Psoriasis Clinical Trial

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

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Summary

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).

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Full Description

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.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

521

Study ID:

NCT02134210

Recruitment Status:

Completed

Sponsor:

Coherus Biosciences, Inc.

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There are 88 Locations for this study

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Arizona Research Center
Phoenix Arizona, 85020, United States
Radiant Research - Scottsdale
Scottsdale Arizona, 85251, United States
Anaheim Clinical Trials
Anaheim California, 92801, United States
Dream Team Clinical Research
Anaheim California, 92801, United States
Private Practice
Encino California, 91436, United States
Kaiser Permanente
Los Angeles California, 90027, United States
Skin Surgery Medical Group, Inc
San Diego California, 92117, United States
Clinical Science Institute
Santa Monica California, 90404, United States
Healthcare Partners Medical Group
Torrance California, 90503, United States
Horizons Clinical Research Center
Denver Colorado, 80220, United States
The Savin Center
New Haven Connecticut, 06511, United States
New England Research Associates
Trumbull Connecticut, 06611, United States
Florida Academic Dermatology Center (U of Miami Hospital)
Miami Florida, 33136, United States
Radiant Research - Pinellas Park
Pinellas Park Florida, 33781, United States
Atlantic Clinical Research Collaborative
West Palm Beach Florida, 33406, United States
Palm Beach Research Center
West Palm Beach Florida, 33409, United States
Radiant Research - Atlanta
Atlanta Georgia, 30328, United States
Private Practice - Jamie Weisman
Atlanta Georgia, 30342, United States
Altman Dermatology Associates
Arlington Heights Illinois, 60005, United States
Springfield Clinic
Springfield Illinois, 62703, United States
The Indiana Clinical Trials Center
Plainfield Indiana, 46168, United States
Kansas City Dermatology
Overland Park Kansas, 66215, United States
Derm Research
Louisville Kentucky, 40217, United States
Hamzavi Dermatology Clinical Research
Fort Gratiot Michigan, 48059, United States
Grekin Skin Institute
Warren Michigan, 48093, United States
Radiant Research - Edina
Edina Minnesota, 55435, United States
Central Dermatology
Saint Louis Missouri, 63117, United States
The Psoriasis Treatment Center of Central New Jersey
East Windsor New Jersey, 08520, United States
Skin Search of Rochester, Inc
Rochester New York, 14623, United States
DermResearch Center of New York
Stony Brook New York, 11790, United States
PMG Research of Carey, LLC
Cary North Carolina, 27518, United States
DJL Clinical Research
Charlotte North Carolina, 28210, United States
PMG Research of Wilmington
Wilmington North Carolina, 28401, United States
Radiant Research
Cincinnati Ohio, 45249, United States
Health Research of Oklahoma
Oklahoma City Oklahoma, 73103, United States
Altoona Center for Clincal Research
Duncansville Pennsylvania, 16635, United States
Clinical Research Center of Reading
Wyomissing Pennsylvania, 19610, United States
Radiant Research - Anderson
Anderson South Carolina, 29621, United States
Dermatology and Laser Center of Charleston
Charleston South Carolina, 29414, United States
Radient Research - Greer
Greer South Carolina, 29650, United States
Rivergate Dermatology
Goodlettsville Tennessee, 37072, United States
Neighborhood Medical Center
Dallas Texas, 75254, United States
Center for Clinical Studies
Houston Texas, 72004, United States
Heights Dermatology and Aesthetic Center
Houston Texas, 77008, United States
Progressive Clinical Research - San Antonio
San Antonio Texas, 78229, United States
