Psoriasis Clinical 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)
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.
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
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There are 41 Locations for this study
Auburn Alabama, 36832, United States
Phoenix Arizona, 85006, United States
Anaheim California, 92804, United States
Fountain Valley California, 92708, United States
Los Angeles California, 90045, United States
Thousand Oaks California, 91320, United States
Aurora Colorado, 80012, United States
Boca Raton Florida, 33428, United States
Hialeah Florida, 33016, United States
Jacksonville Florida, 32256, United States
Jacksonville Florida, 32277, United States
Miami Florida, 33155, United States
Miami Florida, 33186, United States
Pembroke Pines Florida, 33024, United States
Pembroke Pines Florida, 33028, United States
Wellington Florida, 33449, United States
Rome Georgia, 30161, United States
Savannah Georgia, 31419, United States
Chicago Illinois, 60611, United States
Overland Park Kansas, 66210, United States
Topeka Kansas, 66614, United States
Metairie Louisiana, 70005, United States
Brighton Massachusetts, 02135, United States
Clarkston Michigan, 48346, United States
Detroit Michigan, 48202, United States
Saint Joseph Michigan, 49085, United States
Saint Louis Missouri, 63110, United States
Lebanon New Hampshire, 03756, United States
Portsmouth New Hampshire, 03801, United States
Bronx New York, 10468, United States
Forest Hills New York, 11375, United States
Rocky Mount North Carolina, 27804, United States
Marion Ohio, 43302, United States
Tulsa Oklahoma, 74135, United States
Philadelphia Pennsylvania, 19103, United States
Pittsburgh Pennsylvania, 15213, United States
Arlington Texas, 76011, United States
Houston Texas, 77030, United States
Laredo Texas, 78041, United States
San Antonio Texas, 78218, United States
Seattle Washington, 98105, United States
Calgary , , Canada
Calgary , , Canada
Edmonton , , Canada
Montreal , , Canada
Red Deer , , Canada
St- John's , , Canada
Vancouver , , Canada
Carolina , , Puerto Rico
Ponce , , Puerto Rico
San Juan , , Puerto Rico
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