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)

Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled (12-17 Years) Including a Single Open-Label Arm (6-11 Years) Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Certolizumab Pegol (CZP) in Pediatric Study Participants With Moderate to Severe Chronic Plaque Psoriasis (PSO)

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.

Study Overview

• Status: 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 (Estimated): 150
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: UCB Cares; Phone Number: 0018445992273; Email: ucbcares@ucb.com

Study Locations

• Canada
  • Calgary, Canada
    • Recruiting
    • Ps0007 50163
  • Calgary, Canada
    • Recruiting
    • Ps0007 50183
  • Edmonton, Canada
    • Recruiting
    • Ps0007 50187
  • Montreal, Canada
    • Withdrawn
    • Ps0007 50167
  • Red Deer, Canada
    • Recruiting
    • Ps0007 50225
  • St- John's, Canada
    • Recruiting
    • Ps0007 50215
  • Vancouver, Canada
    • Withdrawn
    • Ps0007 50279
• Puerto Rico
  • Carolina, Puerto Rico
    • Recruiting
    • Ps0007 50231
  • Ponce, Puerto Rico
    • Withdrawn
    • Ps0007 50278
  • San Juan, Puerto Rico, 00917
    • Recruiting
    • Ps0007 50265
• United States
  • Alabama
    • Auburn, Alabama, United States, 36832
      • Withdrawn
      • Ps0007 50214
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Completed
      • Ps0007 50175
  • California
    • Anaheim, California, United States, 92804
      • Withdrawn
      • Ps0007 50213
    • Fountain Valley, California, United States, 92708
      • Recruiting
      • Ps0007 50162
    • Los Angeles, California, United States, 90045
      • Recruiting
      • Ps0007 50161
    • Thousand Oaks, California, United States, 91320
      • Recruiting
      • Ps0007 50196
  • Colorado
    • Aurora, Colorado, United States, 80012
      • Recruiting
      • Ps0007 50312
  • Florida
    • Boca Raton, Florida, United States, 33428
      • Recruiting
      • Ps0007 50217
    • Hialeah, Florida, United States, 33016
      • Recruiting
      • Ps0007 50248
    • Jacksonville, Florida, United States, 32256
      • Recruiting
      • Ps0007 50169
    • Jacksonville, Florida, United States, 32277
      • Withdrawn
      • Ps0007 50318
    • Miami, Florida, United States, 33155
      • Recruiting
      • Ps0007 50268
    • Miami, Florida, United States, 33186
      • Withdrawn
      • Ps0007 50216
    • Pembroke Pines, Florida, United States, 33024
      • Recruiting
      • Ps0007 50246
    • Pembroke Pines, Florida, United States, 33028
      • Withdrawn
      • Ps0007 50184
    • Wellington, Florida, United States, 33449
      • Completed
      • Ps0007 50269
  • Georgia
    • Rome, Georgia, United States, 30161
      • Completed
      • Ps0007 50230
    • Savannah, Georgia, United States, 31419
      • Withdrawn
      • Ps0007 50274
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Ps0007 50168
  • Kansas
    • Overland Park, Kansas, United States, 66210
      • Withdrawn
      • Ps0007 50222
    • Topeka, Kansas, United States, 66614
      • Completed
      • Ps0007 50286
  • Louisiana
    • Metairie, Louisiana, United States, 70005
      • Withdrawn
      • Ps0007 50188
  • Massachusetts
    • Brighton, Massachusetts, United States, 02135
      • Recruiting
      • Ps0007 50158
  • Michigan
    • Clarkston, Michigan, United States, 48346
      • Recruiting
      • Ps0007 50178
    • Detroit, Michigan, United States, 48202
      • Recruiting
      • Ps0007 50232
    • Saint Joseph, Michigan, United States, 49085
      • Recruiting
      • Ps0007 50186
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Withdrawn
      • Ps0007 50105
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Withdrawn
      • Ps0007 50185
    • Portsmouth, New Hampshire, United States, 03801
      • Withdrawn
      • Ps0007 50159
  • New York
    • Bronx, New York, United States, 10468
      • Recruiting
      • Ps0007 50247
    • Forest Hills, New York, United States, 11375
      • Recruiting
      • Ps0007 50160
  • North Carolina
    • Rocky Mount, North Carolina, United States, 27804
      • Withdrawn
      • Ps0007 50229
  • Ohio
    • Marion, Ohio, United States, 43302
      • Withdrawn
      • Ps0007 50326
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74135
      • Recruiting
      • Ps0007 50212
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19103
      • Recruiting
      • Ps0007 50150
    • Pittsburgh, Pennsylvania, United States, 15213
      • Recruiting
      • Ps0007 50157
  • Texas
    • Arlington, Texas, United States, 76011
      • Completed
      • Ps0007 50156
    • Houston, Texas, United States, 77030
      • Withdrawn
      • Ps0007 50226
    • Laredo, Texas, United States, 78041
      • Withdrawn
      • Ps0007 50281
    • San Antonio, Texas, United States, 78218
      • Recruiting
      • Ps0007 50277
  • Washington
    • Seattle, Washington, United States, 98105
      • Withdrawn
      • Ps0007 50227

