Comparison of CHS-1420 Versus Humira in Subjects With Chronic Plaque Psoriasis

Last updated: March 27, 2020
Sponsor: Coherus Biosciences, Inc.
Overall Status: Completed

Phase

3

Condition

Psoriasis And Psoriatic Disorders

Rash

Warts

Treatment

N/A

Clinical Study ID

NCT02489227
CHS-1420-02
  • Ages > 18
  • All Genders

Study Summary

This is a 3-period study comparing CHS-1420 to Humira in patients with chronic plaque psoriasis.

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 of 0-5),

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

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: 545
Study Start date:
August 01, 2015
Estimated Completion Date:
March 31, 2017

Study Description

This is a 55-week, randomized, double-blind, active-control, parallel group, multicenter, global study in subjects with active, moderate to severe, chronic PsO.

The study will consist of 24 weeks of administration of blinded study drug, divided into Treatment Period 1 and Treatment Period 2, then 23 weeks of administration of open-label CHS-1420 and a Follow-up visit 8 weeks after the last dose. Subjects who meet inclusion/exclusion criteria will be stratified by body mass index (BMI), and age and randomized 1:1 to receive CHS-1420 or Humira in Treatment Period 1. Subjects assigned to CHS-1420 will continue to receive CHS-1420 in Period 2. Subjects assigned to Humira in Period 1 will be randomly assigned (1:1) to either continue with Humira in Treatment Period 2 or to switch to CHS-1420 in Treatment Period 2. All subjects will receive open label CHS-1420 in Treatment Period 3.

Connect with a study center

  • Center for Dermatology and Venerology Diseases, EOOD, Sofia City

    Sofia, 1415
    Bulgaria

    Site Not Available

  • Kingsway Clinical Research

    Etobicoke, Ontario M8X 1Y9
    Canada

    Site Not Available

  • Dermatology Center

    London, Ontario N5X 2P1
    Canada

    Site Not Available

  • Lynderm Research Inc.

    Markham, Ontario L3P 1X2
    Canada

    Site Not Available

  • North Bay Dermatology Centre

    North Bay, Ontario P1B 3Z7
    Canada

    Site Not Available

  • Research by ICLS

    Oakville, Ontario L6J 7W5
    Canada

    Site Not Available

  • Skin Centre for Dermatology

    Peterborough, Ontario K9J 5K2
    Canada

    Site Not Available

  • The Centre for Dermatology

    Richmond Hill, Ontario L4B 1A5
    Canada

    Site Not Available

  • Research Toronto

    Toronto, Ontario M5S 3B4
    Canada

    Site Not Available

  • Probity Medical Research, Inc.

    Waterloo, Ontario N2J 1C4
    Canada

    Site Not Available

  • Windsor Clinical Research

    Windsor, Ontario N8W 5L7
    Canada

    Site Not Available

  • Centro Intrnacional de Estudios Clinicos- CIEC

    Santiago, 8420383
    Chile

    Site Not Available

  • Clinica Dermacross SA

    Santiago, 7640881
    Chile

    Site Not Available

  • Antonio Guglielmetti, MD

    Viña Del Mar, 2520000
    Chile

    Site Not Available

  • Naftalan, Special Hospital for Medical Rehabilitation

    Ivanić-Grad, 10310
    Croatia

    Site Not Available

  • Clinical Hospital Centre "Osijek"

