Psoriasis Clinical Trial
Efficacy and Safety Study of Certolizumab Pegol (CZP) Versus Active Comparator and Placebo in Subjects With Plaque Psoriasis (PSO)
Summary
The purpose of this study is to investigate the efficacy and safety of two dose levels of certolizumab pegol compared to active comparator and placebo in adults with moderate to severe chronic plaque psoriasis.
Full Description
This study consists of the following Periods:
Initial Treatment Period from Week 0 to Week 16
Maintenance Treatment Period from Week 16 to Week 48
Open-label Extension Treatment Period (96 weeks)
Safety Follow-Up (10 weeks)
Eligibility Criteria
Inclusion Criteria:
Provided informed consent
Adult men or women >= 18 years
Chronic plaque psoriasis for at least 6 months
Baseline psoriasis activity and severity index >= 12 and body surface area >= 10 % and Physician's Global Assessments score >= 3
Candidate for systemic psoriasis therapy and/or phototherapy and/or chemophototherapy
Other protocol-defined inclusion criteria may apply
Exclusion Criteria:
Erythrodermic, guttate, generalized pustular form of psoriasis
History of current, chronic, or recurrent infections of viral, bacterial, or fungal origin as described in the protocol
Congestive heart failure
History of a lymphoproliferative disorder including lymphoma or current signs and symptoms suggestive of lymphoproliferative disease
Concurrent malignancy or a history of malignancy as described in the protocol
History of, or suspected, demyelinating disease of the central nervous system (e.g., multiple sclerosis or optic neuritis)
Female subjects who are breastfeeding, pregnant, or plan to become pregnant during the study or within 5 months following last dose of study drug in the UK, Czech Republic, Germany, and France, and within 3 months for all other countries. Male subjects who are planning a partner pregnancy during the study or within 5 months following the last dose in France and within 10 weeks in all other countries
Any other condition which, in the Investigator's judgment, would make the subject unsuitable for participation in the study
Other protocol-defined exclusion criteria may apply
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There are 19 Locations for this study
Mobile Alabama, 36608, United States
Little Rock Arkansas, 72204, United States
Beverly Hills California, 90212, United States
Los Angeles California, 90045, United States
San Diego California, 92123, United States
Washington District of Columbia, 20037, United States
West Palm Beach Florida, 33409, United States
Springfield Illinois, 62703, United States
West Dundee Illinois, 60118, United States
Indianapolis Indiana, 46256, United States
Henderson Nevada, 89052, United States
Verona New Jersey, 07044, United States
Buffalo New York, 14203, United States
Portland Oregon, 97223, United States
Johnston Rhode Island, 02919, United States
Dallas Texas, 75246, United States
Houston Texas, 77065, United States
San Antonio Texas, 78213, United States
Webster Texas, 77598, United States
Dupnitsa Kyustendil, , Bulgaria
Sofia Sofia-Grad, , Bulgaria
Plovdiv , , Bulgaria
Varna , , Bulgaria
Pardubice District Of Columbia, , Czechia
Pardubice , , Czechia
Praha , , Czechia
Ústà nad Labem , , Czechia
Nice cedex 3 , , France
Toulouse Cedex 9 , , France
Friedrichshafen Baden-Wuerttemberg, , Germany
Muenchen Bayern, , Germany
Frankfurt am Main Hessen, , Germany
Bochum Nordrhein-Westfalen, , Germany
Wuppertal Nordrhein-Westfalen, , Germany
Mainz Rheinland-Pfalz, , Germany
Kiel Schleswig-Holstein, , Germany
Erfurt Thueringen, , Germany
Berlin , , Germany
Berlin , , Germany
Berlin , , Germany
Dresden , , Germany
Giessen , , Germany
Hamburg , , Germany
Hannover , , Germany
Orosháza Bekes, , Hungary
Debrecen Hajdú-Bihar, , Hungary
Budapest , , Hungary
Budapest , , Hungary
Budapest , , Hungary
Breda , , Netherlands
Wrocław Dolnoslaskie, , Poland
Torun Kujawsko-pomorskie, , Poland
Lublin Lubelskie, , Poland
Warszawa Mazowieckie, , Poland
Warszawa Mazowieckie, , Poland
Bialystok Podlaskie, , Poland
Katowice Slaskie, , Poland
Poznań Wielkopolskie, , Poland
Białystok , , Poland
Gdańsk , , Poland
Gdynia , , Poland
Szczecin , , Poland
Warszawa , , Poland
Wrocław , , Poland
Dundee Angus, , United Kingdom
Hexham Northumberland, , United Kingdom
Cardiff Wales, , United Kingdom
Edgbaston , , United Kingdom
Liverpool , , United Kingdom
Manchester , , United Kingdom
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