An Efficacy and Safety Study of Two Dose Levels of Certolizumab Pegol (CZP) in Subjects With Plaque Psoriasis (PSO)

Completed · Phase 3 · Has a placebo group

Conditions studied: Psoriasis, Plaque Psoriasis

In brief

The purpose of this study is to investigate the efficacy and safety of two dose levels of certolizumab pegol in adults with moderate to severe chronic plaque psoriasis when administered every 2 weeks.

Key facts

Study ID

NCT02326298

Run by

UCB Biopharma S.P.R.L.

People needed

234

Starts

2014-12-16

Expected to finish

2018-10-24

Last updated by the study team

2019-11-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 Czech Republic and Germany) and within 3 months for all other countries. Male subjects who are planning a partner pregnancy during the study or within 10 weeks following the last dose of study drug
• 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

Where it is running

• Ps0005 504 — San Diego, California, United States
• Ps0005 502 — West Des Moines, Iowa, United States
• Ps0005 500 — Baton Rouge, Louisiana, United States
• Ps0005 506 — Boston, Massachusetts, United States
• Ps0005 505 — St Louis, Missouri, United States
• Ps0005 507 — Albuquerque, New Mexico, United States
• Ps0005 508 — Nashville, Tennessee, United States
• Ps0005 501 — Houston, Texas, United States
• Ps0005 597 — Edmonton, Alberta, Canada
• Ps0005 591 — Surrey, British Columbia, Canada
• Ps0005 596 — Ajax, Ontario, Canada
• Ps0005 590 — Hamilton, Ontario, Canada
• Ps0005 593 — Toronto, Ontario, Canada
• Ps0005 595 — Drummondville, Quebec, Canada
• Ps0005 594 — Québec, Quebec, Canada
• Ps0005 553 — Náchod, Czechia
• Ps0005 550 — Olomouc, Czechia
• Ps0005 551 — Ostrava-Poruba, Czechia
• Ps0005 552 — Prague, Czechia
• Ps0005 562 — Mahlow, Brandenburg, Germany
• Ps0005 565 — Witten, North Rhine-Westphalia, Germany
• Ps0005 569 — Lübeck, Schleswig-Holstein, Germany
• Ps0005 560 — Berlin, Germany
• Ps0005 561 — Dresden, Germany
• Ps0005 563 — Hamburg, Germany

Full record on ClinicalTrials.gov

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