Back to resultsA 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)
Primary Purpose
Moderate Chronic Plaque Psoriasis, Severe Chronic Plaque Psoriasis, Mixed Guttate/Plaque Psoriasis
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Certolizumab pegol
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Moderate Chronic Plaque Psoriasis focused on measuring Chronic plaque psoriasis, Certolizumab pegol, Cimzia, Pediatric study, Phase 3
Eligibility Criteria
Inclusion Criteria:
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
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
Sites / Locations
- Ps0007 50214
- Ps0007 50175
- Ps0007 50213
- Ps0007 50162Recruiting
- Ps0007 50161Recruiting
- Ps0007 50196Recruiting
- Ps0007 50312Recruiting
- Ps0007 50217Recruiting
- Ps0007 50248Recruiting
- Ps0007 50169Recruiting
- Ps0007 50318
- Ps0007 50268Recruiting
- Ps0007 50216
- Ps0007 50246Recruiting
- Ps0007 50184Recruiting
- Ps0007 50269Recruiting
- Ps0007 50230
- Ps0007 50274
- Ps0007 50168Recruiting
- Ps0007 50222Recruiting
- Ps0007 50286Recruiting
- Ps0007 50188
- Ps0007 50158Recruiting
- Ps0007 50178Recruiting
- Ps0007 50232Recruiting
- Ps0007 50186Recruiting
- Ps0007 50105
- Ps0007 50185
- Ps0007 50159
- Ps0007 50247Recruiting
- Ps0007 50160Recruiting
- Ps0007 50229Recruiting
- Ps0007 50326
- Ps0007 50212Recruiting
- Ps0007 50150Recruiting
- Ps0007 50157Recruiting
- Ps0007 50156
- Ps0007 50226Recruiting
- Ps0007 50281Recruiting
- Ps0007 50277Recruiting
- Ps0007 50227Recruiting
- Ps0007 50163Recruiting
- Ps0007 50183Recruiting
- Ps0007 50187Recruiting
- Ps0007 50167
- Ps0007 50225Recruiting
- Ps0007 50215Recruiting
- Ps0007 50279Recruiting
- Ps0007 50231Recruiting
- Ps0007 50278
- Ps0007 50265Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Experimental
Arm Label
Cohort A - certolizumab pegol
Cohort A - placebo
Cohort B - certolizumab pegol
Arm 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.
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04123795
Brief Title
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)
Acronym
CIMcare
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 21, 2020 (Actual)
Primary Completion Date
September 18, 2024 (Anticipated)
Study Completion Date
August 14, 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Biopharma SRL
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate Chronic Plaque Psoriasis, Severe Chronic Plaque Psoriasis, Mixed Guttate/Plaque Psoriasis
Keywords
Chronic plaque psoriasis, Certolizumab pegol, Cimzia, Pediatric study, Phase 3
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cohort A - certolizumab pegol
Arm Type
Experimental
Arm 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.
Arm Title
Cohort A - placebo
Arm Type
Placebo Comparator
Arm 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.
Arm Title
Cohort B - certolizumab pegol
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Certolizumab pegol
Intervention Description
Certolizumab Pegol
Pharmaceutical Form: Solution for injection in pre-filled syringe
Route of Administration: Subcutaneous use
Other Names:
Cimzia
CDP870
CZP
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Pharmaceutical Form: Solution for injection in pre-filled syringe
Route of Administration: Subcutaneous use
Other Names:
-PBO
Primary Outcome Measure Information:
Title
Percentage of participants achieving a 75% or higher improvement in Psoriasis Area and Severity Index (PASI) score at Week 16
Description
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.
Time Frame
Week 16
Title
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
Description
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.
Time Frame
Week 16
Secondary Outcome Measure Information:
Title
Percentage of participants achieving a 90% or higher improvement in Psoriasis Area and Severity Index (PASI) score at Week 16
Description
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.
Time Frame
Week 16
Title
Percentage of participants achieving CDLQI score of 0 or 1 at Week 16
Description
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.
Time Frame
Week 16
Title
Percentage of participants achieving a 100% improvement in Psoriasis Area and Severity Index (PASI) score at Week 16
Description
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.
Time Frame
Week 16
Title
Percentage of participants achieving a 75% or higher improvement in Psoriasis Area and Severity Index (PASI) score at Week 52
Description
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.
Time Frame
Week 52
Title
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
Description
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.
Time Frame
Week 52
Title
Percentage of participants achieving a 90% or higher improvement in Psoriasis Area and Severity Index (PASI) score at Week 52
Description
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.
Time Frame
Week 52
Title
Percentage of participants achieving a 100% improvement in Psoriasis Area and Severity Index (PASI) score at Week 52
Description
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.
Time Frame
Week 52
Title
Percentage of participants achieving CDLQI score of 0 or 1 at Week 52
Description
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.
Time Frame
Week 52
Title
Incidence of serious treatment emergent adverse events
Description
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
Time Frame
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)
Title
Incidence of treatment emergent adverse events leading to withdrawal
Description
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.
