A Study to Evaluate the Pharmacokinetics, Safety, and Effectiveness of Certolizumab Pegol in Children With Moderate to Severe Chronic Plaque Psoriasis
- Conditions
- Moderate Chronic Plaque PsoriasisSevere Chronic Plaque PsoriasisMixed Guttate/Plaque Psoriasis
- Interventions
- Drug: Placebo
- Registration Number
- NCT04123795
- Lead Sponsor
- UCB Biopharma SRL
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
-
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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort A - certolizumab pegol 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. Cohort A - placebo Certolizumab pegol 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. Cohort A - placebo 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. Cohort B - certolizumab pegol - Open-label Certolizumab pegol 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.
- Primary Outcome Measures
Name Time Method Plasma anti-CZP antibody titers at Week 52 Week 52 Blood samples will be collected for measurement of anti-CZP antibody titers at Week 52.
Plasma concentrations of CZP at Week 52 Week 52 Blood samples will be collected for measurement of plasma concentrations of CZP at Week 52.
Plasma concentrations of Certolizumab pegol (CZP) at Week 16 Week 16 Blood samples will be collected for measurement of plasma concentrations of CZP at Week 16.
Plasma anti-CZP antibody titers at Week 16 Week 16 Blood samples will be collected for measurement of anti-CZP antibody titers at Week 16.
- Secondary Outcome Measures
Name Time Method Percentage of participants achieving a 75% or higher improvement in Psoriasis Area and Severity Index (PASI) score at Week 16 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 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.
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) 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 aboveIncidence 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) 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.
Trial Locations
- Locations (51)
Ps0007 50214
🇺🇸Auburn, Alabama, United States
Ps0007 50175
🇺🇸Phoenix, Arizona, United States
Ps0007 50213
🇺🇸Anaheim, California, United States
Ps0007 50162
🇺🇸Fountain Valley, California, United States
Ps0007 50161
🇺🇸Los Angeles, California, United States
Ps0007 50248
🇺🇸Hialeah, Florida, United States
Ps0007 50196
🇺🇸Thousand Oaks, California, United States
Ps0007 50312
🇺🇸Aurora, Colorado, United States
Ps0007 50217
🇺🇸Boca Raton, Florida, United States
Ps0007 50169
🇺🇸Jacksonville, Florida, United States
Ps0007 50268
🇺🇸Miami, Florida, United States
Ps0007 50216
🇺🇸Miami, Florida, United States
Ps0007 50246
🇺🇸Pembroke Pines, Florida, United States
Ps0007 50318
🇺🇸Jacksonville, Florida, United States
Ps0007 50184
🇺🇸Pembroke Pines, Florida, United States
Ps0007 50269
🇺🇸Wellington, Florida, United States
Ps0007 50230
🇺🇸Rome, Georgia, United States
Ps0007 50274
🇺🇸Savannah, Georgia, United States
Ps0007 50168
🇺🇸Chicago, Illinois, United States
Ps0007 50222
🇺🇸Overland Park, Kansas, United States
Ps0007 50286
🇺🇸Topeka, Kansas, United States
Ps0007 50188
🇺🇸Metairie, Louisiana, United States
Ps0007 50158
🇺🇸Brighton, Massachusetts, United States
Ps0007 50178
🇺🇸Clarkston, Michigan, United States
Ps0007 50232
🇺🇸Detroit, Michigan, United States
Ps0007 50186
🇺🇸Saint Joseph, Michigan, United States
Ps0007 50105
🇺🇸Saint Louis, Missouri, United States
Ps0007 50185
🇺🇸Lebanon, New Hampshire, United States
Ps0007 50159
🇺🇸Portsmouth, New Hampshire, United States
Ps0007 50247
🇺🇸Bronx, New York, United States
Ps0007 50160
🇺🇸Forest Hills, New York, United States
Ps0007 50229
🇺🇸Rocky Mount, North Carolina, United States
Ps0007 50326
🇺🇸Marion, Ohio, United States
Ps0007 50212
🇺🇸Tulsa, Oklahoma, United States
Ps0007 50150
🇺🇸Philadelphia, Pennsylvania, United States
Ps0007 50157
🇺🇸Pittsburgh, Pennsylvania, United States
Ps0007 50156
🇺🇸Arlington, Texas, United States
Ps0007 50226
🇺🇸Houston, Texas, United States
Ps0007 50281
🇺🇸Laredo, Texas, United States
Ps0007 50277
🇺🇸San Antonio, Texas, United States
Ps0007 50227
🇺🇸Seattle, Washington, United States
Ps0007 50163
🇨🇦Calgary, Canada
Ps0007 50183
🇨🇦Calgary, Canada
Ps0007 50225
🇨🇦Calgary, Canada
Ps0007 50187
🇨🇦Edmonton, Canada
Ps0007 50167
🇨🇦Montreal, Canada
Ps0007 50215
🇨🇦St- John's, Canada
Ps0007 50279
🇨🇦Vancouver, Canada
Ps0007 50231
🇵🇷Carolina, Puerto Rico
Ps0007 50278
🇵🇷Ponce, Puerto Rico
Ps0007 50265
🇵🇷San Juan, Puerto Rico