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 |
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).
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.
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
50
sites
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59 One Mile Road
East Windsor, New Jersey 08520
East Windsor, New Jersey 08520
609-443-4500
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1897 Palm Beach Lakes Boulevard
West Palm Beach, Florida 33409
West Palm Beach, Florida 33409
561-689-0606
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Anaheim Clinical Trials, LLC Anaheim Clinical Trials (ACT) is a research center of excellence for...
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PMG Research of Wilmington PMG Research of Wilmington has two offices situated in a 1...
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