegol can help children aged 6 to 17 with moderate to severe chronic plaque psoriasis feel better and improve their skin.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment150 (estimated)
Ages6 Years to 17 Years
SexAll
SponsorUCB Pharma Industry-sponsored
Drugs / interventionscertolizumab
Locations51 sites (Auburn, Alabama and 50 other locations)
Trial IDNCT04123795 on ClinicalTrials.gov

What this trial studies

This study aims to assess the pharmacokinetics, safety, and effectiveness of certolizumab pegol in children aged 6 to 17 years who have moderate to severe chronic plaque psoriasis. Participants will receive either the medication or a placebo to determine how well the drug works and how it is processed in the body. The study will focus on children with significant skin involvement and those who are candidates for systemic therapy or phototherapy. The findings will help support the use of this treatment in pediatric patients.

Who should consider this trial

Good fit: Ideal candidates are children aged 6 to 17 years with moderate to severe chronic plaque psoriasis affecting at least 10% of their body surface area.

Not a fit: Patients with mild psoriasis or those who have not been diagnosed with chronic plaque psoriasis may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide an effective treatment option for children suffering from moderate to severe chronic plaque psoriasis.

How similar studies have performed: Other studies have shown success with similar biologic treatments for psoriasis, indicating a promising approach for this condition.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Auburn, Alabama and 50 other locations

+1 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Moderate Chronic Plaque PsoriasisSevere Chronic Plaque PsoriasisMixed Guttate/Plaque PsoriasisChronic plaque psoriasisCertolizumab pegolCimziaPediatric studyPhase 3
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.