Time Frame
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
UCB Cares
Phone
0018445992273
Email
UCBCares@ucb.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Cares
Organizational Affiliation
001 844 599 2273 (UCB)
Official's Role
Study Director
Facility Information:
Facility Name
Ps0007 50214
City
Auburn
State/Province
Alabama
ZIP/Postal Code
36832
Country
United States
Individual Site Status
Withdrawn
Facility Name
Ps0007 50175
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Individual Site Status
Terminated
Facility Name
Ps0007 50213
City
Anaheim
State/Province
California
ZIP/Postal Code
92804
Country
United States
Individual Site Status
Withdrawn
Facility Name
Ps0007 50162
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Individual Site Status
Recruiting
Facility Name
Ps0007 50161
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Individual Site Status
Recruiting
Facility Name
Ps0007 50196
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91320
Country
United States
Individual Site Status
Recruiting
Facility Name
Ps0007 50312
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Individual Site Status
Recruiting
Facility Name
Ps0007 50217
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33428
Country
United States
Individual Site Status
Recruiting
Facility Name
Ps0007 50248
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Individual Site Status
Recruiting
Facility Name
Ps0007 50169
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Individual Site Status
Recruiting
Facility Name
Ps0007 50318
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32277
Country
United States
Individual Site Status
Withdrawn
Facility Name
Ps0007 50268
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Individual Site Status
Recruiting
Facility Name
Ps0007 50216
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
Individual Site Status
Withdrawn
Facility Name
Ps0007 50246
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Individual Site Status
Recruiting
Facility Name
Ps0007 50184
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
Country
United States
Individual Site Status
Recruiting
Facility Name
Ps0007 50269
City
Wellington
State/Province
Florida
ZIP/Postal Code
33449
Country
United States
Individual Site Status
Recruiting
Facility Name
Ps0007 50230
City
Rome
State/Province
Georgia
ZIP/Postal Code
30161
Country
United States
Individual Site Status
Completed
Facility Name
Ps0007 50274
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31419
Country
United States
Individual Site Status
Withdrawn
Facility Name
Ps0007 50168
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Name
Ps0007 50222
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Individual Site Status
Recruiting
Facility Name
Ps0007 50286
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66614
Country
United States
Individual Site Status
Recruiting
Facility Name
Ps0007 50188
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70005
Country
United States
Individual Site Status
Withdrawn
Facility Name
Ps0007 50158
City
Brighton
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Individual Site Status
Recruiting
Facility Name
Ps0007 50178
City
Clarkston
State/Province
Michigan
ZIP/Postal Code
48346
Country
United States
Individual Site Status
Recruiting
Facility Name
Ps0007 50232
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Name
Ps0007 50186
City
Saint Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Individual Site Status
Recruiting
Facility Name
Ps0007 50105
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Withdrawn
Facility Name
Ps0007 50185
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Individual Site Status
Withdrawn
Facility Name
Ps0007 50159
City
Portsmouth
State/Province
New Hampshire
ZIP/Postal Code
03801
Country
United States
Individual Site Status
Withdrawn
Facility Name
Ps0007 50247
City
Bronx
State/Province
New York
ZIP/Postal Code
10468
Country
United States
Individual Site Status
Recruiting
Facility Name
Ps0007 50160
City
Forest Hills
State/Province
New York
ZIP/Postal Code
11375
Country
United States
Individual Site Status
Recruiting
Facility Name
Ps0007 50229
City
Rocky Mount
State/Province
North Carolina
ZIP/Postal Code
27804
Country
United States
Individual Site Status
Recruiting
Facility Name
Ps0007 50326
City
Marion
State/Province
Ohio
ZIP/Postal Code
43302
Country
United States
Individual Site Status
Withdrawn
Facility Name
Ps0007 50212
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74135
Country
United States
Individual Site Status
Recruiting
Facility Name
Ps0007 50150
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States
Individual Site Status
Recruiting
Facility Name
Ps0007 50157
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Name
Ps0007 50156
City
Arlington
State/Province
Texas
ZIP/Postal Code
76011
Country
United States
Individual Site Status
Completed
Facility Name
Ps0007 50226
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
Ps0007 50281
City
Laredo
State/Province
Texas
ZIP/Postal Code
78041
Country
United States
Individual Site Status
Recruiting
Facility Name
Ps0007 50277
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78218
Country
United States
Individual Site Status
Recruiting
Facility Name
Ps0007 50227
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Individual Site Status
Recruiting
Facility Name
Ps0007 50163
City
Calgary
Country
Canada
Individual Site Status
Recruiting
Facility Name
Ps0007 50183
City
Calgary
Country
Canada
Individual Site Status
Recruiting
Facility Name
Ps0007 50187
City
Edmonton
Country
Canada
Individual Site Status
Recruiting
Facility Name
Ps0007 50167
City
Montreal
Country
Canada
Individual Site Status
Withdrawn
Facility Name
Ps0007 50225
City
Red Deer
Country
Canada
Individual Site Status
Recruiting
Facility Name
Ps0007 50215
City
St- John's
Country
Canada
Individual Site Status
Recruiting
Facility Name
Ps0007 50279
City
Vancouver
Country
Canada
Individual Site Status
Recruiting
Facility Name
Ps0007 50231
City
Carolina
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Name
Ps0007 50278
City
Ponce
Country
Puerto Rico
Individual Site Status
Withdrawn
Facility Name
Ps0007 50265
City
San Juan
Country
Puerto Rico
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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 URL
http://www.Vivli.org
Learn more about this trial
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)
We'll reach out to this number within 24 hrs