A Study to Evaluate the Efficacy and Safety 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.
Key facts
- Study ID
- NCT02326272
- Run by
- UCB Biopharma S.P.R.L.
- People needed
- 227
- Starts
- 2014-12-15
- Expected to finish
- 2018-09-12
- Last updated by the study team
- 2019-10-03
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 3 months following last dose of study drug. Male subjects who are planning a partner pregnancy during the study or within 10 weeks following the last dose
- 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
- Ps0002 203 — Phoenix, Arizona, United States
- Ps0002 214 — Bakersfield, California, United States
- Ps0002 212 — Santa Monica, California, United States
- Ps0002 204 — Ormond Beach, Florida, United States
- Ps0002 207 — Portsmouth, New Hampshire, United States
- Ps0002 202 — East Windsor, New Jersey, United States
- Ps0002 210 — New York, New York, United States
- Ps0002 206 — Rochester, New York, United States
- Ps0002 209 — Wilmington, North Carolina, United States
- Ps0002 205 — Cleveland, Ohio, United States
- Ps0002 200 — Portland, Oregon, United States
- Ps0002 201 — Greer, South Carolina, United States
- Ps0002 208 — San Antonio, Texas, United States
- Ps0002 213 — Richmond, Virginia, United States
- Ps0002 253 — Graz, Styria, Austria
- Ps0002 221 — Barrie, Ontario, Canada
- Ps0002 223 — London, Ontario, Canada
- Ps0002 222 — Peterborough, Ontario, Canada
- Ps0002 220 — Richmond Hill, Ontario, Canada
- Ps0002 224 — Waterloo, Ontario, Canada
- Ps0002 232 — Krakow, Lesser Poland Voivodeship, Poland
- Ps0002 231 — Wroclaw, Poland
- Ps0002 230 — Kielce, Świętokrzyskie Voivodeship, Poland
Full record on ClinicalTrials.gov
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