Comparison of CHS-0214 to Enbrel (Etanercept) in Patients With Chronic Plaque Psoriasis (PsO)



Status:Active, not recruiting
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:June 2014
End Date:May 2016

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A Double-Blind, Randomized, Parallel-Group, Active-Control Study to Compare the Efficacy and Safety of CHS-0214 Versus Enbrel in Subjects With Chronic Plaque Psoriasis (RaPsOdy)

This is a two part study comparing CHS-0214 to Enbrel in patients with chronic plaque PsO
who have not yet received any biologic therapy for any indication (other than insulin or
hormones).

Pt. 1 is a 12-week randomized, double-blind, active-control, parallel-group, multi-center
global study. The primary end point is 75% improvement from baseline according to the
Psoriasis Area and Severity Index (PASI-75). Comparing CHS-0214 to Enbrel for efficacy and
safety at a dosage of 50mg subcutaneous (Sc) twice weekly.

Pt. 2 is a 40-week randomized, double-blind, active-control, parallel-group, multi-center
global study where CHS-0214 and Enbrel dosage is reduced to 50mg Sc weekly for maintenance.

Inclusion Criteria:

- Male or female adults

- PsO diagnosis for 6 months

- Active disease: PASI greater than or equal to 12, Physician's Static Global
Assessment (PSGA) score greater than or equal to 3 (based on a scale or 0-5),

- Body Surface Area (BSA) involved with PsO greater than or equal to 10%

- Dermatology Life Quality Index (DQLI) greater than or equal to 10

- Previously received phototherapy or systemic non-biologic therapy for PsO

Exclusion Criteria:

- Forms of Psoriasis other than PsO

- Drug induced Psoriasis

- Positive QuantiFERON-tuberculosis (TB) Gold Test

- Presence of significant comorbid conditions

- Chemistry and hematology values outside protocol specified range

- Major systemic infections
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Clarksburg, West Virginia 26301
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1100 Lake Hearn Dr
Atlanta, Georgia 30342
404-255-6005
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4495 Hale Parkway
Denver, Colorado 80220
303-399-4067
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59 One Mile Road
East Windsor, New Jersey 08520
609-443-4500
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1897 Palm Beach Lakes Boulevard
West Palm Beach, Florida 33409
561-689-0606
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1085 N Harbor Blvd
Anaheim, California 92801
(714) 774-7777
Anaheim Clinical Trials, LLC Anaheim Clinical Trials (ACT) is a research center of excellence for...
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760 North Euclid Street
Anaheim, California 92801
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Anderson, South Carolina 29621
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Arlington Heights, Illinois 60005
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Atlanta, Georgia 30342
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Cary, North Carolina 27518
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Charleston, South Carolina 29414
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Charlotte, North Carolina 28210
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Cincinnati, Ohio 45249
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Dallas, Texas 75254
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Duncansville, Pennsylvania 16635
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Edina, Minnesota 55435
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Encino, California 91436
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Fort Gratiot, Michigan 48059
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Goodlettsville, Tennessee 37072
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Greer, South Carolina 29650
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Houston, Texas 77030
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New Haven, Connecticut 06511
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Oklahoma City, Oklahoma 73103
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Phoenix, Arizona 85023
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Pinellas Park, Florida 33781
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Plainfield, Indiana 46168
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Rochester, New York 14623
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Seattle, Washington 98101
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Springfield, Illinois 62703
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Warren, Michigan 48093
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West Palm Beach, Florida 33406
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1907 Tradd Ct
Wilmington, North Carolina 28401
(910) 799-5500
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Wyomissing, Pennsylvania 19610
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