Psoriasis Clinical Trial

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

Summary

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

View Full Description

Full 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.

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 of 0-5),
Body Surface Area (BSA) involved with PsO greater than or equal to 10%

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:

545

Study ID:

NCT02489227

Recruitment Status:

Completed

Sponsor:

Coherus Biosciences, Inc.

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There are 94 Locations for this study

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Sadra Sasha Jazayeri, MD
Phoenix Arizona, 85032, United States
Encino Research Center
Encino California, 91436, United States
Center for Dermatology and Laser Surgery
Sacramento California, 95819, United States
Kenneth M Stein, MD
Santa Rosa California, 95405, United States
HealthCare Partners Medical Group Clinical Research Center
Torrance California, 90503, United States
Horizons Clinical Research Center, LLC.
Denver Colorado, 80220, United States
New England Research Associates LLC
Trumbull Connecticut, 06611, United States
Francisco A Kerdel, MD
Coral Gables Florida, 33134, United States
Linda Tripodis Murray, DO
Pinellas Park Florida, 33781, United States
ACRC-Dermatology
West Palm Beach Florida, 33406, United States
Mark A Knautz, MD
Marietta Georgia, 30060, United States
The Indiana Clinical Trials Center
Plainfield Indiana, 46168, United States
Grekin Skin Institute
Warren Michigan, 48088, United States
Jack C Scott, MD
Edina Minnesota, 55435, United States
Central Dermatology
Saint Louis Missouri, 63117, United States
Craig L Leonardi, MD
Saint Louis Missouri, 63117, United States
PMG Research of Raleigh, LLC
Cary North Carolina, 27518, United States
Box Arthritis & Rheumetology of the Carolinas
Charlotte North Carolina, 28210, United States
Michael Joseph Noss, MD
Cincinnati Ohio, 45249, United States
Central Sooner Research
Norman Oklahoma, 73031, United States
Health Research of Oklahoma
Oklahoma City Oklahoma, 73103, United States
Dermatology and Skin Surgery Center, PC
Exton Pennsylvania, 19341, United States
James Henry Kopp, MD
Anderson South Carolina, 29621, United States
PMG Research of Bristol, LLC
Bristol Tennessee, 37620, United States
Arlington Research Center, Inc.
Arlington Texas, 76011, United States
Center for Clinical Studies TMC/ Museum District Office
Houston Texas, 77004, United States
Center for Clinical Studies
Houston Texas, 77065, United States
Center for Clinical Studies
Webster Texas, 77598, United States
Center for Dermatology and Venerology Diseases, EOOD, Sofia City
Sofia , 1415, Bulgaria
Kingsway Clinical Research
Etobicoke Ontario, M8X 1, Canada
Dermatology Center
London Ontario, N5X 2, Canada
Lynderm Research Inc.
Markham Ontario, L3P 1, Canada
North Bay Dermatology Centre
North Bay Ontario, P1B 3, Canada
Research by ICLS
Oakville Ontario, L6J 7, Canada
Skin Centre for Dermatology
Peterborough Ontario, K9J 5, Canada
The Centre for Dermatology
Richmond Hill Ontario, L4B 1, Canada
Research Toronto
Toronto Ontario, M4W 2, Canada
Research Toronto
Toronto Ontario, M5S 3, Canada
Probity Medical Research, Inc.
Waterloo Ontario, N2J 1, Canada
Windsor Clinical Research
Windsor Ontario, N8W 5, Canada
Clinica Dermacross SA
Santiago , 76408, Chile
Centro Intrnacional de Estudios Clinicos- CIEC
Santiago , 84203, Chile
Antonio Guglielmetti, MD
Viña Del Mar , 25200, Chile
Naftalan, Special Hospital for Medical Rehabilitation
Ivanić-Grad , 10310, Croatia
Clinical Hospital Centre "Osijek"
Osijek , 31000, Croatia
Tartu University Hospital, Dermatology Clinic
Raja Tartu, 50417, Estonia
Innomedica OÜ
Tallinn , 10117, Estonia
North Estonian Medical Centre Foundation Skin and Sexual Diseases Center
Tallinn , 13419, Estonia
Aleksandre Aladshvili Clinic LLC
Tbilisi , 0102, Georgia
Tbilisi State Medical University Alexandre Aladashvili University Clinic
Tbilisi , 0144, Georgia
Scientific/Research National Center of Dermatology and Venereology