    Osijek, 31000
    Croatia

    Site Not Available

  • Tartu University Hospital, Dermatology Clinic

    Raja, Tartu 50417
    Estonia

    Site Not Available

  • Innomedica OÜ

    Tallinn, 10117
    Estonia

    Site Not Available

  • North Estonian Medical Centre Foundation Skin and Sexual Diseases Center

    Tallinn, 13419
    Estonia

    Site Not Available

  • Aleksandre Aladshvili Clinic LLC

    Tbilisi, 0102
    Georgia

    Site Not Available

  • Health Institute LLC

    Tbilisi, 0160
    Georgia

    Site Not Available

  • Medical Center Clto Ltd

    Tbilisi, 0179
    Georgia

    Site Not Available

  • Scientific/Research National Center of Dermatology and Venereology

    Tbilisi, 0159
    Georgia

    Site Not Available

  • Tbilisi State Medical University Alexandre Aladashvili University Clinic

    Tbilisi, 0144
    Georgia

    Site Not Available

  • Department of Dermatology- Ha'Emek Medical Center

    Afula, 1834111
    Israel

    Site Not Available

  • Meir Medical Center Dermatologic Clinic

    Kfar Saba, 4428164
    Israel

    Site Not Available

  • Rabin Medical Center Department of Dermatology

    Petah tikva, 49100
    Israel

    Site Not Available

  • Department of Dermatology Phototherapy and Day Care Center

    Ramat Gan, 52621
    Israel

    Site Not Available

  • Department of Clinical and Molecular Sciences Dermatologic Clinic

    Ancona,
    Italy

    Site Not Available

  • Department of Internal Medicine and Medical Specialties Unit of Dermatology

    Reggio Emilia,
    Italy

    Site Not Available

  • Istituto di Clinica Dermosifilopatica Univeristà Cattolica del S.Cuore

    Rome,
    Italy

    Site Not Available

  • Janis Kisis, MD

    Jurmala, LV-2008
    Latvia

    Site Not Available

  • Kristine Berzina, MD, PhD

    Riga, LV-1046
    Latvia

    Site Not Available

  • Riga 1st Hospital Skin and Sexually Transmitted Diseases Clinical Centre

    Riga, LV-1001
    Latvia

    Site Not Available

  • PMSI Institute of Cardiology

    Chisinau, MD2025
    Moldova, Republic of

    Site Not Available

  • ClinicMed Badurski i wspólnicy Spółka Jawna

    Białystok, 15-879
    Poland

    Site Not Available

  • Zdrowie Osteo-Medic s.c.

    Białystok, 15-351
    Poland

    Site Not Available

  • Centrum Badań Kliniccznych

    Gdańsk, 80-456
    Poland

    Site Not Available

  • Grażyna Pulka Specjalistyczny Ośrodek, "ALL-MED"

    Krakow, 31-023
    Poland

    Site Not Available

  • CenterMed Kraków Śp. z o. o.

    Kraków, 31-530
    Poland

    Site Not Available

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

    Poznań, 60-702
    Poland

    Site Not Available

  • Niepubliczny Zaklad Opieki Zdrowtnej "NASZ LEKARZ"

    Toruń, 87-100
    Poland

    Site Not Available

  • Synexus Polska Śp. z o.o.

    Warsaw, 01-192
    Poland

    Site Not Available

  • Wojewodzki Szpital Specjalistyczny we Wrocławiu, Oddział Dermatologiczny

    Wrocław, 51-124
    Poland

    Site Not Available

  • Altay State Medical University

    Barnaul, 651045
    Russian Federation

    Site Not Available

  • Moscow Scientific and Practical Center of Dermatovenereology and Cosmetology of the Public Health Department of Moscow

    Moscow, 109044
    Russian Federation

    Site Not Available

  • Moscow State University and Dentistry named after Evdokimov

    Moscow, 121614
    Russian Federation

    Site Not Available

  • Alliance Biomedical Group

    Saint Petersburg, 94356
    Russian Federation

    Site Not Available

  • Imc "Sogaz"

    Saint Petersburg, 191186
    Russian Federation

    Site Not Available

  • Olga Mikerina, MD

    Saint Petersburg, 195257
    Russian Federation

    Site Not Available

  • Clinic of Skin and Venereal Diseases of the Saratov State Medical University

    Saratov, 410028
    Russian Federation

    Site Not Available

  • DOST - Dermatovenerologicke oddelenie sanatorneho typu

    Svidník, 089 01
    Slovakia

    Site Not Available

  • Panorama Medical Centre, Room 136

    Panorama, Cape Town 7500
    South Africa

    Site Not Available

  • Medicross Pretoria West 1st Floor

    Pretoria West, Pretoria 0183
    South Africa

    Site Not Available

  • Zubar Fazal Ahmed Vawda. MD

    Durban, 4091
    South Africa

    Site Not Available

  • The Park, Room 201, 2nd Floor

    Pinelands, 7405
    South Africa

    Site Not Available

  • Synopsis Research cc

    Rondebosch, 7700
    South Africa

    Site Not Available

  • Synexus Heiderberg Clinical Research Centre

    Somerset West, 7130
    South Africa

    Site Not Available

  • Clinical Projects Research SA (PTY) Ltd.

