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.

View Eligibility Criteria

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

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

150

Study ID:

NCT04123795

Recruitment Status:

Recruiting

Sponsor:

UCB Biopharma SRL

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There are 42 Locations for this study

See Locations Near You

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

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

150

Study ID:

NCT04123795

Recruitment Status:

Recruiting

Sponsor:


UCB Biopharma SRL

How clear is this clinincal trial information?

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