Tbilisi , 0159, Georgia
Health Institute LLC
Tbilisi , 0160, Georgia
Medical Center Clto Ltd
Tbilisi , 0179, Georgia
Department of Dermatology- Ha'Emek Medical Center
Afula , 18341, Israel
Meir Medical Center Dermatologic Clinic
Kfar Saba , 44281, Israel
Rabin Medical Center Department of Dermatology
Petah tikva , 49100, Israel
Department of Dermatology Phototherapy and Day Care Center
Ramat Gan , 52621, Israel
Department of Clinical and Molecular Sciences Dermatologic Clinic
Ancona , , Italy
Department of Internal Medicine and Medical Specialties Unit of Dermatology
Reggio Emilia , , Italy
Istituto di Clinica Dermosifilopatica Univeristà Cattolica del S.Cuore
Rome , , Italy
Janis Kisis, MD
Jurmala , LV-20, Latvia
Riga 1st Hospital Skin and Sexually Transmitted Diseases Clinical Centre
Riga , LV-10, Latvia
Kristine Berzina, MD, PhD
Riga , LV-10, Latvia
PMSI Institute of Cardiology
Chisinau , MD202, Moldova, Republic of
Zdrowie Osteo-Medic s.c.
Białystok , 15-35, Poland
ClinicMed Badurski i wspólnicy Spółka Jawna
Białystok , 15-87, Poland
Centrum Badań Kliniccznych
Gdańsk , 80-45, Poland
Grażyna Pulka Specjalistyczny Ośrodek, "ALL-MED"
Krakow , 31-02, Poland
CenterMed Kraków Śp. z o. o.
Kraków , 31-53, Poland
Synexus Polska Sp. z o. o. Oddzial w Poznaniu
Poznań , 60-70, Poland
Niepubliczny Zaklad Opieki Zdrowtnej "NASZ LEKARZ"
Toruń , 87-10, Poland
Synexus Polska Åšp. z o.o.
Warsaw , 01-19, Poland
Wojewodzki Szpital Specjalistyczny we Wrocławiu, Oddział Dermatologiczny
Wrocław , 51-12, Poland
Altay State Medical University
Barnaul , 65104, Russian Federation
Moscow Scientific and Practical Center of Dermatovenereology and Cosmetology of the Public Health Department of Moscow
Moscow , 10904, Russian Federation
Moscow State University and Dentistry named after Evdokimov
Moscow , 12161, Russian Federation
Imc "Sogaz"
Saint Petersburg , 19118, Russian Federation
Olga Mikerina, MD
Saint Petersburg , 19525, Russian Federation
Alliance Biomedical Group
Saint Petersburg , 94356, Russian Federation
Clinic of Skin and Venereal Diseases of the Saratov State Medical University
Saratov , 41002, Russian Federation
DOST - Dermatovenerologicke oddelenie sanatorneho typu
Svidník , 089 0, Slovakia
Panorama Medical Centre, Room 136
Panorama Cape Town, 7500, South Africa
Medicross Pretoria West 1st Floor
Pretoria West Pretoria, 0183, South Africa
Zubar Fazal Ahmed Vawda. MD
Durban , 4091, South Africa
The Park, Room 201, 2nd Floor
Pinelands , 7405, South Africa
Synopsis Research cc
Rondebosch , 7700, South Africa
Synexus Heiderberg Clinical Research Centre
Somerset West , 7130, South Africa
Clinical Projects Research SA (PTY) Ltd.
Worcester , 6850, South Africa
Medical Center Private Enterprise "Dzerkalo"
Dnipropetrovs'k , 49044, Ukraine
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
Municipal Healthcare Institution "Kharkiv City Dermatovenereological Dispensary #2
Kharkiv , 61038, Ukraine
Khmel'nytskyy Regional Dermatovenereological Dispensary
Khmel'nyts'kyy , 29009, Ukraine
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
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
Odesa National Medical University, Department of Dermatic and Venereologic Diseases based on Odesa Regional Dermatovenereological Dispensary
Odesa , 65006, Ukraine
Municipal Institution "Rivne Regional Dermatology and Venereology Dispensary" of Rivne Regional Council
Rivne , 33028, Ukraine
Municipal Institution of Ternopil Regional Council Ternopil Regional Clinical Dermatovenereological Dispensary
Ternopil' , 46006, Ukraine
Diagnostic and Treatment Dermatology and Gynecology Center
Uzhhorod , 88000, Ukraine
Municipal Institution "Zaporizhzhya Regional Dermatology and Venereology Clinical Dispensary" of Zaporizhzhya Regional Council
Zaporizhzhya , 69063, Ukraine

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

545

Study ID:

NCT02489227

Recruitment Status:

Completed

Sponsor:


Coherus Biosciences, Inc.

How clear is this clinincal trial information?

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