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.

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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)

View Eligibility Criteria

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

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

559

Study ID:

NCT02346240

Recruitment Status:

Completed

Sponsor:

UCB Biopharma S.P.R.L.

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There are 19 Locations for this study

See Locations Near You

Ps0003 317
Mobile Alabama, 36608, United States
Ps0003 306
Little Rock Arkansas, 72204, United States
Ps0003 301
Beverly Hills California, 90212, United States
Ps0003 307
Los Angeles California, 90045, United States
Ps0003 405
San Diego California, 92123, United States
Ps0003 316
Washington District of Columbia, 20037, United States
Ps0003 304
West Palm Beach Florida, 33409, United States
Ps0003 302
Springfield Illinois, 62703, United States
Ps0003 313
West Dundee Illinois, 60118, United States
Ps0003 310
Indianapolis Indiana, 46256, United States
Ps0003 400
Henderson Nevada, 89052, United States
Ps0003 319
Verona New Jersey, 07044, United States
Ps0003 404
Buffalo New York, 14203, United States
Ps0003 407
Portland Oregon, 97223, United States
Ps0003 309
Johnston Rhode Island, 02919, United States
Ps0003 401
Dallas Texas, 75246, United States
Ps0003 403
Houston Texas, 77065, United States
Ps0003 406
San Antonio Texas, 78213, United States
Ps0003 311
Webster Texas, 77598, United States
Ps0003 345
Dupnitsa Kyustendil, , Bulgaria
Ps0003 343
Sofia Sofia-Grad, , Bulgaria
Ps0003 344
Plovdiv , , Bulgaria
Ps0003 342
Varna , , Bulgaria
Ps0003 353
Pardubice District Of Columbia, , Czechia
Ps0003 351
Pardubice , , Czechia
Ps0003 352
Praha , , Czechia
Ps0003 350
Ústí nad Labem , , Czechia
Ps0003 320
Nice cedex 3 , , France
Ps0003 325
Toulouse Cedex 9 , , France
Ps0003 374
Friedrichshafen Baden-Wuerttemberg, , Germany
Ps0003 373
Muenchen Bayern, , Germany
Ps0003 368
Frankfurt am Main Hessen, , Germany
Ps0003 378
Bochum Nordrhein-Westfalen, , Germany
Ps0003 371
Wuppertal Nordrhein-Westfalen, , Germany
Ps0003 370
Mainz Rheinland-Pfalz, , Germany
Ps0003 365
Kiel Schleswig-Holstein, , Germany
Ps0003 363
Erfurt Thueringen, , Germany
Ps0003 367
Berlin , , Germany
Ps0003 372
Berlin , , Germany
Ps0003 375
Berlin , , Germany
Ps0003 369
Dresden , , Germany
Ps0003 361
Giessen , , Germany
Ps0003 362
Hamburg , , Germany
Ps0003 366
Hannover , , Germany
Ps0003 381
Orosháza Bekes, , Hungary
Ps0003 380
Debrecen Hajdú-Bihar, , Hungary
Ps0003 382
Budapest , , Hungary
Ps0003 383
Budapest , , Hungary
Ps0003 384
Budapest , , Hungary
Ps0003 340
Breda , , Netherlands
Ps0003 422
Wrocław Dolnoslaskie, , Poland
Ps0003 330
Torun Kujawsko-pomorskie, , Poland
Ps0003 335
Lublin Lubelskie, , Poland
Ps0003 338
Warszawa Mazowieckie, , Poland
Ps0003 421
Warszawa Mazowieckie, , Poland
Ps0003 333
Bialystok Podlaskie, , Poland
Ps0003 334
Katowice Slaskie, , Poland
Ps0003 424
Poznań Wielkopolskie, , Poland
Ps0003 425
Białystok , , Poland
Ps0003 427
Gdańsk , , Poland
Ps0003 423
Gdynia , , Poland
Ps0003 332
Szczecin , , Poland
Ps0003 336
Warszawa , , Poland
Ps0003 339
Wrocław , , Poland
Ps0003 390
Dundee Angus, , United Kingdom
Ps0003 391
Hexham Northumberland, , United Kingdom
Ps0003 395
Cardiff Wales, , United Kingdom
Ps0003 393
Edgbaston , , United Kingdom
Ps0003 394
Liverpool , , United Kingdom
Ps0003 392
Manchester , , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

559

Study ID:

NCT02346240

Recruitment Status:

Completed

Sponsor:


UCB Biopharma S.P.R.L.

How clear is this clinincal trial information?

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