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(JKR-0772) LY2439821 in Patients with Moderate-to-Severe Plaque Psoriasis


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A Multicenter Study with a Randomized, Double-Blind, Placebo-Controlled Induction Dosing Period Followed by a Randomized Maintenance Dosing Period and a Long-Term Extension Period to Evaluate the Efficacy and Safety of LY2439821 in Patients with Moderate-to-Severe Plaque Psoriasis

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

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

Contact Information:
Clinical Research Support Office
The Rockefeller University
1230 York Avenue
New York, NY 10065
Telephone: 1-800-RUCARES
Alt. Telephone: 800-782-2737
Email: RUCARES@Rockefeller.edu
Enrollment Status:
Not yet recruiting

Brief Summary of Protocol:
This study is being done to see how well LY2439821 will work to help people with moderate-to-severe plaque psoriasis, and is it safe to use. “Investigational” means that the drug being tested has not been approved for routine clinical use or for the use described in this study by the United States Food and Drug Administration (FDA). However the FDA has allowed the use of this drug for research.



Detailed Description of Protocol:
If you choose to be in this study, your maximum time participating in the study is expected to last up to approximately 264 weeks of treatment (approx 5 years), and up to approximately 24 weeks after last regular study visit. The research study as a whole will last about 5 ½ years.

Up to approximately 1296 people will be taking part in this study. There is competitive enrollment for this study. Therefore, even if you qualify for the study, you might not get in if enrollment closes.

You will be “randomized” into one of the study groups described below at the start of the study. Randomization means that you are placed into a group by chance (like the flip of a coin). Neither you nor your study doctor can choose the group that you will be placed in, and neither you nor your doctor will know to what group you have been assigned. You will have a one in three chance of being placed in any group. At 12 Weeks, you may be reassigned to another treatment. Your second assignment to LY2439821 or to placebo (inactive substance) will be determined by your original assignment and your response to treatment.



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

- Diagnosed with moderate to severe plaque type psoriasis
- Have at least 10% body surface area (BSA) affected
- Generally healthy

Gender:
Both

Age(s):
18+

Children permitted to participate:
No

Potential Benefits.....
You may or may not receive any benefit from being in this study. It is possible that you may get better, stay the same, or get worse. If you take part in this study, other people with moderate-to-severe plaque psoriasis may be helped.

You may receive information from physical examinations, laboratory tests, or other testing that is done in this study but these tests may not have any impact on your health. Information obtained from this study will benefit the sponsor of the study and may benefit patients in the future.



Compensation:
Compensation is provided.