    Worcester, 6850
    South Africa

    Site Not Available

  • Medical Center Private Enterprise "Dzerkalo"

    Dnipropetrovs'k, 49044
    Ukraine

    Site Not Available

  • Ivano-Frankivsk National Medical Univeristy, Dept. of Dermatology and Venereology based on Ivano-Frankivsk Regional Clinical Dermatology and Venereology Dispensary

    Ivano-Frankivs'k, 76018
    Ukraine

    Site Not Available

  • Municipal Healthcare Institution "Kharkiv City Dermatovenereological Dispensary #2

    Kharkiv, 61038
    Ukraine

    Site Not Available

  • Khmel'nytskyy Regional Dermatovenereological Dispensary

    Khmel'nyts'kyy, 29009
    Ukraine

    Site Not Available

  • National Medical University named after O.O.Bohomolets, Dept. of Dermatology and Venereology based on Oleksandrivska Clinical Hospital of Kyiv City, Dept. of Dermatology

    Kyiv, 01601
    Ukraine

    Site Not Available

  • National Medical University named after Danyla Galytskoho, Dept. of Family Medicine and Dermatology, Venereology based on Dept. of Dermatovenereology of the clinical Hospital of Ukrainian State Border Guard Services

    Lviv, 79014
    Ukraine

    Site Not Available

  • Odesa National Medical University, Department of Dermatic and Venereologic Diseases based on Odesa Regional Dermatovenereological Dispensary

    Odesa, 65006
    Ukraine

    Site Not Available

  • Municipal Institution "Rivne Regional Dermatology and Venereology Dispensary" of Rivne Regional Council

    Rivne, 33028
    Ukraine

    Site Not Available

  • Municipal Institution of Ternopil Regional Council Ternopil Regional Clinical Dermatovenereological Dispensary

    Ternopil', 46006
    Ukraine

    Site Not Available

  • Diagnostic and Treatment Dermatology and Gynecology Center

    Uzhhorod, 88000
    Ukraine

    Site Not Available

  • Municipal Institution "Zaporizhzhya Regional Dermatology and Venereology Clinical Dispensary" of Zaporizhzhya Regional Council

    Zaporizhzhya, 69063
    Ukraine

    Site Not Available

  • Sadra Sasha Jazayeri, MD

    Phoenix, Arizona 85032
    United States

    Site Not Available

  • Encino Research Center

    Encino, California 91436
    United States

    Site Not Available

  • Center for Dermatology and Laser Surgery

    Sacramento, California 95819
    United States

    Site Not Available

  • Kenneth M Stein, MD

    Santa Rosa, California 95405
    United States

    Site Not Available

  • HealthCare Partners Medical Group Clinical Research Center

    Torrance, California 90503
    United States

    Site Not Available

  • Horizons Clinical Research Center, LLC.

    Denver, Colorado 80220
    United States

    Site Not Available

  • New England Research Associates LLC

    Trumbull, Connecticut 06611
    United States

    Site Not Available

  • Francisco A Kerdel, MD

    Coral Gables, Florida 33134
    United States

    Site Not Available

  • Linda Tripodis Murray, DO

    Pinellas Park, Florida 33781
    United States

    Site Not Available

  • ACRC-Dermatology

    West Palm Beach, Florida 33406
    United States

    Site Not Available

  • Mark A Knautz, MD

    Marietta, Georgia 30060
    United States

    Site Not Available

  • The Indiana Clinical Trials Center

    Plainfield, Indiana 46168
    United States

    Site Not Available

  • Grekin Skin Institute

    Warren, Michigan 48088
    United States

    Site Not Available

  • Jack C Scott, MD

    Edina, Minnesota 55435
    United States

    Site Not Available

  • Central Dermatology

    Saint Louis, Missouri 63117
    United States

    Site Not Available

  • Craig L Leonardi, MD

    Saint Louis, Missouri 63117
    United States

    Site Not Available

  • PMG Research of Raleigh, LLC

    Cary, North Carolina 27518
    United States

    Site Not Available

  • Box Arthritis & Rheumetology of the Carolinas

    Charlotte, North Carolina 28210
    United States

    Site Not Available

  • Michael Joseph Noss, MD

    Cincinnati, Ohio 45249
    United States

    Site Not Available

  • Central Sooner Research

    Norman, Oklahoma 73031
    United States

    Site Not Available

  • Health Research of Oklahoma

    Oklahoma City, Oklahoma 73103
    United States

    Site Not Available

  • Dermatology and Skin Surgery Center, PC

    Exton, Pennsylvania 19341
    United States

    Site Not Available

  • James Henry Kopp, MD

    Anderson, South Carolina 29621
    United States

    Site Not Available

  • PMG Research of Bristol, LLC

    Bristol, Tennessee 37620
    United States

    Site Not Available

  • Arlington Research Center, Inc.

    Arlington, Texas 76011
    United States

    Site Not Available

  • Center for Clinical Studies

    Houston, Texas 77065
    United States

    Site Not Available

  • Center for Clinical Studies TMC/ Museum District Office

    Houston, Texas 77004
    United States

    Site Not Available

  • Center for Clinical Studies

    Webster, Texas 77598
    United States

    Site Not Available

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