PS0007 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) 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. Medical Condition Moderate chronic plaque psoriasis Min. Age 6 Years Max. Age 17 Years Who Can Join? All Status Recruiting 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 Study Medication Description Study Medication: CIMZIA Other Descriptive Name: certolizumab pegol Placebo Yes Comparator: No Share this study Share Facebook Share Twitter Share LinkedIn Refer to a friend Via email Study Dates January 2020 Actual Start Date of Enrollment August 2034 Planned Study Completion Date General Information Study ID: PS0007 EudraCT Number: 2021-003371-33 CT.gov Number: NCT04123795 Phase: Phase 3 Locations Click here to find out where the clinical study is conducted Interested in our clinical studies? Just contact us Austria UCBCares.AT@ucb.com +43 (0) 1 291 80 08 0800-296176 (freephone) Belgium UCBCares.BE@ucb.com +32 2 559 92 00 0800 38 008 (freephone) www.ucbcares.be Bulgaria UCBCares.BG@ucb.com +359 2 962 9933 www.ucbcares.bg Canada +1 866 709 8444 Czech Republic UCBCares.CZ@ucb.com +420 221 773 442 800 144 395 (freephone) www.ucbcares.cz Denmark UCBCares.DK@ucb.com +45 32462480 80 253827 (freephone) www.ucbcares.dk Finland UCBCares.FI@ucb.com +358 942733300 0800 9 13353 (freephone) www.ucbcares.fi France UCBCares.FR@ucb.com +33 1 47 29 45 55 0 805 222 949 (freephone) www.ucbcares.fr Germany UCBCares.DE@ucb.com +49 2173 48 48 48 www.ucbcares.de Greece UCBCares.GR@ucb.com +30 21 0997 4200 0080 012 9910 (freephone) www.ucbcares.gr Hungary UCBCares.HU@ucb.com +36 1 472 5060 06 80 021 486 (freephone) www.ucbcares.hu Ireland UCBCares.IE@ucb.com +353 1 463 2371 1800 93 00 75 (freephone) www.ucbcares.co.uk Italy UCBCares.IT@ucb.com +39 02 3007 9300 8009-86932 (freephone) www.ucbcares.it Japan https://ucbcares.jp Luxemburg UCBCares.LU@ucb.com +32 2 559 92 12 8002 3204 (freephone) Norway UCBCares.NO@ucb.com +45 32462482 800-10101 (freephone) www.ucbcares.no Poland UCBCares.PL@ucb.com +48 22 596 97 97 00 800 121 68 25 (freephone) www.ucbcares.pl Portugal UCBCares.PT@ucb.com +351 213 025 300 800-8-56033 (freephone) Romania +4021 300 19 07 Slovakia UCBCares.SK@ucb.com +421 2 592 020 23 0800 002 566 (freephone) www.ucbcares.sk Spain UCBCares.ES@ucb.com +34 915 70 06 49 8000-99684 (freephone) www.ucbcares.es Sweden UCBCares.SE@ucb.com +45 32462481 0200 898 671 (freephone) www.ucbcares.se Switzerland +41 58 822 3180 The Netherlands UCBCares.NL@ucb.com +31 76 573 1130 0800 3434335 (freephone) www.ucbcares.nl UK UCBCares.UK@ucb.com +44 1753 777 100 0800 279 3177 (freephone) www.ucbcares.co.uk USA UCBCares@ucb.com +1-844-599-2273 www.ucb-usa.com/Patients/Patients Email Print Back to results