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(JKR-0744) Phase 3, randomized, double-blind, placebo-controlled, parallel-group study of the efficacy and safety of 2 oral doses of CP-690,550 in subjects with moderate to severe chronic plaque psoriasis


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A Phase 3, multi-site, randomized, double-blind, placebo-controlled, parallel-group study of the efficacy and safety of 2 oral doses of CP-690,550 in subjects with moderate to severe chronic plaque psoriasis

Principal Investigator:
James G. Krueger M.D., Ph.D.

Investigators:
Mary Sullivan-Whalen N.P.
Michelle Lowes MD, PhD
Ali Jabbari MD, PhD
Patricia Gilleaudeau N.P.

Contact Information:
Clinical Research Support Office
The Rockefeller University
1230 York Ave.
New York, NY 10065
Telephone: 1.800.RUCARES
Email: RUCARES@Rockefeller.edu
Enrollment Status:
Closed to Enrollment

Brief Summary of Protocol:
This study will evaluate the safety and tolerability of CP-690,550 as treatment of moderate to severe chronic plaque psoriasis. It has been given to approximately 2300 people in other studies of psoriasis, rheumatoid arthritis, inflammatory bowel disease, and dry eye.

CP-690,550 blocks enzymes in your body called Janus kinases (JAK), which act like a gate into the cells of the immune system (which protects you from infections). By blocking this enzyme, the cells of the immune system are expected to produce fewer chemicals known to cause the psoriasis flare-up on your skin.



Detailed Description of Protocol:
If you are eligible for this study you will be given CP-690,550 or a placebo for the first 16 weeks. Placebo is a pill that does not contain any drug. After 16 weeks, all study subjects will receive CP-690,550. The study has three different study drug groups:

- CP-690,550 5 mg tablet twice a day for the entire study
- CP-690,550 10 mg tablet twice a day for the entire study
- Placebo tablet twice a day for 16 weeks, followed by CP-690,550 5 mg tablet twice a day OR 10 mg tablet twice a day for the rest of the study.

This research study is being conducted for Pfizer. Pfizer is sponsoring the study and will be paying Rockefeller University to conduct the study.

You will be in this study for approximately 52 weeks/one year. You will need to visit the research site at least 12 times during the study. There will be approximately 825 people enrolled in this study. The study is being done at approximately 70 different research sites in 12 countries. Up to 20 people will be enrolled at this site.



What specifically makes a person eligible for the study?
You may be eligible to enter this study:

- Diagnosed with plaque type psoriasis, covering at least 10% of your body
- Generally healthy

Gender:
Both

Age(s):
18-99

Children permitted to participate:
No

Potential Benefits.....
It is possible that your condition or health may improve because of study treatment or because of your visits to the research site. However, there is no guarantee that you will benefit in any way. Information from this study may help other people in the future.

You will get study drug and all medical treatment in this study at no cost to you. You may have a good response to the treatment. It is possible that you will receive no direct health benefit from being in this study.



Compensation:
Compensation is provided for study participation.