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

Last updated: June 7, 2019
Sponsor: Coherus Biosciences, Inc.
Overall Status: Completed

Phase

3

Condition

Skin Wounds

Rosacea

Warts

Treatment

N/A

Clinical Study ID

NCT02134210
CHS-0214-04
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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

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 Design

Total Participants: 521
Study Start date:
June 16, 2014
Estimated Completion Date:
May 12, 2016

Study 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.

Connect with a study center

  • Woden Dermatology Pty

    Phillip, Australian Capital Territory 2606
    Australia

    Site Not Available

  • Dr S P Shumack (St George Dermatology and Skin Cancer Center)

    Kogarah, New South Wales 2217
    Australia

    Site Not Available

  • Dr S P Shumack (Central Sydney Dermatology)

    Sydney, New South Wales 2000
    Australia

    Site Not Available

  • North Eastern Health Specialists

    Hectorville, South Australia 5073
    Australia

    Site Not Available

  • Sinclair Dermatology

    East Melbourne, Victoria 3002
    Australia

    Site Not Available

  • E and D Woolner Professional Corporation

    Calgary, Alberta
    Canada

    Site Not Available

  • Institute for Skin Advancement Inc

    Calgary, Alberta
    Canada

    Site Not Available

  • CCA Medical Research Corporation

    Ajax, Ontario
    Canada

    Site Not Available

  • Lynderm Research Inc

    Markham, Ontario
    Canada

    Site Not Available

  • North Bay Dermatology Centre Inc

    North Bay, Ontario
    Canada

    Site Not Available

  • Institute of Cosmetic and Laser Surgery

    Oakville, Ontario
    Canada

    Site Not Available

  • SKiN Center for Dermatology

    Peterborough, Ontario
    Canada

    Site Not Available

  • Private Practice

    Richmond Hill, Ontario
    Canada

    Site Not Available

  • Research Toronto

    Toronto, Ontario
    Canada

    Site Not Available

  • K. Papp Clinical Research Inc

    Waterloo, Ontario
    Canada

    Site Not Available

  • MVZ Reichenberger Str., Aerztehaus "Rudolf Virchow

    Berlin, 13055
    Germany

    Site Not Available

  • Klinische Forschung Dresden GmbH

    Dresden, 01069
    Germany

    Site Not Available

  • Hautklinik Universitaetsklinikum Erlangen

    Erlangen, 91054
    Germany

    Site Not Available

  • Johann Wolfgang Hospital - Goethe University

    Frankfurt, 60590
    Germany

    Site Not Available

  • Dermatologikum Hamburg

    Hamburg, 20354
    Germany

    Site Not Available

  • University Hospital Schleswig-Holstein - Campus Luebeck

    Luebeck, 23538
    Germany

    Site Not Available

  • Haemek Medical Center

    Afula, 18101
    Israel

    Site Not Available

  • Rambam Health Care Campus

    Haifa, 31096
    Israel

    Site Not Available

  • Rabin Medical Center Beilinson Campus

    Petah Tikva, 49100
    Israel

    Site Not Available

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239
    Israel

    Site Not Available

  • Sheba Medical Center

    Tel Hashomer, 52621
    Israel

    Site Not Available

  • NZOZ Osteo-Medic s.c. Artur Racewicz, Jerzy Supronik

    Bialystok, 15540
    Poland

    Site Not Available

  • Niepubliczny Zaklad Opieki Zdrowotnej Centrum Osteoporozy i Chorób Kostno-Stawowych J. Badurski S.J

