Efficacy and Safety Study of Certolizumab Pegol (CZP) Versus Active Comparator and Placebo 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 compared to active comparator and placebo in adults with moderate to severe chronic plaque psoriasis.

Key facts

Study ID

NCT02346240

Run by

UCB Biopharma S.P.R.L.

People needed

559

Starts

2015-02-11

Expected to finish

2018-12-17

Last updated by the study team

2021-07-16

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 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

Where it is running

• Ps0003 306 — Little Rock, Arkansas, United States
• Ps0003 301 — Beverly Hills, California, United States
• Ps0003 307 — Los Angeles, California, United States
• Ps0003 405 — San Diego, California, United States
• Ps0003 316 — Washington D.C., District of Columbia, United States
• Ps0003 304 — West Palm Beach, Florida, United States
• Ps0003 302 — Springfield, Illinois, United States
• Ps0003 313 — West Dundee, Illinois, United States
• Ps0003 310 — Indianapolis, Indiana, United States
• Ps0003 400 — Henderson, Nevada, United States
• Ps0003 319 — Verona, New Jersey, United States
• Ps0003 404 — Buffalo, New York, United States
• Ps0003 407 — Portland, Oregon, United States
• Ps0003 309 — Johnston, Rhode Island, United States
• Ps0003 401 — Dallas, Texas, United States
• Ps0003 403 — Houston, Texas, United States
• Ps0003 406 — San Antonio, Texas, United States
• Ps0003 311 — Webster, Texas, 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 317 — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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