Center for Clinical Studies
Webster Texas, 77598, United States
Dermatology Associates, PLLC
Seattle Washington, 98101, United States
Premier Clinical Research
Spokane Washington, 99204, United States
Wenatchee Valley Hospital and Clinics
Wenatchee Washington, 98801, United States
Mountain State Clinical Research
Clarksburg West Virginia, 26301, United States
Woden Dermatology Pty
Phillip Australian Capital Territory, 2606, Australia
Dr S P Shumack (St George Dermatology and Skin Cancer Center)
Kogarah New South Wales, 2217, Australia
Dr S P Shumack (Central Sydney Dermatology)
Sydney New South Wales, 2000, Australia
North Eastern Health Specialists
Hectorville South Australia, 5073, Australia
Sinclair Dermatology
East Melbourne Victoria, 3002, Australia
E and D Woolner Professional Corporation
Calgary Alberta, , Canada
Institute for Skin Advancement Inc
Calgary Alberta, , Canada
CCA Medical Research Corporation
Ajax Ontario, , Canada
Lynderm Research Inc
Markham Ontario, , Canada
North Bay Dermatology Centre Inc
North Bay Ontario, , Canada
Institute of Cosmetic and Laser Surgery
Oakville Ontario, , Canada
SKiN Center for Dermatology
Peterborough Ontario, , Canada
Private Practice
Richmond Hill Ontario, , Canada
Research Toronto
Toronto Ontario, , Canada
K. Papp Clinical Research Inc
Waterloo Ontario, , Canada
MVZ Reichenberger Str., Aerztehaus "Rudolf Virchow
Berlin , 13055, Germany
Klinische Forschung Dresden GmbH
Dresden , 01069, Germany
Hautklinik Universitaetsklinikum Erlangen
Erlangen , 91054, Germany
Johann Wolfgang Hospital - Goethe University
Frankfurt , 60590, Germany
Dermatologikum Hamburg
Hamburg , 20354, Germany
University Hospital Schleswig-Holstein - Campus Luebeck
Luebeck , 23538, Germany
Haemek Medical Center
Afula , 18101, Israel
Rambam Health Care Campus
Haifa , 31096, Israel
Rabin Medical Center Beilinson Campus
Petah Tikva , 49100, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv , 64239, Israel
NZOZ Osteo-Medic s.c. Artur Racewicz, Jerzy Supronik
Bialystok , 15540, Poland
Niepubliczny Zaklad Opieki Zdrowotnej Centrum Osteoporozy i Chorób Kostno-Stawowych J. Badurski S.J
Bialystok , 15879, Poland
Centrum Badan Klinicznych PI-House Sp. Z o.o
Gdansk , 80546, Poland
Synexus Polska Sp. z o.o. Oddzial w Gdyni
Gdynia , 81384, Poland
Synexus Polska Sp. z o.o. Oddzial w Katowicach
Katowice , 40040, Poland
Specjalistyczny Osrodek ALL-MED
Krakow , 31023, Poland
Krakowskie Centrum Medyczne
Krakow , 31501, Poland
Center Med
Krakow , 31530, Poland
Specjalistyczne Gabinety Lekarskie "Dermed
Lodz , 90265, Poland
Centrum Medyczne SYNEXUS POZNAN
Poznan , 60702, Poland
Centrum Medyczne Medyk
Rzeszow , 35055, Poland
SANUS Szpital Specjalistyczny Sp. z o.o
Stalowa Wola , 37450, Poland
EuroMedis Sp. z o.o.
Szczecin , 70111, Poland
NZOZ "Nasz Lekarz" Praktyka Grupowa Lekarzy z Przychodnia Specjalistyczna
Torun , 87100, Poland
Synexus Polska Sp. z o.o. Oddzial w Warszawie
Warszawa , 01192, Poland
MTZ Clinical Research Sp. z o.o.
Warszawa , 02106, Poland
Synexus Polska sp. z o.o
Wroclaw , 50088, Poland
Dermmedica Sp. z o.o
Wroclaw , 51318, Poland
Vincent Pallotti Hospital
Pinelands Cape Town, 7405, South Africa
Synopsis Research
Rondebosch Cape Town, 7700, South Africa
Jongaie Research
Pretoria West Pretoria, 0183, South Africa
Helderberg Clinical Trial Centre
Somerset West Western Cape, 7130, South Africa
Dr IC Louw
Cape Town , 7500, South Africa
Winelands Rheumatology Centre
Stellenbosch , , South Africa
Clinical Projects Research
Worcester , 6850, South Africa
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How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

521

Study ID:

NCT02134210

Recruitment Status:

Completed

Sponsor:


Coherus Biosciences, Inc.

How clear is this clinincal trial information?

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