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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) (CIMcare)

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UCB

Status and phase

Enrolling
Phase 3

Conditions

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

Treatments

Drug: Certolizumab pegol
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

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.

Enrollment

150 estimated patients

Sex

All

Ages

6 to 17 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

150 participants in 3 patient groups, including a placebo group

Cohort A - certolizumab pegol
Experimental group
Description:
Enrolling study participants aged 12 to 17 years (inclusive). Study participants in this arm will receive weight-based subcutaneous doses of certolizumab pegol from Week 1 to Week 52 and through the subsequent Open-Label Extension Period.
Treatment:
Drug: Certolizumab pegol
Cohort A - placebo
Placebo Comparator group
Description:
Enrolling study participants aged 12 to 17 years (inclusive). Study participants in this arm will receive weight-based subcutaneous doses of placebo from Week 1 to 16 and certolizumab pegol to Week 52 and through the subsequent Open-Label Extension Period.
Treatment:
Drug: Placebo
Drug: Certolizumab pegol
Cohort B - certolizumab pegol
Experimental group
Description:
Enrolling study participants aged 6 to 11 years (inclusive). Study participants in this arm will receive weight-based subcutaneous doses of certolizumab pegol from Week 1 to Week 52 and through the subsequent Open-Label Extension Period.
Treatment:
Drug: Certolizumab pegol

Trial contacts and locations

51

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Central trial contact

UCB Cares

Data sourced from clinicaltrials.gov

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