A Study to Evaluate the Efficacy and Safety of Two Dose Levels of Certolizumab Pegol (CZP) in Subjects With Plaque Psoriasis (PSO)



Status:Completed
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:10/19/2018
Start Date:December 15, 2014
End Date:September 12, 2018

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A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Group, Study Followed by a Dose-Blind Period and Open-Label Follow-Up to Evaluate the Efficacy and Safety of Certolizumab Pegol in Subjects With Moderate to Severe Chronic Plaque Psoriasis

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.

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 Treatment Period from Week 48 to Week 144

- Safety Follow-Up Period from Week 144 to Week 152

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 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
We found this trial at
15
sites
Richmond, Virginia
342
mi
from 43215
Richmond, VA
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Bakersfield, California
1980
mi
from 43215
Bakersfield, CA
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Cleveland, Ohio
126
mi
from 43215
Cleveland, OH
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East Windsor, New Jersey
?
mi
from 43215
East Windsor, NJ
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Graz, Steiermark
?
mi
from 43215
Graz,
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Greer, South Carolina
350
mi
from 43215
Greer, SC
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New York, New York
442
mi
from 43215
New York, NY
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Ormond Beach, Florida
746
mi
from 43215
Ormond Beach, FL
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Phoenix, Arizona
1662
mi
from 43215
Phoenix, AZ
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Portland, Oregon
2026
mi
from 43215
Portland, OR
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Portsmouth, New Hampshire
668
mi
from 43215
Portsmouth, NH
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Rochester, New York
356
mi
from 43215
Rochester, NY
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San Antonio, Texas
1138
mi
from 43215
San Antonio, TX
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Santa Monica, California
1986
mi
from 43215
Santa Monica, CA
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Wilmington, North Carolina
485
mi
from 43215
Wilmington, NC
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