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(JKR-0653) Safety and Tolerability of the Investigational Medicine AbGn-168 in the Treatment of Chronic Plaque Psoriasis


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Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Single Rising, Open-label Doses of AbGn-168 Administered by Intravenous Infusion to Patients with Chronic Plaque Psoriasis

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

Investigators:
Mary Sullivan-Whalen N.P.
Patricia Gilleaudeau N.P.

Contact Information:
Patricia Gilleaudeau
1230 York Avenue
New York, NY 10065
Telephone: 212-327-8333
Email: gilleap@rockefeller.edu
Contact Information:
Mary Sullivan-Whalen
Telephone: 212-327-7212
Alt. Telephone:
E-Mail: whalems@rockefeller.edu


Enrollment Status:
Closed to Enrollment

Brief Summary of Protocol:
The main purpose of this research study is to test the safety and tolerability of single increasing doses of AbGn-168 given intravenously (injection of a substance into a vein) in patients with chronic plaque psoriasis. A secondary objective is to assess how the body uses and gets rid of the study drug (Pharmacokinetic or PK testing) and to determine the chemical and physical effects of the drug within the body (Pharmacodynamic or PD testing). The effects of AbGn-168 on psoriasis disease activity in skin cells will be assessed by obtaining three small pieces of skin (biopsies) at different times (baseline (pre-treatment), 2 weeks and 4 weeks after treatment) during the study.



Detailed Description of Protocol:
The Screening period may last up to 42 days. Participants will receive a single dose of study drug on study Day 1 (Visit 2). Participants will be required to remain in the study site under medical observation overnight after receiving the study drug and will be required to return to the study site for a series of 13 additional visits. The last visit will be about 14 weeks after receiving the study drug.

PROCEDURES
Screening tests will be performed to see if you can take part in the study and will include the following:
• Basic information, medical history, psoriasis history and current medicines
• Skin assessment
• Physical examination including height, weight and after resting for 10 minutes, vital signs (blood pressure and pulse rate) and body temperature
• Blood tests
• Urine tests
• Electrocardiogram (ECG)
• Tuberculosis skin test
• Photographs of your skin may be taken

Visit 2 (Day 1)
The following tests and procedures will be done:
• Health assessment
• Vital Signs recorded (oral temperature, blood pressure, heart rate and breathing rate)
• Blood and urine tests
• Electrocardiograms (ECGs)
• Skin examination
• Skin biopsy
• Photographs of your skin may be taken

Visits 3 -15 and End of Study Visit (Weeks 1 – 14) (Days 3-96)
Depending on the visit number, the procedures at each visit may include some or all the following:
• Health assessment
• Physical exam
• Temperature, heart rate, breathing rate, oral body temperature, and blood pressure recorded
• Skin examination
• Blood and urine tests
• Electrocardiograms (ECGs)
• Skin biopsies
• Photographs of your skin may be taken
Profile:
Study participants must have psoriasis.



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

You must have plaque type psoriasis. You must be between the ages of 18 and 65 years old. If you are a female and able to become pregnant, you may not participate.

Gender:
Both

Age(s):
18-65

Children permitted to participate:
No

Potential Benefits.....
There will be no benefit to patients participating in the study.

By taking part in this study, you may contribute information about AbGn-168 that may benefit other patients in the future and may lead to another medicine to treat psoriasis.



Compensation:
Total compensation for this study is $1900.