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Active (not recruiting) Phase 3 NCT04123795

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

Phase 3 – large-scale trial before approval
Conditions: Moderate Chronic Plaque Psoriasis Severe Chronic Plaque Psoriasis Mixed Guttate/Plaque Psoriasis

Sponsor: UCB Biopharma SRL

trial.available_in: БГ
Overview
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.
Who can participate
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
Interventions
Certolizumab pegol
DRUG
Placebo
DRUG
Locations 19
Canada (3)
Ps0007 50183
Calgary
Ps0007 50225
Calgary
Ps0007 50187
Edmonton
Puerto Rico (1)
Ps0007 50265
San Juan
United States (15)
Ps0007 50156
Arlington , Texas
Ps0007 50217
Boca Raton , Florida
Ps0007 50168
Chicago , Illinois
Ps0007 50232
Detroit , Michigan
Ps0007 50162
Fountain Valley , California
Ps0007 50248
Hialeah , Florida
Ps0007 50169
Jacksonville , Florida
Ps0007 50161
Los Angeles , California
Ps0007 50268
Miami , Florida
Ps0007 50175
Phoenix , Arizona
Ps0007 50230
Rome , Georgia
Ps0007 50277
San Antonio , Texas
Ps0007 50196
Thousand Oaks , California
Ps0007 50286
Topeka , Kansas
Ps0007 50269
Wellington , Florida
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
6 Years
Maximum age
17 Years
Healthy volunteers
No
Start date
21.01.2020
Completion date
02.07.2026
Registry ID
NCT04123795
Source
clinicaltrials.gov
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