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
1 other identifier
interventional
49
3 countries
19
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jan 2020
Longer than P75 for phase_3
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 9, 2019
CompletedFirst Posted
Study publicly available on registry
October 11, 2019
CompletedStudy Start
First participant enrolled
January 21, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 9, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
July 2, 2026
ExpectedApril 24, 2026
April 1, 2026
6.2 years
October 9, 2019
April 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 Outcomes (2)
Incidence of serious treatment emergent adverse events
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
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)
Study Arms (3)
Cohort A - certolizumab pegol
EXPERIMENTALEnrolling 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.
Cohort A - placebo
PLACEBO COMPARATOREnrolling 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.
Cohort B - certolizumab pegol - Open-label
EXPERIMENTALEnrolling 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.
Interventions
Certolizumab Pegol * Pharmaceutical Form: Solution for injection in pre-filled syringe * Route of Administration: Subcutaneous use
Placebo * Pharmaceutical Form: Solution for injection in pre-filled syringe * Route of Administration: Subcutaneous use
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Ps0007 50175
Phoenix, Arizona, 85006, United States
Ps0007 50162
Fountain Valley, California, 92708, United States
Ps0007 50161
Los Angeles, California, 90045, United States
Ps0007 50196
Thousand Oaks, California, 91320, United States
Ps0007 50217
Boca Raton, Florida, 33428, United States
Ps0007 50248
Hialeah, Florida, 33016, United States
Ps0007 50169
Jacksonville, Florida, 32256, United States
Ps0007 50268
Miami, Florida, 33155, United States
Ps0007 50269
Wellington, Florida, 33449, United States
Ps0007 50230
Rome, Georgia, 30161, United States
Ps0007 50168
Chicago, Illinois, 60611, United States
Ps0007 50286
Topeka, Kansas, 66614, United States
Ps0007 50232
Detroit, Michigan, 48202, United States
Ps0007 50156
Arlington, Texas, 76011, United States
Ps0007 50277
San Antonio, Texas, 78218, United States
Ps0007 50183
Calgary, Canada
Ps0007 50225
Calgary, Canada
Ps0007 50187
Edmonton, Canada
Ps0007 50265
San Juan, Puerto Rico
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
UCB Cares
001 844 599 2273 (UCB)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 9, 2019
First Posted
October 11, 2019
Study Start
January 21, 2020
Primary Completion
April 9, 2026
Study Completion (Estimated)
July 2, 2026
Last Updated
April 24, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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.
- 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.
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.