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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Moderate Chronic Plaque Psoriasis; Severe Chronic Plaque Psoriasis; Mixed Guttate/Plaque Psoriasis
• Intervention / Treatment: Drug: Certolizumab pegol; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Calgary, Canada
    • Ps0007 50183
  • Calgary, Canada
    • Ps0007 50225
  • Edmonton, Canada
    • Ps0007 50187
• Puerto Rico
  • San Juan, Puerto Rico
    • Ps0007 50265
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Ps0007 50175
  • California
    • Fountain Valley, California, United States, 92708
      • Ps0007 50162
    • Los Angeles, California, United States, 90045
      • Ps0007 50161
    • Thousand Oaks, California, United States, 91320
      • Ps0007 50196
  • Florida
    • Boca Raton, Florida, United States, 33428
      • Ps0007 50217
    • Hialeah, Florida, United States, 33016
      • Ps0007 50248
    • Jacksonville, Florida, United States, 32256
      • Ps0007 50169
    • Miami, Florida, United States, 33155
      • Ps0007 50268
    • Wellington, Florida, United States, 33449
      • Ps0007 50269
  • Georgia
    • Rome, Georgia, United States, 30161
      • Ps0007 50230
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Ps0007 50168
  • Kansas
    • Topeka, Kansas, United States, 66614
      • Ps0007 50286
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Ps0007 50232
  • Texas
    • Arlington, Texas, United States, 76011
      • Ps0007 50156
    • San Antonio, Texas, United States, 78218
      • Ps0007 50277

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort A - certolizumab pegol; 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 of the Active Treatment period and through the subsequent Open-Label Extension Period.	Drug: Certolizumab pegol; Certolizumab Pegol; Pharmaceutical Form: Solution for injection in pre-filled syringe; Route of Administration: Subcutaneous use; Other Names: -Cimzia; -CDP870; -CZP
Placebo Comparator: Cohort A - placebo; Enrolling study participants aged 12 to 17 years (inclusive) under Amendment 4 and earlier. Study participants in this arm will receive weight-based subcutaneous doses of placebo from Week 1 to Week 16 of the Active Treatment period.	Drug: Certolizumab pegol; Certolizumab Pegol; Pharmaceutical Form: Solution for injection in pre-filled syringe; Route of Administration: Subcutaneous use; Other Names: -Cimzia; -CDP870; -CZP; Drug: Placebo; Placebo; Pharmaceutical Form: Solution for injection in pre-filled syringe; Route of Administration: Subcutaneous use
Experimental: Cohort B - certolizumab pegol - Open-label; Enrolling study participants aged 6 to 17 years (inclusive). Study participants in this arm will receive weight-based subcutaneous doses of certolizumab pegol from Week 1 to Week 52 of the Open-label Period and through the subsequent Open-Label Extension Period.	Drug: Certolizumab pegol; Certolizumab Pegol; Pharmaceutical Form: Solution for injection in pre-filled syringe; Route of Administration: Subcutaneous use; Other Names: -Cimzia; -CDP870; -CZP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma concentrations of Certolizumab pegol (CZP) at Week 16	Blood samples will be collected for measurement of plasma concentrations of CZP at Week 16.	Week 16
Plasma anti-CZP antibody titers at Week 16	Blood samples will be collected for measurement of anti-CZP antibody titers at Week 16.	Week 16
Plasma concentrations of CZP at Week 52	Blood samples will be collected for measurement of plasma concentrations of CZP at Week 52.	Week 52
Plasma anti-CZP antibody titers at Week 52	Blood samples will be collected for measurement of anti-CZP antibody titers at Week 52.	Week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of serious treatment emergent adverse events	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	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)
Incidence of treatment emergent adverse events leading to withdrawal	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.	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)

Collaborators and Investigators

• Sponsor: UCB Biopharma SRL
• Investigators: Study Director: UCB Cares, 001 844 599 2273 (UCB)

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2020
• Primary Completion (Actual): April 9, 2026
• Study Completion (Estimated): July 2, 2026

Study Registration Dates

• First Submitted: October 9, 2019
• First Submitted That Met QC Criteria: October 9, 2019
• First Posted (Actual): October 11, 2019

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Cimzia; Phase 3; Chronic plaque psoriasis; Certolizumab pegol; Pediatric study
• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Psoriasis; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Polymers; Macromolecular Substances; Immunoglobulin Fragments; Peptide Fragments; Polyethylene Glycols; Immunoglobulin Fab Fragments; Certolizumab Pegol
• Other Study ID Numbers: PS0007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
• IPD Sharing Time Frame: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
• IPD Sharing Access Criteria: Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No