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 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). 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.	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 Other Names: -PBO
Experimental: Cohort B - certolizumab pegol; 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.	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
Percentage of participants achieving a 75% or higher improvement in Psoriasis Area and Severity Index (PASI) score at Week 16	The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.	Week 16
Percentage of participants who achieve a Physician's Global Assessment (PGA) Clear or Almost Clear response (with at least a 2-category improvement) at Week 16	The Investigator assess the overall severity of Psoriasis (PSO) using the following 5-point scale: 0= clear, 1= almost clear, 2= mild, 3= moderate, 4= severe.	Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants achieving a 90% or higher improvement in Psoriasis Area and Severity Index (PASI) score at Week 16	The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.	Week 16
Percentage of participants achieving CDLQI score of 0 or 1 at Week 16	The Children's Dermatology Life Quality Index (CDLQI) is a dermatology-specific quality of life instrument designed to assess the impact of the disease on a child's quality of life (Lewis-Jones and Finlay, 1995). The CDLQI is a 10-item questionnaire with 4 response options (Not at all/Not relevant=0, A little=1, Quite a lot=2, and Very much=3) and a recall period of 1 week. In addition to evaluating overall quality of life, the CDLQI can be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, leisure, school or holidays, personal relationships, sleep, and treatment. The CDLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0; the higher the score, the greater impairment in quality of life.	Week 16
Percentage of participants achieving a 100% improvement in Psoriasis Area and Severity Index (PASI) score at Week 16	The PASI100 response assessments are based on 100% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.	Week 16
Percentage of participants achieving a 75% or higher improvement in Psoriasis Area and Severity Index (PASI) score at Week 52	The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.	Week 52
Percentage of participants who achieve a Physician's Global Assessment (PGA) Clear or Almost Clear response (with at least a 2-category improvement) at Week 52	The Investigator assess the overall severity of Psoriasis (PSO) using the following 5-point scale: 0= clear, 1= almost clear, 2= mild, 3= moderate, 4= severe.	Week 52
Percentage of participants achieving a 90% or higher improvement in Psoriasis Area and Severity Index (PASI) score at Week 52	The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.	Week 52
Percentage of participants achieving a 100% improvement in Psoriasis Area and Severity Index (PASI) score at Week 52	The PASI100 response assessments are based on 100% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.	Week 52
Percentage of participants achieving CDLQI score of 0 or 1 at Week 52	The Children's Dermatology Life Quality Index (CDLQI) is a dermatology-specific quality of life instrument designed to assess the impact of the disease on a child's quality of life (Lewis-Jones and Finlay, 1995). The CDLQI is a 10-item questionnaire with 4 response options (Not at all/Not relevant=0, A little=1, Quite a lot=2, and Very much=3) and a recall period of 1 week. In addition to evaluating overall quality of life, the CDLQI can be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, leisure, school or holidays, personal relationships, sleep, and treatment. The CDLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0; the higher the score, the greater impairment in quality of life.	Week 52
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	A treatment emergent adverse event (TEAE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	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 (Estimated): September 18, 2029
• Study Completion (Estimated): August 14, 2034

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): March 29, 2024
• Last Update Submitted That Met QC Criteria: March 28, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Cimzia; Phase 3; Chronic plaque psoriasis; Certolizumab pegol; Pediatric study
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Tumor Necrosis Factor Inhibitors; 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