    Bialystok, 15879
    Poland

    Site Not Available

  • Centrum Badan Klinicznych PI-House Sp. Z o.o

    Gdansk, 80546
    Poland

    Site Not Available

  • Synexus Polska Sp. z o.o. Oddzial w Gdyni

    Gdynia, 81384
    Poland

    Site Not Available

  • Synexus Polska Sp. z o.o. Oddzial w Katowicach

    Katowice, 40040
    Poland

    Site Not Available

  • Center Med

    Krakow, 31530
    Poland

    Site Not Available

  • Krakowskie Centrum Medyczne

    Krakow, 31501
    Poland

    Site Not Available

  • Specjalistyczny Osrodek ALL-MED

    Krakow, 31023
    Poland

    Site Not Available

  • Specjalistyczne Gabinety Lekarskie "Dermed

    Lodz, 90265
    Poland

    Site Not Available

  • Centrum Medyczne SYNEXUS POZNAN

    Poznan, 60702
    Poland

    Site Not Available

  • Centrum Medyczne Medyk

    Rzeszow, 35055
    Poland

    Site Not Available

  • SANUS Szpital Specjalistyczny Sp. z o.o

    Stalowa Wola, 37450
    Poland

    Site Not Available

  • EuroMedis Sp. z o.o.

    Szczecin, 70111
    Poland

    Site Not Available

  • NZOZ "Nasz Lekarz" Praktyka Grupowa Lekarzy z Przychodnia Specjalistyczna

    Torun, 87100
    Poland

    Site Not Available

  • MTZ Clinical Research Sp. z o.o.

    Warszawa, 02106
    Poland

    Site Not Available

  • Synexus Polska Sp. z o.o. Oddzial w Warszawie

    Warszawa, 01192
    Poland

    Site Not Available

  • Dermmedica Sp. z o.o

    Wroclaw, 51318
    Poland

    Site Not Available

  • Synexus Polska sp. z o.o

    Wroclaw, 50088
    Poland

    Site Not Available

  • Vincent Pallotti Hospital

    Pinelands, Cape Town 7405
    South Africa

    Site Not Available

  • Synopsis Research

    Rondebosch, Cape Town 7700
    South Africa

    Site Not Available

  • Jongaie Research

    Pretoria West, Pretoria 0183
    South Africa

    Site Not Available

  • Helderberg Clinical Trial Centre

    Somerset West, Western Cape 7130
    South Africa

    Site Not Available

  • Dr IC Louw

    Cape Town, 7500
    South Africa

    Site Not Available

  • Winelands Rheumatology Centre

    Stellenbosch,
    South Africa

    Site Not Available

  • Clinical Projects Research

    Worcester, 6850
    South Africa

    Site Not Available

  • Ashgate Medical Practice

    Chesterfield, S404AA
    United Kingdom

    Site Not Available

  • Alverton Practice

    Cornwall, TR184JH
    United Kingdom

    Site Not Available

  • Poole Hospital NHS Foundation Trust

    Dorset, BH152JB
    United Kingdom

    Site Not Available

  • Oak Tree Surgery

    Liskeard Cornwall, PL143XA
    United Kingdom

    Site Not Available

  • Rame Research

    Torpoint, PL112TB
    United Kingdom

    Site Not Available

  • Arizona Research Center

    Phoenix, Arizona 85020
    United States

    Site Not Available

  • Radiant Research - Scottsdale

    Scottsdale, Arizona 85251
    United States

    Site Not Available

  • Anaheim Clinical Trials

    Anaheim, California 92801
    United States

    Site Not Available

  • Dream Team Clinical Research

    Anaheim, California 92801
    United States

    Site Not Available

  • Private Practice

    Encino, California 91436
    United States

    Site Not Available

  • Kaiser Permanente

    Los Angeles, California 90027
    United States

    Site Not Available

  • Skin Surgery Medical Group, Inc

    San Diego, California 92117
    United States

    Site Not Available

  • Clinical Science Institute

    Santa Monica, California 90404
    United States

    Site Not Available

  • Healthcare Partners Medical Group

    Torrance, California 90503
    United States

    Site Not Available

  • Horizons Clinical Research Center

    Denver, Colorado 80220
    United States

    Site Not Available

  • The Savin Center

    New Haven, Connecticut 06511
    United States

    Site Not Available

  • New England Research Associates

    Trumbull, Connecticut 06611
    United States

    Site Not Available

  • Florida Academic Dermatology Center (U of Miami Hospital)

