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
We found this trial at
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Stony Brook, New York 11790
144
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Stony Brook, NY
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1100 Lake Hearn Dr
Atlanta, Georgia 30342
404-255-6005
925
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Atlanta, GA
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4495 Hale Parkway
Denver, Colorado 80220
303-399-4067
1760
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59 One Mile Road
East Windsor, New Jersey 08520
609-443-4500
229
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East Windsor, NJ
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1897 Palm Beach Lakes Boulevard
West Palm Beach, Florida 33409
561-689-0606
1194
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West Palm Beach, FL
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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...
2578
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Anaheim, CA
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760 North Euclid Street
Anaheim, California 92801
2579
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Anderson, South Carolina 29621
826
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Anderson, SC
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Arlington Heights, Illinois 60005
862
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Arlington Heights, IL
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Atlanta, Georgia 30342
934
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Cary, North Carolina 27518
612
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Cary, NC
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Charleston, South Carolina 29414
818
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Charleston, SC
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Charlotte, North Carolina 28210
724
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Charlotte, NC
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Cincinnati, Ohio 45249
722
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Clarksburg, West Virginia 26301
527
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Clarksburg, WV
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Dallas, Texas 75254
1552
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Dallas, TX
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Duncansville, Pennsylvania 16635
402
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Edina, Minnesota 55435
1121
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Edina, MN
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Encino, California 91436
2597
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Encino, CA
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Fort Gratiot, Michigan 48059
578
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Goodlettsville, Tennessee 37072
930
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Goodlettsville, TN
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Greer, South Carolina 29650
792
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Greer, SC
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Houston, Texas 77030
1606
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Houston, TX
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Houston, TX
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Los Angeles, California 90027
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Los Angeles, CA
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Louisville, Kentucky 40217
821
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Louisville, KY
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1256
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Miami, FL
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New Haven, Connecticut 06511
118
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New Haven, CT
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Oklahoma City, Oklahoma 73103
1489
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Oklahoma City, OK
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Overland Park, Kansas 66215
1256
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Phoenix, Arizona 85023
2287
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Pinellas Park, Florida 33781
1196
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Plainfield, Indiana 46168
816
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Plainfield, IN
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Rochester, New York 14623
335
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Rochester, NY
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1763
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San Antonio, TX
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San Diego, California 92117
2574
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San Diego, CA
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Santa Monica, California 90404
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Santa Monica, CA
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Scottsdale, Arizona 85251
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Seattle, Washington 98101
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Spokane, Washington 99204
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Springfield, Illinois 62703
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St. Louis, Missouri 63117
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Torrance, California 90503
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Trumbull, Connecticut 06611
134
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Warren, Michigan 48093
607
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Webster, Texas 77598
1600
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Wenatchee, Washington 98801
2392
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West Palm Beach, Florida 33406
1198
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1907 Tradd Ct
Wilmington, North Carolina 28401
(910) 799-5500
PMG Research of Wilmington PMG Research of Wilmington has two offices situated in a 1...
672
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Wyomissing, Pennsylvania 19610
288
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Wyomissing, PA
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