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

Study Details

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

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

Study ID

DER99037 (PS0007)

Study 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.

Eligibility Requirements

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

Principal Investigator

Ana Margarita Duarte, MD

Director, Division of Dermatology

More Information: Miami

Clinical Interests:
Vascular lesions, birthmarks, port wine stains (PWS)

More Information


This page was last updated on: 4/2/2026 12:25:15 PM