    Miami, Florida 33136
    United States

    Site Not Available

  • Radiant Research - Pinellas Park

    Pinellas Park, Florida 33781
    United States

    Site Not Available

  • Atlantic Clinical Research Collaborative

    West Palm Beach, Florida 33406
    United States

    Site Not Available

  • Palm Beach Research Center

    West Palm Beach, Florida 33409
    United States

    Site Not Available

  • Private Practice - Jamie Weisman

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • Radiant Research - Atlanta

    Atlanta, Georgia 30328
    United States

    Site Not Available

  • Altman Dermatology Associates

    Arlington Heights, Illinois 60005
    United States

    Site Not Available

  • Springfield Clinic

    Springfield, Illinois 62703
    United States

    Site Not Available

  • The Indiana Clinical Trials Center

    Plainfield, Indiana 46168
    United States

    Site Not Available

  • Kansas City Dermatology

    Overland Park, Kansas 66215
    United States

    Site Not Available

  • Derm Research

    Louisville, Kentucky 40217
    United States

    Site Not Available

  • Clinical Trials of America - Monroe

    Monroe, Louisiana 71203
    United States

    Site Not Available

  • Beacon Clinical Research

    Brockton, Massachusetts 02301
    United States

    Site Not Available

  • Hamzavi Dermatology Clinical Research

    Fort Gratiot, Michigan 48059
    United States

    Site Not Available

  • Grekin Skin Institute

    Warren, Michigan 48093
    United States

    Site Not Available

  • Radiant Research - Edina

    Edina, Minnesota 55435
    United States

    Site Not Available

  • Central Dermatology

    Saint Louis, Missouri 63117
    United States

    Site Not Available

  • Central Dermatology

    St. Louis, Missouri 63117
    United States

    Site Not Available

  • The Psoriasis Treatment Center of Central New Jersey

    East Windsor, New Jersey 08520
    United States

    Site Not Available

  • Skin Search of Rochester, Inc

    Rochester, New York 14623
    United States

    Site Not Available

  • DermResearch Center of New York

    Stony Brook, New York 11790
    United States

    Site Not Available

  • PMG Research of Carey, LLC

    Cary, North Carolina 27518
    United States

    Site Not Available

  • DJL Clinical Research

    Charlotte, North Carolina 28210
    United States

    Site Not Available

  • PMG Research of Wilmington

    Wilmington, North Carolina 28401
    United States

    Site Not Available

  • Radiant Research

    Cincinnati, Ohio 45249
    United States

    Site Not Available

  • Health Research of Oklahoma

    Oklahoma City, Oklahoma 73103
    United States

    Site Not Available

  • Altoona Center for Clincal Research

    Duncansville, Pennsylvania 16635
    United States

    Site Not Available

  • Clinical Research Center of Reading

    Wyomissing, Pennsylvania 19610
    United States

    Site Not Available

  • Radiant Research - Anderson

    Anderson, South Carolina 29621
    United States

    Site Not Available

  • Dermatology and Laser Center of Charleston

    Charleston, South Carolina 29414
    United States

    Site Not Available

  • Radient Research - Greer

    Greer, South Carolina 29650
    United States

    Site Not Available

  • Rivergate Dermatology

    Goodlettsville, Tennessee 37072
    United States

    Site Not Available

  • PMG Research of Bristol

    Kingsport, Tennessee 37660
    United States

    Site Not Available

  • Neighborhood Medical Center

    Dallas, Texas 75254
    United States

    Site Not Available

  • Center for Clinical Studies

    Houston, Texas 72004
    United States

    Site Not Available

  • Heights Dermatology and Aesthetic Center

    Houston, Texas 77008
    United States

    Site Not Available

  • Progressive Clinical Research - San Antonio

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Center for Clinical Studies

    Webster, Texas 77598
    United States

    Site Not Available

  • Dermatology Associates, PLLC

    Seattle, Washington 98101
    United States

    Site Not Available

  • Premier Clinical Research

    Spokane, Washington 99204
    United States

    Site Not Available

  • Wenatchee Valley Hospital and Clinics

    Wenatchee, Washington 98801
    United States

    Site Not Available

  • Mountain State Clinical Research

    Clarksburg, West Virginia 26301
    United States

    Site Not Available

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