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

Use our guide to learn which trials are right for you!

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
Bakersfield, California
?
mi
from
Bakersfield, CA
Click here to add this to my saved trials
Cleveland, Ohio
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
East Windsor, New Jersey
?
mi
from
East Windsor, NJ
Click here to add this to my saved trials
Graz, Steiermark
?
mi
from
Graz,
Click here to add this to my saved trials
Greer, South Carolina
?
mi
from
Greer, SC
Click here to add this to my saved trials
New York, New York
?
mi
from
New York, NY
Click here to add this to my saved trials
Ormond Beach, Florida
?
mi
from
Ormond Beach, FL
Click here to add this to my saved trials
Phoenix, Arizona
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Portland, Oregon
?
mi
from
Portland, OR
Click here to add this to my saved trials
Portsmouth, New Hampshire
?
mi
from
Portsmouth, NH
Click here to add this to my saved trials
Richmond, Virginia
?
mi
from
Richmond, VA
Click here to add this to my saved trials
Rochester, New York
?
mi
from
Rochester, NY
Click here to add this to my saved trials
San Antonio, Texas
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
Santa Monica, California
?
mi
from
Santa Monica, CA
Click here to add this to my saved trials
Wilmington, North Carolina
?
mi
from
Wilmington, NC
Click here to add this to my saved trials